GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS

K063562 · ETHICON, Inc. · OTP · Feb 26, 2007 · Obstetrics/Gynecology

Device Facts

• Record ID: K063562
• Device Name: GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS
• Applicant: ETHICON, Inc.
• Product Code: OTP · Obstetrics/Gynecology
• Decision Date: Feb 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5980
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The GYNECARE PROSIMA Pelvic Floor Repair Systems, through the placement of GYNECARE GYNEMESH* PS Nonabsorbable PROLENE* Soft Mesh Implants, are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor, either as mechanical support or bridging material for the fascial defect. The Systems provide maintenance of the vaginal canal during the period of healing following surgical repair of vaginal wall prolapse, while supporting the position of the Mesh Implants.

Device Story

System comprises pre-cut nonabsorbable polypropylene mesh implants, vaginal support balloon assembly, and manual insertion instruments; used by surgeons in clinical settings for pelvic floor repair. Mesh provides structural reinforcement for fascial defects; balloon assembly, inflated with air, maintains vaginal canal patency and supports mesh position during initial 24-hour healing period; silicone support device remains for up to four weeks to facilitate tissue in-growth. System reduces risk of contracture, stenosis, and adhesions post-surgery. Benefits include stabilized pelvic floor anatomy and improved healing outcomes for vaginal wall prolapse.

Clinical Evidence

No clinical data. Evidence consists of bench testing and cadaver testing to verify functional performance and material biocompatibility per ISO 10993-1.

Technological Characteristics

System includes nonabsorbable polypropylene mesh (PROLENE) and silicone vaginal support balloon. Materials assessed per ISO 10993-1. Manual insertion instruments included. Mechanical support provided by mesh; post-operative canal maintenance provided by air-inflated silicone balloon. No software or electronic components.

Indications for Use

Indicated for patients requiring tissue reinforcement and stabilization of pelvic floor fascial structures, including mechanical support or bridging for fascial defects, and maintenance of the vaginal canal following surgical repair of vaginal wall prolapse.

Regulatory Classification

Identification

Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).

Predicate Devices

• GYNECARE GYNEMESH PS Nonabsorbable PROLENE Soft Mesh
• Silimed Vaginal Stent

Submission Summary (Full Text)

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K063562 1/2

# 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:

Patrice Napoda Mgr. Requlatory Affairs Ethicon, Inc., A Johnson & Johnson Company Route 22 West, PO Box 151 Somerville, NJ 08876

FEB 26 2007

#### Name/Classification of Device:

Class II in 21 CFR § 878.3300, Surgical Mesh (OTP) Class II in 21 CFR§ 884.3900, Vaginal Stent Class I in 21 CFR § 880.6960 Irrigating syringe Class I in 21 CFR § 878.4800 Manual surgical instrument for general use

#### Trade Name:

GYNECARE PROSIMA* Pelvic Floor Repair Systems

#### Predicate Devices:

GYNECARE GYNEMESH* PS Nonabsorbable PROLENE* Soft Mesh Silimed Vaginal Stent

#### Statement of Intended Use:

The GYNECARE PROSIMA Pelvic Floor Repair Systems, through the placement of GYNECARE GYNEMESH* PS Nonabsorbable PROLENE* Soft Mesh Implants, are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor, either as mechanical support or bridging material for the fascial defect. The Systems provide maintenance of the vaginal canal during the period of healing following surgical repair of vaginal wall prolapse, while supporting the position of the Mesh Implants.

#### DESCRIPTION

The GYNECARE PROSIMA Anterior, Posterior, and Combined Pelvic Floor Repair Systems consist of pre-cut GYNECARE GYNEMESH PS Mesh Implant(s), and instruments to facilitate Mesh Implant placement and postoperative support. The following table summarizes the components included with each System:

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| | COMPONENTS | | | | |
|-------------------------------------|--------------------------------------|----------------------------------------------------------------|-----------------------------|------------------------------|----------------|
| PELVIC<br>FLOOR<br>REPAIR<br>SYSTEM | Mesh<br>Implant in<br>Carrier<br>(A) | Vaginal<br>Support<br>Device -<br>Balloon<br>Assembly<br>(B&C) | Anterior<br>Inserter<br>(D) | Posterior<br>Inserter<br>(E) | Syringe<br>(F) |
| Anterior | 1 | 1 | 1 | | 1 |
| Posterior | 1 | 1 | | 1 | 1 |
| Combined | 2 | 1 | 1 | 1 | 1 |

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

The modified device has similar technological characteristics to those of the predicate devices. Like currently marketed devices, the system contains a sterile, mesh implant made from GYNECARE GYNEMESH* PS Nonabsorbable Prolene Soft Mesh and is intended for the repair of fascial structures of the pelvic floor. Like several of the currently marketed devices, the mesh implant within the proposed device is made of nonabsorbable polymers. The polymers used are identical to those found in GYNECARE GYNEMESH* PS Nonabsorbable Prolene Soft Mesh, currently marketed by Ethicon. Inc.

The Vaginal Support Device-Balloon Assembly of the system, as in the predicate vaginal stent, provides support to the vaginal canal after surgery, thus reducing the possibility of contracture, stenosis and vaginal canal adhesions. The balloon portion of the assembly is inflated with air, similar to the predicate device, filling the vaginal canal space for the first twenty-four hours. The Vaginal Support Device of the assembly is made of silicon, as is the predicate device, and remains in the vaginal canal for up to four weeks, providing continuing support to the vagina and the Mesh Implants as tissue in-growth occurs. The predicate vaginal stent is intended to remain in the vaginal canal for up to twelve weeks while tissue healing occurs.

## Performance Data:

Biological reactivity of the materials has been assessed using methods specified in ISO Standard 10993-1, with results to date demonstrating that the materials are acceptable for the intended use. Results of functional performance testing (bench and cadaver testing) indicate that the proposed device meets or exceeds all functional requirements.

## Conclusions:

Based on the similarities to the predicate devices identified in this submission, we conclude that the modified device is substantially equivalent to the predicate devices under the Federal Food, Drug, and Cosmetic Act.

· Trademark of Ethicon, Inc.

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

Ms. Patrice Napoda Sr. Project Manger Ethicon, Inc. Route 22 West, P.O. Box 151 SOMERVILLE NJ 08876

SEP 2 8 2012

Re: K063562 Trade/Device Name: GYNECARE PROSIMA* Pelvic Floor Repair Systems Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP Dated: January 25, 2007 Received: January 26, 2007

Dear Ms. Napoda:

This letter corrects our substantially equivalent letter of February 26, 2007.

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Benjamin R. Perkins

Beniamin 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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Kass 62

Indications for Use

510(k) Number (if known): Ko C 3 C 3 C 3 C 3 C 3 C 3 C 3 C 3 C 3 C 3 C 3 C 3 C 3

Device Name: GYNECARE PROSIMA* Pelvic Floor Repair Systems

Indications for Use:

The GYNECARE PROSIMA* Pelvic Floor Repair Systems, through the placement of GYNECARE GYNEMESH* PS Nonabsorbable PROLENE Soft Mesh, are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor, either as mechanical support or bridging material for the fascial defect. The Systems provide maintenance of the vaginal canal during the period of healing following surgical repair of vaginal wall prolapse, while supporting the position of the Mesh Implants.

*Trademark.

Prescription Use ___________________________________________________________________________________________________________(21 CFR 801 Subpa (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)

Neil R. Oskie

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

510(k) Number K063562

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