SURGICAL FABRICS

K963226 · Boston Scientific Corp · FTL · Nov 15, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K963226
• Device Name: SURGICAL FABRICS
• Applicant: Boston Scientific Corp
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Nov 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The proposed Surgical Fabrics are implants which are intended to reinforce soft tissue where weakness exists for the urological, gynecological and gastroenterological anatomy inclusive but not limited to the following procedures: pubourethral support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor, bladder support, and sacrocolposuspension.

Device Story

Surgical Fabrics consist of woven or knitted polymer fibers; precut into patches. Used for soft tissue reinforcement in urological, gynecological, and gastroenterological surgical repairs. Implanted by surgeons during procedures to address anatomical weaknesses. Device provides mechanical support to tissues; facilitates repair of prolapse and pelvic floor defects. Benefits include structural reinforcement of weakened tissue sites.

Clinical Evidence

Bench testing only; comparative performance testing against predicate devices demonstrated substantial equivalence.

Technological Characteristics

Woven or knitted polymer fibers; precut patch form factor; implantable material.

Indications for Use

Indicated for patients requiring soft tissue reinforcement in urological, gynecological, and gastroenterological procedures, including pubourethral support, urethral/vaginal prolapse repair, colon/rectal prolapse repair, pelvic floor reconstruction, bladder support, and sacrocolposuspension.

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

• Trelex Natural® Mesh
• Supple Peri-Guard®
• Gore-Tex® Soft Tissue Patch
• Marlex® Mesh
• Mersilene® Mesh

Submission Summary (Full Text)

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K963226
510(k) Premarket Notification
Surgical Fabrics
August 12, 1996
Boston Scientific Corporation
One Boston Scientific Place
Natick, MA 01760-1537

NOV 15 1996

## SECTION VII

## Summary of Safety and Effectiveness

Proprietary and Confidential Information of Boston Scientific Corporation
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# 510 (k) Summary Of Safety And Effectiveness

Sponsor: Boston Scientific Corporation
One Scientific Place
Natick, MA 01760-1537

Contact Person: Carol J. Holloway
Regulatory Affairs Specialist

Submission Date: August 12, 1996

Predicate Devices: Trelex Natural® Mesh
Supple Peri-Guard®
Gore-Tex® Soft Tissue Patch
Marlex® Mesh
Mersilene® Mesh

Description of Device: The Surgical Fabrics are woven or knitted from polymer fibers, and precut into patches for soft tissue reinforcement in surgical repair procedures.

Intended Uses: The proposed Surgical Fabrics are implants which are intended to reinforce soft tissue where weakness exists for the urological, gynecological and gastroenterological anatomy inclusive but not limited to the following procedures: pubourethral support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor, bladder support, and sacrocolposuspension.

Substantial Equivalence: The proposed devices are Substantially Equivalent to the predicate currently marketed devices indicated for use for reinforcement of soft tissue areas where weakness exists.

Product Testing: The proposed devices have been tested and compared to the predicate devices. The results indicate that the proposed devices are Substantially Equivalent to the predicate devices in terms of performance characteristics tested.