FDA 510(k) submission - redacted

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 Version

FOI - Page 1 of 223

510K SUMMARY - 5 pages 1

CORRESPONDENCE - 11 pages 6

ORIGINAL - 87 pages 17

REVIEWER INFORMATION - 27 pages 104

SUPPLEMENT - 91 pages 131

FOI - Page 2 of 223

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 Agency's 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.

000016

FOI - Page 3 of 223

/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.i7

FOI - Page 4 of 223

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.
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 FDA's 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 Act's 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


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

Enclosure

FOI - Page 6 of 223

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,

510(k) Number 6S ' a)

GYNECARE TVT SECUR System
GYNECARE, a division of ETHICON. Inc.

FOI - Page 7 of 223

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

9200 Corporate Boulevard
NOV 2 8 2005 Rockville MD 20850

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 FDA's 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 Act's 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


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
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

2_
FOI - Page 9 of 223

I sr~so
INDICATIONS FOR USE


Device Name: GVNECARE TVT SECITR* Systemi

incontinence (SUI) resulting from urethral hypermobility and/or

Prescription Use X AND/OR Over-The-Counter Use ___

(Part 21 CFR 801 Subpart 0) (21 CFR 801 Subpart C)

NEEDED)


Division of General, Restorative,

510(k) Number 9 )

(GYNECARETVT SECi. It Systerm
GYNECARE, a di vision of ETI-1ICON, Inc.

FOI - Page 10 of 223

Pages 11 through 18 have been removed.

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



Section 1: Medical Device User Fee Cover Sheet (Form FDA 8601)

000001


Pages 21 and 22 have been removed.

Section 2: CDRH Premarket Review Submission Cover Sheet


000004


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


( )

( )

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

000005


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
5'Continued 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.


000006


* a]eII La0iFimI* 6'eW 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.


000007


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. ~ CF'MI I: tII IrL,-111 Ik'tI
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


GYNECARE ( 908 ) 218-2893

P.O. Box 151; Route 22 West ( 908 ) 218-2595


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


(

(


FDA Establishment Registration Number Manufacturer Contract Sterilizer

[] Add n5Delete Contract Manufacturer 5 Repackager / Relabeler


(




000008


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

Organization

2

Organization

3

Organization

4

Organization

5

Organization

6

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:

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


000009


Section 3: 510(k) Cover Letter



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, a division of ETHICON, Inc. L_

0000o0


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
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:


000011


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, a division of ETHICON, Inc. /A

000012


Section 4: Indications for Use Statement

000013
AY,)


INDICATIONS FOR USE


Device Name: GYNECARE TVT SECTJR* System

incontinence (SUL) resulting from urethral hypermobility and/or

Prescription Use _A AND/OR Over-The-Counter Use ___

(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

NEEDED)


GYNECARE TVT SECIJR Systeim
GYNECARE. a division of ETHICON, Inc.


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 Agency's 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:


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
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.


000016


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.
ETHICON, INC.
Rt. 22 West
Somerville, NJ 08876-0151

Phone: (908) 218-2893
Fax: (908) 218-2595

Date August 30, 2005


0OD017


Section 6: Truthful and Accuracy Statement

000018


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.

Senior Project Manager
GYNECARE, a division of ETHICON

Date


000019


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.

0000£0


Section 8: Financial Certification or Disclosure Statement

This section is not applicable since clinical study information is not required as part of this
submission.


000021


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).

000022
Sts-

Section 10: Executive Summary


00002,3
stA

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

Device Comparison Table:

Refer to Section 12.

Summary of Performance Testing:

Refer to Section 19.


000024


Section 11: Device Description


00002


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, a division of ETHICON, Inc. 0 0 2


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, a division of ETHICON, hic. 0 0 2


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, a division of ETHICON, Inc. 0 0 2


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.


000029


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


000030


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.

000031


I

o

OOMWARSTW I
soomsy1fto

000032

FOI - Page 51 of 223 MMM POS
, - -HHH.
; ..
u
M -m.......
....... . ..-

Section 12: Substantial Equivalence Discussion


000 33


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


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
000035


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.


000036


Section 13: Proposed Labeling

000037


SECTION 13

PROPOSED DRAFT LABELING


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, a division of ETHICON, Inc. 000038

005

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
d'in...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

01001039


nil !

Ii
J,.
~~ ~ ~ ~ ~ ~ n Law

;~~~x
ii

1 ~~~~000040


Li %

oll!

,I!'

unt!Jil

I fi

tIiifll
iitI~~~~~~~~~~~~~~~~~
L~~~~~~~~~~~~~~~~~~~~~~~~iii

'!i
Ji (4 )

* (4

ihill

TVTS

FLO-TXXXXXXX

OtEAETV? SE

LO XXXXX

GYECARE IV SEWtR-

TVTS -

OYECARE TV SECJW

TVTS

xxxxxxx
FOT

Patient Tracking
Labels

000042


Pages 62 through 77 have been removed.

Predicate Labeling

GYNECARE TVT Obturator System

GYNECARE TVT SECUR System 0OO0s9


FDA 510(k) submission - redacted

FDA 510(k) submission - redacted

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