MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)

K960653 · ETHICON, Inc. · GAN · Mar 28, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K960653
• Device Name: MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)
• Applicant: ETHICON, Inc.
• Product Code: GAN · General, Plastic Surgery
• Decision Date: Mar 28, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4830
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MONOCRYL suture, dyed is intended for use in general soft tissue approximation and/or ligation.

Device Story

Monofilament synthetic absorbable surgical suture; composed of copolymer of glycolide and epsilon-caprolactone; dyed violet with D&C Violet No. 2. Used by surgeons for general soft tissue approximation and ligation. Device provides wound support during healing; absorbed by body over time. Subject device features increased breaking strength retention (BSR) compared to predicate.

Clinical Evidence

Nonclinical laboratory testing performed to determine breaking strength retention. Biocompatibility and clinical data deemed unnecessary to support the labeling change.

Technological Characteristics

Monofilament synthetic absorbable suture; copolymer of glycolide and epsilon-caprolactone; dyed with D&C Violet No. 2. Increased breaking strength retention (BSR) profile compared to predicate.

Indications for Use

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

Regulatory Classification

Identification

An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation.

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

• MONOCRYL (poliglecaprone 25) suture, dyed

Submission Summary (Full Text)

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K960653 (P1 OF 2)

MAR 28 1996

MAR 28 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:** MONOCRYL (poliglecaprone 25) suture, dyed

**PREDICATE DEVICE NAME:** Predicate device MONOCRYL (poliglecaprone 25) suture, dyed

### 510(k) SUMMARY

**Device Description**

MONOCRYL suture, dyed is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and epsilon-caprolactone. MONOCRYL suture is dyed violet using D&C Violet No. 2.

**Intended Use**

MONOCRYL suture, dyed is intended for use in general soft tissue approximation and/or ligation.

MONOCRYL suture, dyed has the same intended use as predicate device MONOCRYL suture, dyed.

Continued on next page

MONOCRYL (Poliglecaprone 25) Suture, Dyed ETHICON, Inc.

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K460653 (320-2)

# SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

| | 510(k) SUMMARY, Continued |
| --- | --- |
| Indications Statement | MONOCRYL sutures, dyed are indicated for soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery. |
| 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, dyed MONOCRYL suture, MONOCRYL suture, dyed has an increased breaking strength retention (BSR) profile. |
| Performance Data | Nonclinical laboratory testing was performed to determine breaking strength retention. Biocompatibility and clinical was deemed unnecessary to support this labeling change. |
| 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.
Director, Regulatory Affairs
ETHICON, Inc.
Rt. #22, West
Somerville, NJ 08876-0151 |
| Date | February 14, 1996 |

MONOCRYL (Poliglecaprone 25) Suture, Dyed
ETHICON, Inc.