“Are Fingerprints the New Check?” Dis associated Press Omaha, NE (DP) – Watson MegaTech one of the world’s largest technology development companies announced a new product aimed at stopping the identity theft epidemic. The product is called BioBanking and uses a combination of Radio Frequency technology and personal attributes to uniquely identify a person making a financial transaction. The technology works by embedding a patented nano-scale RF transmitter in the finger of a banking customer. The RF transmitter then fuses with the fingerprint structure and the epidermal blood flow to become cybernetic. Each time a customer wants to make a transaction they simply press their finger in a reader and less than a second later the transaction is approved. The transmitter is also a receiver and new accounts can be added at a financial institution by simply encoding the new account information to the BioBanking device. Each of the transaction readers will be attached to the global financial network allowing basic transactions in stores as well at Automated Teller Machine (ATM) transactions. A variety of financial accounts can be embedded on the BioBanking device. This includes regular banking type accounts or line of credit accounts. The device enables features that allow the use of multiple accounts to pay for a single transaction, something that is difficult to accomplish with current card technologies. Company spokesman and CEO Chad Watson says “With this technology you can buy a $500 item and split the payment up to be $100 from your bank account and the remainder on a credit account. This is a significant leap forward in financial transaction flexibility”. The nano-scale device works like a cell phone in that it can be reprogrammed when the customer changes banks or accounts. A cell phone receives a reprogrammed sim card and the new carrier information is embedded in the phone. If a customer changes banks the new bank will encode their transaction codes and the account information to the transmitter. Currently the BioBanking device will accept up to five different financial institution codes. If demand suggests more are necessary the company has the ability to increase the count. Watson MegaTech has cleared compliance hurdles with the US Food and Drug Administration (FDA) for embedded devices. The device interacts with the user’s finger anatomy to preclude invasive theft of the device. The BioBanking device uses the fingerprint as identification but also requires the temperature to be within limits for the human body to operate. This is intended to stop a thief from cutting off the finger to steal the account information. Initial deployment for BioBanking would be targeted at locations that currently accept any type of payment card. In the future a home reader for online purchases is planned and will be available as the technology gains momentum. Chad Watson believes “this device will be a revolutionary step forward in preventing identity .

1. “Are Fingerprints the New Check?”
Dis associated Press
Omaha, NE (DP) – Watson MegaTech one of the world’s largest
technology development companies announced a new product
aimed at stopping the identity theft epidemic. The product is
called BioBanking and uses a combination of Radio Frequency
technology and personal attributes to uniquely identify a person
making a financial transaction.
The technology works by embedding a patented nano-scale RF
transmitter in the finger of a banking customer. The RF
transmitter then fuses with the fingerprint structure and the
epidermal blood flow to become cybernetic. Each time a
customer wants to make a transaction they simply press their
finger in a reader and less than a second later the transaction is
approved. The transmitter is also a receiver and new accounts
can be added at a financial institution by simply encoding the
new account information to the BioBanking device. Each of the
transaction readers will be attached to the global financial
network allowing basic transactions in stores as well at
Automated Teller Machine (ATM) transactions.
A variety of financial accounts can be embedded on the
BioBanking device. This includes regular banking type accounts
or line of credit accounts. The device enables features that
allow the use of multiple accounts to pay for a single
transaction, something that is difficult to accomplish with
current card technologies. Company spokesman and CEO Chad
Watson says “With this technology you can buy a $500 item and
split the payment up to be $100 from your bank account and the
remainder on a credit account. This is a significant leap forward
in financial transaction flexibility”.
The nano-scale device works like a cell phone in that it can be
reprogrammed when the customer changes banks or accounts. A
cell phone receives a reprogrammed sim card and the new
carrier information is embedded in the phone. If a customer

2. changes banks the new bank will encode their transaction codes
and the account information to the transmitter. Currently the
BioBanking device will accept up to five different financial
institution codes. If demand suggests more are necessary the
company has the ability to increase the count.
Watson MegaTech has cleared compliance hurdles with the US
Food and Drug Administration (FDA) for embedded devices.
The device interacts with the user’s finger anatomy to preclude
invasive theft of the device. The BioBanking device uses the
fingerprint as identification but also requires the temperature to
be within limits for the human body to operate. This is intended
to stop a thief from cutting off the finger to steal the account
information.
Initial deployment for BioBanking would be targeted at
locations that currently accept any type of payment card. In the
future a home reader for online purchases is planned and will be
available as the technology gains momentum. Chad Watson
believes “this device will be a revolutionary step forward in
preventing identity theft”.
Chad Watson
Patent Agent
U.S. Patent & Trademark Office Registration Number 38449
United States Patent Patent Number:
9,998,473
Watson Date of Patent: Dec.
15, 2009
_____________________________________________________
______________________

3. BioBanking Biometric Insert
Inventor: Chad Watson, 5800 Industrial Blvd, Omaha, NE,
68135
Appl. No: 658,232
Filed: June, 11, 2007
Int. Cl. ………………. C38J 44/14
U.S. Cl. ……………… 83/169.5;83/170.1
Field of Search ………. 83/167, 168, 169.1, 169.2,
83/170.1, 83/169.5
References Cited
US Patent Documents
4,185,318 1/1997 Xiu . .………… 83/171
6,143,270 12/2002 Long ………… 83/171
7,083,614 7/2005 Koeppel ………. 83/167
Foreign Patent Documents
None Noted
Primary Examiner – Randolph J. Scott
Assistant Examiner – Mortimer Snifflehause
Attorney, Agent, or Firm – Chad Watson
Abstract
The BioBanking Insert is a radio frequency device that is
installed in the finger of a human to enable financial
transactions in a more secure manner. The device is encoded
with account identification information and the fingerprint of
the individual is used as the authentications mechanism. All
processing and power are included in the device.

4. Chad Watson
Patent Agent
U.S. Patent & Trademark Office Registration Number 38449
U.S. Patent Dec. 15, 2009 Sheet 1 of 2
9,998,473
Chad Watson
Patent Agent
U.S. Patent & Trademark Office Registration Number 38449
U.S. Patent Dec. 15, 2009 Sheet 2 of 2
9,998,473
Chad Watson
Patent Agent
U.S. Patent & Trademark Office Registration Number 38449
9,998,473
BioBanking Insert
Background of the Invention
The present invention relates generally to biometric readers
designed for security purposes. These readers have always been
passive and interrogated the biometric feature of the individual
to be authenticated.
This inventions specifically relates to biometric security
scanners that use fingerprints as an authentication mechanism.

5. These are now common throughout security systems worldwide.
Some examples of fingerprint scanners are seen in the following
US patents:
Xiu, US Patent No. 4,185,318 illustrates a fingerprint scanner
based on basic 14-point outline and contour mapping. The
device had an analog output that could be mis-interpreted by the
security system it interfaces with.
Long, US Patent No. 6,143,270 further evolved the passive
fingerprint scanner with a digital interface that could allow
longer range transmission of the fingerprint data. However, no
further refinement was made in the passive interrogation
techniques for the fingerprints.
Koeppel, US Patent No. 7,083,614 refined identification
techniques for financial transaction security with biometric
identifiers in debit and credit cards. These mechanisms allowed
bank cards to be manufactured with specific biometric markers
for each end user. However, these markers did not preclude
identity theft as it was a one-time encoding.
Summary of Current Invention
The object of the present inventions is to advance financial
transaction security by requiring both active biometric
interrogation with RF account information simultaneously.
Without both elements the transaction will fail.
The device is a small implanted device in the finger of the user
coupled with a modified fingerprint reader. The third element in
the system is an RF encoder to imprint or modify account
information once the device has been implanted.
Another technological evolution is the fact that the BioBanking
insert device requires precise biological monitoring that will
preclude it from working should the device become detached
from the host.
The BioBanking system represents a significant step forward in
reducing or eliminating identity theft and financial fraud.
Chad Watson

6. Patent Agent
U.S. Patent & Trademark Office Registration Number 38449
9,998,473
Brief Description of the Drawing
The invention will be more clearly understood and the
technological advances more clearly understood with a detailed
description using the accompanying drawings.
Fig. 1 is an overall drawing of the biometric insert device with
the salient features pointed out.
Fig. 2 is a detailed drawing depicting the RF arrays and controls
for the active RF send and receive.
Fig. 3 shows the general placement and relative size of the
implanted device.
Fig. 4 clearly shows the exact placement within the fingerprint
structure for best resolution of the authentication mechanisms.
Description of the Preferred Embodiments
Referring to the drawings and especially to FIGS 1 and 2 we see
the features that enable operation of the BioBanking device.
The desire is to have onboard power that is not dangerous to the
wearer of the device. Additionally, the power system had to
meet the requirements of fitting into a very small space.
References 22 and 34 in Fig. 1 show the location of the solar
energy collection grid and the solar energy storage module.
Since the device is sub-cutaneous there is enough light
penetration to power the device. The technology is similar in
nature to the watch Eco-Drive solar technology.
Fig. 1 reference 35 shows the location of the main power
conversion and distribution system. The power distribution
system converts the solar energy into 12 volt direct current
(DC) power for efficiency and distributes it to the ambient
temperature sensors and the RF array.
Fig. 1 references 38 and 41 and Fig. 2 show the placement and

7. details of the heart of the device which are the RF transmit and
receive arrays. Fig. 2 references 14, 18, and 21 show the power
and control systems for the RF array. The Frequency Modulator
[14] and RF Control Processor [21] handle the operation of the
RF array to achieve 110 degrees of coverage for receive and 180
degrees of coverage on transmit. This range of coverage is
required when the device is presented in off-angle situations to
ensure high probability of transaction success.
Fig. 2 references 16 and 20 are the transmit and receive arrays
respectively. The RF arrays use wafer technology to allow the
Chad Watson
Patent Agent
U.S. Patent & Trademark Office Registration Number 38449
9,998,473
most transmit surface area in the least amount of space.
The final technical feature of the device is depicted in Fig. 1 at
reference 42. This is the ambient temperature sensors that make
the device unique in the fingerprint authentication market. With
other fingerprint biometric devices the severed finger might be
used to gain unauthorized access to the security system. The
ambient temperature sensors ensure that the device is in a very
precise temperature band environment centered on the 98.6
degree nominal human body temperature.
Now we turn the attention to placement of the device in the
user. Fig. 3 and Fig. 4 define overall size and placement of the
insert for maximum effectiveness. The device size is small
enough to be implemented without a surgical procedure by a
person trained in the procedure. The device size requirements
were to not exceed 50 millimeters in length and width. The
optimal placement is in the right index finger as it has the most
range of motion of any of the digits. Fig. 4 shows an enlarged
image of the device just below the main central swirls of the

8. finger print. This is the most optimal placement due to this area
being central to most 14 point interrogation systems for
fingerprint analysis. This keeps the device in line with current
fingerprint identification technology.
*******
Figure 21816212014
22 –Solar Collectors34 –Solar Storage35 –Power Distribution38
–RF Transmission Array41 –RF Receive Array42 –Ambient
Temperature Sensors
Figure 1223834354142
16 –180 degree Transmission Array18 –RF Power
Distribution20 –110 degree Receive Array14 –Frequency
Modulators21 –RF Control Processor
“Biometric Security Comes to Banking”
Ramrod Biggerstaff for the Associated Press
Omaha, NE (AP) – Watson MegaTech one of the world’s largest
technology development companies announced a partnership
with three of the country’s major financial institutions for
deployment of its BioBanking system. The product is a giant
leap forward in transaction security for the individual consumer.
Watson MegaTech is teaming with Citigroup Financial, Bank of

9. America, and Wells Fargo & Company to make initial
deployment of this importnt technology. Wells Fargo spokesman
Leroy Schnitterfleuffelhoferinstein states “Deployment and
maturation of this technology will virtually eliminate identity
theft and financial tranaction fraud. This will allow corporate
banks to focus attention on corporate transaction security. This
is also a great benefit to our customers because of the payment
flexibility and guaranteed security”
Initial deployment of the BioBanking technology will be limited
to main branches and headquarters. Deployment to all branches
and point of sale devices will begin in about a year and be
complete in roughly 14 months after start.
Chad Watson CIS 629 Term Project BioBanking Marketing
Strategy
Marketing Strategy
BioBanking Financial Transaction Security System
Watson MegaTech Inc.
Chad Watson President and CEO
Target Market
BioBanking is a revolutionary approach to minimize fraud and

10. identity theft that affects consumers and companies alike.
Financial crimes are at epidemic proportions and many
organizations must come together to put an end to this heinous
invasion of the financial markets.
There are many points of invasion of the financial system. Many
of these invasion points involve activity by individuals. It is
this human vulnerability that BioBanking seeks to influence and
stop. Many things like identity theft, money laundering, and
terrorism funding can be significantly reduced with
implementation of the BioBanking technology and long-term
implementation strategy.
Identity Theft and Fraud Epidemic
Identity theft has been the number one reported consumer crime
over the last five years according to the Center for Identity
Management and Information Protection (CIMIP). The CIMIP
uses data from the Federal Trade Commission (FTC) Consumer
Sentinel Network (CSN) to track cases of identity theft among
the many consumer complaints. Figure 1 shows the total identity
theft and consumer fraud complaints reported over the last five
years.
Federal Trade Commission
Consumer Sentinel Network Data Book Report
Year
Fraud and Identity theft Complaints
Identity Theft Complaints
2006
670,000
241,200
2007
800,000
256,000
2008
1,200,000
312,000
2009

11. 1,300,000
273,000
2010
1,300,000
247,000
Figure 1: FTC CSN Reported Identity Theft
Out of this total number of complaints a large percentage relate
directly to bank cards, consumer loans, and government
document/benefits fraud. All of these are financial crimes and
cost consumers or company’s money.
Another key area of fraud involving individuals is money
laundering. This includes both the organized crime element and
for terrorist activities. In money laundering cases there is
usually an individual or group of individuals completing
legitimate transactions of ill-gotten money. To combat this
transactions must be controlled and accounted for at the
individual level. (Gordon & Wilcox, 2003)
BioBanking in the Financial Sector
Control of financial transactions at the individual level is where
a technology like BioBanking can really make an impact. The
use of individually coded biometric devices to authenticate,
audit, and complete financial transactions will greatly reduce
the ability of unscrupulous individuals to perform acts of
financial fraud.
The greatest benefit will be to financial institutions that are left
with the loss in most cases of fraud of any form. Data suggests
that fraudulent financial activities cost financial institutions
more than $48 billion per year. This is a substantial amount and
well worth investing in new technologies to prevent.
BioBanking for Individual Protection
The second main target market for BioBanking is the individual.
Having an identity stolen can be devastating and cause complete
upheaval in a person’s life. Getting all their identification
papers changed, their accounts closed and reopened, and

12. clearing up their credit reports can take months or years. There
are three main types of identity fraud/theft against and
individual:
· Identity Theft involves the theft of another person’s personal
information specifically for establishing an identity for criminal
activity or financial gain.
· Account Takeover occurs when a fraudster obtains an
individual's personal information (account number and social
security number), and then uses that information to change that
individual's mailing address with the financial institution. Once
this is accomplished, the fraudster can perform transactions
without the victim's knowledge.
· Transaction Fraud includes schemes that may or may not
utilize identity fraud. Examples include: Credit Card Fraud, as
when someone uses a credit card account without the intention
to pay the bills incurred; Check Fraud, which describes various
activities such as check kiting, counterfeiting, forgery and
writing checks on closed accounts (paperhanging). (Yaeger,
2005)
All of these activities can be combatted with the use of the
BioBanking technology. The combination of both biometric
authentication and encoded account information make each of
these individual fraud mechanisms obsolete. Technology
Overview
BioBanking is not a singular technology but is a combination of
three key components that can initially overlay the current
financial transaction network. The three major components of
BioBanking are the Insert, the Active Reader, and the Device
Encoder. The insert is the part of the system that represents the
greatest technological leap forward in security authentication
mechanisms. The reader and encoder are modifications to
existing technologies to try and account for some industry
disruption with the new paradigm.

13. The patented BioBanking Insert is the heart of the system. This
is a 50 mm x 50 mm device that is implanted in the sub-
cutaneous area of the finger roughly in the center of the finger
print. Figure 2 shows the enlarged view of the product and the
associated structures in this nano-scale device.
Figure 2: BioBanking Patented Insert Device
The insert has both transmit and receive radio frequency (RF)
arrays to perform system actions. These arrays are powered by
solar power. This is done to eliminate the need for battery
replacement in the device so it is a long-term stable and viable
insert. The solar technology used is similar to the Eco-Drive
patented technology used in watches. The Insert also has on-
board processors and memory for account information and
control of the RF transmit and receive. Lastly, the device has
ambient temperature sensors to ensure the device transitions to
shut down if the user’s finger is severed. The ambient
temperature sensors are another layer in the defense in depth
security offered by BioBanking.
The second major part of the technology is an active RF
interrogation fingerprint reader. This device both reads the
swirls and points of the fingerprint as well as reads the RF
transmission from the Insert device. The Interrogator allows the
opportunity to select active accounts as well as mix accounts,
both credit and debit, for payment.
Figure 3: BioBanking Active Interrogator
The last major component of the system is the Account Encoder.
This device allows banks or financial institutions to transmit RF
signals with account information encoded on them. This account
information is then encoded in the memory of the Insert device
like firmware. Overwriting the account information for a new
bank is easily accomplished with the appropriate security
overwrite code.
A complete description of the technology is included in
Attachment A: Technology Description. Financial Industry

14. Transformation
Currently almost all individual financial transactions use a card
media and short passcode of some sort. Many now offer RF
proximity swiping for ease of use. These technologies are
convenient to the customer but are extremely convenient to the
identity thief as well. Stealing a card and using it is very simple
with the advent of online purchasing where the identity of the
consumer is anonymous. The RF card material is often picked
by a simple RF scanner waved over the user’s person without
their knowledge. Since there are no other authentication
mechanisms, the card information is now free to use for the
identity thief.
These technologies are not convenient to financial institutions.
The banks have to manage the issue and revocation of cards,
manage the personal identification numbers (PIN), and re-issue
stolen or lost cards. This is a huge overhead burden considering
the number of cards issues in the US. The total numbers of
cards issued in the US through the end of 2010 are:
· American Express credit: 48.9 million
· MasterCard credit: 171 million
· MasterCard debit: 123 million
· Visa credit: 269 million, as of Sept. 30, 2010
· Visa debit: 397 million, as of Sept. 30, 2010
Each of these has the potential for identity theft or financial
fraud. (Woolsley & Shulz, 2011) An added complexity is that
these represent the major financial institutions. There are also
many store cards and revolving debt cards that have the same
archaic authentication mechanisms.
There is currently a huge financial infrastructure in place with
current readers and automated teller machines (ATM). To
migrate toward BioBanking for individual financial transactions
will require an overlay that works with these technologies until
they are phased out over time. Watson MegaTech has a plan for
accomplishing this. Figure 4 shows the overall four year
timeline to completely overhaul the individual transaction

15. system.
Figure 4: Timeline for BioBanking Deployment
· Year One requires the deployment of the readers and encoders
at major financial institutions. This will begin at the major
financial centers and headquarters. First deployments will
reside alongside the current card reader technology but will use
the same network infrastructure.
· Year Two will begin the deployment of encoders and readers
to financial institution branches and to point of sale locations.
This will use the same paradigm as year one BioBanking
technology will sit next to legacy card readers and use the same
network infrastructure. Year two will also see the installation of
the BioBanking Inserts into partner banking customers.
· Year Three of the deployment will see the ATM network
replaced with hybrid card/BioBanking interrogators at all
locations as well as beginning to replace point of sale
technology with new hybrid BioBanking/card interrogators.
· Year Four sees the deployment complete through the US and
installs a major network upgrade to raise the reliability of
financial transactions and speed up traffic.
Since the financial network is global in nature and the United
States attracts many visitors from all over the world, it will
likely be impossible to completely replace card readers in the
near future. The alternative is to deploy hybrid card readers that
also serve as BioBanking point of sale interrogators. This is the
technology targeted at the year three and year four efforts.
Technology Disruption
By virtue of the technology and implementation there will be
some current technologies that will be displaced. This is
inevitable as innovation marches on and new paradigms are
developed. Watson MegaTech is sensitive to the economic
impact of the technology disruptions and has devised a strategy
that will allow near-term harmony among all the technologies
with a gradual phase-out of some current methods. Table 1
generally outlines the perceived technology disruptions and the

16. near and far-term strategies for them.
Table 1: Technology Disruption Efficiency Strategy
· BioBanking will cause great upheaval in the current magnetic
stripe card readers for point of sale devices and ATM. The
single thread payment options and single method security
contribute to their lack of utility and potential for identity theft.
However, in the near-term BioBanking readers will reside
adjacent to magnetic card readers then become integrated with
them. Magnetic cards will become obsolete in the far-term and
this industry will need to look at other markets.
· The deployment of BioBanking will also change the network
protocols because of the mixed payment capability. The
networks will have to be much faster because the consumer can
use up to five different accounts to pay for an item. This
requires balance checks and authorizations quickly. In the far-
term single payment option cards will go away.
· Security will fundamentally change with BioBanking. For the
short-term the single authentication cards will still be allowed
on normal readers. In the far-term all financial transaction
security must be active interrogation with biometric
authentication.
· Lastly, the current methods for buying online will remain the
same. However, Watson MegaTech has a design and plan to
develop a home BioBanking receiver that will plug into the
computer to offer the same level of protection for online as in-
store shopping.US Patent and FDA Compliance Report
The BioBanking technology is the subject of a US patent
offering seven years of competition protection or franchising
rights. The Insert device is the subject of US Patent 9,998,473
since it is the most technologically complex part of the system.
The patent was awarded December 15, 2009.
Since the BioBanking system relies on implanted devices and
radio frequency, the US Food and Drug Administration (FDA)
has strict governance over these type devices under Sections
531 through 542 of the Radiation Control for Health and Safety

17. Act of 1968. Additional governance is located under 21 CFR
814 over clinical trials of the device and proof for three years
that it has caused no human illness. Watson MegaTech applied
for a US FDA Pre-Market Approval (PMA) to manufacture and
distribute the BioBanking Insert device. PMA approval was
granted under PMA P091462 on December 1, 2011.
Both of these documents are on file for reference as part of the
technology development package.Long-Term Technology Plans
There are two major market segments that can be penetrated for
significantly more growth in the BioBanking segment. These are
the international market segment and the home network personal
online shopping segment.
Since many US financial institutions do business around the
globe and have reciprocal relationships with overseas banks,
expansion into the global BioBanking market is a planned future
endeavor. If magnetic cards are deleted from financial
institutions in the US, there is still a problem with Americans
traveling abroad where the technology is not available.
Expansion into the global financial market will allow complete
eradication of magnetic card banking and mostly terminate
individual identity theft.
Many consumers are now buying online and the use a
BioBanking for these type purchases will be prohibitive. To
combat this the next easy growth step is to develop personal
BioBanking readers for home use. These would be peripherals
just like a printer and attach via something like Universal Serial
Bus (USB) connection on the home computer. To maximize the
utility, the most likely progression will be to develop an
application for Smart Phones or Tablets so online purchases can
be executed via a BioBanking Insert on the customer’s phone.
This will represent a giant leap forward in utility for the
product and will be a natural extension for very little capital
investment.
The last area for long-term migration of this technology could
be in the field of personal records. This could include all
medical records and, in some cases, criminal records. The

18. encoding in the device would allow interrogators on different
frequencies to access the correct set of information. This could
represent a huge potential market segment.Concluding Remarks
Identity theft and financial fraud are significant problems for
individual and corporate entities. An Identity theft can destroy a
person’s life very quickly and requires hundreds or thousands of
hours to correct. Identity theft and non-payment of debt
accounts can cost financial institutions billions of dollars.
Combatting this requires a new approach and a new technology.
BioBanking is that new paradigm for financial transaction
security. This is a patented and FDA approved technology that
requires an unprecedented level of account and personal
security authentication. Watson MegaTech has a sound strategy
for fielding the system without disrupting the current paradigm.
Lastly, Watson MegaTech has a solid roadmap for future
development of the market.
We recommend that you strongly consider becoming a partner in
this world-class venture to eradicate identity theft and
individual financial fraud.
References:
Gordon, G., & Wilcox, N. (2003). Identity Fraud: A Critical
National and Global Threat. Utica, NY: Lexis Nexis and Utica
College.
Woolsley, B., & Shulz, M. (2011, July). Credit card statistics,
industry facts, debt statistics . Retrieved Feb 2012, from Credit
Cards.com: http://www.creditcards.com/credit-card-news/credit-
card-industry-facts-personal-debt-statistics-1276.php
Yaeger, C. (2005). Identity Fraud – Impact for Financial
Institutions. Atlanta: Benchmark Consulting Inc.
Attachments:
Attachment A – BioBanking Technology Description
22 –Solar Collectors34 –Solar Storage35 –Power Distribution38
–RF Transmission Array41 –RF Receive Array42 –Ambient
Temperature Sensors

19. Figure 1223834354142
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Center for Devices and Radiological Heath
Office of Communication, Education and Radiation Programs
Document Mail Center – WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Watson Megatech, Inc.
% Chad Watson
Dec 1, 2011
President and CEO
5800 Industrial Blvd
Suite 11
Omaha, NE 68135
Re: P091462
BioBanking
Filed: Jan 9, 2010
Amended: August 5, September 8 and 13, 2010; February 22,
2011; September 22, 2011; October 6, 2011 and November 1,
2011.
Procode: RLD
Dear Mr. Watson:
The Center for Devices and Radiological Health (CDRH) of the
Food and Drug Administration
(FDA) has completed its review of your premarket approval
application (PMA) for the BioBanking Device.
BioBanking is intended to be for sub-dermal use as a radio
frequency (RF) emitter in the prevention of identity theft and

20. financial fraud. The device will interact with external scanners
through radio frequency to identify the individual as well as
financial account information. The device will also interact with
external encoders for the purposes of addition or removal of
financial account information. The device is solar powered and
does not need internal batteries that would provide potential
medical issues in the PMA review process.
The BioBanking insertion process can be administered by non-
medical personnel trained in the implementation of the product.
Financial institution personnel responsible for this
administration will be trained and certified in application of the
BioBanking device.
The sub-dermal BioBanking device is one element of the total
transaction system. There is also a reader for the RF signals.
Since the reader is a passive device it does not fall under
provisions of the CDRH purview.
We are pleased to inform you that the PMA is approved. You
may begin commercial distribution
of the device in accordance with the conditions of approval
described below. You may continue
commercial distribution of the device upon receipt of this letter.
Page 2 – Mr. Watson
The sale and distribution of this device are governed by The
Radiation Control provisions (originally enacted as the
Radiation Control for Health and Safety Act of 1968) located in
Sections 531 through 542 of the Act. They apply to any
"electronic product" which is defined as: any manufactured or
assembled product (or component, part, or accessory of such
product) which, when in operation,
i. contains or acts as part of an electronic circuit and

21. ii. emits (or in the absence of effective shielding or other
controls would emit) electronic product radiation.
"Electronic product radiation" is defined as:
i. any ionizing or non-ionizing electromagnetic or particulate
radiation, or
ii. any sonic, infrasonic, or ultrasonic wave, which is emitted
from an electronic product as the result of the operation of an
electronic circuit in such product.
The device is restricted under section 515(d)(l)(B)(ii) of the act
insofar as the labeling must specify the specific training or
experience practitioners need in order to use the device. FDA
has determined that these restrictions on sale and distribution
are necessary' to provide reasonable assurance of the safety and
effectiveness of the device. Your device is therefore a restricted
device subject to the requirements in sections 502(q) and (r) of
the act, in addition to the many other FDA requirements
governing the manufacture, distribution, and marketing of
devices.
Continued approval of this PMA is contingent upon the
submission of periodic reports, required
under 21 CFR 814.84, at intervals of one year (unless otherwise
specified) from the date of
approval of the original PMA. Two copies of this report,
identified as "Annual Report" (please use this title even if the
specified interval is more frequent than one year) and bearing
the applicable PMA reference number, should be submitted to
the address below. The Annual Report should indicate the
beginning and ending date of the period covered by the report
and should include the information required by 21 CFR 814.84.

22. In addition to the above, and in order to provide continued
reasonable assurance of the safety and
effectiveness of the device, the Annual Report must include,
separately for each model number (if applicable), the number of
devices sold and distributed during the reporting period,
including those distributed to distributors. The distribution data
will serve as a denominator and provide necessary context for
FDA to ascertain the frequency and prevalence of adverse
events, as FDA evaluates the continued safety and effectiveness
of the device.
Page 3 – Mr. Watson
In addition to the Annual Report requirements, you must
provide the following data in post approval study reports (PAS).
Two copies, identified as "PMA Post-Approval Study Report"
and
bearing the applicable PMA reference number, should be
submitted to the address below.
1. You must conduct a post approval study that will evaluate
whether BioBanking causes adverse skin reaction in the
majority of consumers where it is implemented.
2. The study will be a multi-center, single arm, observational,
prospective study to gather data
on whether the insertion procedures introduce pathogens into
the consumer. The study must be completed on a statistically
relevant set of consumers and the findings independently
verified.
FDA would like to remind you that you are required to submit
separate PAS Progress Reports
every six months during the first two years and annually
thereafter. The reports should clearly be
identified as Post-Approval Study Report. Two copies for each
study, identified as "PMA Post-

23. Approval Study Report" and bearing the applicable PMA
reference number, should be submitted to the address below.
For more information on post-approval studies, see the FDA
guidance
document entitled, "Procedures for Handling Post-Approval
Studies Imposed by PMA Order"
(www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/ucm070974htm#2).
Be advised that the failure to conduct any such study in
compliance with the good clinical
laboratory practices in 21 CFR part 58 (if a non-clinical study
subject to part 58) or the institutional review board regulations
in 21 CFR part 56 and the informed consent regulations in 21
CFR part 50 (if a clinical study involving human subjects) may
be grounds for FDA withdrawal of approval of the PMA.
Within 30 days of your receipt of this letter, you must submit a
PMA supplement that includes a
complete protocol of your post-approval study. Your PMA
supplement should be clearly labeled
as a "Post-Approval Study Protocol" and submitted in triplicate
to the address below. Please
reference the PMA number above to facilitate processing. If
there are multiple protocols being
finalized after PMA approval, please submit each protocol as a
separate PMA supplement. For
more information on post-approval studies, see the FDA
guidance document entitled, "Procedures for Handling Post-
Approval Studies Imposed by PMA Order"
(www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/ucm070974.htm#2).
Before making any change affecting the safety or effectiveness
of the device, you must submit a
PMA supplement or an alternate submission (30-day notice) in

24. accordance with 21 CFR 814.39.
All PMA supplements and alternate submissions (30-day notice)
must comply with the applicable requirements in 21 CFR
814.39. For more information, please refer to the FDA guidance
document entitled, "Modifications to Devices Subject to
Premarket Approval (PMA) - The PMA Supplement Decision-
Making Process"
(wwv.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/ucm089274.htm).
Page 4 – Mr. Watson
CDRH will notify the public of its decision to approve your
PMA by making available, among other information, a summary
of the safety and effectiveness data upon which the approval is
based. The information can be found on the FDA CDRH Internet
Home Page located at:
www.fda.gov/RadiologicalDevices/Products/DeviceApprovalsan
dClearances/PMAApprovals/default.htm.
Failure to comply with any post-approval requirement
constitutes a ground for withdrawal of
approval of a PMA. The introduction or delivery for
introduction into interstate commerce of a
device that is not in compliance with its conditions of approval
is a violation of law.
You are reminded that, as soon as possible and before
commercial distribution of your device, you must submit an
amendment to this PMA submission with copies of all approved
labeling in final printed form. Final printed labeling that is
identical to the labeling approved in draft form will not
routinely be reviewed by FDA staff when accompanied by a
cover letter stating that the" final printed labeling is identical to
the labeling approved in draft form. If the final printed labeling
is not identical, any changes from the final draft labeling should
be highlighted and explained in the amendment.

25. All required documents should be submitted in triplicate, unless
otherwise specified, to the address below and should reference
the above PMA number to facilitate processing. One of those
three copies may be an electronic copy (eCopy), in an electronic
format that FDA can process, review and archive.
U.S. Food and Drug Administration
Center for Devices and Radiological Health
PMA Document Mail Center - WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
If you have any questions concerning this letter, please contact
Atiq Chowdhury at 301-796-6391.
Sincerely yours,
Christy Foreman
Director
Office of Device Evaluation
Center for Devices and Radiological Health
Food and Drug Administration