GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR

K013718 · Gynecare, A Div. of Ethicon, Inc. · OTO · Jan 8, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K013718
• Device Name: GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR
• Applicant: Gynecare, A Div. of Ethicon, Inc.
• Product Code: OTO · General, Plastic Surgery
• Decision Date: Jan 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This mesh is intended for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Device Story

GYNEMESH PROLENE Soft Mesh is a nonabsorbable, synthetic surgical mesh used for pelvic floor repair. Constructed of knitted, extruded polypropylene monofilaments; design features reduced fiber diameter and interlinked junctions providing bi-directional elasticity and 50% greater flexibility than standard PROLENE mesh. Blue monofilaments provide contrast striping. Device is cut to desired shape/size by surgeon for implantation to reinforce or bridge fascial defects. Material is non-reactive and retains strength indefinitely. Intended for use in clinical settings by surgeons.

Clinical Evidence

No new clinical trials performed. Substantial equivalence supported by published clinical data on predicate PROLENE and MERSILENE meshes used for reinforcing or bridging fascial deficiencies of the pelvic wall. Bench testing conducted per FDA guidance for surgical mesh.

Technological Characteristics

Knitted polypropylene monofilament mesh. Features reduced diameter fibers and interlinked fiber junctions for bi-directional elasticity. 50% more flexible than standard PROLENE mesh. Nonabsorbable. Sterilized.

Indications for Use

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.

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

• PROLENE Soft (Polypropylene) Mesh
• PROLENE (Polypropylene) Mesh
• MERSILENE Mesh

Submission Summary (Full Text)

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

K013718

#### 8 2002 JAN

#### SECTION 7

## SUMMARY OF SAFETY AND EFFECTIVENESS

| 510(k) Summary of<br>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. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.<br><br>MODIFIED DEVICE NAME: GYNEMESH PROLENE Soft (Polypropylene) Mesh<br><br>PREDICATE DEVICE NAME: PROLENE Soft (Polypropylene) Mesh, PROLENE* (Polypropylene) Mesh and MERSILENE* Mesh<br><br>510(k) SUMMARY |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | GYNEMESH PROLENE Soft Mesh is constructed of knitted filaments of extruded polypropylene identical in composition to that used in PROLENE* Polypropylene Suture, Nonabsorbable Surgical Sutures, U.S.P. (ETHICON, INC.). The mesh affords excellent strength, durability and surgical adaptability, with sufficient porosity for necessary tissue ingrowth. Blue PROLENE monofilaments have been incorporated to produce contrast striping in the mesh. The mesh is constructed of reduced diameter monofilament fibers, knitted into a unique design that results in a mesh that is approximately 50 percent more flexible than standard PROLENE Mesh. This material, when used as a suture, has been reported to be non-reactive and to retain its strength indefinitely in clinical use. |
| | 510(k) SUMMARY, Continued |
| Description (continued) | GYNEMESH PROLENE Soft Mesh is knitted by a process which<br>interlinks each fiber junction and which provides for elasticity in<br>both directions. This construction permits the mesh to be cut into<br>any desired shape or size without unraveling. The bi-directional<br>elastic property allows adaption to various stresses encountered in<br>the body. |
| Intended Use | This mesh is intended for the repair of hernia or other fascial<br>defects that require the addition of a reinforcing or bridging<br>material to obtain the desired surgical result. |
| Indications Statement | This mesh is used for the repair of hernia or other fascial defects<br>that require the addition of a reinforcing or bridging material to<br>obtain the desired surgical result. |
| Technological<br>Characteristics | For technological characteristics, the values are the same as<br>PROLENE Soft Mesh and are less than those of PROLENE Mesh,<br>but greater than those of MERSILENE Mesh do. GYNEMESH<br>PROLENE Soft Mesh, PROLENE Soft Mesh and PROLENE Mesh are<br>constructed of polypropylene fibers. GYNEMESH PROLENE Soft M<br>and PROLENE Soft Mesh offers a 50% more flexible monofilament<br>mesh. |
| Performance Data | Nonclinical laboratory testing was not performed as there is no<br>change to the clinical intended use as compared to the two<br>predicate devices. Sufficient bench testing was conducted in<br>accordance with the FDA guidance document 'Guidance for the<br>Preparation of a Premarket Notification Application for a Surgical<br>Mesh.' |
| | Published clinical data on the use of PROLENE Mesh and<br>MERSILENE mesh was submitted to support the used of these<br>materials as reinforcing or bridging materials in fascial deficiencies<br>of the pelvic wall. |
| | Continued on next page |

Continued on next page

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

### SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

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

#### SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

Based on the 510(k) summaries and 510(k) statements (21 CFR Conclusions 807) and the information provided herein, we conclude that the new device is substantially equivalent to the Predicate Device under the Federal Food, Drug, and Cosmetic Act. Gregory R. Jones Contact Director, GYNECARE QA/RA ETHICON, Inc. Rt. #22, West Somerville, NJ 08876-0151

Date

November 6, 2001

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

Image /page/3/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 three lines forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circle's perimeter. The text is in all caps and is evenly spaced around the circle.

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

Mr. Gregory R. Jones Director, GYNECARE RA/QA Ethicon, Inc. P.O. Box 151 SOMERVILLE NJ 08876

SEP 2 8 2012

Re: K013718 Trade/Device Name: GYNEMESH PROLENE Soft Nonabsorbable Synthetic Surgical Mesh for Pelvic Floor Repair Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO Dated: November 6, 2001 Received: November 8, 2001

Dear Mr. Jones:

This letter corrects our substantially equivalent letter of January 8, 2002.

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

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

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

Enclosure

{5}------------------------------------------------

# INDICATION FOR USE ાળી રેમવ

510(k) Number (if known):

Device Name:

Indications for Use:

GYNEMESH PROLENE Soft (Polypropylene) Mesh is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

GYNEMESH PROLENE* Soft (Polypropylene) Mesh

lro for cmw

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

<013718 510(k) Number -

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The Counter Use

(Optional Format 1-2-9G)

GYNEMESH PROLENE* Soft (Polypropylene) Mesh ETHICON, Inc.

iii