SILICONE COATED GUIDEWIRE

{0}------------------------------------------------ 510(k) Premarket Notification K041740 | Submitter: | ARROW International, Inc.<br>2400 Bernville Road<br>Reading, PA 19605-9607 USA | |---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact person: | Suzanne Schorle<br>Regulatory Affairs Associate<br>Phone: 610-378-0131, ext. 3443<br>Fax: 610-478-3167<br>Email: suzanne.schorle@arrowintl.com | | Date summary prepared: | June 24, 2004 | | Device trade name: | Silicone Coated Guidewire | | Device common name: | Silicone Coated Guidewire | | Device classification name: | Guidewire | | Legally marketed devices to<br>which the device is<br>substantially equivalent: | K905581 Lake Region Mfg. Silicone Coated Guidewire | | Description of the device: | The proposed device is a silicone coated stainless steel<br>guidewire. It consists of a coiled wire around a solid<br>stainless steel core wire. The internal core wire is secured<br>at both ends to the outer core wire. These guidewires are<br>used to place intravascular catheters. | | Intended use of the device: | The Arrow guide wire will be used to facilitate the<br>placement of catheters during diagnostic and<br>interventional procedures. | | Technological<br>characteristics: | The proposed guidewires have the same technological<br>design characteristics as the predicate devices. | | Performance tests: | The following tests were performed to demonstrate<br>substantial equivalence:<br>• Tensile Strength<br>• Catheter Compatibility<br>• Coating Durablity/Lubricity<br>• Flexing Test<br>• Fracture Test<br>• Tip Flexibility | | Conclusions: | The results of the laboratory tests demonstrate that the<br>guidewires are substantially equivalent to the legally<br>marketed predicate devices. | {1}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Image /page/1/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 a stylized caduceus, which is a traditional symbol of medicine. ## OCT 1 5 2004 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Arrow International c/o Ms. Suzanne Schorle Regulatory Affairs Associate 2400 Bernville Road Reading, PA 19605 Re: K041740 > Trade/Device Name: Silicone Coated Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: September 2, 2004 Received: September 3, 2004 Dear Ms. Schorle: 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 {2}------------------------------------------------ Page 2 - Ms. Suzanne Schorle 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. product rainell 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 premarked 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) 276-0120. 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, Donna R. Lachner 6/\ Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Silicone Coated Guidewire 4. - - - - - - - - - - - | SECTION 3.0 INDICATIONS FOR USE STATEMENT | | |-------------------------------------------|---------------------------| | 510(k) Number: | K041740 | | Device Name: | Silicone Coated Guidewire | To facilitate the placement of devices used during diagnostic Indications for Use: and interventional procedures. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) una R. bochner (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number K041740