ETHICON ABSORBABLE POLY (L-LACTIDE/GLYCOLIDE) SURGICAL SUTURE, UNDYED

K964345 · ETHICON, Inc. · GAM · Dec 16, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K964345
• Device Name: ETHICON ABSORBABLE POLY (L-LACTIDE/GLYCOLIDE) SURGICAL SUTURE, UNDYED
• Applicant: ETHICON, Inc.
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Dec 16, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed is intended for use in general soft tissue approximation and/or ligation as is the predicate device Coated VICRYL* (Polyglactin 910) suture.

Device Story

Synthetic braided absorbable surgical suture; composed of poly(L-lactide/glycolide) copolymer; coated with caprolactone and glycolide copolymer. Used by surgeons for soft tissue approximation and ligation. Provides mechanical support during healing; absorbed by body over time. Offers increased breaking strength retention and absorption profile compared to predicate.

Clinical Evidence

Bench testing only. Nonclinical laboratory testing performed for breaking strength retention. Biocompatibility and functionality testing conducted to assess safety and effectiveness. Results confirmed high biocompatibility and functionality within indicated uses.

Technological Characteristics

Synthetic braided suture; poly(L-lactide/glycolide) copolymer; coated with caprolactone/glycolide copolymer. Absorbable. Similar to predicate Coated VICRYL (Polyglactin 910).

Indications for Use

Indicated for soft tissue approximation and/or ligation. Contraindicated for use in ophthalmic, cardiovascular, or neurological tissue.

Regulatory Classification

Identification

An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

• VICRYL* (Polyglactin Suture)

Reference Devices

• Johnson & Johnson Absorbable Tendon Suture
• Coated VICRYL* II (Polyglactin 910) suture

Submission Summary (Full Text)

{0}

K964345

# 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:** ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed

**PREDICATE DEVICE:** VICRYL* (Polyglactin Suture)

**REFERENCE DEVICE NAMES:** Predicate device Johnson & Johnson Absorbable Tendon Suture and Coated VICRYL* II (Polyglactin 910) suture.

510(k) SUMMARY

Device Description

Synthetic ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed is a synthetic braided absorbable surgical suture prepared from a copolymer of lactide and glycolide. The suture is coated with a copolymer of caprolactone and glycolide.

Intended Use

ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed is intended for use in general soft tissue approximation and/or ligation as is the predicate device Coated VICRYL* (Polyglactin 910) suture.

Continued on next page

ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed
ETHICON, Inc.

{1}

SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

| | 510(k) SUMMARY, Continued |
| --- | --- |
| Indications Statement | ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed is indicated for soft tissue approximation and/or ligation, but not for use in ophthalmic, cardiovascular, or neurological tissue. |
| Technological Characteristics | The new device has similar technological characteristics as the predicate device Coated VICRYL (Polyglactin 910) suture. The new device has the same chemical composition as the reference device, Absorbable Tendon Suture.

When compared to the predicate devices, ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed, Undyed increased breaking strength retention (BSR) and absorption profile. |
| Performance Data | Nonclinical laboratory testing was performed to determine breaking strength retention. Biocompatibility and Functionality testing was conducted to assess the safety and effectiveness of ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed. Results indicated that the device was highly biocompatible and was functional within its indicated uses. |
| Conclusions | Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the new device is substantially equivalent to the Predicate Devices under the Federal Food, Drug, and Cosmetic Act. |
| Contact | John D. Paulson, Ph.D.
Vice President, Regulatory Affairs
ETHICON, Inc.
Rt. #22, West
Somerville, NJ 08876-0151 |
| Date | October 31, 1996 |

ETHICON Absorbable poly(L-lactide/glycolide) Surgical Suture, Undyed
ETHICON, Inc.

31