GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL

K063435 · W. L. Gore & Associates, Inc. · FTL · Nov 28, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K063435
• Device Name: GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL
• Applicant: W. L. Gore & Associates, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Nov 28, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GORE DUALMESH® PLUS and GORE MYCROMESH® PLUS Biomaterials are indicated for use in the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects.

Device Story

GORE DUALMESH® PLUS and GORE MYCROMESH® PLUS are surgical patch materials composed of expanded polytetrafluoroethylene (ePTFE) impregnated with antimicrobial agents (chlorhexidine diacetate and silver carbonate). The material features a microporous node and fibril structure with regularly spaced macropores to facilitate host tissue fixation and vascularization. The antimicrobial agents serve as a preservative to prevent bacterial colonization during the short-term postoperative period. The device is intended for use by surgeons in clinical settings for hernia repair and soft tissue reconstruction. It is provided in various thicknesses (1 mm, 1.5 mm, and 2 mm) to address specific surgical needs.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison of design, material, and performance attributes to the predicate device.

Technological Characteristics

Material: expanded polytetrafluoroethylene (ePTFE). Additives: chlorhexidine diacetate and silver carbonate. Structure: microporous node and fibril with macropores. Thicknesses: 1 mm, 1.5 mm, 2 mm. Energy source: none (passive implant).

Indications for Use

Indicated for patients requiring reconstruction of hernias, soft tissue deficiencies, or temporary bridging of fascial defects.

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

• GORE DUALMESH® PLUS BIOMATERIAL (K946106)

Submission Summary (Full Text)

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

K063435

## 510(k) Summary of Substantial Equivalence (21 CFR 807.92)

## Applicant:

W.L. Gore and Associates Inc. 3250 W. Kiltie Lane Flagstaff, AZ 86001

#### Contact person:

Michael E. Ivey

## Date Prepared:

November 10, 2006

## Trade or Proprietary Name:

GORE DUALMESH® PLUS BIOMATERIAL GORE MYCROMESH® PLUS BIOMATERIAL

## Common or Usual Name:

Polymeric Surgical Mesh

#### Classification

21 CFR 878.3300, FTL: General and Plastic Surgery Devices

#### Device Predicate:

# GORE DUALMESH® PLUS BIOMATERIAL (K946106)

## Device Description:

The GORE DUALMESH® PLUS and GORE MYCROMESH® PLUS Biomaterials are patch materials composed solely of expanded polytetrafluoroethylene (ePTFE) loaded with two antimicrobial preservative agents, chlorhexidine diacetate and silver carbonate (referred to as PLUS). The device incorporates a microporous node and fibril structure with regularly spaced macropores. This structure ensures early fixation to host tissue with minimal foreign body response and extensive vascularization. The PLUS acts as a preservative and prevents bacterial colonization of the device during the short-term postoperative period. The GORE DUALMESH PLUS Biomaterial is intended for reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. The device is available in 1 mm, 1.5 mm, and 2 mm thicknesses.

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

Korb 34 3(

#### Statement of Intended Use:

2/2

The GORE DUALMESH® PLUS and GORE MYCROMESH® PLUS Biomaterials are indicated for use in the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects.

## Substantial Equivalence:

Tests, assessments, and comparisons contained within this submission demonstrate that the GORE DUALMESH® PLUS and GORE MYCROMESH® PLUS Biomaterials are substantially equivalent to the predicate device in terms of composition, design, intended use, mode of operation and performance attributes.

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

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, with the eagle's head facing left and its wings represented by three curved lines.

Public Health Service

NOV 2 8 7005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K063435

Trade/Device Name: GORE DUALMESH® PLUS Biomaterial GORE MYCROMESH® PLUS Biomaterial Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: November 10, 2006 Received: November 13, 2006

Dear Mr. Ivey:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the

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

Page 2 - Mr. Michael Ivey

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a 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 contact the Office of Compliance 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 Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

K063430

#### XIV. Indications for Use Statement

510(k) Number (if known): TBD

GORE DUALMESH® PLUS Biomaterial Device Name:

GORE MYCROMESH® PLUS Biomaterial

Indications for Use: Reconstruction of Hernias and Soft Tissue Deficiencies and for the Temporary Bridging of Fascial Defects

Prescription Use ﮯ (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)

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

3435

**510(k) Number**