VERIPATH PERIPHERAL GUIDING CATHETER

{0}------------------------------------------------ K994229 ## Appendix A - 510(k) Summary | Submitter | Guidant Corporation, Vascular Intervention<br>Advanced Cardiovascular Systems, Inc.<br>26531 Ynez Road, Temecula CA 92591<br>Contact: Stacey Simon<br>Phone: (909) 914-2800, Fax: (909) 914-2146 | |------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date | December 15, 1999 | | Device name | Device Trade Name: VERIPATH™ Peripheral Guiding Catheter<br>Device Common Name: Percutaneous Catheter<br>Device Classification Name: Guiding Catheter<br>Device Classification: Class II | | Summary of<br>substantial<br>equivalence | The design, materials, method of operation, and intended use features<br>of the Guidant VERIPATH™ Peripheral Guiding Catheter are<br>substantially equivalent with regard to these features in the predicate<br>device, the ACS VIKING™ Guiding Catheter (K972484). | | Device<br>description | The VERIPATH™ Peripheral Guiding Catheter is recommended for<br>use during vascular procedures in conjunction with interventional<br>and/or diagnostic devices such as balloon dilatation catheters,<br>atherectomy devices, stent delivery systems, intravascular ultrasound<br>devices, etc. | {1}------------------------------------------------ #### Appendix A - 510(k) Summary, Continued Device description, Continued Guiding Catheter The guiding catheter is a single lumen catheter that allows contrast medium iniections and facilitates the intravascular passage of diagnostic and therapeutic devices into the vascular system. The guiding catheter has a standard working length of 50 cm and a standard overall length of 56 cm, but can be produced in overall lengths from 40 to 80 cm, depending upon physician preference and patient size. The guiding catheter is available in three diameters/French sizes (F), as follows: 6F (0.068" ID, 0.82" OD), 7F (0.078" ID, 0.93" OD), 8F (0.088" ID, 0.105" OD). The guiding catheter is available in varying tip shapes designed for peripheral use. Each shape is specific for patient anatomy and physician preference, and therefore a wide range of shapes is available. #### Inner Catheter Also included in the VERIPATH™ device package is an inner catheter. The inner catheter is a single lumen catheter with a luer at the proximal end and is recommended for use with the guiding catheter to aid in the introduction and withdrawal of the guiding catheter. The inner catheter has a standard working length of 65 cm and a standard overall length of 67 cm, but can be produced in lengths from 55 to 95 cm depending upon physician preference and patient size. The inner catheter is straight and available in three diameters/French sizes (F), as follows: 6F (0.062" OD), 7F (0.072" OD), and 8F (0.082" OD) and may be sold either with or without a taper at the tip. {2}------------------------------------------------ # Appendix A - 510(k) Summary, Continued | Intended use | The peripheral guiding catheter is intended to provide a pathway<br>through which therapeutic and diagnostic devices are introduced into<br>the peripheral vasculature. | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications<br>statement | Please see above for intended use statement. | | Technological<br>characteristics | The Guidant VERIPATH™ Peripheral Guiding Catheter incorporates<br>similar design, components, method of operation, and intended use of<br>the predicate device, the ACS VIKING™ Guiding Catheter, with<br>exception of the dimensions. | | Performance<br>data | The safety and effectiveness of the VERIPATH™ Peripheral Guiding<br>Catheter have been demonstrated through data collected from<br>nonclinical bench tests and analyses. | {3}------------------------------------------------ 920 Boo FEB 25 2000 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Stacey Simon Guidant Corporation Vascular Intervention Group 26531 Ynez Road Temecula, CA 92591-4628 Re: K994229 VERIPATH™ Peripheral Guiding Catheter Regulatory Class: II (two) Product Code: DQY February 9, 2000 Dated: February 10, 2000 Received: Dear Ms. Simon: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {4}------------------------------------------------ Page 2 - Ms. Stacey Simon This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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, Autry Smith for Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ FEB 2 5 2000 #### GUIDANT ### Indications for Use Statement | 510(k) number (if known): | The 510(k) number has not been issued yet. | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device name | VERIPATH™ Peripheral Guiding Catheter | | Intended Use | The peripheral guiding catheter is intended to provide a pathway through which therapeutic and diagnostic devices are introduced into the peripheral vasculature. | | | The inner catheter is intended to provide support during the introduction and withdrawal of a guiding catheter. | Division Sign-Off), vascular, Respiratory, Respiratory, Division of Cardiovascular, Respiratory, Division of Carcal Devices Bod Neurological Devices Off) (Division Sign-Off Cardio) (Division of Cardios Division of Cardio devices Division of Cardiogical Devices Division of Cardiogical Devices and Neurological Devices Devices and Neurological Devices (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter (Optional Format 1-1-96) Guidant Corporation Vascular Intervention Group 26531 Ynez Road, Temecula, CA 92591-4628 Mailing Address: P.O. Box 9018, Temecula, CA 92589-9018 Tel 909.914.2400