mock 510(k) for UCSC Extension Regulatory Submissions Devices and Diagnostics 19315_012

Sunnyvale Surgical, Inc.
123 Easy Street
Sunnyvale, CA 94041
800-220-1570
Date March 28, 2013
Food and Drug Administration
Center for Devices and Radiological Health
Document Mail Center – WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Attention: Document Control Clerk
RE: Traditional Premarket Notification, CLARITY Aneurysm Clip
Dear Sir or Madam:
In accordance with section 510(k) of the Food, Drug and Cosmetic Act as amended by the Medical
Device Amendment of 1976 and the Safe Medical Devices Act of 1990, this submission is to inform
you that Sunnyvale Surgical, Inc. intends to manufacture and market a medical device known as the
CLARITY Aneurysm Clip.
The information contained in this notification and our intent to market this device is considered
confidential commercial information and we request that the FDA consider it as such. The company
has taken reasonable precautions to protect this confidentiality.
No Premarket Approval application is pending for this same device. Clinical studies are not included
with this submission.
The attached CD contains an eCopy which is an exact duplicate of the paper copy of this submission.
All correspondence for this submission should be directed to Joanne Pelaschier, Director QA/RA, at the
above address. Alternatively, you can email me at Joanne.Pelaschier@sunnsurg.com or phone at 800
220 1570.
Thank you in advance for your review of this submission.
Sincerely,
Joanne Pelaschier
Director QA/RA

Section 1: User Fee Form...........................................................................................................................3
Section 2: CDRH Premarket Review Submission Cover Sheet ................................................................4
Section 3: Traditional (or Abbreviated) 510(k) Notification Cover Letter ................................................9
Section 4: Indications for Use Statement.................................................................................................11
Section 5: 510(k) Summary .....................................................................................................................12
Section 6: Truthful and Accuracy Statement............................................................................................14
Section 7: Class III Summary and Certification ......................................................................................15
Section 8: Financial Certification or Disclosure Statement .....................................................................16
Section 9: Declarations of Conformity and Summary Reports................................................................17
Section 10: Executive Summary..............................................................................................................18
Section 11: Device Description................................................................................................................21
Section 12: Substantial Equivalence Discussion .....................................................................................27
A. Tabular Comparison to Predicate Device ................................................................................ 27
B. Textual Comparison to Predicate Device...................................................................................31
C. 510(k) Flowchart Comparison to Predicate Device ..................................................................33
D. Summary of Supporting Data....................................................................................................35
Section 13: Proposed Draft Labeling.......................................................................................................36
Section 14: Sterilization and Shelf Life ...................................................................................................45
Section 15: Biocompatibility ...................................................................................................................48
Section 16: Software................................................................................................................................50
Section 17: Electromagnetic Compatibility and Electrical Safety...........................................................56
Section 18: Performance Testing - Bench................................................................................................57
Section 19: Performance Testing - Animal ..............................................................................................69
Section 20: Performance Testing - Clinical .............................................................................................71
Section 21: Design Control Activities (Special 510(k) only) ..................................................................72
Tab 2: Predicate 510k Summaries............................................................................................................73
Tab 3: Standards Certification Forms (3654)...........................................................................................79
Tab 4: Biocompatibility Reports..............................................................................................................80
Tab 5: Design Verification Reports (if necessary) ...................................................................................81
Tab 6: Software Support Documentation (if necessary) ..........................................................................82
Tab 7: IFU & Labeling (if not included in section 13 of 510k ................................................................83
Tab 8: References (if necessary) ..............................................................................................................84

CONFIDENTIAL Page 3 of 84
Section 1: User Fee Form

Section 2: CDRH Premarket Review Submission Cover Sheet

Section 3: Traditional (or Abbreviated) 510(k) Notification Cover Letter
Device Information: Category Comments
Date of Submission March 28, 2013
Device Common Name: Aneurysm Clip
Sponsor / Submitter: Sunnyvale Surgical
123 Easy Street
Sunnyvale, CA 94101
Tel: 800-220-1570
Correspondent Contact Information: Joanne Pelaschier
Sunnyvale Surgical
123 Easy Street
Sunnyvale, CA 94101
Tel: 800-220-1570
Fax: 800-220-1571
Confidentiality Preference The information contained in this notification and our
intent to market this device is considered confidential
commercial information and we request that the FDA
consider it as such (per 21 CFR 807.95). The
company has taken reasonable precautions to protect
this confidentiality.
Device Classification Regulation & Name: 21 CFR 882.5200
Name from CFR 882.5200
Device Classification &
Product Code:
Class II,
HCH
Panel: Neurological
Prior FDA Document Numbers None
Device Proprietary Name: CLARITY Aneurysm Clip
Basis of submission New Device;
Kit Description None
Number of Devices in Submission, List if
more than one
One
See Design and Use table on the next page.

Design and Use table:
Question YES NO
Is the device intended for prescription use (21 CFR 801 Subpart D)? X
Is the device intended for over-the-counter use (21 CFR 807 Subpart C)? X
Does the device contain components derived from a tissue or other
biologic source?
X
Is the device provided sterile? X
Is the device intended for single use? X
Is the device a reprocessed single use device? X
If yes, does this device type require reprocessed validation data? X
Does the device contain a drug? X
Does the device contain a biologic? X
Does the device use software? X
Does the submission include clinical information? X
Is the device implanted? X

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Section 4: Indications for Use Statement
510(k) Number (if known): Unknown
Device Name: Sunnyvale Surgical CLARITY Aneurysm Clip
Indications For Use: The CLARITY Aneurysm Clip is intended for use in implantation for permanent
occlusion of cerebral aneurysms.
Prescription Use __X____ AND/OR Over-The-Counter Use _______
(Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
_______________________________________________________________
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of _____

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Section 5: 510(k) Summary
Device Information: Category Comments
Sponsor: Sunnyvale Surgical
123 Easy Street
Sunnyvale, CA 94101
Tel: 800-220-1570
Correspondent Contact Information: Joanne Pelaschier
Sunnyvale Surgical
123 Easy Street
Sunnyvale, CA 94101
Tel: 800-220-1570
Fax: 800-220-1571
Device Classification Number: From CFR 21 882.5200
Product Code:
Class II
HCH
Device Proprietary Name: CLARITY Aneurysm Clip
Predicate Device Information:
Sugita Titaniun Aneurysm Clip
Predicate Device Manufacturer: Mizuho America, Inc
Predicate Device Common Name: Aneurysm Clip
Predicate Device Premarket
Notification #
K990202
Predicate Device Classification: 21 CFR 882.5200
Predicate Device Classification &
Product Code:
Class II,
HCH
b. Date Summary Prepared
March 28, 2013
c. Description of Device
Sunnyvale Surgical CLARITY Aneurysm Clips are designed to be used as implants for isolation of
cerebral aneurysms from normal blood flow. The CLARITY Aneurysm Clips are made of injection
molded PEEK (Zeniva® polyetheretherketone). There are six different clip designs within this 510(k).
The clips consist of a single piece which has two regions, one gripped by the clip placement tool (the
shaft) and the second (the clipper) which acts to isolate the aneurysm from blood flow. The clippers act
as a pair of jaws, opening when pressure is applied by the clip placement tool and closing as the
pressure from the clip placement tool is released when the clip placement tool is withdrawn.
The CLARITY Aneurysm Clip product includes multiple clipper shape designs: straight, bent, slightly
bent, curved, and slightly curved to allow for best access to the aneurysm(s) as they present. All
CLARITY Aneurysm Clips have a tapered jaw and use rounded teeth on the jaw for additional gripping
security.

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CLARITY Aneurysm Clips are designed for permanent implantation. They are MRI safe and
transparent to MRI and CAT scans.
d. Indications for Use
The CLARITY Aneurysm Clip is intended for use in permanent implantation for occlusion of cerebral
aneurysms.
e. Comparison to Predicate Device
The Sunnyvale Surgical CLARITY Aneurysm Clip is substantially equivalent in intended use and
technology to the predicate device, Sugita Titanium Aneurysm Clip (K990202).
Both devices provide permanent occlusion of cerebral aneurysm. Both devices use a shaft and jaw
design where the pressure of the clip application tool on the shaft results in jaws opening. Both devices
are designed such that as the clip application tool is removed, pressure on the shaft is relieved and the
jaws close, thus providing force to hold the aneurysm closed.
Both devices use a tapered jaw design. The CLARITY Aneurysm Clip uses a rounded tooth jaw design
on the clipper jaws, where rounded teeth are present on the jaw for additional gripping security. The
predicate device does not employ rounded teeth on the jaw.
The devices use different materials. The Sugita Titanium Aneurysm Clip is manufactured of Elgiloy.
The Sunnyvale Surgical CLARITY Aneurysm Clip is manufactured of Zeniva® PEEK
polyetheretherketone. The Company device may be more appropriate for those patients who will
require MRI or CAT imaging as part of post surgical medical care.
The testing described below demonstrates that the differences in the devices do not raise any
unresolved issues of safety or efficacy.
Both devices are single use only. Sugita Titanium Aneurysm Clip is provided not sterile. Sunnyvale
Surgical Aneurysm Clip is provided steam sterilized.
Company concludes that the devices are substantially equivalent.
f. Summary of Supporting Data
Biocompatibility data demonstrates that the device is in compliance with ISO 10993.
Bench testing has demonstrated that the device is in compliance with ISO 9713:2009, ASTM F0252-
06e1, ASTM F2119-07, ASTM F2129-08, ASTM F2182-11a, ASTM F2213-06, and the expectations
of the medical community and the product labeling.
Animal testing demonstrated that the device can be permanently implanted with no significant effect on
behavior, EEG measurements, or seizure latency threshold.

Section 6: Truthful and Accuracy Statement
I certify that in my capacity as the President and Chief Executive Officer of Company, I believe to the
best of my knowledge, that all data and information submitted in the premarket notification are truthful
and accurate and that no material fact has been omitted.
_____________________________________________________
Signature
______________________________________________________
Typed Name
_______________________________________________________
Date
_______________________________________________________
Premarket notification (510(k)) Number

Section 7: Class III Summary and Certification
This section does not apply. This device is a Class II device.

Section 8: Financial Certification or Disclosure Statement
This section does not apply. There is no clinical study supporting this application.

Section 9: Declarations of Conformity and Summary Reports
The CLARITY Aneurysm Clip was tested to the following list of standards and found to conform to the
requirements of those standards. Devices which are equivalent to the final product to be marketed were
used for all testing.
Standard /
Version
Standard Title Status FDA Consensus
#
Self-
Declared?
Comments /
Deviations
ASTM
F2052-06e1
Standard Test Method for
Measurement of
Magnetically
Induced Displacement Force
on Medical Devices in the
Magnetic Resonance
Environment.
Met all
requirements
030 Yes No deviations
from standard
ASTM
F2119-07
Evaluation of MR Image
Artifacts from Passive
Implants
Met all
requirements
from standard
ASTM
F2129-08
Conducting Cyclic
Potentiodynamic
Polarization Measurements
to Determine the Corrosion
Susceptibility of Small
Implant Devices
Met all
requirements
17-9 Yes No deviations
from standard
ASTM
F2182-11a
Measurement of Radio
Frequency Induced Heating
On or Near Passive Implants
During Magnetic Resonance
Imaging.
Met all
requirements
from standard
ASTM
F2213-06
(Reapproved
2011)
Measurement of
Magnetically Induced
Torque on Medical Devices
in the Magnetic Resonance
Environment.
Met all
requirements
from standard
EN ISO
9713:2009
Neurosurgical implants.
Self-closing intracranial
aneurysm clips
Met all
requirements
N/a Yes No deviations
from standard

Section 10: Executive Summary
Category Comments
Sponsor: Sunnyvale Surgical, Inc.
123 Easy Street
Sunnyvale, CA 94041
800-220-1570
Correspondent Contact
Information:
Joanne Pelaschier
123 Easy Street
Sunnyvale, CA 94041
800-220-1570
Code:
Class II, HCH
Device Classification
Name:
Aneurysm Clip (21 CFR 882.5200)
Device Proprietary
Name:
CLARITYAneurysm Clip
Predicate Device Information:
Predicate Device: Sugita Titanium Aneurysm Clip
510(k) K990202
Predicate Device Manufacturers: Mizuho America, Inc.
Predicate Device Common Name: Aneurysm Clip
Predicate Device Classification
and Code:
Class II
HCH
Reference Device Information:
Reference Device: RoG™ Sports Medicine Suture Anchor
510(k) K110229
Predicate Device Manufacturers: RoG Sports Medicine, Inc.
Predicate Device Common Name: Suture Anchor
Predicate Device Classification
and Code:
Class II
MBI
Date Summary Prepared
March 28, 2013

Description of Device
Sunnyvale Surgical CLARITY Aneurysm Clips are designed to be used for the permanent occlusion of
cerebral aneurysms. The clips are intended to be used in conjunction with the manual surgical tool, the
Sunnyvale Surgical LittleJaw clip placement tool.
When a clip is picked up with the LittleJaw tool, the pressure of the tool on the clip base causes the clip
jaws to open to their maximum width. After the clip is maneuvered into place, the LittleJaw tool is
removed, releasing the pressure on the clip base. The spring within the clip contracts, causing the clip
to close, occluding blood flow to the aneurysm.
The CLARITY Aneurysm Clips are formed from Zeniva® PEEK (polyetheretherketone) with no
colorants added and are not coated with any surface coating. The clips come singly packed and sterile.
Intended Use
The CLARITY Aneurysm Clips are intended for use in implantation for permanent occlusion of
cerebral aneurysms.
Comparison to Predicate Device
The Sunnyvale Surgical CLARITY Aneurysm Clip is substantially equivalent in intended use,
technology, design and materials to the predicate device: Sugita Titanium Aneurysm Clip (K990202).
The predicate device is made of Elgilory (cobalt/nickel alloy with 17% iron included.) The CLARITY
Aneurysm Clip is manufactured out of Zeniva® PEEK (polyetheretherketone) which is not present in
the Sugita Titanium Aneurysm Clip but is substantially equivalent in intended use, technology, design
and materials to the reference device: RoG™ Sports Medicine Suture Anchor (K110229).
The predicate clip and the application clip are both intended for use in implantation for permanent
occlusion of cerebral aneurysms. The reference device and the material in the application device are
both for implantation use and are both used as permanent implants.

The Sugita Titanium Aneurysm Clip and the CLARITY Aneurysm Clip both provide closing force to
occlude the arteries which provide normal blood flow to cerebral aneurysms. Both devices provide
closing force via a pair of blades or jaws which close onto the artery. Both devices are available in a
range of blade shapes and widths to allow for an appropriate fit to a wide variety of aneurysm forms
and presentations.
The predicate device is designed to be used with a device specific surgical tool, the Sugita Aneurysm
Clip Applier. Likewise, the application device is designed to be used with a device specific surgical
tool, the Sunnyvale Surgical LittleJaw clip placement tool.
The predicate device functions by occluding blood flow to the aneurysm after clip placement. The
CLARITY Aneurysm Clip is identical in function, occluding blood flow to the aneurysm after clip
placement.
The predicate device is intended for permanent implantation. The CLARITY Aneurysm Clip is also
intended for permanent implantation.
Both the predicate and the application device are provided as single use only. The predicate device is
provided non sterile. The application device is provided sterile.
Sunnyvale Surgical, Inc concludes that the devices are substantially equivalent.
Summary of Supporting Data
Electrical safety testing demonstrates that the device is in compliance with EN 60601.
Bench testing including a simulated use protocol has demonstrated that the device is in compliance
with the medical community’s expectations, the product labeling, and the following standards and
guidelines:
ISO 9713, ASTM F2052, ASTM F2213, ASTM F218, ASTM F2119.
Animal testing using permanent intracranial implantation of the CLARITY Clip demonstrated that the
CLARITYAneurysm Clip is suitable for permanent intracranial implantation.

Section 11: Device Description
A. Description
Sunnyvale Surgical CLARITY Aneurysm Clips are designed to be used as implants for isolation of
cerebral aneurysms from normal blood flow. The CLARITY Aneurysm Clips are made of injection
molded Zeniva® PEEK (polyetheretherketone). There are six different clip designs within this 510(k).
For details of clip design, see Table 1 below.
Table 1: CLARITYAneurysm Clip part numbers and design features
Sunnyvale Surgical
part number
Design
Number
Length of
Clip (mm)
Open Clip
Width (mm)
Clip
Shape
SUNNSURG-001 1 7-10 8.0-9.0 straight
SUNNSURG-002 2 8-10 8.0-9.0 bent
SUNNSURG-003 3 10-12 8.0-10.0 slightly bent
SUNNSURG-004 4 11-13 9.0-10.0 curved
SUNNSURG-005 5 11-13 9.0-10.0 medium curved
SUNNSURG-006 6 20-40 17.0-23.0 straight
For each of these designs, the clip can be described as one single unit, the clip, which can be described
as two different regions: a region held by the tool (the shaft) and a region which clips onto the
aneurysm (the clipper). There are two identical shaft regions per clip, which are joined at the bottom by
a continuation of the shaft material (the join).
The shafts of the CLARITY Aneurysm Clips are identical for all clipper designs used. The shaft of a
CLARITY Aneurysm Clip is flat, straight, and made of the same material as the clipper. The clipper
region is on both sides of the clip and has three main descriptors: length of clip region, open width of
clip, and shape of clip. The clipper regions vary between the different designs in: length of clipper
region, maximum clipper open width, and clip shape.

The figures below shows sketches of CLARITY Aneurysm Clips with the shaft, join (spring) and
clipper regions called out.
A: CLARITY Aneurysm Clip with straight shaft, SUNNSURG-001. From this view, the join (spring)
coils are not visible.
B: CLARITY Aneurysm Clip with curved shaft, SUNNSURG-004. From this view, the join (spring)
coils are visible and one of the curved clippers can be seen.
shaft
join
clipper
shaft
join
clipper

The figures below show the clipper jaw shapes for the CLARITY Aneurysm Clip: straight, bent,
slightly bent, curved, and slightly curved.
The figure below shows a sketch of a close up of the rounded teeth on the clip surfaces. Teeth are
present on the clip surface with ten teeth per mm.
straight
bent
slightly bent
curved
slightly curved

The CLARITY Aneurysm Clips are manufactured by injection molding of Zeniva® PEEK
(polyetheretherketone). No colorants are added and no additional surface finishes are applied to the
PEEK material after injection molding. Zeniva® PEEK has a long history of use in implants and is well
established as biocompatible. This material meets ASTM F2026-07 requirements as a
polyetheretherketone (PEEK) polymer for surgical implant applications.
The injection molding process results in a fully formed clip which contains two clipper and shaft pieces
joined via a PEEK spring. Closing force for the clip is provided through action of this PEEK spring.
The CLARITY Aneurysm Clips use this spring design to provide the closing force required to occlude
blood flow to the aneurysm. The spring of the clip is compressed when pressure is applied to the clip
shaft by the surgeon's tool, the LittleJaw clip applier (see below). As the tool is released, the pressure
compressing the spring is relieved and the clip jaws will close. This spring force is sufficient to occlude
blood flow to the aneurysm.
During the design phase of the CLARITY clip, finite element analysis (FEA) was used to predict the
stresses and mechanical behavior of Zeniva® PEEK within the application. After FEA results were
found to be consistent with acceptable mechanical behavior of Zeniva® PEEK under application
conditions, clips were formed for bench testing to validate device performance.
Blade holding force is a key parameter in aneurysm clip specifications. The blade holding force for a
clip must be sufficient to occlude blood flow to the aneurysm. CLARITY Aneurysm Clips designs
include two sets of specifications for the clip blade holding force, those for Long clip designs and those
for Regular clip designs.
Long clip designs are those for which the blade length is between 21 and 40 mm. Long clip designs
have blade holding force specifications that fall within the range of 150-160 g, measured at a point one
third of the way in from the distal limit of the clip blade. Within the Long class, each individual clip
design is assigned a design specific blade holding force that falls within the Long range.
Regular clip designs are those for which the blade length is up to and including 20 mm. Regular clip
designs have blade holding force specifications that fall within the range of 135-145 g, measured at a
point one third of the way in from the distal limit of the clip blade. Within the Regular class, each
individual clip design is assigned a design specific blade holding force that falls within the Regular
range.
The CLARITY Aneurysm Clips are intended to be used in conjunction with the manual Sunnyvale
Surgical LittleJaw tool for placement.
(Note: The Sunnyvale Surgical LittleJaw tool is a Class II device subject according to 21 CFR
882.4175 and is not the subject of this submission. The LittleJaw tool is already cleared, refer to
K12345678 for further information.)
The clips come sterile and individually packaged. The CLARITY Aneurysm Clip is a sterile, single use,
non absorbable device.
The test data provided below demonstrates that the CLARITY Aneurysm Clips have the holding force
specified for their designs and that they can performs acceptably under the conditions for which they
are intended to be used.

CLARITYANEURYSM CLIP
B. Intended Use
The CLARITY Aneurysm Clips are intended for use in implantation for permanent occlusion of
cerebral aneurysms.
C. Substantial Equivalence
The Sunnyvale Surgical CLARITY Aneurysm Clip is made out of a material that is not present in the
Sugita Titanium Aneurysm Clip, PEEK (Zeniva® polyetheretherketone.) The material used in the
Sunnyvale Surgical CLARITY Aneurysm Clip is substantially equivalent in technology and materials
to another reference device: the RoGTM
Sports Medicine Suture Anchor (K110229).
The predicate aneurysm clip and the application aneurysm clip are both intended for use in
implantation for the permanent occlusion of cerebral aneurysms.
The reference device is a suture anchor. It is manufactured from PEEK (Zeniva® polyetheretherketone)
identical to the resin used in the CLARITY Aneurysm Clip. The reference device is cleared for the
following indications: soft tissue reattachment procedures in the shoulder, elbow, wrist/hand, foot/ankle
and knee. The reference device is inserted into bone and the allows the surgeon to secure a suture of
their selection to the top of the anchor. While the reference device and the submission device do
experience different loads and tensions in their use, the test data provided below demonstrates that the
CLARITYAneurysm Clip performs acceptably under the conditions for which it is intended to be used.
The Sunnyvale Surgical CLARITY Aneurysm Clip and the Sugita Titanium Aneurysm Clip both isolate
cerebral aneurysms from normal circulation. Both the Sunnyvale Surgical CLARITY Aneurysm Clip
and the Sugita Titanium Aneurysm Clip are placed across the base (or neck) of the aneurysm and
function to block the normal blood flow from entering the aneurysm.

Both devices are used with clip applying tools: the Sunnyvale Surgical CLARITY Aneurysm Clip is
used with the Sunnyvale Surgical LittleJaw tool and the Sugita Titanium Aneurysm Clip is used with
the Sugita Clip Applying Forceps.
Both devices are used during surgery. In surgeries using either the Sunnyvale Surgical CLARITY
Aneurysm Clip or the Sugita Titanium Aneurysm Clip, the patient is placed under general anesthesia
and a craniotomy (opening of the skull) performed. After the aneurysm is located, the clip is moved
into position with the application tool. Both the Sunnyvale Surgical CLARITY Aneurysm Clip and the
Sugita Surgical Aneurysm Clip are brought into place with the jaws of the clip held in an open position
by their application tool. As the clip is released from the tool, the jaws close, applying pressure to the
neck of the aneurysm and cutting off blood flow.
Both the predicate device and the Sunnyvale Surgical CLARITY Aneurysm Clip use a jawed tooth
design to minimize clamp slippage after placement. The Sunnyvale Surgical CLARITY Aneurysm Clip
employs a “soft jaw” design, with a different number of teeth and a different tooth shape.
Both the predicate device and the Sunnyvale Surgical CLARITY Aneurysm Clip are single use devices
The predicate device has the lot number engraved on each clip for tracking purposes. The Sunnyvale
Surgical CLARITY Aneurysm Clip has production lot numbers laser etched onto each clip for tracking
purposes.
The predicate device is not provided sterile. It can be placed into a storage/sterilization tray for
sterilization at the hospital, in order to allow physicians to assemble the necessary collection of clip
lengths and shapes. The Sunnyvale Surgical CLARITYAneurysm Clip is provided sterile.
Both devices are intended for permanent implantation.

Section 12: Substantial Equivalence Discussion
A. Tabular Comparison to Predicate Device
Characteristic Predicate: Device Name
Sugita Titanium Aneurysm Clip
(K990202)
CLARITYAneurysm Clip Comparison
Indications for
Use
The Sugita Titanium Aneurysm Clips
are intended for use in implantation
for permanent occlusion of cerebral
aneurysms.
The CLARITY Aneurysm Clip is
intended for use in implantation for
permanent occlusion of cerebral
aneurysms.
Identical
Principal
Operator
Surgeon Surgeon Identical
Use Location Operating room Operating room Identical
Design
Clips are provided individually
packaged.
Clips are provided individually
packaged.
Identical
Clips are provided not sterile. Clips are provided sterile. Different
Clip designs provided in Long shaft
length (length from 21 to 40 mm)
Clip designs provided in Long shaft
length (length from 21 to 40 mm)
Identical
Clip designs provided in Regular shaft
length (up to and including 20 mm)
Clip designs provided in Regular shaft
length (up to and including 20 mm)
Identical

(K990202)
Design
Clip designs provided with range of
jaw shapes including: straight, bent,
curved, slightly bent, slightly curved
Clip provided with straight jaw Identical
Clip provided with fenestrated jaw. Not provided with fenestrated jaw Identical
Clip provided with bayonet jaw Not provided with bayonet jaw Identical
Clip jaws shape is pyramidal, tapering
from proximal to distal end
Clip jaws shape is pyramidal, tapering
from proximal to distal end
Identical
Clip jaws are smooth, without any
toothing included in their pyramidal
surface
Clip jaws have rounded teeth included
in their pyramidal surface
Different
Materials (body
contacting)
Elgiloy (cobalt/nickel alloy with 17%
iron included).
Zeniva® PEEK
(polyetheretherketone)
with no added colorants.
Clinically equivalent, both are
intended to be used as implant
materials
Clamp
mechanism
Crossed leg clamp with pre loaded
spring providing closing force.
Crossed leg clamps with pre loaded
spring providing closing force.
Identical

(K990202)
Clamp closing
force
Clips are classified into long and
regular length, based on blade length.
Regular length clips (blade length up
to 20 mm): 110-150 g, precise values
specified for each clip within the
class.
Long length clips (blade length
between 20 and 40 mm): 150-200 g,
precise values specified for each clip
within the class.
Clips are classified into long and
regular length, based on blade length.
Regular length clips (blade length up
to 20 mm): 105-145 g, precise values
specified for each clip within the class.
Long length clips (blade length
between 20 and 40 mm): 145-195 g,
precise values specified for each clip
within the class.
Equivalent – closing force ranges are
not identical but cover a similar range
for each design class
Single Use? Single patient use Single patient use Identical
MRI
compatible
Safety compatible with MRI scans.
May cause imaging artifacts.
Safety compatible with MRI scans.
Does not cause imaging artifacts under
conditions tested. Refer to testing
results.
Identical in safety compatibility with
MRI scans.
Sterilization
Steam sterilization suggested.
Steam sterilization protocol validated.
Performance characteristics tested
after steam sterilization protocol.
Steam sterilization suggested.
Steam sterilization protocol validated.
Performance characteristics tested
after steam sterilization protocol.
Identical
How provided
Single clip, packaged in a heat
resistant silicone sponge.
Sterile, packaged in a tray with
wrapper
Identical
Technology
Enables clinicians to occlude
aneurysms from normal blood flow.
Enables clinicians to occlude
aneurysms from normal blood flow.
Identical

(K990202)
Technology
Clips suitable for use with aneurysms
having necks 4 mm or wider.
having necks 4 mm or wider
Identical
with distinct necks. Not suitable for
use with aneurysm without distinct
neck (where ratio of aneurysm bulge
to neck circumference is < 3).
with distinct necks. Not suitable for
use with aneurysm without distinct
neck (where ratio of aneurysm bulge to
neck circumference is < 3).
Identical
The clip occludes blood flow to the
aneurysm, preventing further growth
of the aneurysm or bleeding from the
weakened arterial wall. Subsequent to
occlusion, the aneurysm decays
The clip occludes blood flow to the
aneurysm, preventing further growth
of the aneurysm or bleeding from the
weakened arterial wall. Subsequent to
occlusion, the aneurysm decays.
Identical

B. Textual Comparison to Predicate Device
Comparison to Predicate Device
Intended use
The predicate aneurysm clip and the application aneurysm clip are both intended for use in
implantation for permanent occlusion of cerebral aneurysms.
Technology (usage)
Both the predicate device and the application device are used during surgery for occlusion of
aneurysms.
Both devices are used with an application tool that applies force to the clip shaft, opening the jaws of
the clip.
Both devices are positioned at the neck of the aneurysm after which their positioning tool is released,
removing the pressure which held the clip open.
Both devices are for use with aneurysms with distinct necks.
Both devices are not suitable for use with aneurysms without distinct necks, where the ratio of
aneurysm bulge to neck circumference is < 3.
Both devices are suitable for use only for aneurysms with necks 4 mm or wider.
Technology (design)
The predicate aneurysm clip and the application aneurysm clip are both designed with two distinct
regions: a region that is gripped by the relevant clip applying tool (the shaft) and a region that is held
open and then allowed to close upon the aneurysm (the jaws).
Both devices provides closing force through a cross legged design built around a spring which is
compressed when the applying tool holds the shaft of the clamp.
Both devices use clip jaws with a pyramidal shape, tapering from the proximal to distal ends.
The predicate device uses a smooth clip jaw with no toothing in the design. The application device has
rounded teeth included in the pyramidal jaw surfaces.
Both the predicate and the application clip are provided in a range of shapes including straight, angled,
curved, and slight curved.

Both devices are provided in two different clip length ranges, Long and Regular. Both devices have
clip closing force ranges for the Long and Regular clip designs.
Both devices further specify a design specific clip closing force specification for each clip design
within either the Long or Regular clip length range.
Technology (materials)
The predicate device is manufactured out of Elgilory (cobalt/nickel alloy with 17% iron included.)
The application device is manufactured out of PEEK (Zeniva® polyetherketone) Zeniva® PEEK has a
long history of use in implants, such as the reference device RoG Sports Medicine Suture Anchor
(K110229). The technology and materials used to prepare the Zeniva® PEEK resin are identical for
both the CLARITY Aneurysm Clip and the reference device RoG Sports Medicine Suture Anchor, refer
to attached manufacturer's Master File.
The reference device material and the material in the CLARITY Aneurysm Clip are both for permanent
implantation and are biocompatible per ISO 10993.
Finite Element Analysis (FEA) demonstrated that Zeniva® PEEK could perform acceptably under
application conditions, yielding sufficient clip closing force for the intended use. Bench testing and
animal studies were consistent with this.
Technology (packaging and sterilization)
Both devices are packaged individually. Both devices are packaged with a tear off label for attaching to
patient charts.
The predicate device is provided non-sterile. The application device is provided sterile, steam
sterilization is used.
Conclusion

C. 510(k) Flowchart Comparison to Predicate Device
Is the predicate device legally marketed?
YES.
The predicate device was cleared under premarket notification K990202.
Do the devices have the same intended use?
YES.
The intended uses are identical, as evidenced by the similarity of the indications for use. There
are no differences in the indications for use.
Do the devices have the same technological characteristics?
NO.
Both of these devices are designed to occlude cerebral aneurysms from normal blood flow by
clamping off the neck of the aneurysm. Both devices are designed with jaws that are held in the open
configuration when the device is held within the device application tool. Both devices are designed
such that the jaws close when the application tool is released, applying sufficient force to close off the
blood vessel supplying the aneurysm.
They differ in that the predicate is machined out of Elgiloy (cobalt/nickel alloy with 17% iron
included) and the application device is injection molded out of Zeniva® PEEK (polyetheretherketone).
The predicate is electropolished for optimal surface smoothness (to decrease potential corrosion and to
lower the risk of serving as a scaffold for biofilm formation).
The predicate device has a surface coating for identification as a permanent aneurysm clamp. It
is coated with a blue coloring. The application device is not coated with any surface coating. The
application device is manufactured out of Zeniva® PEEK with no colorants added.
Do the devices raise different questions of safety or effectiveness?
NO.
The devices have the same intended use. The devices are intended for the same patient cohort.
The differences in technology do not raise different questions of safety and efficacy because the test
data provided below demonstrates that the essential performance characteristics of the devices are
identical.
Are the testing methods acceptable?
YES.
Accepted standards are used and accepted testing methodologies are employed (refer to list in

Section 9: Declarations of Conformity and Summary Reports). See sections 18 through 20 for
supporting evidence.
Do the data demonstrate equivalence and support the indications?
YES.
All mechanical testing (e.g., clamp force testing, clamp reliability testing), biocompatibility,
electrical safety testing, magnetic susceptibility testing, functional testing, and animal data demonstrate
that the CLARITYAneurysm Clip is adequate for its intended use, as is the predicate system.
CONCLUSION: SUBSTANTIALLY EQUIVALENT DECISION

D. Summary of Supporting Data
Material compatibility: Zeniva® PEEK is compliant with ASTM F2026-10, Standard Specification for
Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications. Refer to manufacturer's
Master File, Appendix N.
Electrical safety testing demonstrates that the device is in compliance with EN 60601.
Bench testing including a simulated use protocol has demonstrated that the device is in compliance
with the medical community’s expectations, the product labeling, and the following standards and
guidelines:
ISO 9713, ASTM F2052, ASTM F2213, ASTM F218, ASTM F2119.
Animal testing using permanent intracranial implantation of the CLARITY Clip demonstrated that the
CLARITYAneurysm Clip is suitable for permanent intracranial implantation.

Section 13: Proposed Draft Labeling
Instructions for Use:
CLARITYANEURYSM CLIP (US Patent No. 123456; Additional Patents Pending )
Catalog Numbers: SUNNSURG-001, SUNNSURG-002, SUNNSURG-003, SUNNSURG-004,
SUNNSURG-005, SUNNSURG-006,
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
Carefully read all instructions prior to use. Observe all contraindications, warnings and precautions
noted in these directions. Failure to do so may result in patient complications.
Read and observe the instructions for use and keep them in a safe place. The product may only be used
for its intended application, see intended use.
Contact information: Sunnyvale Surgical
123 Easy Street
Sunnyvale, CA 94041
800-220-1570 (24 hour contact line)
Instructions for use:

Device Description:
 Sunnyvale Surgical CLARITY Aneurysm Clips are individually packaged and provided sterile
in double sterile packaging including instructions for use and labels. Each clip package is
labeled with the part number, part name, lot number and clip nominal closing force. The
instructions below are common to all CLARITY ANEURYSM CLIP part numbers listed above.
Refer to each clip package label for expiration date.
 Sunnyvale Surgical CLARITY Aneurysm Clips manufactured out of Zeniva® PEEK
(polyetheretherketone) by injection molding. The CLARITY Aneurysm Clips are for use by
surgeons in surgery to treat aneurysms.
Indications for Use:
 The Sugita Titanium Aneurysm Clips are intended for use in implantation for permanent
occlusion of cerebral aneurysms.
 Contraindications: None
DANGER
The application of aneurysm clips involves the following severe risks:
Shifting or breakage of the aneurysm clip
Yawing of the jaw parts
Rupture of the aneurysm due to puncture
Incomplete contact of the clip jaws on the aneurysm neck
Cerebrovascular spasm
Sudden death.
For large aneurysms - reduction of the blood vessel cross-section close to the edge of the blood
vessel with consequential impeded circulation in the region affected.
In addition, as in any surgery, infections of the operation wound and general surgical complications
are also possible risks.

DANGER
Sunnyvale Surgical CLARITY aneurysm clips are manufactured from Zeniva® PEEK
(polyetheretherketone) and are not ferromagnetic. They are safe for MRI and CAT scans. However,
patients who have previously been clipped with other aneurysm clips may be at risk for interactions
between the clip and the magnetic field of the scanner.
Sunnyvale Surgical recommends that all patients with a history of aneurysm in need of MRI or
CAT scan undergo an X-ray to determine the number of clips and or/coils present. If aneurysm clips
or coils are present, the patient's medical records should be examined to determine if the identity
(and MRI/CAT scan compatibility can be confirmed. If the identity and MRI/CAT scan
compatibility can not be confirmed for every clip and coil present, the hospital should perform a
risk/benefit review and assessment and obtain patient consent prior to any further actions.
DANGER
Sunnyvale Surgical CLARITY Aneurysm Clips are designed for single use only. If clips exceed
their expiration date but are not otherwise compromised, they must be considered no longer sterile
and must be sterilized prior to use. Use a validated sterilization protocol for clip sterilization.
Reuse, reprocessing or re-sterilization may create a risk of contamination of the device and/or cause
patient infection or cross-infection, including, but not limited to, the transmission of infectious
disease(s) from one patient to another. Contamination of the device may lead to injury, illness or
death of the patient. Any aneurysm clip that has come in contact with a patient's blood or bodily
fluid should not, under any circumstances, be cleaned, re-sterilized or in any other way prepared for
use in another patient. Any aneurysm clip that has come into contact with any patient’s blood or
bodily fluids and which is not implanted should be disposed of in accord with local regulations.
CAUTION
To exclude damage, inaccurate functioning or incorrect clip closing force always apply each
Sunnyvale Surgical CLARITY Aneurysm Clip with the LittleJaw tool. If clip removal or
repositioning is required, remove each Sunnyvale Surgical CLARITY Aneurysm Clip with the
appropriate forceps, the BackOut forceps.
Never use the aneurysm clips with appliers or removal forceps from other manufacturers.
Sunnyvale Surgical CLARITY Aneurysm Clips are manufactured from PEEK and must be used
with the Sunnyvale Surgical tools. The LittleJaw tool has a specially lined clip holding area to
protect the clip from scratching or other damage.
For further information on suitable appliers and removal forceps, please contact Sunnyvale Surgical.

Instructions for use:
Inspection -
 Upon receipt, inspect each aneurysm clip package. Carefully inspect the package prior to use
for any breach of the sterile barrier or damage to the contents. If the sterile barrier integrity is
compromised (open, torn, perforated or otherwise damaged), DO NOT USE and contact your
Sunnyvale Surgical representative
NOTE - Each permanent aneurysm clips package contains additional labels showing the Sunnyvale
Surgical part number and the production lot number of the clip. To facilitate the subsequent
radiological examination, the patient’s file (for the hospital) and the patient ID (see below) should
be marked with these labels.
Storage -
 Store Sunnyvale Surgical CLARITY Aneurysm Clips in their sterile packaging in a dry and dust
free area protected from chemical fumes and extreme air or temperature fluctuations.
Pre use inspection –
 If the sterility of the aneurysm clip has “expired” (use-by date)”, the aneurysm clip must be
regarded as unsterile. It must be sterilized according to the instructions given in the sections on
cleaning and sterilizing.
 Open the clip packaging inside a sterile field and examine the clip prior to use. Sunnyvale
Surgical CLARITY permanent aneurysm clips are clear in color and etched with their
production lot code. Check that the clip lot number on the package and clip lot number etched
onto the clip are identical. If the lot numbers do not match, DO NOT USE. Contact your
Sunnyvale Surgical representative.
 Inspect the clip. Any clip found with one or more of the following characteristics should not be
used:
Signs of damage
Incorrect jaw position
Bent components
Changed closing force
Misalignment
 Prior to each use, inspect the LittleJaw tool and BackOut forceps for damage. If the LittleJaw
tool or BackOut forceps appears to be loose, bent, broken, cracked, worn, or fractured DO NOT
USE. Set them aside and contact your Sunnyvale Surgical representative.

Clip placement tools -
 The Sunnyvale Surgical LittleJaw tool and Sunnyvale Surgical BackOut forceps must be used
for applying and removing the CLARITY Aneurysm Clips.
 The Sunnyvale Surgical CLARITY Aneurysm Clip must never be used with appliers or removal
forceps from any other manufacturers. The LittleJaw tool and BackOut forceps have a specially
lined clip holding area to protect the Sunnyvale Surgical CLARITY Aneurysm Clips from
scratching or other damage.
Procedure prior to clip placement -
 Examine the region for each aneurysm to be clipped to determine whether there are other clips
in place already and how these will affect positioning of the clips to be placed.
 Examine the aneurysm itself and confirm that the neck to aneurysm ratio is within a factor of
three or greater. If the aneurysm has a neck to sack ratio of less than three, DO NOT USE the
Sunnyvale Surgical CLARITY Aneurysm Clip. The Sunnyvale Surgical CLARITY Aneurysm
Clips are not for use with aneurysms with neck to sack ratios of less than three.
 Access the aneurysm and obtain vascular control upstream of the desired clip position. After
confirmation of vascular control, determine of the appropriate clip shape for use.
Picking up clips –
CAUTION
Never open an aneurysm clip with your fingers. Avoid manual and/or mechanical manipulation of
the aneurysm clip. Excessive, rough or repeated handling, especially opening and closing can
change closing force and impair clinical effectiveness.
 Pick up the CLARITY Aneurysm Clip using the Sunnyvale Surgical LittleJaw tool. The clip
jaws will open as pressure is applied to the clip base through the LittleJaw tool. Use a steady
and smooth manual pressure to grasp the clip base.
 When picking up the aneurysm clips, carefully pick up the whole aneurysm clip with the jaw
piece of the Sunnyvale Surgical LittleJaw tool.

CAUTION
If an aneurysm clip appears changed or shows signs of damage, e.g. incorrect jaw position, bent
parts or changed closing force, DO NOT USE and contact your Sunnyvale Surgical representative.
After picking up the aneurysm clip with the LittleJaw tool, observe the opening of the clip jaws. If
the clip jaws do not open to the full width, DO NOT USE and contact your Sunnyvale Surgical
representative.
 These directions for use must also be observed when using the removal forceps.
Clip placement -
 Maneuver the LittleJaw tool into position near the neck of the aneurysm and close to the blood
vessel. Align the blades of the clip with the aneurysm. Slowly and smoothly release the grip of
the LittleJaw tool, allowing the clip to close. Observe the aneurysm during release of the grip of
the LittleJaw tool. Do not remove the LittleJaw tool until the clip is seated.
 Observe the position of the CLARITY Aneurysm Clip on the aneurysm. Make certain that the
clip sits on the aneurysm neck and close to the blood vessel. If there is any concern about the
clip position, use the BackOut forceps to remove and replace the clip. Sunnyvale Surgical does
not recommend more than two placement attempts per clip.
 If additional clips are needed to control an aneurysm, additional clips may be placed at this
time. If aneurysms are found which are not candidates for clipping, this must be noted and a
further treatment plan developed.
 Observe all clipped aneurysms for conclusive evidence of complete vascular control prior to
closing.
NOTE - if placement of the clip fails, but the LittleJaw tool is in good order and used correctly,
this may mean that the clip length or shape chosen are incorrect and that a different clip will be
successfully place.
CAUTION
To preclude the possibility of a galvanic reaction, avoid implanting permanent aneurysm clips made
of different materials and/or by different manufacturers in such a way that they touch each other.

Additional steps – label and Patient ID -
 Each permanent aneurysm clips package contains additional labels showing the Sunnyvale
Surgical part number and the production lot number of the clip. To facilitate the subsequent
radiological examination, the patient’s file (for the hospital) and the patient ID (see below)
should be marked with these labels. One label should be placed on the patient's file and the
patient ID for each clip implanted.
 The Patient ID contains important information concerning the aneurysm clip implanted and the
operation can be noted down on the patient ID. The contents of the Patient ID are:
– Patient data
– Hospital data
– Date of operation
– Name of surgeon
– Article number and individual serial number of the aneurysm clip implanted
 To facilitate postoperative radiological examination, each patient should receive a patient ID.
Additional steps – after use
 After use, dispose of product and packaging in accordance with hospital, administrative and/or
local government policy. Do not attempt to use this product before thoroughly reading the
Manual and Directions for Use. For future reference, keep these documents in a convenient,
easily accessible place.
Typical results to be expected from use of the Sunnyvale Surgical CLARITYAneurysm Clip -
Permanent occlusion of the aneurysm(s) clipped.

Cleaning and Disinfection:
WARNING
Permanent aneurysm clips that have been implanted before or been in contact with blood, tissue, or
body fluids must be set aside for disposal. They must not be sterilized or reused.
 Each aneurysm clip in its unopened original packaging has been packed and sterilized
individually and is supplied as a sterile product.
 Aneurysm clips must be regarded as unsterile if the sterile packaging is open, torn, perforated or
damaged, or if the sterility of the product has “expired” because the date of use is later than the
use-by date. If desired, sterilization can be carried out on aneurysm clips.
 Sterilization has to be carried out through a validated sterilization process. e.g. in a sterilizer
conforming to standards EN 285/ANSI/AAMI/ISO 11134-1993, ANSI/AAMI ST46-1993 and
validated according to EN 554/ISO 13683. Using a non-validated sterilization process may
result in the aneurysm clip being unsterile
 Sterilization of the device may be accomplished by steam under generally accepted hospital in-
use conditions.. Sunnyvale Surgical does not recommend the device be sterilized by "Flash" or
chemical sterilization.
 Recommended sterilization parameters are as follows:
Sterilization method – pre vacuum
Temperature – 270-275 F
Minimum exposure time (wrapped) – 5 min
Minimum exposure time (in a sterile container system) – 5 min

Section 14: Sterilization and Shelf Life
The Sunnyvale Surgical CLARITY Aneurysm Clip is provided sterile but may be sterilized at the
hospital using a validated sterilization protocol.
The Sunnyvale Surgical LittleJaw tool is provided not sterile and is designed for sterilization at the
hospital where it will be used.
The Sunnyvale Surgical CLARITY Aneurysm Clip is a designed as a single use device and is not
intended for reuse.
In the event that the Sunnyvale Surgical CLARITY Aneurysm Clip is stored for longer than its
expiration date, it must be considered no longer sterile and would need to be sterilized prior to use. In
the even that the opened clip package is placed onto a tray for an operation but the clip is not used, it
would no longer be sterile and would need to be sterilized prior to return to stock for use in any
following operation.
The Sunnyvale Surgical LittleJaw tool is designed for reuse within the hospital. Cleaning and
disinfection instructions for the Sunnyvale Surgical LittleJaw Surgical tool are not included in this
510(k) premarket notification. Rather, cleaning, disinfection, and sterilization instructions for the
Sunnyvale Surgical LittleJaw tool are provided in the labeling for the LittleJaw tool.
Listed below are the responses to the requirements set forth by the FDA memo dated December 12,
2008: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions
for Devices Labeled as Sterile.
a. Sterilization method to be used:
Gamma Radiation
Contract Sterilizer: Sterigenics International
Contact: Patrick Stewart
5900 Obata Way
Gilroy, CA 95020
Telephone: 408-848-4035
Establishment Registration Number: 3004784675
b. Description of the method to be used to validate the sterilization cycle:
Validation of the sterilization cycle will be conducted in accordance with AAMI/ANSI/ISO 11137-
1+2+3:2006, Sterilization of health care products – Radiation, and AAMI TIR33:2005 for setting
irradiation dose used.
The Vdmax method will be used for validation of the sterilization cycle. Thirty clips (ten clips each
from three prototype production lots) will be used in an initial bioburden determination to measure the
average bioburden found in the CLARITY clips. Although the clips are smooth surfaced and do not
possess any lumens or cavities in their design, both wiping and rinsing methods will be used in
conjunction to measure bioburden.
Based on the average bioburden determined, the initial verification dose will be set according to the

guidelines in AAMI TIR33:2005. Ten clips from one lot will be irradiated at the initial verification dose
and then checked for any remaining bioburden after irradiation.
Following the initial verification of the irradiation dosage, periodic dose audits will be performed
according to the guidelines in the New Products section of the Sunnyvale Surgical Master Validation
Protocol. After four passed audits and at least one year, dose audits will be shifted to the schedule for
Production Products in the Sunnyvale Surgical Master Validation Protocol.
c. A description of the packaging to maintain the device’s sterility:
Packaging and sterilization of the device meets the conditions set forth by the FDA consensus standards
for sterile devices: AAMI/ANSI/ISO 11607-1 and 2:2006, Packaging for terminally sterilized medical
devices. Packaging is designed to be compatible with the sterilization method to retain sterile integrity
of the product and avoid damage to the devices until opened.
Additionally, the entire shipping configuration will be tested to be in accordance with ASTM D4169,
Performance Testing of Shipping Containers and Systems and ASTM F88-99, Standard Test Method for
Seal Strength of Flexible Barrier Materials. Testing data is not required per guidance described above.
The devices are packaged in the following materials: Tyvek/Mylar pouch around tray containing
device.
d. If sterilization involves EO, the maximum levels of residuals of EO and ethylene chlorhydrin
that remain on the device:
The device is not sterilized with EO.
e. Sterility Assurance Level (SAL) required:
The SAL for the device will be 10-6
or better. The probability of an organism surviving a given cycle
will not be more than one out of one million.
f. Whether the product is non-pyrogenic and the method used to make that determination:
The product will not be labeled as “Nonpyrogenic.” However, Sunnyvale Surgical has demonstrated
that the surfaces of the clamp which make contact with the brain are nonpyrogenic. See Section 15.
g. Radiation Sterilization Dose:
>25kGy. Exact amount used will be set afterthe average bioburden is measured and sterilization dose
is then set according to the Vdmax method as detailed in AAMI TIR33:2005.
h. Sterilization by User:
The device is single use only. If the user needs to sterilize the device, Sunnyvale Surgical suggests use
of a validated steam sterilization protocol.

i. Expiration Date:
The expiration date for the device will be 1 years after the manufactured date based upon the product
having passed a 1 year (accelerated) shelf life study. This study will involve test sample clips from
three lots that have been sterilized with the validated irradiation dose. The study will be performed
according to the guidelines in the FDA Guidance for Industry, Shelf Life of Medical Devices (dated
April 1991).
Packaged, terminally sterilized clips will be stored under typical distribution center conditions
(humidity, air flow, and exposure to light). For acceleration, clips will be stored at 40 C, 15 degrees
above the storage temperature specified on the labeling.
At 15 degrees above room temperature, aging due to temperature related processes happens at a rate
2.41 fold greater than at room temperature. Clips will be stored at 40 C for 5 months, equivalent to an
accelerated 12 month aging. The clips within packaging will be tested for the integrity of the package
and package seal. Copies of the Storage of Shelf Life Samples and Accelerated Aging Parameters are
available upon request.
Testing of clips will include pull tests for the pouch itself and for the seal region in specific. In addition
to testing clips off the shelf, clips from storage will be placed under simulated shipping and handling
stress to determine whether shipping and handling can compromise the seal or the package itself.
Copies of the Testing Protocol and the Simulated Shipping and Handling Stresses Protocol are
available on request. The company will support the accelerated life test data with a standard life test,
and anticipates that it will validate 1 year of shelf life prior to commercialization.

Section 15: Biocompatibility
The biocompatibility of the CLARITY Aneurysm Clip was assessed by evaluating the results of the
testing recommended by ISO 10993: Biological Evaluation of Medical Devices Part 1: Evaluation and
Testing and by reviewing the medical literature for pertinent interactions with the patient contacting
materials.
In accordance with the definition of ISO 10993, the following materials of the CLARITY Aneurysm
Clip come in direct or indirect contact with the patient:
Material Body Contact Contact Duration
Zeniva® PEEK
(polyetheretherketone)
Implant Permanent
The materials listed above were subjected to at least the following biocompatibility tests listed in the
table below. The materials were tested as whole devices that had undergone all manufacturing
processes including sterilization. All testing was conducted in accordance with the pertinent parts of
ISO 10993.
Test name Methodology Result
Cytotoxicity LDH (lactate dehydrogenase)
assay
Pass
Sensitization Guinea Pig Maximization Test
(Magnusson-Kligman Method )
Pass
Irritation Intracutaneous Test Pass
Intracutaneous reactivty Intracutaneous Test Pass
Systemic toxicity (acute) Material Mediated Pyrogen Pass
Systemic toxicity (acute) Bacterial endotoxin (LDL Test) Pass
Systemic toxicity (subacute) Intraperitoneal administration
(murine)
Pass
Genotoxicity Ames test Pass
Genotoxicity Chromosomal abberation Pass
Genotoxicity Mouse micronucleus Pass
Implantation Histopathological analysis of
implant sites (murine)
Pass
Hemocompatibility Coagulation assay Pass
Hemolysis Hemolysis assay Pass
Thrombosis In vivo method (murine) Pass
The CLARITY Aneurysm Clip passed all ISO 10993 testing. Copies of the original reports can be seen
in Appendix B of Section 21.

The CLARITY Aneurysm Clip is used intracranially and is in no way load bearing. Under use, the clip
will not experience load or torque, and after placement is not at risk of snapping or breaking due to
loads or torques.
Review of the medical literature demonstrates that this material has been used in medical devices in a
similar patient contact manner for many years. Examples of such devices include the RoGTM
Sports
Medicine Suture Anchor. As a result, it can be concluded that the medical community is satisfied that the
benefits of these materials outweigh the risks of patient interactions. No additional warnings are necessary
to mitigate any interaction risks.
The materials in the CLARITY Aneurysm Clip passed all tests recommended by the international standards,
and their interaction risks, as presented in other devices and/or described in the medical literature, can be
mitigated to a point that is acceptable to the medical community.
It can be concluded that the materials in the CLARITY Aneurysm Clip do not pose a risk of negative
interaction with the patients.
The benefits of the device outweigh the biocompatibility risks of the device.

Section 16: Software
This section does not apply. This device has no software.

A: Overview

B: Level of Concern

C: Software Location

D: Software Functionality

E: Software Development and Testing

Section 17: Electromagnetic Compatibility and Electrical Safety
This section does not apply. The CLARITYAneurysm Clip does not have any electrical component.

Section 18: Performance Testing - Bench
The Sponsor has followed the recommendations for performance data outlined in applicable device-specific guidance document, special
control, and/or consensus standards listed below:
Item Product
Spec
Location
Spec name/
Description/
Test purpose
Verification Method:
Standard/Testing Method/
Audit
Acceptance Criteria
Pass/
Fail
Report
Number/
Location
Comments
1 Testing to validate
structural integrity of
clips.
Test lab, BESS MTI, Inc
performed: Microscopic
examination of all stressed,
worked, and critical areas on
sterilized and non sterile
clamps.
Absence of cracks,
voids, and other visible
defects in observed
material under 100X
and 400Xmagnification
Data
collection
only
ENG_REP_1234 Samples of clips from the first
three prototype production lots
were inspected, 1% of all
future production lots will be
inspected in this manner
clips - post
sterilization.
Vickers hardness test on
sterilized and non sterile
clamps, per ASTM E384.
No significant change
in Vickers hardness
after sterilization.
Data
collection
only
were inspected.
clips after simulated
use.
See Simulated Use and Test
Protocol below.
As in 1, but after
Simulated Use in
Simulated Use Test
Protocol performed.
Data
collection
only
were tested.
4 Measurement of
nominal clip closing
force.
Closing force measured at a
distance one third of the way
from the distal end of each jaw,
using piezoelectric crystal force
meter per ISO 9713.
The mean of clip
closing force for all
clips tested (for each
design) must be no
more than 2% different
from the nominal
closing force calculated
for that design.
Each individual clip
must have a nominal
closing force within 3%
of the mean nominal
force measured for all
the clips of its design.
Pass
Pass
were tested. All twelve clip
designs were tested and results
for all twelve clip designs
nominal closing force and
variation of individual clip
nominal closing force from the
mean are within report
ENG_REP_3465

5 Repeatability of clip
closing force.
Measure clip closing force as
described in 4. Repeat
measurement three times and
evaluate results per ISO 9713.
For each clip tested, the
mean of three
measurements shall be
within 2% of the
nominal closing force
calculated for the clip's
design.
No individual clip
closing force
measurement may be
more than 3% different
from the mean closing
force measured for that
individual clip.
Pass
Pass
were tested. All twelve clip
designs were tested and results
for all twelve clip designs
closing force repeatability are
found in ENG_REP_3465
functional
performance of clips
after simulated use.
See Simulated Use Protocol
below. After Simulated Use in
Simulated Use Test Protocol
performed, clamped tubing was
checked for leakage of
fluorescently spiked saline.
No fluorescence
detectable outside the
clamped area.
Pass ENG_REP_2345 Samples of clips from the first
were tested.
functional
below. After Simulated Use in
performed, retention of blade
alignment was tested.
Blade alignment must
be within 2% of
original alignment as
measured in Alignment
Fixture
were tested.
functional
After Simulated Us (See
Simulated Use Protocol below)
clamp closing force was
measured and compared to
closing force prior to Simulated
Use Protocol
Clip closing force will
not vary by more than
2% from the closing
force values obtained
before Simulated Use
Protocol.
were tested.
functional
below.After Simulated Use in
performed, clamps were
checked for slippage on test
tubing.
No clips may slip off
tubing during the extent
of this test.
Clips must remain
within the marked areas
where they were placed
Pass
Pass
were tested.

10 Testing to determine
whether clamps
corrode during
conditions of
simulated use.
below. After the Simulated Use
Protocol, tests per ASTM
F2129-08 for Corrosion
Susceptibility were performed.
Clips must give results
(for all parameters) at
least as good at the
reference Sugita
Titanium aneurysm clip
tested.
were tested.
11 Displacement force
on clip in MRI field
ASTM F2052 Clips must give results
reference Sugita
Titanium Aneurysm
Clip tested.
Pass ENG_REP5678 Samples of clips from the first
were tested.
CLARITY clips tested showed
95% lower displacement forces
than the reference Sugita
Titanium Aneurysm Clips
tested.
12 Induced torque on
clip in MRI field
reference Sugita
Titanium Aneurysm
Clip tested.
were tested.
95% lower induced torques
tested.
13 Induced heating on
clip in MRI field
reference Sugita
Titanium Aneurysm
Clip tested.
were tested.
99% lower induced heating
tested, below limit of detection
in test method.

14 Evaluation of image
artifacts in MRI field
reference Sugita
Titanium Aneurysm
Clip tested.
were tested.
no detectable artifacts under
any conditions tested.

TM-002: CLARITY Aneurysm Clip Simulated Use Testing
Purpose:
This test method assesses the performance characteristics of the clips after placement in a simulated use
environment.
Scope:
This testing covers the CLARITY Aneurysm Clip. The worst case design of the clips, clip design
number 5 was tested. Clip design number 5 incorporates an 11 mm clip jaw length, a 9.5 mm maximum
open clip width, and a slightly curved jaw design.
Modeling and simulation showed that of all clip designs included, clip design 5 had the greatest
calculated probability of slippage (by ten fold compared to the design with the next highest slippage
probability.) Clip design number 5 was also calculated to have the greatest potential variation in clip
closing force (by a factor of six fold compared to the design with the next highest calculated potential
variation in clip closing force.)
Equipment and Materials:
 Sunnyvale Surgical LittleJaw tool (LTLJ-5)
 ArteriortubeTM
artery testing material
(Arteriotools part number 123456, 5 mM internal diameter)
 Fixture# FX-001: Piezoelectric clip closing force test fixture
(Calibrated 2/1/13 due 4/1/13)
 Fixture# FX-002: Cranerco in line pressure monitor
 Fixture# FX-003: SuckerBlo high resolution alternating peristaltic pump
 Saline solution: Bicarbonate buffered normal saline (0.9 percent)
(BloodCo part number 12345, lot number 23456, expiry date 06/01/13)
 Colorant: SuperStrong Pink and Fluorescent Colorant
(WorldOColor part number 1234A, lot number 1234QT, expiry date 01/01/2100)
 Blood vessel fittings – custom made at Sunnyvale Surgical, see below
 Fixture FX-004: Heated temperature bath
 Fixture FX-005: Clip alignment tester fixture, custom made at Sunnyvale Surgical.
 Beakers

Sample Size:
 39 clips (13 each from three production lots) are to be used for each clip design.
 9 clips are for microscopic examination by test laboratory after simulated use protocol is
performed.
 30 clips are for functional testing by test laboratory after simulated use protocol is performed.
Test Method:
1. Each clip shall be sterilized as per the sterilization procedure before test begins. All clips should
be sterilized in the same load to minimize variation.
2. Check clip alignment with clip alignment tester, Fixture FX-005. Record results as “pass” or
“fail” on data sheet A.(Data sheet A is in the complete test report.)
3. Measure the nominal closing force for each clip using the method and piezoelectric force crystal
measurement system described in Sunnyvale Surgical TM-001. Record the nominal clip
closing force for each clip in column 1 of data sheet B.
4. Measure the closing force for each clip a total of three more times, using the method and
apparatus described in Sunnyvale Surgical TM-001. Record the clip closing forces in columns 2
through 4 of data sheet B.
5. For each clip under test, calculate the average of the three closing force measurements and
record in data sheet A. For each clip under test, calculate the percent difference between each of
the three clip closing measurements and the nominal closing force measured. Record percent
differences in data sheet A.
6. Prepare clips for simulated use – Fill test vessels with bicarbonate buffered saline and bring to
37 degrees. For each clip tested, take a 5 cm piece of Arteriortube tubing and fit a Blood Vessel
stopper fitting into one end of the tubing. Fill the clip with 666 microliters of bicarbonate
buffered saline with 0.001% colorant added.
7. Prepare clips for simulated use – Using the Sunnyvale Surgical LittleJaw tool, apply one
aneurysm clip onto each prepared piece of tubing. Take care to place each clip so that the jaws
close in the region between the two pink Clip Placement Lines on the Arteriotube tubing. After
clip is applied, wash the tubing thoroughly to remove any possible leaked or spilled saline with
colorant. Fill beyond the clipped portion of the Arteriotube tubing with bicarbonate buffered
saline. Allow some saline to spill out of the tubing to ensure no bubbles remain in tubing.

8. Apply a Blood Vessel Manifold fitting to the end of each piece of Arteriortube tubing. Connect
the Blood Vessel Manifold fittings to the manifold attachment on the SuckerBlo high resolution
alternating peristaltic pump. Make sure that the CranerCo in line pressure monitor is in place
between the mainfold and the SuckerBlo high resolution peristaltic pump. Check that the
feedback sensors from the CranerCo in line pressure monitor are connected to the SuckerBlo
inputs.
9. Set the SuckerBlo alternating peristaltic pump to a push-pull cycle of 60 cycles per minute with
pressure feedback of 300 mm Hg. Program the SuckerBlo for 31.56 million cycles. Cycling will
last one year.
10. During cycling, carefully check the test vessels for sufficient buffered saline and lack of
microbial growth or contamination. Cycling vessels should be checked at least once every day.
Any vessels which lose clips should be removed from test and the clips analyzed.
11. Leakage test: When cycling ends, remove each piece of Arteriotube tubing (with clip and
fittings) from the test vessel. Place the tube with clip and fittings into blacklight chamber and
excite at mid wavelength. Carefully rotate each clip under blacklight, looking for any evidence
of fluorescence around the clip application area or elsewhere. Photograph the region around the
clip application area from all sides and place photographs in the test data file. Note findings on
data sheet A. If any tubing shows fluorescence, it has leaked and the clip must be marked as
failed.
12. Blade alignment test: Check clip alignment with clip alignment tester, Fixture FX-005. Record
results as “pass” or “fail” on data sheet A.
13. Slipping test: Observe each clip on the tubing. Is the clip still seated between the pink lines
where it was originally placed? If yes, mark YES in data sheet A. If clip has slipped, note the
direction of the slip (toward the stopper fitting or away from it) and the degree of slip in mm.
14. Clamp closing force test: Measure the nominal closing force for each clip using the method and
apparatus described in Sunnyvale Surgical TM-001. Record the nominal clip closing force for
each clip in column 5 of data sheet B.
15. Clamp closing force calculation: Record the percent change in clamp closing force after
simulated use as measured against the nominal clamp closing force before simulated use.
Record the percent change in column 6 of data sheet B.
16. Clamp closing force evaluation: If the percent change in clamp closing force is less than 2%,
mark a PASS in column 15. If the percent change is greater than 2%, mark FAIL in column 7 of
data sheet B.
17. Corrosion susceptibility test: Corrosion susceptibility of each clip will be tested by
ReferenceLabs Inc. Carefully package each clip for shipping to ReferenceLabs Inc. The reports
for each clip tested at ReferenceLabs Inc. should be attached to the final Test Report. For each
clip which passes corrosion susceptibility testing, mark a PASS in data sheet A. For each clip
which fails, mark a FAIL in data sheet A.

18. MRI interaction test and Image Artifact test: Carefully package the clips for shipping to
Magnetolabs. Magnetolabs will test the clips for potential interaction in MRI magnetic fields as
documented in the MRI Interaction Test Protocol. Magnetolabs will test clips for potential
image artifact formation in MRI scans of test mystery material as documented in the Image
Artifact Test Protocol.
The MRI Interaction Test Report and the Image Artifact Test Report should be attached to the
final Test Report. For each clip which passes MRI interaction, mark a PASS in data sheet A. For
any clip which fails, mark a FAIL in data sheet A. For each clip which passes the Image Artifact
test, mark a PASS in data sheet A. For any clip which fails, mark a FAIL in data sheet A.

Acceptance Criteria:
1. Nominal closing force of all clips is within 2% of the value given for their clip design. For
nominal closing forces for each clip design, refer to Appendix.
2. For each clip, the average of three clip measurements will be within 2% of the nominal clip
closing force. No individual clip closing force measurement will vary from the nominal clip
closing force by more than 3%.
3. Each clip will pass the leakage test – after the Simulated Use is completed, no fluorescent
marker should be visible near the clip when viewed under black light.
4. Each clip will pass the blade alignment test after the Simulated Use is completed.
5. No clip will slip during the Simulated Use test. All clips will remain seated between the pink
lines where they were originally placed.
6. Clamp closing force after Simulated Use will not change by more than 2% of the original
nominal value.
7. Corrosion susceptibility testing – each clip will pass the Corrosion Susceptibility test per ASTM
F2129-08.
8. Magnetic susceptibility testing – each clip will pass the Magnetolabs testing for displacement
force in MRI field, induced torque in MRI field, and induced heating in MRI field. Test criteria
per the relevant standard and included in Magnetolabs report.
9. Image Artifact testing – no clip will show any image artifact with a total integrated volume of
greater than 1% of that of a Sugita Titanium Aneurysm Clip under identical test conditions
(field strength, mystery material, scan parameters).

Results:
1. 39 clips from each design were tested with the protocol above. Results and data below are for
clip design #1, production lot 1201A. (Additional results and data are included for clip design
#1, lot 1201B and 1201C in Appendix. Additional results and data for all other clip designs are
included in Appendix.)
2. All clips tested passed the blade alignment test before the Simulated Use Protocol began.
3. The nominal closing force expected for clip design #1 is 140.5 g. All clips tested were within
3% of the nominal closing force expected.
4. Repeat closing force measurements were made for 36 clips from design #1. For each clip tested,
the average of three measurements was within 2% of the nominal closing force measured for
that clip.
5. In no case did any single repeat closing force measurement for any clip vary by more than 3%
from the nominal closing force measurement for that clip.
6. All three clips sent for microscopic examination after the Simulated Use Protocol were free of
cracks, defects, or scars.
7. All clips passed the leakage test after the Simulated Use Protocol was executed
8. All clips passed the blade alignment test after the Simulated Use Protocol was executed.
9. All clips passed the slipping test after the Simulated Use Protocol was executed.
10. All clips had closing force values within 2% of the original nominal closing force value after
the Simulated Use Protocol was executed.
11. All clips passed corrosion susceptibility testing per ASTM F2129-08 after the Simulated Use
Protocol was executed.
12. All clips passed magnetic susceptibility testing in all criteria – displacement force in MRI field,
induced torque in MRI field, and induced heating in MRI field.
13. All clips passed image artifact testing. 35 clips showed no artifacts at all, one clip showed one
single artifact with a total integrated volume of 0.2% that observed with Sugita clip under
identical conditions.

Conclusion:
The CLARITY Aneurysm Clip closes with the stated nominal closing force (within a 2% tolerance)
when applied with the LittleJaw tool.
The CLARITY Aneurysm Clip is not dislodged, displaced, or misaligned during simulated use. The
CLARITY Aneurysm Clip does not become susceptible to corrosion and does not decrease in closing
force after simulated use.
The CLARITY Aneurysm Clip is MRI safe, with performance equal to or better than the Sugita
Titanium Aneurysm Clip with regard to displacement force in MRI field, induced torque in MRI field,
and induced heating in MRI field.
The CLARITY Aneurysm Clip provided low distortion on MRI scans, without artifacts. For 35 clips
tested, no artifacts were detectable under any conditions tested. One clip did show artifacts, but total
integrated volume of artifacts was 0.2% that of Sugita clip under identical conditions. CLARITY clips
performance was superior to Sugita Titanium Aneurysm Clip.

Table Four – Data sheet B for testing of CLARITY Aneurysm Clip design #1 in Simulated Use Protocol
1 2 3 4 5 6 7
Clip lot
number
Clip
number
Nominal
closing
force (g)
Closing
force (g)
1st
Closing
force (g)
2nd
Closing
force (g)
3rd
Closing
force (g)
Avg.
Avg. closing
force within
2% of nom.
Pass/Fail
change
1201A 1 140.2 140.2 140.2 140.2 n.a n.a n.a
1201A 2 140.4 140.2 140.4 140.6 n.a n.a n.a
1201A 3 140.6 140.8 140.7 140.5 n.a n.a n.a
1201A 4 140.2 140.2 140.2 140.2 140.2 Y P
1201A 5 140.6 140.8 140.7 140.5 140.8 Y P
1201A 6 140.4 140.2 140.4 140.6 140.2 Y P
1201A 7 140.6 140.8 140.7 140.5 140.5 Y P
1201A 8 140.2 140.2 140.2 140.2 140.2 Y P
1201A 9 140.2 140.8 140.6 140.8 140.3 Y P
1201A 10 140.4 140.6 140.4 140.6 140.2 Y P
1201A 11 140.7 140.8 140.7 140.5 140.8 Y P
1201A 12 140.5 140.2 140.4 140.5 140.5 Y P
1201A 13 140.2 140.5 140.3 140.2 140.4 Y P

Section 19: Performance Testing - Animal
Animal testing was performed to collect data on the suitability of the CLARITY Aneurysm Clip for
permanent implantation. The testing was performed per Protocol Animal-001. A summary of the
protocol and results follow.
In conclusion, the animal testing showed that the CLARITYAneurysm Clip is suitable for permanent
implantation. There were no significant changes in behavior in implanted animals monitored. EEG
evaluations showed no significant differences between animals implanted with the CLARITY
Aneurysm Clip and those implanted with the Sugita Titanium Aneurysm Clip.
Sunnyvale Surgical, Inc
Animal Study—001
Purpose:
The objective of the animal study is to collect data on the suitability of the CLARITY Aneurysm Clip
for permanent implantation in the brain.
Study Endpoint / Pre-defined Acceptance Criteria:
Behavior of rabbits implanted was monitored on a daily basis for nine months, three months pre
implantation and six months post implantation. No significant differences in four behaviors scored
should be seen between rabbits implanted with the CLARITY clip and rabbits implanted with the
Sugita Titanium Aneurysm Clip.
Secondary endpoints of the study were to observe EEG evaluations from rabbits implanted with the
CLARITY clip and the Sugita Titanium Aneurysm Clip and to measure seizure threshold in implanted
rabbits. Rabbits implanted with CLARITY Aneurysm Clip shall not show gross differences in EEG
evaluations when compared to rabbits implanted with Sugita Titanium Aneurysm Clips. No significant
difference in seizure thresholds should be seen.
Methods and Materials:
1. Sunnyvale Surgical commissioned a six month intracranial, non-clinical implant study of 30
rabbits, divided into three groups:
 12 rabbits were implanted with the Sunnyvale Surgical CLARITY Aneurysm Clip
 12 rabbits were implanted with the Sugita Titanium Aneurysm Clip
 6 were non implanted controls.
2. To establish a baseline, prior to implantation, all rabbits were monitored daily for three months. The
following four behaviors were monitored and scored: appetite, sleep, aggression, and curiosity.
3. To establish a baseline, prior to implantation, all rabbits underwent one EEG at the onset of the
study and one additional EEG two days before implantation.
4. To establish a baseline, prior to implantation, all rabbits underwent testing for seizure threshold
latency at the onset of the study and once more two days before implantation.

5. After three months observation, rabbits were implanted with either the Sunnyvale Surgical
CLARITY Aneurysm Clip, the Sugita Titanium clip, or underwent a sham procedure (no clip
implanted control).
6. Behavior of rabbits was monitored on a daily basis for six months. The following four behaviors
were monitored and scored: appetite, sleep, aggression, and curiosity.
7. Once each month, rabbits underwent an EEG. EEG results from each month were overlaid on the
baseline EEGs. EEGs from each month were overlaid on EEGs from all post implantation months
to analyze for negative trends.
8. Once each month, rabbits were tested to determine seizure threshold latency.
9. Study was concluded six months post implantation.
Results:
Both the rabbits implanted with the Sunnyvale Surgical CLARITY Aneurysm Clip and the rabbits
implanted with the Sugita Titanium clip showed no statistically significant changes in any of the four
behaviors monitored at any time period post implantation compared to the rabbits treated with the sham
procedure.
Both the rabbits implanted with the Sunnyvale Surgical CLARITY Aneurysm Clip and the rabbits
implanted with the Sugita Titanium clip showed no statistically significant changes in seizure threshold
latency at any time period post implantation when compared to rabbits treated with the sham procedure.
Both rabbits implanted with the Sunnyvale Surgical CLARITY Aneurysm Clip and implanted with the
Sugita Titanium clip showed no significant differences in EEGs as compared to rabbits treated with the
sham procedure at any time period post implantation.
Conclusion:
The animal testing showed that the CLARITY Aneurysm Clip is suitable for permanent implantation in
the brain.

Section 20: Performance Testing - Clinical
This section does not apply. No human testing was necessary to demonstrate substantial equivalence or
to demonstrate that the device can meet its labeling claims.
In accordance with the FDA’s Guidance, no Form 3674 “Certification of Compliance, under 42 U.S.C.
§ 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (42 U.S.C. § 282(j))” is necessary
for this premarket notification since no clinical trials were conducted to support this submission.

Section 21: Design Control Activities (Special 510(k) only)
This section does not apply. This is a traditional 510(k) submission.

Tab 2: Predicate 510k Summaries

Tab 3: Standards Certification Forms (3654)

Tab 4: Biocompatibility Reports

Tab 5: Design Verification Reports (if necessary)

Tab 6: Software Support Documentation (if necessary)

Tab 7: IFU & Labeling (if not included in section 13 of 510k)

Tab 8: References (if necessary)

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