MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED

{0} DEC 18 1996 SECTION 7 K964072 # 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. MODIFIED DEVICE NAME: MONOCRYL (poliglecaprone 25) suture, undyed PREDICATE DEVICE NAME: MONOCRYL (poliglecaprone 25) suture, dyed 510(k) SUMMARY | | --- | --- | | Device Description | MONOCRYL suture, undyed is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and epsilon-caprolactone. | | Intended Use | MONOCRYL suture, undyed is intended for use in general soft tissue approximation and/or ligation. MONOCRYL suture, undyed has the same intended use as predicate device MONOCRYL suture, dyed. Continued on next page | MONOCRYL (poliglecaprone 25) suture, undyed ETHICON, Inc. 23 {1} SUMMARY OF SAFETY AND EFFECTIVENESS, Continued 510(k) SUMMARY, Continued Indications Statement Modified MONOCRYL sutures, undyed 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 material or chemical compound. Modified MONOCRYL suture, undyed has an increased breaking strength retention (BSR) profile identical to the predicate device. Performance Data Nonclinical laboratory testing was performed to determine breaking strength retention profile after implantation. It was determined that the BSR profile for Modified MONOCRYL suture, undyed is identical to the predicate device. 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 October 9, 1996 MONOCRYL (poliglecaprone 25) suture, undyed ETHICON, Inc.