PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH

K962530 · ETHICON, Inc. · FTL · Aug 9, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K962530
• Device Name: PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH
• Applicant: ETHICON, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Aug 9, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Modified PROLENE mesh is intended for the repair of hernia and other fascial deficiencies that require the addition of a reinforcing or bridging material, to obtain the desired surgical result.

Device Story

Modified PROLENE mesh; nonabsorbable synthetic surgical mesh; knitted filaments of extruded polypropylene; used for hernia repair and fascial deficiency reinforcement; provides bridging material to support surgical site; surgeon-operated in clinical/surgical setting; precut keyhole shapes provided for surgical convenience; maintains strength indefinitely; nonreactive material.

Clinical Evidence

Bench testing only; burst strength testing conducted to compare modified device to predicate.

Technological Characteristics

Knitted filaments of extruded polypropylene; nonabsorbable; thickness approximately 0.027 inches; identical material composition to PROLENE suture (U.S.P.).

Indications for Use

Indicated for repair of hernia and other fascial deficiencies requiring reinforcing or bridging material in patients requiring surgical 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

• PROLENE polypropylene mesh nonabsorbable synthetic surgical mesh

Submission Summary (Full Text)

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K962530

AUG - 9 1996

# SECTION 7

## SUMMARY OF SAFETY AND EFFECTIVENESS

510(k) Summary of Safety and Effectiveness

Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.

**NEW DEVICE NAME:** Modified PROLENE* polypropylene mesh nonabsorbable synthetic surgical mesh

**PREDICATE DEVICE NAME:** PROLENE* polypropylene mesh nonabsorbable synthetic surgical mesh

510(k) SUMMARY

Device Description

Modified PROLENE mesh is constructed of knitted filaments of extruded polypropylene identical in composition to that used in PROLENE suture nonabsorbable surgical sutures, U.S.P. (ETHICON, INC.). The mesh is approximately 0.027 inches thick. This material, when used as a suture, has been reported to be nonreactive and to retain its strength indefinitely in clinical use.

Intended Use

Modified PROLENE mesh is intended for the repair of hernia and other fascial deficiencies that require the addition of a reinforcing or bridging material, to obtain the desired surgical result.

Continued on next page

Modified PROLENE polypropylene mesh nonabsorbable synthetic surgical mesh ETHICON, Inc.

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SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

510(k) SUMMARY, Continued

Intended Use (continued)
Modified PROLENE mesh has the same intended use as the
preamendment predicate device PROLENE mesh.

Indications Statement
Modified PROLENE mesh is intended for the repair of hernia
and other fascial deficiencies that require the addition of a
reinforcing or bridging material.

Technological
Characteristics
The modified device has the same technological characteristics
as the predicate device. There is no change in chemistry,
material or composition.

When compared to the predicate device, Modified PROLENE
mesh differs in the additional sizes that are being supplied and a
key hole shape which is being provided precut as a convenience
to the surgeon.

Performance Data
Burst strength testing was conducted to compare the predicate
device and the modified device.

Conclusions
Based on the 510(k) summaries and 510(k) statements (21 CFR
807) and the information provided herein, we conclude that the
modified device is substantially equivalent to the Predicate
Device under the Federal Food, Drug, and Cosmetic Act.

Continued on next page

Modified PROLENE polypropylene mesh nonabsorbable synthetic surgical mesh
ETHICON, Inc.

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SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

| Contact | John D. Paulson, Ph.D.
Vice President, Regulatory Affairs
ETHICON, Inc.
Rt. #22, West
Somerville, NJ 08876-0151 |
| --- | --- |
| Date | June 25, 1996 |

Modified PROLENE polypropylene mesh nonabsorbable synthetic surgical mesh
ETHICON, Inc.