MICRUS GUIDE WIRE, WATUSI 0.014

{0}------------------------------------------------ ## ll. Safety and Efficacy Summary K053265 APR 2 8 2005 #### Contact Information A. Margaret Webber Director, Regulatory and Clinical Affairs Micrus Corporation 610 Palomar Avenue Sunnyvale, CA 94085 B. Device Name Micrus Watusi 0.014" Guide Wire Device: Wire, Guide, Catheter Regulation Number: 870.1330 Product Code: DQX Device Class: 2 #### C. Predicate Device(s) | Number | Description | Clearance<br>Date | |---------|---------------------------------------|-------------------| | K971254 | Transend Ex Platinum 0.014 Guide Wire | July 1, 1997 | #### D. Device Description The Micrus guide wire consists of these major components: - A flexible proximal shaft. . - A distal, atraumatic, radiopaque, coiled tip. . - A tapered core wire. . - A hydrophilic coating covering the distal end. . - A detachable torque device (pin vise type). . - An insertion tool or shaping mandrel . #### E. Intended Use Micrus Watusi guide wire is intended for general intravascular use, including the neuro and peripheral vasculature. The guide wire can be torqued to facilitate the selective placement of diagnostic or therapeutic catheters. A torque device (pin vise) in included with the guide wire to facilitate directional manipulation of the guide wire. An introducer device is included to introduce the guide wire into the catheter or hemostatic valve, and can also be used to shape the flexible tip of the guide wire, as desired. ### Intended Use Predicate Device (per products' Instructions for Use) F. Boston Scientific Target's Transend Ex family guide wires are intended for general intravascular use, including the neuro and peripheral vasculature. The guide wire can be torqued to facilitate the {1}------------------------------------------------ selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries. A torque device (pin vise) is included with the guide wire to facilitate directional manipulation of the guide wire. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three curved lines representing snakes or streams. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 2 8 2006 Micrus Endovascular c/o Ms. Margaret Webber Director, Regulatory and Clinical Affairs 821 Fox Lane San Jose, CA 95131 Re: K053265 Trade/Device Name: Micrus Watusi 0.014" Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: April 14, 2006 Received: April 17, 2006 Dear Ms. Webber: 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 {3}------------------------------------------------ Page 2 - Ms. Margaret Webber 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) 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) 276-0120. 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/industry/support/index.html. Sincerely vours. Duna R. Vichner Image /page/3/Picture/5 description: The image shows a signature. The signature is illegible, but it appears to be written in cursive. The signature is black and is on a white background. The signature is simple and does not contain any elaborate flourishes. 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 14053265 510(k) Number (if known): Micrus Guide Wire. Watusi 0.014 Device Name: Indications For Use: Micrus Watusi guide wire is intended for general intravascular use, including the neuro and peripheral vasculature. The Watusi guide wire is not intended for use in the coronary arteries. The guide wire can be torqued to facilitate the selective placement of diagnostic or therapeutic catheters. A torque device (pin vise) in included with the guide wire to facilitate directional manipulation of the guide wire. An introducer device is included to introduce the guide wire into the catherer or hemostatic valve, and can also be used to shape the tlexible tip of the guide wire, as desired. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH. Office of Device Evaluation (ODE) Duna P. Viclunes (Division Sign-Off) (Division or Cardiovascular Devices Page 1 of __ .10(k) Number K653265