SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETIC SUTURE, UNDYED

{0}------------------------------------------------ ## JAN 2 8 2002 ## 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS SUBSTANTIAL EQUIVALENCY Surgical Specialties Corporation Submitter: Address: 100 Dennis Drive Reading, PA 19606 610 404 1000, ext. 2231 Telephone: Elizabeth Lazaro Contact Person: Regulatory Affairs Specialist December 3, 2001 Date Prepared: Sharpoint® Coated FAST ABSORBINGTM Name of Device: PolyGlycolic Acid braided, synthetic absorbable suture, undyed. Common / Usual Suture, Absorbable, Synthetic, PolyGlycolic Acid Classification Name: Predicate Device: Ethicon, Inc. Coated VICRYL RAPIDE (polyglactin 910) braided synthetic absorbable, suture, undyed. Coated FAST ABSORBING PolyGlycolic Acid Device Description Suture is a synthetic absorbable braided, sterile, surgical suture composed of a homopolymer of Glycolic Acid. The suture material is coated with a copolymer of Polycaprolactone and PolyGlycolic Acid. The substances contained in the coating and suture are noncollagenous and nonantigenic. Continue on next page Coated FAST ABSORBING PolyGlycolic Acid suture, undyed Surgical Specialties Corporation / {1}------------------------------------------------ # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued) | Intended Use: | Coated FAST ABSORBING PolyGlycolic Acid<br>suture is indicated only for use in superficial general<br>soft tissue approximation of the skin and mucosa<br>where only short-term wound support (7-10 days)<br>is required. | |--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Coated FAST ABSORBING PolyGlycolic Acid<br>suture is not intended for use in ligation,<br>ophthalmic, cardiovascular or neurological<br>procedures. | | | The coated FAST ABSORBING PolyGlycolic Acid<br>suture, undyed has the same intended use as the<br>predicate device. | | Technological Characteristics: | Coated FAST ABSORBING PolyGlycolic Acid<br>suture, undyed is composed of 100% PolyGlycolic<br>Acid, a material equivalent to the material<br>comprising the predicate VICRYL Rapide device.<br>The suture has the same design as the VICRYL<br>Rapide predicate devices, being a sterile, flexible<br>suture available in a coated braided multifilament<br>form. | | Performance Data: | Physical testing was conducted on the Coated<br>FAST ABSORBING PolyGlycolic Acid suture to<br>USP 24, including <861> Sutures - Diameter,<br><871> Sutures- Needle Attachment, and <881><br>Tensile Strength. Animal testing was performed for<br>conformance to ISO 10993 for biocompatibility and<br>implant studies in animals to demonstrate rates of<br>tensile strength and mass loss. | Continue on next page K014021 page 2/3 Coated FAST ABSORBING PolyGlycolic Acid suture, undyed Surgical Specialties Corporation {2}------------------------------------------------ K014021 page 3/3 9 The FAST ABSORBING PolyGlycolic Acid Synthetic Absorbable surgical suture is similar in intended use, materials, design, and performance characteristics to the Ethicon VICRYL Rapide Synthetic Absorbable Surgical Suture (K944110). The determination of substantial equivalence for this device was based on a detailed device description, physical testing (U.S.P. 24) and animal testing for conformance with performance standards e.g. ISO 10993-1 Biological Evaluation of Medical Devices and the FDA Guidance Document for Surgical Suture 510(k)s issued on August 10, 2000. Based on the 510(k) summaries (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. {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 2 8 2002 Ms. Elizabeth Lazaro Regulatory Affairs Specialist Surgical Specialties Corporation 100 Dennis Drive Reading, Pennsylvania 19606 Re: K014021 Trade/Device Name: Sharpoint® Coated FAST ABSORBING™ Polyglycolic Acid Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(glycolide/L-lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM Dated: December 05, 2001 Received: December 06, 2001 Dear Ms. Lazaro: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {4}------------------------------------------------ Page 2 - Ms. Elizabeth Lazaro This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Miriam C. Provost Of Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ### Page _1_ of _1__ 6 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Sharpoint® Coated FAST ABSORBING™ PolyGlycolic Acid Device Name: Synthetic Absorbable Surgical Suture Indications for Use: Sharpoint® Coated Fast Absorbing™ PolyGlycolic Acid Suture is indicated only for use in superficial soft tissue approximation of the skin and mucosa where only short term wound support (7 – 10 days) is required. Coated Fast Absorbing™ PolyGlycolic Acid Suture is not intended for use in ligation, ophthalmic cardiovascular or neurological procedures. Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Muriam C. Provost (Division Sign-Off) Division of Coneral, Rostorative and Neurological Devices 510(k) Number KO1 402