Who is the manufacturer of SURGICAL FABRICS?

Boston Scientific Corp filed the 510(k) submission for SURGICAL FABRICS (K963226).

What is the FDA product code for SURGICAL FABRICS?

FTL. It is classified under 21 CFR 878.3300 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for SURGICAL FABRICS?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SURGICAL FABRICS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SURGICAL FABRICS

Q: What are the predicate devices for SURGICAL FABRICS?

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

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

Related Devices

K051245 — POLYFORM SYNTHETIC MESH · Proxy Biomedical , Ltd. · Jun 17, 2005
K992159 — SURGISIS SLING · Cook Biotech, Inc. · Sep 23, 1999
K963141 — KUGEL HERNIA PATCH · Douglas Bueschel · Oct 11, 1996
K040521 — MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH · American Medical Systems, Inc. · Mar 24, 2004
K182259 — Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal · Acell, Inc. · Feb 7, 2019

Submission Summary (Full Text)

{0} 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 82 {1} # 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.