GYNECARE TVT SECUR SYSTEM

K052401 · ETHICON, Inc. · PAH · Nov 28, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K052401
• Device Name: GYNECARE TVT SECUR SYSTEM
• Applicant: ETHICON, Inc.
• Product Code: PAH · General, Plastic Surgery
• Decision Date: Nov 28, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 Story

GYNECARE TVT SECUR System is a sterile, single-use sub-urethral sling for treating female stress urinary incontinence. Device consists of a PROLENE polypropylene mesh tape (approx. 1.1cm x 8.0cm) with ends reinforced by polyglactin 910/polydioxanone fleece coated with polydioxanone film to provide stiffness and tactile feedback. Two curved, stainless steel, single-use introducers deliver the implant. Designed for 'Hammock' or 'U' surgical approaches, the system enables a sub-urethral sling procedure without the delivery device or implant exiting the skin (exit-less). Used by surgeons in clinical settings to support the mid-urethra, potentially improving patient continence.

Clinical Evidence

Bench testing only. Verification testing confirmed the product meets established performance requirements.

Technological Characteristics

Sterile, single-use sub-urethral sling. Materials: PROLENE polypropylene mesh, polyglactin 910/polydioxanone fleece, polydioxanone film. Delivery: Two curved, stainless steel, single-use introducers. Form factor: 1.1cm x 8.0cm mesh. Operation: Mechanical placement of sub-urethral sling via Hammock or U approach.

Indications for Use

Indicated for female patients with stress urinary incontinence (SUI) caused by urethral hypermobility and/or intrinsic sphincter deficiency.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Predicate Devices

• GYNECARE TVT System
• GYNECARE TVT Obturator System

Submission Summary (Full Text)

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K052401
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NOV 2 8 2005

## Section 5

## 510(k) SUMMARY

| Statement | Information supporting claims of substantial equivalence, as<br>defined under the Federal Food, Drug, and Cosmetic Act,<br>respecting safety and effectiveness is summarized below. For the<br>convenience of the Reviewer, this summary is formatted in<br>accordance with the Agency's final rule “.... 510(k) Summaries<br>and 510(k) Statements .…” (21 CFR 807) and can be used to<br>provide a substantial equivalence summary to anyone requesting it<br>from the Agency.<br><br>MODIFIED DEVICE NAME:<br><br>GYNECARE TVT SECUR* System<br><br>PREDICATE DEVICE NAME:<br><br>GYNECARE TVT System and GYNECARE TVT Obturator<br>System |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | The GYNECARE TVT SECUR* device is a sterile, single patient<br>use device, consisting of one piece of undyed or blue<br>(Phtalocyanine blue, Color index Number 74160) PROLENE*<br>polypropylene mesh (tape) approximately 1.1cm x 8.0cm<br>(approximately ½ x 4 inches). The ends of the device will be<br>sandwiched between pieces of fleece made of polyglactin<br>910/polydioxanone coated with polydioxanone film. The coated<br>ends are added to facilitate passage (stiffens the ends) and<br>placement (tactile feel for the surgeon) of the mesh implant. Two<br>curved, stainless steel, single use introducers are used to deliver the<br>implant. The introducers are supplied fixed to the implant via a<br>wire through the coated ends and inserters. TVT SECUR is<br>designed to accommodate two surgical techniques: the “Hammock<br>approach” and the “U approach”. The GYNECARE TVT<br>Universal System is a less invasive 'exit less' device which will<br>enable the physician to perform a suburethal sling procedure<br>placing the mesh under the mid urethra without either the delivery<br>device or the implant exiting the skin. |

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

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052401\$_{2/2}\$

| Intended Use | A pubourethral sling for treatment of stress urinary incontinence<br>(SUI), for female urinary incontinence resulting from urethral<br>hypermobility and/or intrinsic sphincter deficiency. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications Statement | GYNECARE TVT SECUR* is indicated for the treatment of stress<br>urinary incontinence (SUI), for female urinary incontinence<br>resulting from urethral hypermobility and/or intrinsic sphincter<br>deficiency. |
| Technological<br>Characteristics | The modified device has the same technological characteristics as<br>the predicate device. The form, fit, function and method of<br>operation are similar. |
| Performance Data | Results of verification testing indicates that the product meets the<br>established performance requirements. |
| Conclusion | Based upon the 510(k) summaries and 510(k) statements (21 CFR<br>807) and the information provided herein, we conclude that the<br>subject device is substantially equivalent to the predicate devices<br>under the Federal Food, Drug and Cosmetic Act. |
| Contact | Patricia M. Hojnoski, M.S.<br>Senior Project Manager, Regulatory Affairs<br>ETHICON, INC.<br>Rt. 22 West<br>Somerville, NJ 08876-0151<br>Phone: [phone]<br>Fax: [phone] |
| Date | August 30, 2005 |

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

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. The eagle is facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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 NJ 08876

SEP 2 8 2012

Re: K052401 Trade/Device Name: GYNECARE TVT SECUR* System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: PAH Dated: October 25, 2005 Received: November 17, 2005

Dear Ms. Hojnoski:

This letter corrects our substantially equivalent letter of November 28, 2005.

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 (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 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

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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Benjamin R. Perkins

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Kes240)

## INDICATIONS FOR USE

| 510(k) Number (if known): | |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | GYNECARE TVT SECUR* 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 × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (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)

Saibare Buchur

(Division Sign-Off Division of General, Restorative, and Neurological Devices

510(k) Number K052401

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

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