V-14 CONTROL WIRE GUIDEWIRE

{0}------------------------------------------------ Special 510(k) Notification Pri: V-14 ControlWire Guidewire Guidewire K112745 OCT 1 8 2011 . ## 510(k) Summary per 21 CFR §807.92 (c) | Submitter's Name<br>and Address | Boston Scientific Corporation<br>One Scimed Place<br>Maple Grove, MN 55311 | | | |---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-----------------| | Contact Name and<br>Information | Shannon Pettit<br>Senior Regulatory Affairs Specialist<br>Tel: 763-494-2833<br>Fax: 763-494-2222<br>E-mail: Shannon.Pettit@bsci.com | | | | Date Prepared | 20 September 2011 | | | | Trade Name | V-14TM ControlWire® Guidewire | | | | Common Name | Wire, Guide, Catheter | | | | Classification | Class II | | | | Product Code | DQX (21 CFR 870.1330) | | | | Predicate Device | Boston Scientific<br>PT Graphix Guidewire<br>(Formerly SCIMED<br>CholCE PT Vision) | K962572 | SE: 17 Dec 1996 | | Reason for<br>Submission | To gain clearance for the V-14 ControlWire Guidewire based on a<br>narrowed intended use of the currently marketed PT Graphix<br>Guidewire cleared under K962572. | | | | Device<br>Description | The V-14 ControlWire Guidewire is a hydrophilic coated polymer<br>tipped guide wire intended to facilitate the placement of balloon<br>dilatation catheters, and/or other therapeutic devices during peripheral<br>vascular procedures.<br><br>V-14 ControlWire core wire is constructed using 304V stainless steel<br>wire. The distal portion of the core wire is tapered in diameter to<br>provide added flexibility. The distal portion of the core wire is covered<br>by a two part polymer sleeve. The polymer sleeve is coated with a<br>hydrophilic coating to create a lubricious surface and improve wire<br>handling. The proximal portion of the core wire is coated with<br>polytretraflouroethylene (PTFE).<br><br>The V-14 ControlWire comes in two length configurations (182 cm and<br>300 cm), two distal tip configurations (Straight and Angled) and two<br>taper lengths (Short Taper and Long Taper). | | | {1}------------------------------------------------ K112745 P.2 of 3 Special 510(k) Notification V-14 ControlWire Guidewire | Indications for<br>Use | The V-14 ControlWire Guidewires are intended to facilitate the<br>placement and exchange of balloon dilatation catheters or other<br>therapeutic devices during Percutaneous Transluminal Angioplasty<br>(PTA) or other intravascular interventional procedures.<br><br>The V-14 ControlWire Guidewires are not intended for use in the<br>cerebral vasculature.<br><br>The devices are provided non-pyrogenic, sterile, and intended for one<br>procedure only. | |---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Comparison of<br>Technological<br>Characteristics | The narrowed intended use of the V-14 ControlWire Guidewire as<br>compared to PT Graphix Guidewire does not affect or alter the<br>fundamental scientific technology of the cleared components. The<br>design, operating principles, shelf-life, materials, construction,<br>accessories, performance, sterilization method, and manufacturing of<br>the devices will remain unchanged. | ﺪ {2}------------------------------------------------ | Non-Clinical<br>Performance Data | Determination of substantial equivalence is based on an assessment<br>of non-clinical performance data. Non-clinical performance data<br>submitted in support of the overall safety and efficacy of the device is<br>based on the Failure Modes/Effects Analysis (FMEA) risk analysis<br>method completed for the V-14 ControlWire to demonstrate that the<br>proposed devices are suitable for their intended use.<br><br>All testing performed and data demonstrate passing results according<br>to executed verification protocols. Therefore, results of non-clinical<br>performance data, including biocompatibility, sterility, and packaging<br>testing, supports the safety and efficacy of the V-14 ControlWire | | | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | | Guidewires.<br>The following performance tests were performed:<br>Torqueability Radiopacity Polymer sleeve lubricity / wire movement Magnetic segment resiliency Magnetic performance Distal tip tensile Proximal tensile Surface Inspection Bends Corrosion resistance Flexing test Biocompatibility: Cytotoxicity Sensitization Intracutaneous Reactivity Acute Systemic Toxicity Materials Mediated Rabbit Pyrogen Hemolysis Direct Partial Thromboplastin Time In Vitro Hemocompatibility Assay Complement Activation USP Physicochemical Latex | Tip flexibility Coating adherence Coating durability - distal Magnetic section kink resistance Magnetic section joint kink resistance / fatigue J-tip / angled tip retention Torque strength Polymer sleeve shear Overall length Fracture test | | | Clinical<br>Performance Data | Clinical Evaluation was not required for these devices. | | | | Conclusion | Based on the Indications for Use, unaltered technological<br>characteristics, and submitted non-clinical performance data, the<br>Boston Scientific V-14 ControlWire Guidewire is shown to be<br>appropriate for its intended use and is considered to be substantially<br>equivalent to the PT Graphix Guidewire (K962572). | | | · {3}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/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 & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three curved lines. ## Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Boston Scientific Corporation % Ms. Shannon Pettit One Scimed Place Maple Grove, MN 55311-1566 OCT 1 8 2011 Re: K112745 Trade/Device Name: V-14 ControlWire Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: September 20, 2011 Received: September 21, 2011 Dear Ms. Pettit: 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. Please note: CDRH does not evaluate information related to contractly and i warranties. We remind you, however, that device labeling must be truthful and not misleading. ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device (111) e 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); medical device reporting (reporting of medical {4}------------------------------------------------ Page 2 - Ms. Shannon Pettit device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to - http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Bram D. Zuckerman, M.D. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## Indications for Use 510(k) Number (if known): KU2745 Device Name: V-14™ ControlWire® Guidewire Indications for Use: The V-14 ControlWire Guidewires are intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during Percutaneous Transluminal Angioplasty (PTA) or other intravascular interventional procedures. The V-14 ControlWire Guidewires are not intended for use in the cerebral vasculature. The devices are provided non-pyrogenic, sterile, and intended for one procedure only. Prescription Use X· (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) Signature Division Sign-Off) Pasion for Cardiovasculc.ices 5!ük Number #1121945. Page 1 of _ 1