IQ GUIDE WIRE

{0}------------------------------------------------ FEB 1 2 2004 ## 510(k) Summary per 21 CFR §807.92 | Submitter's Name<br>and Address | Boston Scientific Corporation (BSC)<br>Two Scimed Place<br>Maple Grove, MN 55311 | |---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Name and<br>Information | Anne V. Rossi<br>Specialist, Regulatory Affairs<br>Phone: 763-494-2827<br>Fax: 763-494-2222<br>e-mail: Anne.Rossi@bsci.com | | Date Prepared | January 21, 2004 | | Proprietary<br>Name(s) | IQTM Guide Wire | | Common Name | Catheter Guide Wire | | Product Code | 74DQX | | Classification of<br>Device | Class II, 21 CFR Part 870.1330 | | Predicate Device | | | | IQTM Hydrophilic Guide Wire K032183 August 01, 2003 | | Device<br>Description | The IQTM Guide Wires are silicone-coated, steerable,<br>spring-coil guide wires available in a nominal diameter of<br>0.014 inches (0,36 mm) and nominal lengths of 185 and<br>300 centimeters with Brachial and Femoral marks at<br>90cm and 100cm respectively. The tip will have Floppy<br>flexibility, while the rail will offer Moderate Support (MS).<br>The distal two centimeters of all models are radiopaque<br>and available in either a straight shapeable or a pre-<br>formed J-Tip. The IQTM Guide Wires will be available with<br>and without a lesion length marker system. The 185-<br>centimeter version is designed with a proximal extension<br>section that allows connection to the AddWireTM Extension<br>Wire. | {1}------------------------------------------------ | Intended Use of Device | The IQ ^™ Guide Wires are intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or PTA or other intravascular interventional procedures. The IQ ^™ Guide Wires are not intended for use in the cerebral vasculature. The devices are provided non-pyrogenic, sterile, and intended for one procedure only. | |-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Technological Characteristics | The IQ ^™ Guide Wires utilize similar materials and methods of construction as the IQ ^™ Hydrophilic Guide Wires (K032183, August 01, 2003). The main differences in construction are the full-length outer spring coil with an inner coil instead of a spring tip and polymer sleeve, and silicone coating instead of hydrophilic coating. The IQ ^™ Marker version also has marker coils, which the IQ ^™ Hydrophilic does not. | | Non-Clinical Test Summary | Testing and evaluation of the IQ ^™ Guide Wires included torque response, tip prolapse, tip shapeability, radiopacity, marker location, lubricity, coating adherence/presence, tensile and shear, combined load, visual inspection, device compatibility, biocompatibility, and product shelf-life. <p> Test results verified that the IQ ^™ Guide Wires met all of the minimum requirements and are adequate for their intended use. </p> <p> The IQ ^™ Guide Wires are considered substantially equivalent to guide wires currently marketed by Boston Scientific based on a comparison of intended use, design and the results of <i>in vitro</i> testing and evaluation. </p> | : : ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ - - - {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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 1 2 2004 Boston Scientific Corporation Ms. Anne V. Rossi Regulatory Affairs Specialist Two Scimed Place Maple Grove, MN 55311 K040140 Re: Trade/Device Name: IQ™ Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: January 21, 2004 Received: January 22, 2004 Dear Ms. Rossi: We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(x) prematically equivalent (for the indications referenced above and have determined the device is subsets marketed in interstate referenced above and have decemined the devices marketed in interstate for use stated in the enclosure) to regally manced producal Device Amendments, or to commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the chance with the provisions of the Federal Food. Drug, devices that have been reclassified in accordance while approval application (PMA). and Cosmetic Act (Λct) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that do not require appro the general controls provisions of the Act. The Act. The You may, therefore, market the device, sayee to ure gents for annual registration, listing of general controls provisions of the Act include required withing and general controls provisions of the Fee merade requires against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (see above) mis existing major regulations affecting your device can may be subject to such additional controls. Existing major regents may be subject to such additional controller Linesting of Parts 800 to 898. In addition, FDA may be found in the Code of Featurening your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA stissuance of a raded and and other requirements of the Act that ITA has made a decemmation that Jour Star Federal agencies. You must of ally redelar statutes and regariants aincluding, but not limited to: registration and listing (21 comply with an the Ace srequirements) and manufacturing practice requirements as set {3}------------------------------------------------ Page 2 - Ms. Anne V. Rossi 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. This letter will allow you to begin marketing your device as described in your Section 510(k) rms let notification. The FDA finding of substantial equivalence of your device to a legally premainted 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) 594-4648. 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, Dana R. Lechner Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Device Name: IQ™ Guide Wire___________________________________________________________________________________________________________________________________________________ Indications For Use: The IQ™ Guide Wires are intended to facilitate the placement of balloon dilatation The IQ -- Gulde Villes are intended to facilitate the , PTA, or other intravascular interventional procedures. The IQ™ Guide Wires are not intended for use in the cerebral vasculature. Prescription Use × (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) Doug R. Lochner (Division Sign-Off) Division of Cardiovascular Device Page 1 of ____________________________________________________________________________________________________________________________________________________________________ 510(k) Number_604 614 b