MULTITAK SUTURE SNAP SYSTEM

{0}------------------------------------------------ K013177 Image /page/0/Picture/1 description: The image shows the words "Multitak SS" in a bold, sans-serif font. Below the words is a thick, black line, and below that are the words "FROM BONUTTI RESEARCH" in a smaller, sans-serif font. The words are all black and the background is white. DEC 1 9 2001 ## Bonutti Research, Inc. Multitak Suture Snap System 510(k) Premarket Notification ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS The following information is submitted in accordance with the requirements of 21 CFR 807.92: Patrick Balsmann, MS, RAC, Contact Person: Director, Regulatory/Clinical Affairs & QA Bonutti Research, Inc., P.O. Box 1367, Effingham, Illinois 62401 Phone: 217.342.3412, ext. 321 Date Prepared: September 21, 2001 Proprietary Name: Multitak Suture Snap System Common Name: Resorbable Crimp Classification Name: Fastener, Fixation, Biodegradable, Soft Tissue. Device Description: The Multitak Suture Snap System is designed for approximating and securing soft tissue in arthroscopic and open surgical procedures. The resorbable poly-L securing our assue in tasonically welded to secure suture at the wound repair site and takes the place of tying arthroscopic and open surgical repair knots. The system consists of a generator that provides ultrasonic energy to a handpiece. The energy applied to the handpiece is used to ultrasonically weld a resorbable crimp and secure suture during general tissue wound repair. The resorbable poly-L-lactic acid crimp is gradually degraded into lactic acid and excreted as carbon dioxide and water. Intended Use: The intended use of the Multitak Suture Snap System is in general soft tissue approximation and/or ligation. The system is indicated in securing soft tissue in arthroscopic and open surgical procedures where USP Size No. 2-0 through Size 2 nonabsorbable suture is used. 316 2600 S. Raney St. Effingham, II 62401 Phone: (217) 342-3412 (800) 879-0117 (USA only) Facsimile: (217) 347-338 www.BonuttiResearch.com {1}------------------------------------------------ Predicate Device(s): The Multitak Suture Snap System is similar in intended use and principle of operation to Axya Medical, Inc., Suture Welding System and Kit. Both systems principle of operation to secure suture without tying a knot. The Multitak Suture Snap aso annousonio oneigy to becare salare to Innovasive Devices, Inc., Y-Knot Suture Clip. Both Systems use a two-piece crimp component to secure suture without tying a knot. The Systems as a the proov system resorbable crimp is similar to currently marketed poly-L-lactic acid devices including the Mitek BTB Absorbable (PLA) Cross Pin. Predicate Comparison: Performance testing comparing the mechanical strengths of knotted nonalsorbable braided polyester suture to the same type of suture secured with the Multitak Suture Snap 2 Resorbable Crimp was conducted to demonstrate substantial equivalence. Genzyme Surgical Products, Inc., nonabsorbable suture was used as the predicate comparison device. Results of bench testing and an in vitro degradation study demonstrated no statistical difference in suture secured with the resorbable crimp and knotted suture. The results demonstrate that the Multitak Suture Snap Resorbable Crimp provides an alternative means to tying surgical knots with nonabsorbable suture. Submitted by: Richard Baldwin Patrick Balsmann Director, Regulatory/Clinical Affairs & QA {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus, with three diagonal lines curving into a wavy base. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 1 9 2001 Patrick G. Balsmann Director, Regulatory/Clinical Affairs and QA Bonutti Research, Inc. P.O. Box 1367 Effingham, Illinois 62401 Re: K013177 Trade Name: Multitak Suture Snap System Regulation Number: 878.4493; 888.3040 Regulation Name: Absorbable PGL Suture; Bone Anchor Regulatory Class: II Product Code: GAM; MAI Dated: September 21, 2001 Received: September 24, 2001 Dear Mr. Balsmann: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. {3}------------------------------------------------ ## Page 2 - Mr. Patrick Balsmann This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to begin maing of substantial equivalence of your device to a legally prematicate 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 IT you desire specific acrise for for in vitro diagnostic devices), please contact the Office of additionally 21 CF 1 F ar 857. Additionally, for questions on the promotion and advertising of Comphance at (301) 591-1657 office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). I guiation chittived, "Miooranang on responsibilities under the Act may be obtained from the Oincr general information currers, 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, Neil R.P. Ogden fr Celia M. Witten, Ph.D., M.D. CMW Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Page 1 of 1 510(k) Number (if known): K013177 Multitak Suture y stem Device Name: Sna Indications for Use: The intended use of the Multitak Suture Snap System is in general soft tissue approximation and/or ligation. The system is indicated in securing soft tissue in arthroscopic and open surgical procedures where USP Size No. 2-0 through Size 2 nonabsorbable suture is used. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) NRO for cmw (Division Sign-Of Division of General, Restorative and Neurological Devices 510(k) Number K013177 Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)