COATED VICRYL RAPIDE (POLYGLACTIN 910) BRAIDED, SYNTHETIC ABSORBABLE SUTURE, UNDYED

K962480 · ETHICON, Inc. · GAM · Aug 2, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K962480
• Device Name: COATED VICRYL RAPIDE (POLYGLACTIN 910) BRAIDED, SYNTHETIC ABSORBABLE SUTURE, UNDYED
• Applicant: ETHICON, Inc.
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Aug 2, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

6-0 undyed VICRYL RAPIDE suture is intended for use in superficial general soft tissue approximation where only short term wound support is required.

Device Story

Sterile, flexible, multifilament, synthetic absorbable suture; composed of polyglactin 910 copolymer (glycolide and lactide) with calcium stearate coating. Used by clinicians for superficial soft tissue approximation. Provides short-term wound support; degrades over time. Modification adds size 6-0 to existing product line.

Clinical Evidence

Bench testing only. Assessed knot tensile strength and breaking strength retention. Biocompatibility and clinical data deemed unnecessary for this size modification.

Technological Characteristics

Material: Polyglactin 910 (glycolide/lactide copolymer) with calcium stearate coating. Form: Braided multifilament, size 6-0. Sterile. No change in chemistry or composition from predicate.

Indications for Use

Indicated for superficial general soft tissue approximation of skin and mucosa requiring short-term wound support (7-10 days). Contraindicated for ligation, ophthalmic, cardiovascular, or neurological procedures.

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

• Coated VICRYL RAPIDE (polyglactin 910) braided synthetic absorbable suture, undyed

Submission Summary (Full Text)

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K962480

# SECTION 7

## SUMMARY OF SAFETY AND EFFECTIVENESS

AUG - 2 1996

### 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.

**MODIFIED DEVICE NAME:** Additional size of Coated VICRYL RAPIDE* (polyglactin 910) braided synthetic absorbable suture, undyed, Size 6-0.

**PREDICATE DEVICE NAME:** Coated VICRYL RAPIDE (polyglactin 910) braided synthetic absorbable suture, undyed.

### 510(k) SUMMARY

### Device Description

6-0 Coated VICRYL RAPIDE (polyglactin 910) suture, undyed is a sterile suture, flexible multifilament strand prepared from a copolymer made from glycolide and lactide. The coating for 6-0 undyed VICRYL RAPIDE is prepared with a mixture of copolymer of glycolide and L-lactide and calcium stearate.

### Intended Use

6-0 undyed VICRYL RAPIDE suture is intended for use in superficial general soft tissue approximation where only short term wound support is required.

Size 6-0 Coated VICRYL RAPIDE suture, undyed has the same intended use as the predicate device.

Continued on next page

Coated VICRYL RAPIDE (polyglactin 910) suture, Undyed - Size 6-0
ETHICON, Inc.

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SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

510(k) SUMMARY, Continued

Indications Statement
6-0 undyed Coated VICRYL RAPIDE suture is indicated only for use in superficial general soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required. Coated VICRYL RAPIDE suture is not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Technological Characteristics
6-0 Coated VICRYL RAPIDE suture, undyed has the same technological characteristic as the predicate device. There is no change in chemistry, material or composition.

Performance Data
Benchtop testing was performed to assess knot tensile strength and nonclinical laboratory testing was performed to determine breaking strength retention. Biocompatibility and clinical was deemed unnecessary to support this modification.

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 Device 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
June 24, 1996

Coated VICRYL RAPIDE (polyglactin 910) suture, Undyed - Size 6-0 ETHICON, Inc.