MR-III

{0}------------------------------------------------ OCT 2 3 2000 ### 510(k) Summary # MR-III ### Date Prepared: July 24, 2000 This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 8807.92. ### A. Submitter Smith & Nephew, Inc. Endoscopy Division 160 Dascomb Road Andover, MA 01810 ## B. Company Contact Demetrios Tsakonas Clinical/Regulatory Specialist ### C. Device Name Trade Name: MR-III Suture Retention Device Suture, Nonabsorbable, Polyester Common Name: Classification Name: Suture Retention Device (KGS) Suture, Nonabsorbable, Synthetic, Polyester (GAS) ### Predicate Devices D. T-Fix previously cleared by K925573 and K942442. ### E. Description of Device The MR-III is a suture retention device manufactured from polyester suture, polyacetal bar, stainless steel needle and a plastic handle. {1}------------------------------------------------ ### D. Intended Use MR-III is intended for use as a suture retention device to facilitate pecutaneous or endoscopic soft tissue repair. The indications for the MR-III are for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repair), rotator cuff repair, meniscal repair and gastrostomy. # E. Comparison of Technological Characteristics Both the T-Fix and the MR-III are intended to be used to fixate soft tissue by anchoring the tissue internally from a single access point and securing the suture by a knot. Demetrios Ioakonas Demetrios Tsakonas Clinical/Regulatory Specialist {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 2 3 2000 Mr. Demetrios Tsakonas Clinical/Regulatory Specialist Smith & Nephew, Inc. Endoscopy Division 160 Dascomb Road Andover, Massachusetts 01810 K002261 Re: > Trade Name: MR-III Regulatory Class: II Product Code: GAS Dated: July 24, 2000 Received: July 25, 2000 Dear Mr. Tsakonas: We have reviewed your Section 510(k) 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). 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 HI (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {3}------------------------------------------------ ### Page 2 - Mr. Demetrios Tsakonas This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, L. Mark N. Mellers 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 {4}------------------------------------------------ Kœœ2261 Page 1 of 1 510(k) Number : Device Name : MR-III Indications for Use : MR-III is intended for use as a suture retention device to facilitate pecutaneous or endoscopic soft tissue repair. The indications for the MR-III are for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repair), rotator cuff repair, meniscal repair and gastrostomy. (PLEASE DO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-the-Counter (Optional Format 1-2-96) for Mark N Milburn (Division Sign-Off) Division of General Restorative Devices KOO2261 510(k) Number _