GORE POLYPROPYLENE HERNIA MESH

K043081 · W. L. Gore & Associates, Inc. · FTL · Dec 22, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K043081
• Device Name: GORE POLYPROPYLENE HERNIA MESH
• Applicant: W. L. Gore & Associates, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Dec 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The GORE POLYPROPYLENE Hernia Mesh is a sterile, non-absorbable, knitted polypropylene monofilament mesh intended for the reconstruction of hernias and soft tissue deficiencies. Examples of applications where the GORE POLYPROPYLENE HERNIA MESH may be used include, but are not limited to: Hernia repair (inguinal, femoral, umbilical, abdominal, incisional, epigastric, and intermuscular). Muscle flap reinforcement

Device Story

Non-absorbable, knitted 100% polypropylene monofilament mesh; used for surgical reinforcement of hernias and soft tissue deficiencies. Provided sterile for single use; available in various rectangular and pre-shaped oval configurations. Operated by surgeons in clinical settings; mesh trimmed to size with surgical scissors; secured to host tissue via sutures or tacks. Provides mechanical support to abdominal wall or soft tissue defects; facilitates tissue repair. Benefits include structural reinforcement of weakened tissue areas.

Clinical Evidence

Bench testing only. Device integrity testing performed to verify physical properties and performance against specified requirements; no clinical data provided.

Technological Characteristics

Material: 100% polypropylene monofilament. Construction: Knitted, non-absorbable mesh. Form factor: Sheets (rectangular 2.5x10 cm to 25x35.5 cm) and pre-shaped ovals (6.5x13 cm). Sterilization: Sterile, single-use.

Indications for Use

Indicated for reconstruction of hernias (inguinal, femoral, umbilical, abdominal, incisional, epigastric, intermuscular) and soft tissue deficiencies, including muscle flap reinforcement. For prescription use.

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

• Bard® Mesh (Davol, Inc.)
• Prolene TM Soft Polypropylene Mesh (K001122)
• Atrium Lite "11 Mesh (K002093)

Submission Summary (Full Text)

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

K043081 1/5

GORE POLYPROPYLENE HERNIA MESH

DEC 22 2004

# 510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE

| Proprietary Name: | GORE POLYPROPYLENE HERNIA MESH |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Polypropylene Mesh |
| Classification Name: | Mesh, surgical, polymeric |
| Device Classification: | Class II |
| Product Classification and Code: | 878.3300, FTL |
| Classification Panel: | General and Plastic Surgery Devices |
| Establishment Registration Number: | 2025240 |
| Contact Person: | Michael Ivey<br>Regulatory Affairs<br>Medical Products Division<br>W. L. Gore & Associates, Inc.<br>3450 West Kiltie Lane<br>Flagstaff, AZ 86002-0500<br>Telephone: [phone]<br>Facsimile: [phone]<br>E-mail: [e-mail] |

## Performance Standards

Performance standards do not currently exist for these devices. None established under Section 514.

Image /page/0/Picture/8 description: The image contains the Gore logo on the left and the word "Confidential" on the right. The Gore logo consists of the word "GORE" in bold letters with a right-pointing arrow above the word. Below the word "GORE" is the text "Creative Technologies Worldwide" in a smaller font. The word "Confidential" is in a simple sans-serif font and is positioned to the right of the Gore logo. The image is simple and contains only these two elements.

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

#### Device Description

The GORE POLYPROPYLENE HERNIA MESH is used as reinforcement during surgical repairs of hernias and other soft tissue deficiencies.

GORE POLYPROP YLENE HERNIA MESH is comprised of non-absorbable, knitted 100% polypropylene monofilaments. The GORE POLYPROPYLENE HERNIA MESH is provided STERILE for single use only and offered in several sizes and shapes to accommodate the type and approach of the operation.

The GORE POLYPROPYLENE HERNIA MESH will be supplied in sheets ranging from a rectangular configuration that is 2.5 x 10 cm to a rectangular configuration that is 25 x 35.5 cm. Also available is a pre-shaped oval configuration that is 6.5 x 13 CIII.

The GORE POLYPROPYLENE HERNIA MESH can be trimmed to the desired size and shape using sharp surgical scissors. The mesh should be sutured or tacked to host tissue avoiding excessive tension.

#### Indications for Use

The GORE POLYPROPYLENE Hernia Mesh is a sterile, non-absorbable, knitted polypropylene monofilament mesh intended for the reconstruction of hernias and soft tissue deficiencies. Examples of applications where the GORE POLYPROPYLENE HERNIA MESH may be used include, but are not limited to:

Hernia repair (inguinal, femoral, umbilical, abdominal, incisional, epigastric, and intermuscular).

Muscle flap reinforcement

#### Substantially Equivalent Devices

In W. L. Gore & Associates, Inc.'s opinion, the GORE POLYPROPYLENE HERNIA MESH is believed to be substantially equivalent to the following predicate devices currently in interstate commerce with respect to comparable features, materials of construction and intended use.

- Bard® Mesh (Davol, Inc. Cranston, RI) Pre-amendment Device .
- Prolene TM Soft Polypropylene Mesh (Ethicon Inc, Somerville, NJ) -. K001122
- Atrium Lite "11 Mesh (Atrium Medical Corp, Hudson, New Hampshire) ● - K002093

Image /page/1/Picture/17 description: The image contains the Gore logo on the left side and the word "Confidential" on the right side. The Gore logo consists of the word "GORE" in bold, stylized letters, with a right-pointing arrow above it. Below the word "GORE" are smaller words, "Creative Technologies Worldwide". The word "Confidential" is written in a simple, sans-serif font.

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

#### GORE POLYPROPYLENE HERNIA MESH

#### Summary of Studies

W. I. Gore & Associates, Inc. performed device integrity testing to support that the GORE POLYPROPYLENF: HERNIA MESH is equivalent to the predicate devices. All device integrity test results for the GORE POLYPROPYLENE HERNIA MESH met specified requirements.

### Conclusion (Statement of Equivalence)

Through data and information presented, numerous similarities support a determination of substantial equivalence, and therefore market clearance of the. GORE POLYPROPYLENE HERNIA MESH through this 510(k) Premarket Notification.

Image /page/2/Picture/7 description: The image contains the Gore logo on the left and the word "Confidential" on the right. The Gore logo consists of the word "GORE" in bold letters with a stylized arrow pointing to the right. Below the word "GORE" are smaller words that are difficult to read. The word "Confidential" is written in a simple, sans-serif font.

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized stripes representing its wings or body.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 2 2004

Mr. Michael Ivey Regulatory Affairs Medical Products Division W.L. Gore & Associates, Inc. 3450 West Kiltie Lane P.O. Box 2400 Flagstaff, Arizona 86003

Re: K043081

K045081
Trade/Device Name: Gore Polypropylene Hernia Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: November 5, 2004 Received: November 8, 2004

Dear Mr. Ivey:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premained is substantially equivalent (for the indications referenced above and nave determined the acresed predicate devices marketed in interstate for use stated in the encrosule) to regary manical povice Amendments, or to commerce prior to May 28, 1776, the enactified in accordance with the provisions of the Federal Food. Drug, devices that have been reclassified in accordance what a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval of and Cosmetic Act (Act) that do not require subject to the general controls provisions of the Act. The You may, inerelore, market the device, basjoct of the more of registration, listing of general controls provisions of the field is a prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major filly be subject to such additional controlial "Life 21, Parts 800 to 898. In addition, FDA may be found in the Code of I casial Regerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri- 3 issuated of a statevice complies with other requirements of the Act that IDA has made a decerminations administered by other Federal agencies. You must or any Federal statutes and regulations and instituting, but not limited to: registration and listing (21 Comply with an the Act 810 cm . 11 CFR Part 801); good manufacturing practice requirements as set CFN Fart 607), labeling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 - Mr. Michael Ivey

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icher will and w you're begin finding of substantial equivalence of your device to a legally promatice notification. The classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you dosire specific at not any at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general micrination and Consumer Assistance at its toll-free number [phone] or Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

uriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## Indications for Use

510(k) Number (if known): K043081

#### GORE POLYPROPYLENE HERNIA MESH

Indications for Use:

Device Name:

The GORE POL YPROPYLENE Hernia Mesh is a sterile, non-absorbable, knitted Pholypropylene monofilament mesh intended for the reconstruction of hernias and soft tissue deficiencies. Examples of applications where the GORE® SOLYPROPYLENE HERNIA MESH may be used include, but are not limited to:

Hernia repair (inguinal, femoral, umbilical, abdominal, incisional, epigastric, and intermuscular).

Muscle flap reinforcement

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

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

Page 1 of 1

**510(k) Number** K04308/