NON-ABSORBABLE SILK SUTURE

{0}------------------------------------------------ |< < > | \ | | | 1/2 ## JUL 1 7 2007 ## 510 (k) Summary | Submitter: | ARROW International, Inc.<br>2400 Bernville Road<br>Reading, PA 19605-9607 USA | |---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact person: | Karl Nittinger<br>Regulatory Affairs Specialist<br>Phone: 610-378-0131, ext. 3405<br>Fax: 610-478-3128<br>Email: karl.nittinger@arrowintl.com | | Date summary prepared: | April 11, 2007 | | Device trade name: | Non-Absorbable Silk Suture<br>(21 CFR 878.5030, Product Code GAP) | | Device common name: | Suture | | Device classification name: | Natural non-absorbable silk surgical suture. | | Legally marketed devices to<br>which the device is<br>substantially equivalent: | Surgical Specialties, Inc. Non-Absorbable Silk Suture<br>(K930826) and Ethicon, Inc., Perma-Hand™ Non-<br>Absorbable Silk Suture (N11397) | | Description of the device: | The Arrow Non-Absorbable Silk Suture has the<br>following characteristics:<br><ul><li>Black, braided silk suture thread of '000' (Metric 2) diameter</li><li>30" (75 cm) suture thread length</li><li>Pre-attached, straight, stainless steel needle</li><li>2-3/8" (60 mm) needle length</li></ul> | | Indications for use: | The non-absorbable silk suture is intended for use in<br>general soft tissue approximation, excluding use in<br>cardiovascular, ophthalmic and neurological tissues. | | Technological<br>characteristics: | The proposed non-absorbable silk suture has the same<br>technological design characteristics as the predicate<br>devices. | ,一 {1}------------------------------------------------ |< © 2 || || || | Performance tests: | The following tests were performed to demonstrate substantial equivalence:<br>Suture Tensile Strength (USP 29<881>:2006) Needle Attachment (USP 29<871>:2006) Suture Diameter (USP 29<861>:2006) Biocompatibility (ISO 10993-1:2003) | |----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Assessment of non-clinical performance data: | The results of the bench tests demonstrate that Arrow's non-absorbable silk suture is safe, effective and performs favorably when compared to the Surgical Specialties, Inc. and Ethicon, Inc. predicate sutures. | | Summary | Arrow International's Non-Absorbable Silk Suture has the same intended use as the Ethicon, Inc. predicate device. Based on the assessment of non-clinical performance data to verify this new intended use, and the technological characteristic comparison, Arrow's non-absorbable silk suture is substantially equivalent to the legally marketed predicate devices. | : {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 1 7 2007 Arrow International Inc. % Mr. Karl J. Nittinger Regulatory Affairs Specialist P.O. Box 12888 Reading, Pennsylvania 19612 Re: K071111 Trade/Device Name: Non-Absorbable Silk Suture Regulation Number: 21 CFR 878.5030 Regulation Name: Natural nonabsorbable silk surgical suture Regulatory Class: II Product Code: GAP Dated: April 11, 2007 Received: April 20, 2007 Dear Mr. Nittinger: 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 mav 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. Karl J. Nittinger 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 (240) 276-0115. 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 (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 071111 1/1 Indications for Use Statement 510(k) Number (if known): Device Name: Non-Absorbable Silk Suture Indications for Use: The non-absorbable silk suture is intended for use in general soft tissue approximation, excluding use in cardiovascular, ophthalmic and neurological tissues. Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurance of CDRH, Office of Device Evaluation (ODE) Division Sign-O (Division Sign-Only Division of Goal Devices and Neurological Devices 510(k) Num