DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL

K022782 · W. L. Gore & Associates, Inc. · FTL · Sep 10, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K022782
• Device Name: DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL
• Applicant: W. L. Gore & Associates, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Sep 10, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DualMesh® EMERGE Biomaterial and DualMesh® EMERGE PLUS Biomaterial are indicated for use in the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. The antimicrobial preservative agents act as preservatives, thereby inhibiting bacterial colonization of the device for up to ten days post-implantation. The removable, tinted silicone component facilitates introduction and fixation of the biomaterial. Following fixation of the biomaterial, the silicone component is easily removed.

Device Story

DualMesh® EMERGE and EMERGE PLUS are surgical meshes composed of expanded polytetrafluoroethylene (ePTFE) with one open and one closed microstructure surface. The PLUS version includes antimicrobial agents (chlorhexidine diacetate and silver carbonate). A removable, tinted silicone component is attached to the closed surface to assist surgeons with device introduction and fixation; it is removed post-fixation and is not implanted. Used in surgical settings for hernia repair and soft tissue reconstruction. The device provides a permanent or transient scaffold for tissue support. The antimicrobial agents serve as preservatives to inhibit bacterial colonization for up to ten days post-implantation.

Clinical Evidence

No clinical data. Evidence consists of bench testing (mechanical strength, material characterization), in-vitro antimicrobial activity testing, and in-vivo animal testing (histological tissue response).

Technological Characteristics

Materials: ePTFE, silicone (removable), chlorhexidine diacetate, silver carbonate. Structure: Dual-surface (open/closed microstructure). Energy source: None. Connectivity: None. Sterilization: Not specified (unchanged from predicate).

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-TEX® DualMesh® Biomaterial (K022782)
• GORE-TEX® DualMesh® PLUS Biomaterial (K022782)

Submission Summary (Full Text)

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K022782

SEP 1 0 2002

## Attachment IV Special 510(k) Premarket Notification DualMesh® EMERGE Biomaterial and DualMesh® EMERGE PLUS Biomaterial

### Premarket Notification 510(k) Summary

- A. Submitter W.L. Gore and Associates, Inc. 3750 W. Kiltie Lane P.O. Box 900 Flagstaff, AZ 86002-0900
Contact : R. Larry Pratt

Date Submitted: August 21, 2002

- B. Applicant Device
Trade Name: DualMesh® EMERGE Biomaterial and DualMesh® EMERGE PLUS Biomaterial

Classification Name: Surgical Mesh

- Applicant Device Description C.
Biocompatible, expanded polytetrafluoroethylene (ePTFE) with a removable, tinted silicone component (DualMesh® EMERGE Biomaterial). Biocompatible, ePTFE loaded with antimicrobial preservative agents chlorhexidine diacetate and silver carbonate with a removable, tinted silicone component (DualMesh® EMERGE PLUS Biomaterial). Both devices have one open microstructure surface and one closed microstructure surface. The open microstructure surface is textured with a "ridges and valleys" pattern to aid in surface identification and proper surface orientation.

- D. Applicant Device Indications For Use
DualMesh® EMERGE Biomaterial and DualMesh® EMERGE PLUS Biomaterial are indicated for use in the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. The antimicrobial preservative agents act as preservatives, thereby inhibiting bacterial colonization of the device for up to ten days post-implantation. The removable, tinted silicone component facilitates introduction and fixation of the biomaterial. Following fixation of the biomaterial, the silicone component is easily removed.

- E . Predicate Device
The previously cleared GORE-TEX® DualMesh® Biomaterial and GORE-TEX® DualMesh® PLUS Biomaterial are cited as the predicate devices.

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#### Technological Characteristics F.

This Premarket Notification submission is for a modification to an existing, currently marketed device. The modification is to attach a silicone component to the closed microstructure surface of the ePTFE biomaterial. The silicone component is removed following fixation of the ePTFE component and is not implanted.

These changes do not change the device's intended use or indications. Similarly, the biocompatibility, packaging and sterilization process for the applicant devices have not changed from those for the predicate device.

Bench test data reveal the applicant devices have mechanical strength and material characterization values that are substantially equivalent to the predicate devices.

In-vitro antimicrobial activity test data demonstrate that the antimicrobial version of the applicant device functions both safely and effectively to inhibit bacterial colonization of the device for up to ten days post-implantation.

In-vivo animal test data document that the tissue response for the applicant devices is equivalent to histological controls for the predicate devices.

Design control and verification testing have been performed for this device modification.

#### Safety and Effectiveness Conclusions G.

This Premarket Notification submission concerns a modification to existing, currently marketed devices. The modification is to attach a silicone component to the closed microstructure surface of the ePTFE biomaterial. The silicone component is removed following fixation of the ePTFE component and is not implanted. The implanted portion of the applicant devices is identical to the implanted portion of the predicate devices.

Bench testing, in-vivo animal testing and in-vitro antimicrobial testing demonstrate the applicant devices perform equivalent to the predicate devices.

The modification described in this Premarket Notification does not raise questions of safety or effectiveness that have not been previously addressed. Both the applicant devices and the predicate devices perform their equivalent clinical functions by incorporating biocompatible materials to permanently or transiently bridge or support a tissue defect. The antimicrobial agents loaded on both the applicant DualMesh® EMERGE PLUS device and the predicate GORE-TEX® DualMesh® PLUS device perform an equivalent preservative function by inhibiting bacterial colonization for up to ten days post-implantation.

The applicant devices are substantially equivalent to the previously cleared predicate devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# ED 1 0 2002

W. L. Gore and Associates, Inc. R. Larry Pratt Regulatory Affairs 3750 West Kiltie Lane P.O. Box 900 Flagstaff, Arizona 86002-0900

Re: K022782

Trade/Device Name: DualMesh® EMERGE and EMERGE PLUS Biomaterial Regulation Number: 878.3300 Regulation Name: Surgical mesh, polymeric Regulatory Class: Class II Product Code: FTL Dated: August 21, 2002 Received: August 22, 2002

Dear Mr. Pratt:

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 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.

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Page 2 – Mr. R. Larry Pratt

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours

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

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Page 1 of I

020 510(k) Number (if known): DualMesHOEMERGE Biomaterial Device Name: DualMesh EMERGE PLUS Biomaterial.

Indications For Use:

For the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects.

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

Concurrence of CDRH, Office/of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative
and Neurological Devices

| 510(k) Number | K022782 |
|---------------|---------|
|---------------|---------|

| Prescription Use | OR | Over-The-Counter Use |
|----------------------|----|------------------------|
| (Per 21 CFR 801.109) | | (Optional Format 1-2-) |

(Optional Format 1-2-96)