GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS

K071512 · ETHICON, Inc. · OTP · May 15, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K071512
• Device Name: GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS
• Applicant: ETHICON, Inc.
• Product Code: OTP · Obstetrics/Gynecology
• Decision Date: May 15, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5980
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The GYNECARE PROLIFT* Total, Anterior, and Posterior Pelvic Floor Repair Systems, through the placement of GYNECARE GYNEMESH PS* PROLENE Soft Mesh, are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect. The GYNECARE PROLIFT+M* Total, Anterior, and Posterior Pelvic Floor Repair Systems, through the placement of GYNECARE GYNEMESH M* Partially Absorbable Mesh, are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

Device Story

System comprises pre-cut mesh implants and specialized surgical instruments (guides, retrieval devices, cannulas) for pelvic floor repair. Prolift systems utilize non-absorbable mesh; Prolift+M systems utilize partially absorbable mesh. Used by surgeons in clinical settings to treat vaginal wall prolapse. Instruments facilitate precise placement of mesh to provide mechanical support or bridge fascial defects. Mesh acts as permanent or partially absorbable reinforcement to stabilize pelvic floor structures. Benefit includes long-lasting stabilization of fascial tissues.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing and cadaveric procedural performance evaluation. Biological reactivity assessed per ISO 10993-1.

Technological Characteristics

Mesh implants made of non-absorbable or partially absorbable polymers identical to predicate materials. System includes manual surgical instruments (guides, retrieval devices, cannulas). Biocompatibility tested per ISO 10993-1. Non-electronic, mechanical device.

Indications for Use

Indicated for tissue reinforcement and stabilization of pelvic floor fascial structures in patients with vaginal wall prolapse requiring surgical intervention.

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* PROLENE* Soft Mesh (K013718)
• ULTRAPRO* Mesh (K033337)
• AMS APOGEE Vault Suspension System (K040537)
• AMS PERIGEE System (K040623)

Submission Summary (Full Text)

{0}------------------------------------------------

K071512
pg 1 of 2

# Summary of Safety and Effectiveness

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

### Submitted by:

Bryan A. Lisa Regulatory Affairs Project Manager ETHICON, Inc., A Johnson & Johnson Company Route 22 West, PO Box 151 Somerville, NJ 08876

MAY 1 5 2008

#### Name/Classification of Device:

Class II in 21 CFR § 878.3300, Surgical Mesh (0TP) Class I in 21 CFR § 878.4800, Manual surgical instrument for general use

#### Trade Name:

GYNECARE PROLIFT Total, Anterior, and Posterior Pelvic Floor Repair Systems GYNECARE PROLIFT+M* Total, Anterior, and Posterior Pelvic Floor Repair Systems

#### Predicate Devices:

- GYNECARE GYNEMESH PS* PROLENE* Soft Mesh (ETHICON, Inc.) K013718 .
- ULTRAPRO* Mesh (ETHICON, Inc.) K033337
- AMS APOGEE Vault Suspension System (American Medical Systems, Inc.) K040537
- AMS PERIGEE System (American Medical Systems, Inc.) K040623 .

Statement of Intended Use:

The GYNECARE PROLIFT* Total, Anterior, and Posterior Pelvic Floor Repair Systems, through the placement of GYNECARE GYNEMESH PS* PROLENE Soft Mesh, are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

The GYNECARE PROLIFT+M* Total, Anterior, and Posterior Pelvic Floor Repair Systems, through the placement of GYNECARE GYNEMESH M* Partially Absorbable Mesh, are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

#### Device Description:

The GYNECARE PROLIFT Total, Anterior, and Posterior Pelvic Floor Repair Systems consist of pre-cut non-absorbable mesh implants and a set of instruments to facilitate mesh implant placement. The following table summarizes the instruments included with each system:

#### 510(k) Summary

{1}------------------------------------------------

| REPAIR SYSTEM | COMPONENTS | | | |
|---------------|--------------|-------|-------------------|----------|
| | Mesh Implant | Guide | Retrieval Devices | Cannulas |
| Total | 1 Total | 1 | 6 | 6 |
| Anterior | 1 Anterior | 1 | 4 | 4 |
| Posterior | 1 Posterior | 1 | 2 | 2 |

The GYNECARE PROLIFT+M Total, Anterior, and Posterior Pelvic Floor Repair Systems consist of pre-cut partially absorbable mesh implants and a set of instruments to facilitate mesh implant placement. The following table summarizes the instruments included with each system:

1071512

2022

| REPAIR SYSTEM | COMPONENTS | | | |
|---------------|--------------|-------|-------------------|----------|
| | Mesh Implant | Guide | Retrieval Devices | Cannulas |
| Total | 1 Total | 1 | 6 | 6 |
| Anterior | 1 Anterior | 1 | 4 | 4 |
| Posterior | 1 Posterior | 1 | 2 | 2 |

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

The modified devices have similar technological characteristics as the predicate devices.

GYNECARE PROLIFT: Like currently marketed devices, the implantable component is a sterile, mesh implant intended for the repair of pelvic floor defects. The mesh implant component of the proposed device is made of nonabsorbable polymers, which are identical to those found in GYNECARE GYNEMESH PS, currently marketed by ETHICON, Inc. ....

GYNECARE PROLIFI+M: Like currently marketed devices, the implantable component is a sterile, mesh implant intended for the repair of pelvic floor defects. The mesh implant component of the proposed device is made of nonabsorbable and absorbable polymers, which are identical to those found in ULTRAPRO Mesh, currently marketed by ETHICON, Inc.

#### Performance Data:

Biological reactivity of the materials has been assessed using methods specified in ISO 10993-1. and the materials were found to be acceptable for their intended uses. Results of functional performance testing (bench and cadaver testing) indicate that the proposed device meets or exceeds all functional requirements, based on FDA's Guidance Document "Guidance for the Preparation of a Premarket Notification Arplication for a Surgical Mesh". Preclinical modelling was used to evaluate procedural performance of the systems.

#### 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.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings outstretched, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle emblem.

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

SEP 2 8 2012

Ethicon, Inc. % Mr. Bryan A. Lisa Route 22 West P.O. Box 151 SOMERVILLE NJ 08876

Re: K071512

Trade/Device Name: Gynecare Prolifi™ Total, Anterior, and Posterior Pelvic Floor Repair Systems; Gynecare Prolift +MTM Total, Anterior, and Posterior Pelvic Floor Repair Systems

Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP Dated: February 22, 2008 Received: February 25, 2008

Dear Mr. Lisa:

This letter corrects our substantially equivalent letter of May 15, 2008.

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

{3}------------------------------------------------

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/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

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

{4}------------------------------------------------

BAL-2007-002

## Indications for Use

## 510(k) Number (if known): K071512

## Device Name: GYNECARE PROLIFT* and GYNECARE PROLIFT+M* Total, Anterior, and Posterior Pelvic Floor Repair Systems

Indications for Use:

The GYNECARE PROLIFT* Total, Anterior, and Posterior Pelvic Floor Repair Systems are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

The GYNECARE PROLIFT+M* Total, Anterior, and Posterior Pelvic Floor Repair Systems, through the placement of GYNECARE GYNEMESH M* Partially Absorbable Mesh, are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

*Trademark.

(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)

NILREOL for reims

Division of General, Restorative, and Neurological Devices

510(k) Number K071512

INDICATIONS FOR USE

ETHICON CONFIDENTIAL