GORE-TEX SOFT TISSUE PATCH,MYCROMESHA BIOMATERIAL,DUALMESH BIOMATERIAL,DUALMESH BIOMATERIAL WITH HOLES

K963619 · W. L. Gore & Associates, Inc. · FTL · Oct 25, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K963619
• Device Name: GORE-TEX SOFT TISSUE PATCH,MYCROMESHA BIOMATERIAL,DUALMESH BIOMATERIAL,DUALMESH BIOMATERIAL WITH HOLES
• Applicant: W. L. Gore & Associates, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Oct 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The applicant devices are intended to be used for the reconstruction of hernias and for the temporary bridging of fascial defects and soft tissue deficiencies.

Device Story

GORE-TEX surgical meshes consist of expanded polytetrafluoroethylene (ePTFE) featuring a microstructure of solid nodes interconnected by fibrils. This structure facilitates tissue attachment. Devices are used by surgeons in general surgery applications to bridge or support tissue defects, including hernias and omphaloceles. The meshes provide a scaffold for tissue integration or temporary support during healing. Clinical benefit is derived from the established biocompatibility and performance of ePTFE, supported by over two decades of use in vascular, cardiac, and dural applications.

Clinical Evidence

No new clinical trials were conducted for this submission. Substantial equivalence is supported by over 4,000,000 prior implants of GORE-TEX ePTFE medical products in various surgical applications and published clinical data demonstrating successful performance in soft tissue deficiency repair.

Technological Characteristics

Material: expanded polytetrafluoroethylene (ePTFE). Structure: solid nodes interconnected by a latticework of fibrils. Function: surgical mesh for tissue bridging/support. Biocompatible, non-absorbable.

Indications for Use

Indicated for patients requiring hernia reconstruction, temporary bridging of fascial defects, or soft tissue deficiency repair.

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 Soft Tissue Patch (K963619)
• GORE-TEX MycroMesh Biomaterial (K963619)
• GORE-TEX DualMesh Biomaterial (K963619)
• GORE-TEX DualMesh Biomaterial with Holes (K963619)
• Davis & Geck DEXON Mesh (K830889)
• Ethicon Vicryl Woven Mesh (K810428)

Submission Summary (Full Text)

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OCT 25 1996
K963619

# Premarket Notification Summary

1. **Applicant:**
W. L. Gore and Associates, Inc.
3750 W. Kiltie Lane
Flagstaff, AZ 86002
Phone: [phone]

**Contact:**
John W. Nicholson, Associate
Date of Preparation: 09/06/96

2. a) **Applicant Devices:**
GORE-TEX® Soft Tissue Patch
GORE-TEX® MycroMesh Biomaterial
GORE-TEX® DualMesh Biomaterial
GORE-TEX® DualMesh Biomaterial with Holes

b) **Common Name:** Surgical Mesh

c) **Classification Name:** Surgical Mesh

3. **Predicate Devices:**

GORE cites the following as substantially equivalent predicate devices:

GORE-TEX® Soft Tissue Patch
GORE-TEX® MycroMesh Biomaterial
GORE-TEX® DualMesh Biomaterial
GORE-TEX® DualMesh Biomaterial with Holes
Davis & Geck DEXON Mesh K 830889
Ethicon Vicryl Woven Mesh K 810428

4. **Device Description:**

The applicant GORE surgical meshes are not being changed in any way (except for labeling) as a result of this submission’s clearance. The proprietary manufacturing process that GORE’s surgical meshes undergo creates a pattern of solid nodes of PTFE interconnected by a latticework of PTFE fibrils. The staggering of these nodes and fibrils and the pattern of these structures produces a microstructure which determines the degree and celerity with which tissue attachment occurs. More than 4,000,000 implants of GORE-TEX® ePTFE Medical Products in vascular, cardiac, dural and a broad variety of general surgery applications during the past two decades have established a substantial body of knowledge and experience relating to the biocompatibility and performance of ePTFE. A selected bibliography is provided in Attachment 5.

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5. Intended Use:

The applicant devices are intended to be used for the reconstruction of hernias and for the temporary bridging of fascial defects and soft tissue deficiencies.

6. Technological Characteristics:

The Table below presents some of the basic comparative characteristics of the applicant device and its cited predicate devices.

| GORE-TEX® Soft Tissue Patch | For the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects, such as omphaloceles | ePTFE | FTL |
| --- | --- | --- | --- |
| GORE-TEX® MycroMesh Biomaterial | For the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects, such as omphaloceles | ePTFE | FTL |
| GORE-TEX® DualMesh Biomaterial | For the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects, such as omphaloceles | ePTFE | FTL |
| GORE-TEX® DualMesh Biomaterial with Holes | For the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects, such as omphaloceles | ePTFE | FTL |
| Davis & Geck DEXON Mesh | For use when temporary wound support is required | Polyglycolic Acid | FTM |
| Ethicon VICRYL Woven Mesh | For use as a buttress to provide temporary support during the healing process | Polyglactin 910 | FTL |

The applicant and predicate devices have the same intended use as prostheses for temporary wound or defect support and are classified as surgical meshes. They achieve their equivalent clinical functions by incorporating biocompatible materials to transiently bridge or support a tissue defect. Although not all these devices incorporate the same technological characteristics (i.e. materials), however, the fact that these biomaterials individually have extensive and successful clinical histories indicate that this change of material type does not pose new safety or effectiveness questions. The performance data or clinical experience with GORE-TEX® ePTFE usage in temporary soft tissue deficiencies presented above (Published Clinical Data) describes the successful clinical performance of the devices in a variety of populations. These factors combined provide the basis for a substantial equivalency determination when comparing the applicant devices with their cited predicates.