GYNECARE TVT EXACT CONTINENCE SYSTEM

K132054 · ETHICON, Inc. · OTN · Aug 23, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K132054
• Device Name: GYNECARE TVT EXACT CONTINENCE SYSTEM
• Applicant: ETHICON, Inc.
• Product Code: OTN · General, Plastic Surgery
• Decision Date: Aug 23, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GYNECARE TVT EXACT™ Continence System is intended to be used as a pubourethral sling for treatment of female Stress Urinary Incontinence, resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Device Story

Pubourethral sling system for female stress urinary incontinence treatment. Components: PROLENE polypropylene mesh implant, clear plastic implant sheath, white trocar sheaths, stainless steel trocar shaft, plastic trocar handle. Surgeon inserts mesh via vaginal incision, positioning it through abdominal wall to provide mid-urethral support. Device is sterile, single-use. Provides mechanical support to urethra to restore continence. Used in clinical/surgical settings.

Clinical Evidence

Bench testing only. Design verification testing (trocar assembly tip bending strength) and design validation in simulated field use environments confirmed performance requirements met.

Technological Characteristics

PROLENE polypropylene mesh; stainless steel trocar shaft; plastic trocar handle; sterile, single-use; retropubic sling form factor.

Indications for Use

Indicated for female patients with stress urinary incontinence 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 EXACT™ Continence System (K100485)

Submission Summary (Full Text)

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# Summary of Safety and Effectiveness

Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below.

# Submitted by:

Susan Lin Manager, Regulatory Affairs Ethicon, Inc., a Johnson & Johnson Company Route 22 West, PO Box 151 Somerville, NJ 08876

**AUG 2 3 2013**

# Name/Classification of Device:

Class II in 21 CFR § 878.3300, Surgical Mesh (OTN)

## Trade Name:

GYNECARE TVT EXACT™ Continence System

### Predicate Devices:

GYNECARE TVT EXACT™ Continence System (K100485), ETHICON, Inc.

# Statement of Intended Use:

The GYNECARE TVT EXACT™ Continence System is intended to be used as a pubourethral sling for treatment of female Stress Urinany Incontinence, resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

#### Device Description:

The GYNECARE TVT EXACT™ Continence System consists of the following sterile, single-use components: GYNECARE TVT EXACT™ Continence System Trocar and Trocar Sheath / Implant Assembly.

The GYNECARE TVT EXACT™ Continence System Trocar Sheath / Implant Assembly consists of one piece of PROLENE™ Polypropylene Mesh (Implant) approximately 1/2 inch (1.1 cm) wide, 18 inches (45 cm) long, and approximately 0.027 inches (0.7 mm) thick. The implant is covered by a clear plastic Implant Sheath and held between two white Trocar Sheaths , which are bonded to the Implant and Implant Sheath.

The GYNECARE TVT EXACT™ Continence System Trocar consists of the stainless steel Trocar Shaft and the plastic Trocar Handle. The Trocar Shaft is designed to fit inside the white Trocar Sheaths on the GYNECARE TVT EXACT™ Continence System Implant / Trocar Sheath Assembly, and is used to position the GYNECARE TVT EXACT™ Continence System Implant in the patient from a vaginal incision up through the abdominal wall.

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# Summary of Technological Characteristics of Modified Device to Predicate Devices:

The principle of operation and fundamental scientific technology of the modified device are equivalent to the predicate device. They function in the same manner - Introducing a retropubic synthetic mesh sling in the patient from a vaginal incision to the abdominal skin that provides mid-urethral support.

## Performance Data:

Design Verification Testing Results (Trocar Assembly Tip Bending Strength Testing) indicates that modified device meets the established performance requirements.

Design Validation outcome confirms that the proposed changes do not have an unintended impact within actual or simulated field use environments in a mover consistent with the Instructions for Use of GYNECARE TVT EXACT™ and the surgeon's usual technique.

# Conclusions:

Based on the similarities to the predicate device identified in this submission as well as the outcome of design verification and design validationwe conclude that the modified device is substantially equivalent to the predicate devices under the Federal Food, Drug, and Cosmetic Act.

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Public Health Service

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

August 23. 2013

Ethicon, Inc. Ethicon Women's Health & Urology % Susan Lin Manager, Regulatory Affairs Route 22 West, P.O. Box 151 Somerville, NJ 08876

K132054 Re:

> Trade/Device Name: Gynecare TVT Exact™ Continence System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OTN Dated: July 25, 2013 Received: July 26, 2013

Dear Susan Lin:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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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Page 2 - Susan Lin

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 (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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,

# Herbert P. Lerner -S

for

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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510(k) Number (if known): K132054

Device Name: GYNECARE TVT EXACT™ Continence System

Indications for Use:

The GYNECARE TVT EXACT™ Continence System is intended to be used as a pubourethral sling for treatment of female Stress Urinary Incontinence, resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Prescription Use ____
(Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Herbert P. Lerner -S

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K132054 510(k) Number_