FDA 510(k) submission - redacted

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FDA 510(k) submission - redacted

  1. 1. USER: WEEKS, SUSAN M (smw) FOLDER: K052401 - 223 pages (FOI:07004171) COMPANY: ETHICON, INC. (ETHICON) PRODUCT: MESH, SURGICAL, POLYMERIC (FTL) SUMMARY: Product: GYNECARE TVT SECUR SYSTEM DATE REQUESTED: Tue Jul 17 24:00:00 2007 DATE PRINTED: Wed Aug 22 09:15:57 2007 Note: Releasable VersionFOI - Page 1 of 223
  2. 2. 510K SUMMARY - 5 pages 1 CORRESPONDENCE - 11 pages 6 ORIGINAL - 87 pages 17 REVIEWER INFORMATION - 27 pages 104 SUPPLEMENT - 91 pages 131FOI - Page 2 of 223
  3. 3. NOV 2 8 2005 Section 5 510(k) SUMMARY Statement Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug, and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agencys final rule ".... 510(k) Summaries and 5 10(k) Statements . (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency. MODIFIED DEVICF NAME: GYNECARE TVT SECUR* System PREDICATE DEVICE NAME: GYNECARE TVT System and GYNECARE TVT Obturator System Device Description The GYNECARE TVT SECUR* device is a sterile, single patient use device, consisting of one piece of undyed or blue (Phtalocyanine blue, Color index Number 74160) PROLENE* polypropylene mesh (tape) approximately 1.1cm x 8.0cm (approximately /2 x 4 inches). The ends of the device will be sandwiched between pieces of fleece made of polyglactin 910/polydioxanone coated with polydioxanone film. The coated ends arc added to facilitate passage (stiffens the ends) and placement (tactile feel for the surgeon) of the mesh implant. Two curved, stainless steel, single use introducers are used to deliver the implant. The introducers are supplied fixed to the implant via a wire through the coated ends and inserters. TVT SECUR is designed to accommodate two surgical techniques: the "Hammock approach" and the "U approach". The GYNECARE TVT Universal System is a less invasive exit less device which will enable the physician to perform a suburethal sling procedure placing the mesh under the mid urethra without either the delivery device or the implant exiting the skin. GYNECARE TVT SECUR Svstem GYNECARE, a division of ETHICON, Inc. 000016FOI - Page 3 of 223
  4. 4. /g-o Q3qo i- Intended Use A pubourethral sling for treatment of stress urinary incontinence (SU1), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. Indications Statement GYNECARE TVT SECUR* is indicated for the treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. Technological The modified device has the same technological characteristics as Characteristics the predicate device. The form, fit, function and method of operation are similar. Performance Data Results of verification testing indicates that the product mcets the established performance requirements. Conclusion Based upon the 510(k) summaries and 510(k) statements (21 CFR 807) and the infornation provided herein, we conclude that the subject device is substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act. Contact Patricia M. Hojnoski, M.S. Senior Project Manager, Regulatory Affairs ETHICON, INC. Rt. 22 West Somerville, NJ 08876-0151 Phone: (908) 218-2893 Fax: (908) 218-2595 Date August 30, 2005 GYNECARE TVT SECUR Svstem GYNECARE, a division of I HICON, Inc. U&D.i7FOI - Page 4 of 223
  5. 5. DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard NOV 2 8 2005 Rockville MD 20850 Patricia M. Hojnoski, M.S. Senior Project Manager, Regulatory Affairs Gynecare, A Division of Ethicon, Inc. P.O. Box 151, US Route 22 West Somerville, New Jersey 08876 Re: K052401 Trade/Device Name: GYNECARE TVT SECUR* System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: October25, 2005 Received: November 17, 2005 Dear Ms. Hojnoski: We have reviewed your Section 5 10(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDAs issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Acts requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.FOI - Page 5 of 223
  6. 6. Page 2- Patricia M. Hojnoski, M.S. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industrv/support/index.html. Sincerely yours, Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health EnclosureFOI - Page 6 of 223
  7. 7. INDICATIONS FOR USE 510(k) Number (if known): Device Name: GyNECARE TVT SFFCTTR* System Indications for Use: The GYNECARE TVT SECUR* device is intended for use in women as a sub-urethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency. Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Division of General, Restorative, and Neurological Devices 510(k) Number 6S a) GYNECARE TVT SECUR System GYNECARE, a division of ETHICON. Inc.FOI - Page 7 of 223
  8. 8. DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard NOV 2 8 2005 Rockville MD 20850 Patricia M. Hojnoski, M.S. Senior Project Manager, Regulatory Affairs Gynecare, A Division of Ethicon, Inc. P.O. Box 151, US Route 22 West Somerville, New Jersey 08876 Re: K052401 Trade/Device Name: GYNECARE TVT SECUR* System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: October25, 2005 Received: November 17, 2005 Dear Ms. Hojnoski: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it maybe subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDAs issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Acts requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.FOI - Page 8 of 223
  9. 9. Page 2- Patricia M. Hojnoski, M.S. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.wv/cdrh/industrV/support/index.html. Sincerely yours, arkN. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure 2_FOI - Page 9 of 223
  10. 10. I sr~so INDICATIONS FOR USE 510(k) Number (if known): Device Name: GVNECARE TVT SECITR* Systemi Indications for Use: The GYNECARE TVT SECUR* device is intended for use in women as a sub-urethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency. Prescription Use X AND/OR Over-The-Counter Use ___ (Part 21 CFR 801 Subpart 0) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Division of General, Restorative, and Neurological Devices 510(k) Number 9 ) (GYNECARETVT SECi. It Systerm GYNECARE, a di vision of ETI-1ICON, Inc.FOI - Page 10 of 223
  11. 11. Pages 11 through 18 have been removed.
  12. 12. KogDqu TABLE OF CONTENTS GYNECARE TVT SECUR SYSTEM 510(k) Descriptinn: Page # User Fee Cover Sheet .......................................................... 1 CDRH Cover Sheet ............................................................ 4 5 10(k) Cover Letter ............................................................ 10 Indications for Use Statement ................................................. 13 510(k) Summary ................................................................. 15 Truthful and Accuracy Statement ............................................. 18 Class III Summary and Certification .......................................... 20 Financial Certification or Disclosure .......................................... 21 Declaration of Conformity and Summary Reports ........................... 22 Executive Summary .............................................................. 23 Device Description ............................................................... 25 Substantial Equivalence Discussion ............................................ 33 Proposed Labeling ................................................................ 37 Sterilization and Shelf Life ...................................................... 67 Biocompatibility .................................................................. 69 Software ............................................................................ 73 Electromagnetic Compatibility and Electrical Safety ........................ 74 Bench Testing ...................................................................... 75 Performance Testing - Animal and Human Cadaver ......................... 76 Performance Testing - Clinical .................................................. 85 Kit Certification .................................................................... 86 [7 GYNECARE TVT SECUR System GYNECARE, a division of ETHICON, Inc.FOI - Page 19 of 223
  13. 13. Section 1: Medical Device User Fee Cover Sheet (Form FDA 8601) GYNECARE TVT SECUR System GYNECARE, a division of ETHICON, Inc. 000001FOI - Page 20 of 223
  14. 14. Pages 21 and 22 have been removed.
  15. 15. Section 2: CDRH Premarket Review Submission Cover Sheet GYNECARE TVT SECUR System GYNECARE, a division of ETHICON, Inc. 000004FOI - Page 23 of 223
  16. 16. DEPARTMENT OF HEALTH AND HUMAN SERVICESFomApva FOOD AND DRUG ADMINISTRATION OMB No. 9010-0120 Expiration Date: May 31, 2007. CDRH PREMARKET REVIEW SUBMISSION COVER SHEET See OMB Statement on page 5. Date of Submission User Fee Payment IDNumber FDA Submission Document Number (if known) PMA PMA &HDE Supplement PDP S lg (k) Meeting 5 Original Submission Regular (180 day) Original POP DOriginai Submission: Pre-510(K) Meeting Premarket Report Special Notice of Completion []Traditional Pre-IDE Meeting Modular Submission Panel Track (PMA Only) Amendment to POP 5 Special Pre-PMA Meeting 5 Amendment SO-day Supplement Abbreviated (Complete Pre-PDP Meeting Report 30-day Notice section 1, PageS) Day 100 Meeting Report Amendment Supplement LI Additional informaton [135-day Agreement Meeting 5 Licensing Agreement Me Real-time Review E] Third Party Determination Meeting Amendment to PMA & Other (specify): ]Other IDE Humanitarian Device Class II Exemption Petition Evaluation of Automatic Other Submission Exemption (HDE) Class IIIDesignation 5 Original Submission EOriginal Submission Original Submission (DnS o n 513(g) Amendment Amendment Additional Information Additional Information U Other (describe submission): Report Report Amendment Have you used or cited Standards in your submission? El Yes [ No (if Yes, please complete Section I, Page 5) Company / Institution Name Establishment Registration Number (if known) Ethicon, Inc. 2210968 Division Name (if applicable) Phone Number (including area code) GYNECARE TVT SECUR System ( 908 ) 218-2893 Street Address FAX Number (including area code) P.O. Box 151; Route 22 West ( 908 ) 218-2595 City State / Province ZIP/Postal Code Country Somerville NJ 08876 USA Contact Name --------- ---- ----------- Contact Title Contact E-mail Address Sr. Project Manager ----------------------------- Company / Institution Name Division Name (if applicable) Phone Number (including area code) ( ) Street Address FAX Number (including area code) ( ) City State / Province ZIP/Postal Code Country Contact Name Contact Title Contact E-mail Address FORM FDA 3514 (6/05) PAGE 1 OF 5 PAGES St Mda Ar~ (301) 443 I BEr 000005FOI - Page 24 of 223
  17. 17. Withdrawal [] Change in design, component, or EJLocation change: Additional or Expanded Indications specification: Manufacturer 5 Request for Extension Software/Hardware Sterilizer Post-approval Study Protocol Color Additive Packager Request for Applicant Hold Material Request for Removal of Applicant Hold Specifications Request to Remove or Add Manufacturing Site Other (specify below) DReport Submission: Annual or Periodic L]Process change: Post-approval Study Manufacturing riLabeling change: Adverse Reaction Sterilization Indications Device Defect Packaging Instructions Amendment Other (specify below) Performance Shelf Life Trade Name 5 Change in Ownership Other (specify below) Change in Correspondent FDA correspondence: ]Response to Change ofApplicant Address E Other Reason (specify): 5 New Device 5 Change in: 5 Repose to FDA Letter Concerning: 5]New Indication Correspondent / Applicant Conditional Approval 5] Addition of Institution Design/Device Deemed Approved rJ Expansion / Extension of Study Informed Consent Deficient Final Report IRS Certification Manufacturer Deficient Progress Report Termination of Study Manufacturing Process Deficient Investigator Report 5Withdrawal of Application Protocol - Feasibility Disapproval 5 Unanticipated Adverse Effect Protocol - Other Request Extension of Notification of Emergency Use Sponsor 5Compassionate Use Request Request Meeting 5 Treatment IDE 5 Report submission: Request Headrng 5Continued Access Current Investigator Annual Progress Report Site Waiver Report Final 5 Other Reason (specify): 5 New Device 5 Additional or Expanded Indications []Change in Technology r.1 Other Reason (specify): Modification of existing device. FORM FDA 3514 (6/05) PAGE 2 OF 5 PAGES 000006FOI - Page 25 of 223
  18. 18. * a]eII La0iFimI* 6eW I f Sl Lio S1II[II61111111 Product codes of devices to which substantial equivalence is claimed Summary of, or statement concerning, +K974098 2 K012628 ~ ~ ~ _ _ __d ~ 31 K358safety K033568 11 1 4 and effectiveness information MV~~~~~~~~~510 (k) summary attached 5 510 (k) statement Information on devices to which substantial equivalence is claimed (if known) N3 5IOQQk Number Trade or Proprietary or Model Name Manufacturer 1K974098 GYNEGARE TVT System 1ETHICON, Inc. K012628 2 GYNECARE TVT System ETHICON, Inc. K033568 3 3GYNECARE TVT Obturator System 3 ETHICON, Inc. 4 4 4 5 ~~~~~~~~~5 5 6 ~~~~~~~~~6 6 Common or usual name or classification Class II; Mesh, Surgical, Polymeric (21 CFR 878.3300), common name: pubo-urethral sling I Trade or Proprietary or Model Name for This Device Model Number 1GYNEGARE TVT SEGUR System 2 2 3 3 4 ~~~~~~~~~~~~~~~~~~~~~~~4 5 ~~~~~~~~~~~~~~~~~~~~~~5 FDA document numbers of all pnor related submissions (regardless of outcome) 1 K974098 2 K012628 3K033568 45 6 7 81 19 10 11 1 12 Data Included in Submission Product Code C.F.R. Section (lifapplicable) Device Class * **** *~S 79FTL 21 GFR 878.3300 5l Ciass I 9Csass if Classification Panel General and Plastic Surgery Devices 5Class Ill 5Unclassified Indications (from labeling) The GYNECARE TVT SECUR* device is intended for use in women as a sub-urethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency. FORM FDA 3514 (6/05) PAGE 3 OF 5 PAGES 000007FOI - Page 26 of 223
  19. 19. FDA Document Number (if known) Note: Submission of this information does not affect the need to submit a 2891 or 2891a Device Establishment Registration form. &I ,~1[llIIj 0 re I M to].J,~[ r_, VA 1 1 letw ,Y_7 f,1[tIM. R. r e. ~ CFMI I: tII IrL,-111 IktI L0 Il 1 .1; F,11~[1[l~ :ILI S M Original FDA Establishment Registration Number [ Manufacturer [] Contract Sterilizer 5] Add [] Delete 221 0968 5 Contract Manufacturer 1] Repackager / Relabeler Company / Institution Name Establishment Registration Number Ethicon, Inc. 2210968 Division Name (if applicable) Phone Number (including area code) GYNECARE ( 908 ) 218-2893 Street Address FAX Number (including area code) P.O. Box 151; Route 22 West ( 908 ) 218-2595 City State / Province ZIP/Postal Code Country Somerville NJ 08876 USA Contact Name Contact Title Contact E-mail Address --------- ---- ----------- Sr. Project Manager ---------------------------- 7 Original [ DeleteFDA Establishment Registration Number 5 Manufacturer 5 Contract Sterilizer [] Add E[]elete Contract Manufacturer 5 Repackager / Relabeler Company / Institution Name Establishment Registration Number Division Name (if applicable) Phone Number (including area code) ( Street Address FAX Number (including area code) ( City State / Province ZIP/Postal Code Country Contact Name Contact Title Contact E-mail Address FDA Establishment Registration Number Manufacturer Contract Sterilizer [] Add n5Delete Contract Manufacturer 5 Repackager / Relabeler Company / Institution Name Establishment Registration Number Division Name (if applicable) Phone Number (including area code) ( Street Address FAX Number (including area code) City State / Province ZIP/Postal Code Country Contact Name Contact Title Contact E-mail Address FORM FDA 3514 (6/05) PAGE 4 OF 5 PAGES 000008FOI - Page 27 of 223
  20. 20. Note: Complete this section if your application or submission cites standards or includes a "Declaration of Conformity to a Recognized Standard" statement. Standards No. Standards Standards Title Version Date Organization Standards No. Standards Standards Title Version Date Organization 2 Standards No. Standards Standards Title Version Date Organization 3 Standards No. Standards Standards Title Version Date Organization 4 Standards No. Standards Standards Title Version Date Organization 5 Standards No. Standards Standards Title Version Date Organization 6 Standards No. Standards Standards Title Version Date Organization 7 Please Include any additional standards to be cited on a separate page. Public reporting burden for this collection of information is estimated to average 0.5 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing Ihis burden to: Food and Drug Administration CDRH (HFZ-342) 9200 Corporate Blvd. Rockville, MD 20850 An agency may not conductor sponsor, and a person is not requiredto respond to, a collection of information unless it displays a currently valid OMB control FORM FDA 3514 (6/05) PAGE 5 OF 5 PAGES 000009FOI - Page 28 of 223
  21. 21. Section 3: 510(k) Cover Letter GYNECARE TVT SECUR System GYNECARE, a division of ETHICON, Inc.FOI - Page 29 of 223
  22. 22. Gynecaret A :vso;of ETH]CW , I~ P.O. Box 151 US Route 22 West Somerville, NJ 08876 August 30, 2005 Food and Drug Administration RE: 5 10(k) Notification: Center for Devices and Radiological Health (HFZ-401) GYNECARE TV? Office of Device Evaluation SECUR* System 9200 Corporate Blvd. Rockville, MD 20850 ATTENTION: Document Mail Clerk To Whom It May Concern: Modified Device GYNECARE, a Division of ETHICON, Inc. submits this Notification of Intent to market a modification to the GYNECARE Tension-free Vaginal Tape (TVT) System as described within this Traditional 5 10(k) Device Modification Premarket Notification (21 CFR 807.90(e)). The common name for this device is: pubo-urethral sling. The currently marketed GYNECARE TVT System was cleared by the FDA under: K033568, K012628, and K974098. The modified device is referred to as the GYNECARE TVT SECUR* System. This 510(k) submission has been formatted in accordance with the following Guidance Document: "Format for Traditional and Abbreviated 510(k)s" issued on August 12, 2005. The modifications to the existing device are as follows: - The GYNECARE TVT Universal System is less invasive exit less device that will enable the physician to perform a suburethal sling procedure placing the mesh under the mid urethra without either the GYNECARE TVT SECUR System GYNECARE, a division of ETHICON, Inc. L_ 0000o0FOI - Page 30 of 223
  23. 23. delivery device or the implant exiting the skin. The currently marketed TVT device exits through the abdomen or through the thigh. In addition, for TVT SECUR, the delivering device and mesh will have the flexibility to be placed in either a "U" or "Hammock" direction. Both approaches are similar to existing validated techniques; however, the modified device offers a less invasive approach. The "Hammock" approach affixes into the intemis muscle or into the internis muscle and membrane. The "U" approach affixes into the lower edge of the pubic synthesis in the connective tissue of the endopelvic fascia. The placement will depend on surgeon preference and individual requirements of the patient. The placement of the mesh (midurethra) remains unchanged. - The ends of the mesh will be sandwiched between layers of absorbable material made from polyglactin --- -- polydioxanone fleece material coated with polydioxanone film. The ------ d ends are added to facilitate passage (stiffens the ends) and placement (tactile feel for the surgeon) of the mesh implant, but are then absorbed leaving the ends ingrown into tissue. Two curved, stainless steel, single use introducers are used to deliver the implant. The introducers are supplied fixed to the implant via a wire through the coated ends and inserters. The GYNECARE TVT SECUR System does not change the intended use or the application of the TVT tape. Substantial A discussion of our substantial equivalence conclusion is enclosed Equivalence with this Notification. The conclusion is formatted in accordance with 21 CFR 807.81(a)(3) and the FDA guidance document entitled, "Deciding When to Submit a 510(k) for a Change to an Existing Device". This discussion format is convenient to use as a summary of substantial equivalence to anyone requesting it from the agency. Design and Per the recommendation in the Guidance Document: "Format for Use of the Device Traditional and Abbreviated 510(k)s" the following table is being provided: GYNECARE TVT SECUR System GYNECARE, a division of ETHICON, Inc. 000011FOI - Page 31 of 223
  24. 24. Question Yes No Is the device intended for prescription use (21 CFR 801 Subpart X D)? Is the device intended for over-the-counter use (21 CFR 807 X Subpart C)? Does the device contain components derived from a tissue or other X biologic source? Is the device provided sterile? X Is the device intended for single use? X Is the device a reprocessed single use device? 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 Summary of Safety Included in this 510(k) Device Modification Notification is Effectiveness a Summary of Safety and Effectiveness. Confidentiality In accordance with the Premarket Notification Procedures regarding Confidentiality of Information (21 CFR 807.95), ETHICON, Inc. wishes to certify to the Food and Drug Administration that it has complied with all parts of that section, and considers the content of the submission and its intention to market this device as confidential commercial information. User Fee A copy of the Medical Device User Fee Cover Sheet is appended to this letter. Theuser fee check hasbeen sent to theFDA under separate cover. Contact Please contact the undersigned at (908) 218-2893 or by fax at (908) 218- 2595 for any questions regarding this notification. Sincerely, Paicia M. Hojnoski, M.S. Senior Project Manager Regulatory Affairs GYNECARE, A Division of ETHICON, INC. Submitted in Duplicate *trademark GYNECARE TVT SECUR System GYNECARE, a division of ETHICON, Inc. /A 000012FOI - Page 32 of 223
  25. 25. Section 4: Indications for Use Statement 000013 GYNECARE TVT SECUR System GYNECARE, a division of ETHICON, Inc. AY,)FOI - Page 33 of 223
  26. 26. INDICATIONS FOR USE 510(k) Number (if known): Device Name: GYNECARE TVT SECTJR* System Indications for Use: The GYNECARE TVT SECUR* device is intended for use in women as a sub-urethral sling for the treatment of stress urinary incontinence (SUL) resulting from urethral hypermobility and/or intrinsic sphincter deficiency. Prescription Use _A AND/OR Over-The-Counter Use ___ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) GYNECARE TVT SECIJR Systeim GYNECARE. a division of ETHICON, Inc.FOI - Page 34 of 223
  27. 27. Section 5 510(k) SUMMARY Statement Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug, and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agencys final rule ".... 510(k) Summaries and 5 10(k) Statements .... (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency. MODIFIED DEVTCE NAME: GYNECARE TVT SECUR* System PREDICATE DEVICE NAME: GYNECARE TVT System and GYNECARE TVT Obturator System Device Description The GYNECARE TVT SECUR* device is a sterile, single patient use device, consisting of one piece of undyed or blue (Phtalocyanine blue, Color index Number 74160) PROLENE* polypropylene mesh (tape) approximately 1.1 cm x 8.0cm (approximately ½2 x 4 inches). The ends of the device will be sandwiched between pieces of fleece made of polyglactin 910/polydioxanone coated with polydioxanone film. The coated ends are added to facilitate passage (stiffens the ends) and placement (tactile feel for the surgeon) of the mesh implant. Two curved, stainless steel, single use introducers are used to deliver the implant. The introducers are supplied fixed to the implant via a wire through the coated ends and inserters. TVT SECUR is designed to accommodate two surgical techniques: the "Hammock approach" and the "U approach". The GYNECARE TVT Universal System is a less invasive exit less device which will enable the physician to perform a suburethal sling procedure placing the mesh under the mid urethra without either the delivery device or the implant exiting the skin. GYNECARE TVT SECUR System GYNECARE, a division of ETHICON, Inc. 000016FOI - Page 35 of 223
  28. 28. Intended Use A pubourethral sling for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. Indications Statement GYNECARE TVT SECUR* is indicated for the treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. Technological The modified device has the same technological characteristics as Characteristics the predicate device. The form, fit, function and method of operation are similar. Performance Data Results of verification testing indicates that the product meets the established performance requirements. Conclusion Based upon the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the subject device is substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act. Contact Patricia M. Hojnoski, M.S. Senior Project Manager, Regulatory Affairs ETHICON, INC. Rt. 22 West Somerville, NJ 08876-0151 Phone: (908) 218-2893 Fax: (908) 218-2595 Date August 30, 2005 GYNECARE TVT SECUR System GYNECARE, a division of ETHICON, Inc. 0OD017FOI - Page 36 of 223
  29. 29. Section 6: Truthful and Accuracy Statement GYNECARE TVT SECUR System GYNECARE, a division of ETHICON, Inc. 000018FOI - Page 37 of 223
  30. 30. Section 6 TRUTHFUL AND ACCURACY STATEMENT (As Required by 21 CFR 807.87(k)) Pursuant to 21 CFR. 807.87(k), I, Patricia Hojnoski, certify that to the best of my knowledge and belief and based upon the data and information submitted to me in the course of my responsibilities as Senior Project Manager, Regulatory Affairs of ETHICON, Inc., a Johnson & Johnson company and in reliance thereupon, the data and information submitted in this premarket notification are truthful and accurate and that no facts material to a review of the substantial equivalence of this device have been knowingly omitted from this submission. Patricia M. Hojnoski, M.S. Senior Project Manager GYNECARE, a division of ETHICON Date GYNECARE TVT SECUR System GYNECARE, a division of ETHICON, Inc. 000019FOI - Page 38 of 223
  31. 31. Section 7: Class III Summary and Certification GYNECARE TVT SECUR* device is not a Class III device; therefore a Class III certification is not required. GYNECARE TVT SECUR System GYNECARE, a division of ETHICON, Inc. 0000£0FOI - Page 39 of 223
  32. 32. Section 8: Financial Certification or Disclosure Statement This section is not applicable since clinical study information is not required as part of this submission. GYNECARE TVT SECUR System GYNECARE, a division of ETHICON, Inc. 000021FOI - Page 40 of 223
  33. 33. Section 9: Declarations of Conformity and Summary Reports This section is not applicable since this 510(k) is a "Traditional" not an "Abbreviated" 510(k). GYNECARE TVT SECUR System GYNECARE, a division of ETHICON, Inc. 000022 Sts-FOI - Page 41 of 223
  34. 34. Section 10: Executive Summary GYNECARE TVT SECUR System GYNECARE, a division of ETHICON, Inc. 00002,3 stAFOI - Page 42 of 223
  35. 35. Section 10: Executive Summary Description of Device: The GYNECARE TVT SECUR* device is a sterile, ------- -------- ---- ---- ice, consisting of one piece of undyed or blue ------------------ ------ ------- ------- ---------- --------- PROLENE* polypropylene mesh (tape) approximately 1.1Icm x 8.0cm (approximately Y2 x 4 inches). The ends of the device will be sandwiched between pieces of fleece made of polyglactin --- -- polydioxanone coated with polydioxanone film. The coated ends are added to facilitate passage (stiffens the ends) and placement (tactile feel for the surgeon) of the mesh implant. Two curved, stainless steel, single use introducers are used to deliver the implant. The introducers are supplied fixed to the implant via a wire through the coated ends and inserters. TVT SECUR is designed to accommodate two surgical techniques: the "Hammock approach" and the "U approach". The GYNECARE TVT Universal System is a less invasive exit less device which will enable the physician to perform a suburethal sling procedure placing the mesh under the mid urethra without either the delivery device or the implant exiting the skin. Indications for Use: The GYNECARE TVT SECUR* device is intended for use in women as a sub-urethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency. Device Comparison Table: Refer to Section 12. Summary of Performance Testing: Refer to Section 19. GYNECARE TVT SECUR System GYNECARE, a division of ETHICON, Inc. 000024FOI - Page 43 of 223
  36. 36. Section 11: Device Description GYNECARE TVT SECUR System GYNECARE, a division of ETHICON, Inc. 00002FOI - Page 44 of 223
  37. 37. SECTION 11 MODIFIED DEVICE AND DESCRIPTION Name of the Device CLASSIFICATION COMMON TRADE NAME! NAME NAME PROPRIETARY NAME Mesh, Surgical, Pubo-urethral GYNECARE TVT Polyeric (2l CFR, Sling SECUR* System §878.3300) ________ Establishment GYNECARE is a Division of ETHICON, Inc., a Johnson and Registration Johnson Company. The establishment registration number for Number GYNECARE, a Division of ETHICON, Inc. is #2210968. Device Classification Surgical mesh is classified by the FDA as a Class II Medical Device, General and Plastic Surgery Devices (21CFR, §878.3300, Product Code 79FTL). Predicate Device(s) GYNECARE TVT SECUR* device is a modification of the currently marketed GYNECARE TVT device covered under 510(k) K033568, K012628, and K974098. Change or Modification to an Existing Device The changes to the device are: - The ends of the mesh device will be sandwiched between two layers of polyglactin --- -- polydioxanone fleece material coated with polydioxanone film. The coated ends are added to facilitate passage (stiffens the ends) and placement (tactile feel for the surgeon) of the mesh implant. Two curved, stainless steel, single use introducers are used to deliver the implant. The introducers are supplied fixed to the implant via a wire through the coated ends and inserters. GYNECARE TVT SECUR System GYNECARE, a division of ETHICON, Inc. 0 0 2FOI - Page 45 of 223
  38. 38. o The GYNECARE TVT Universal System is less invasive exit less device that will enable the physician to perform a suburethal sling procedure placing the mesh under the mid urethra without either the delivery device or the implant exiting the skin. The currently marketed TVT device exits through the abdomen or through the thigh. In addition, for TVT SECUR, the delivering device and mesh will have the flexibility to be placed in either a U or Hammock direction. Both approaches are similar to existing validated techniques; however, the modified device offers a less invasive approach. The "Hammock" approach affixes into the intemnis muscle or into the internis muscle and membrane. The "U" approach affixes into the lower edge of the pubic synthesis in the connective tissue of the endopelvic fascia. The placement will depend on surgeon preference and individual requirements of the patient. The placement of the mesh (miduretbra) remains unchanged. The GYNECARE TVT SECUR System does not change the intended use or the application of the TVT tape. Physical Description GYNECARE TVT SECUR* System includes the device and its accessories. The device and accessories are sold as a set. The system consists of the following: Device: GYNECARE TVT SECUR* System (Sterile, Single-Use) Cosstffi Implant Un-Protected Inserter Protected Inserter 2 Finger Pads Protective Cover 2 Release Wires Refer to the photograph in this section for further detail. GYNECARE TVT SECUR System GYNECARE, a division of ETHICON, hic. 0 0 2FOI - Page 46 of 223
  39. 39. GYNECARIF TVT SF.CIJR* Syvtem- The Device (item A) is a sterile, single patient use Device, consisting --- ---e piece of blue ------------------ ------ ------- ------ ---------- --------- PROLENE* polypropylene mesh (tape) approximately 1.1 cm x 8. 0cm (approx 1/2 -- -- inches) with pieces of fleece made from VICRYL*--------------- ------ and PDS* ------- ---------------- undyed yarn whic-- sandwich the end sections of the mesh. The sandwich is bonded ------- er in a thermal process using two pieces of dyed ---------------------- film, this film is dyed violet with D&C Violet No. 2 ------- ------- ----- ---------- This fleece is the same material that is contained in the Codman ETHISORB Durapatch product K991413. Polyglactin ----- is also used to manufacture VICRYL Suture (N17-482 and K946271). Polydioxanone dyed with D&C violet No. 2 is used to manufacture dyed PDS II suture (N418-331). PROLENE polypropylene mesh is constructed of knitted filaments of extruded polypropylene strands identical in composition to that used in PROLENE polypropylene nonabsorbable surgical suture. This material, when used as a suture, has been reported to be non- reactive and to retain its strength indefinitely in clinical use. PROLENE mesh is knitted by a process that interlinks each fiber junction and which provides for elasticity in both directions. This bi-directional elastic property allows adaptation to various stresses encountered in the body. The fleece sandwich is a synthetic absorbable composite material made from VICRYL and PDS yarn. The yarn is knitted, processed into a fleece layer, the layers are then sandwiched to the mesh by using two pieces of dyed ---------------------- film using a thermal process. The resultant fle---- ---------- is of sufficient pore size to allow continuing growth of cells and intrinsic body tissue. The sandwiched fleece ends are mainly undyed, soft, expandable, and pliable. Absorption of sandwiched fleece ends is essentially complete within approximately 90 days, the fleece layers are replaced as connective tissue grows into the mesh. Portions of the PDS yarn/film can be detected up to 180 days post-implantation. GYNECARE TVT SECUR System GYNECARE, a division of ETHICON, Inc. 0 0 2FOI - Page 47 of 223
  40. 40. Two curved stainless steel Inserters are provided to deliver the implant that is secured to the Inserter by release wire. The release wires are secured to the inserter by the fingerpads. The protective cover is used to cover the 2 nd inserter tip and is removed before insertion. A standard needle holder attached to the Inserter delivers the implant. The Inserter allows for common surgical instruments to aid in the smooth and consistent placement of the implant. Packaging The GYNECARE TVT SECUR System will be packaged in an injection molded polypropylene tray. This tray is then sealed in an aluminum foil packet. The foil packet is the sterile barrier. The tray is then placed in an outer carton, either in a 1-up or a 4-up configuration. GYNECARE TVT SECUR System GYNECARE, a division of ETHICON, Inc. 000029FOI - Page 48 of 223
  41. 41. PATIENT-CONTACTING MATERIAL IDENTIFICATION Patient Contacting The patient contacting materials used for the Modified Materials GYNECARE TVT SECUR* device and accessories are identified in the table below: PART MATERIALI PATIENT CONTACT Devic (1) TVT SECUR* device: (a) Mesh PROLENE* Implant -------------------- Mesh ----------- ----- ----- ------------ --------- Ends of mesh Sandwiched by a fleece of Implant undyed polyglactin ----- and polydioxanone filaments, and a film of polydioxanone dyed with D&C violet No. 2. (same material as in Codman ETHISORB Durapatch (K991413). Polyglactin ---- is also used to manufacture VICRYL Suture (N 17-482 and K946271). Polydioxanone dyed with D&C violet No. 2 is used to manufacture dyed PDS II suture (N18-331) Finger pads ----------------- violet None polypropylene anticipated Protective cap ----------------- violet None polypropylene anticipated (b) Surgical steel Inserters ----- Stainless Steel (SS) Transient with release wires GYNECARE TVT SECUR System GYNECARE, a division of ETHICON, Inc. 000030FOI - Page 49 of 223
  42. 42. All patient contacting materials with the exception of the mesh (1)(a) are considered to be externally communicating, coming into contact with tissues for less than 24 hours. The mesh is classified as an implant. Refer to Section 15 for the Biocompatibility Assessment. GYNECARE TVT SECUR System GYNECARE, a division of ETHICON, Inc. 000031FOI - Page 50 of 223
  43. 43. I o OOMWARSTW I soomsy1fto 000032FOI - Page 51 of 223 MMM POS , - -HHH. ; .. u M -m....... ....... . ..-
  44. 44. Section 12: Substantial Equivalence Discussion GYNECARE TVT SECUR System GYNECARE, a division of ETHICON, Inc. 000 33FOI - Page 52 of 223
  45. 45. SECTION 12 SUBSTANTIAL EQUIVALENCE Substantial The modified GYNECARE TVT SECUR* device Equivalence has the following similarities to the predicate device (GYNECARE TVT device) which previously received 510(k) clearance. · Has the same indications for use * Uses the same operating principle · Incorporates the same basic design · Patient contacting materials (are the same except for the ends of the m---- -- hich are sandwiched between two layers of polyglactin ----- polydioxanone fleece material coated with polydioxanone film). Sterilization method is unchanged In summary, the GYNECARE TVT SECUR* System described in this submission is substantially equivalent to the predicate device. See the table on the following page for further comparisons: 000034 GYNECARE TVT SECUR System GYNECARE, a division of ETHICON, Inc.FOI - Page 53 of 223
  46. 46. FEATURE Predicate Predicate Modified GYNECARE TVT GYNECARE GYNECARETVT Device (K974098 and TVT Obturator SECUR* device K012628) Device (K033568) A sub-urethral sling for treatment of stress Intended Use of urinary incontinence (SUI), for female urinary Same Same incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. Knitted filaments of Same Same, but the ends of the polypropylene device (mesh) will be (unpigmented and sandwiched between two Implant pigmented blue) ------s of polyglactin Device PROLENE* ----- polydioxanone fleece material coated with polydioxanone film -dyed violet with D&C Violet No. 2 (same material as in Codman ETHISORB Durapatch K991413). Polyglactin 910 is also used to manufacture VICRYL Suture (N17- 482 and K946271). Polydioxanone dyed with D&C violet No. 2 is used to manufacture dyed PDS II suture (N18-331) Stainless steel needles Plastic tubes Stainless steel needles attached to each end of with receptacle attached to each end of mesh ends attached to mesh each end of mesh Tape Tension-free placement Same Same Placement of tape under Midurethra GYNECARE TVT SECUR System GYNECARE, a division of ETHICON, Inc. 000035FOI - Page 54 of 223
  47. 47. Implant Nonabsorbable Same Same PROLENE mesh Sterilization EtO Sterilization Same Same Re-Use Single Use Device Same Same Thermoformed tray with Same Injection molded Package Tyvek lid. This is then polypropylene tray. This placed in an outer carton. tray is then sealed in an aluminum foil packet. This is then placed in an outer carton. Accessories packaged Accessories Accessories packaged separately packaged with with the device the device TVT Introducer Helical Passers, Stainless steel inserters Accessories TVT Rigid Catheter TVT Rigid Catheter Winged Guide that are supplied attached, te eoe n Guide Guide removed ~~~~~~~~then and discarded after placement TVT Abdominal Guides of the implant. and Couplers Length of -500mm** -450mm** -80mm Tape Surgical "U" (transvaginal) "Hammock" "Hammock" (obturator) Technique approach (obturator) approach and "U" and "abdominal" approach (transvaginal) approach approach ** a portion is cut off and discarded after passage. The GYNECARE TVT SECUR System does not change the intended use or the application of the TVT tape. The GYNECARE TVT Universal System is a less invasive exit less device that will enable the physician to perform a suburethal sling procedure placing the mesh under the mid urethra without either the delivery device or the implant exiting the skin. The currently marketed TVT devices exit through the abdomen or through the thigh. In addition, the delivering device and mesh will have the flexibility to be placed in either a U or Hammock direction. The placement will depend on surgeon preference and individual requirements of the patient. The placement of the mesh (midurethra) remains unchanged. GYNECARE TVT SECUR System GYNECARE, a division of ETHICON, Inc. 000036FOI - Page 55 of 223
  48. 48. Section 13: Proposed Labeling GYNECARE TVT SECUR System GYNECARE, a division of ETHICON, Inc. 000037FOI - Page 56 of 223
  49. 49. SECTION 13 PROPOSED DRAFT LABELING GYNECARE TVT SECUR* System Introduction The device labeling for the GYNECARE TVT SECUR* device is comprised of the primary package label, box labels, patient tracking labels, and package insert Primary Label The primary label is printed on Tyvek which is used as the sterile barrier for the device primary package. Box Labels Individual labeled boxes for 1-up and 4- up configurations Patient Tracking Labels Provided with product for patient record purposes Package Insert The text for the package insert has been updated to reflect the modified device. GYNECARE TVT SECUR System GYNECARE, a division of ETHICON, Inc. 000038 005FOI - Page 57 of 223
  50. 50. Gynecare $0 TVT SECUW system TT Tensue-fr.. S.uppor lncont...nc Disposituemeselle for Con.tet: 1eIce 2 lsres perIncontiee SterileI.Do uei if packagei damaged o or"opend.. Conetenuodisposition 1 Podotto ster Noi .usares Ie. 2~.inn wtr Spen..oingeij eteebeadje I co.e.on stateaperts tegeni.... tineove 5 aniita. lnhoed:I -tunadeed S.Apat eInteso per.tretaento 2 a"dinbrevgnotureniA wedetiolacie n Snorkel. gebrik~ennano de Niot Coenteddo I ddsposimvo 2 nfrddtor vepakking geopord besnhadigd yf i.Enteniiaddo. NA.n odln so a Soceje A.n tension pearsAne. enibalagem etvrdet~rs dv din...ntinec.....n.ini. Os Aborts. Cotton :1Idiopositt, jotredunteurs SisentadeA 2 sapn i In tenitn.in Seeril.No daseltlivr si Ietl geb..p..nee ornoheeiea~h .iotedndo~e9ins stvM.Gotn .,, dv:I d,.ispsiin, spenn....sfreie U.ndeorsijoen 2insetsdor~e bMc MInkMnIoe Estdni. olior si el vovasese N. Irihet 1I pinplatat rnnsabiento n detlado. 2Enl~fhninsnom..rte Steit. Nichtvswvewnn di. Paclusogeatnet oden FLO0TI bescdhadigtwnde. Fs 0 LTOE11 l~e E C 08 YNECARE WORLDWIDE see insoctiorsA div isinoETHICON, NC.cmpn b!freve MadeIv Someto NewJdrsoy o887e-6 lie. 01n Donot reeo/CEMICON, restelzea RX Only ~ INC. 2005 Iradvmonk IVT Primary Label 01001039FOI - Page 58 of 223
  51. 51. nil ! Ii J,. ~~ ~ ~ ~ ~ ~ n Law ;~~~x ii 1 ~~~~000040FOI - Page 59 of 223
  52. 52. Li % oll! ,I! unt!Jil I fi tIiifll iitI~~~~~~~~~~~~~~~~~ L~~~~~~~~~~~~~~~~~~~~~~~~iii !i Ji (4 ) * (4 ihillFOI - Page 60 of 223
  53. 53. TVTS FLO-TXXXXXXX OtEAETV? SE LO XXXXX GYECARE IV SEWtR- TVTS - OYECARE TV SECJW TVTS xxxxxxx FOT Patient Tracking Labels 000042FOI - Page 61 of 223
  54. 54. Pages 62 through 77 have been removed.

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