DURABRAID SUTURE

{0}------------------------------------------------ KOye7sq We are /3 Ainuteman Road over, MA 01810 978 749 1000 978 749 1599 Fax www.smith-nephew.com **JUN - 4 2004** ## VI.510(k) Summary DuraBraid™ Suture Date Prepared: March 26, 2004 This 510(k) summary is being submitted in accordance with the requirement A. Submitter Smith & Nephew, Inc. B. Company Contact Bill McCallum Sr. Regulatory Specialist C. Device Name Trade Name: DuraBraid Sutu Suber France: Braided Polyester Surgical Suture Common Name: Braided Polyester Surgical Suture Classification Name: Nonabsorbable poly(ethylene terephthalate) surgical sutu # D. Predicate Device The Smith & Nephew Dura r its sintin & Trepliew Durgeau Suture is substantially equivals in tubsigh, materials, function and intended use to the following device in commercial distribution surgical E. Description of Device DuraBraid Suture is a nonabsorbable, sterile, surgical suture comprised of braided polyester. It is supplied in several USP sizes white and green, and is available with and it swaged needles attached. raBraid suture is classified by the General and Plastic Surgery Devices panel, S , nonabsorbable poly(ethylene terephthalate) surgical s {1}------------------------------------------------ 2/3 #### F. Intended Use The Smith & Nephew DuraBraid Suture is indicated for use in approximation and/or ligation of soft tissues. #### G. Comparison of Technological Characteristics The Smith & Nephew DuraBraid suture has the same technological characteristics and is composed of the material as the predicate device. The range of sizes offered by Smith & Nephew is within the marketed range of predicate sizes. The DuraBraid Suture material conforms to the following Recognized Consensus Standards: Item 97: USP 26, Nonabsorbable Surgical Sutures Item 100: USP 26, < 881 > Tensile Strength Item 101: USP 26, < 861> Sutures - Diameter Item 102: USP 26, < 871 > Sutures Needle Attachment Item 51: AAMI/ANSI/ISO 10993-1: 1997, Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Item 76: AAMI/ANSI/ISO 10993-7: (R) 2001, Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals Item 103: AAMI/ANSI/ISO 11607: 2000, Packaging for Terminally Sterilized Medical Devices Item 75: AAMI/ANSI/ISO 11137: 1994, Sterilization of Health Care Products-Requirements for Validation and Routine Control-Radiation Sterilization and ISO 11137: 1995 (Amendment 1:2002) Item 25: AAMI/ANSI/ISO 11135: 1994 Medical Devices-Validation and Routine Control of Ethylene Oxide Sterilization. {2}------------------------------------------------ K04 0789 3/3 The design of the Smith & Nephew DuraBraid surgical suture is in conformance with the above identified standards. The signed Declaration of Conformance with Consensus Standards is located in section II of this Abbreviated 510(k) submission. ### Summary of Features and Technological Characteristics in comparison to the Predicate Device | Attribute | DuraBraid | Polyviolene (predicate) | |------------------|------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------| | Suture Material | Braided polyester, nonabsorbable<br>(Ashaway) | Braided polyester, nonabsorbable<br>(Ashaway) | | Suture Treatment | Uncoated, and silicone coated<br>(Ashaway) | Uncoated, and silicone coated<br>(Ashaway) | | Configuration | With and without needles, tipped | With needles and pledgets | | Tipping | Kollidon | Unknown | | Dyed | D&C Green No. 6 | D&C Green No. 6 | | Undyed | White | White | | Sizes | USP sizes 3-0 through 5, USP | USP sizes 11-0 through 5, USP | | Needles | T-13 and T-5, Taper point, ½ Circle | Various Needle Types and lengths | | Indications | Indicated for use in approximation<br>and/or ligation of soft tissues. | Indicated for use in general soft tissue<br>approximation and/or ligation,<br>including use in cardiovascular,<br>ophthalmic and neurological<br>procedures | | Packaging | Sterile, pouches 12 to a carton | Sterile, pouches 12 to a carton | Bill McCallum Senior Regulatory Specialist {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The central symbol consists of three curved lines that resemble a stylized bird or abstract shape. The logo is black and white. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN = 4 2004 Mr. Bill McCallum Senior Regulatory Specialist Smith & Nephew, Inc. Endoscopy Division 150 Minuteman Road Andover, Massachusetts 01810 Re: K040789 Trade/Device Name: DuraBraid™ Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable polyethylene terephthalate surgical suture Regulatory Class: II Product Code: GAT Dated: March 26, 2004 Received: March 29, 2004 Dear Mr. McCallum: 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 - Mr. Bill McCallum 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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, Mark A. Millman 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}------------------------------------------------ K040785 INDICATIONS FOR USE STATEMENT K 046789 510(K) Number: DuraBraid ™ Suture Device Name: Indications For Use: Smith & Nephew Durabraid™ Suture is indicated for use in approximation and/or ligation of soft tissues. Prescription Use X AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (Per 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) CDRAL, Office of Device Evaluatio (Division Sign-Off Division of General, Restorative, and Neurological Devices Ko40-510(k) Number_