SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS

{0}------------------------------------------------ NOV 1 9 1999 #### Sulzer Carbomedics Inc. 1300 East Anderson Lane Austin, Texas 78752-1793 Phone (512) 435-3200 FAX (512) 435-3350 WATS (800) 648-1579 (US and Canada) ### 510(k) SUMMARY SULZER VASCUTEK ePTFE VASCULAR PROSTHESIS The Sulzer Vascutek expanded polytetrafluoroethylene (ePTFE) graft line is substantially equivalent to devices in commercial distribution by Impra, a division of C. R. Bard. All devices referenced under this application are 6mm in diameter or greater and are used to treat diseased or occluded systemic arteries and for A/V access. In addition, the application covers externally supported graft designs. The device is composed of polytetrafluoroethylene, which has been fabricated in tubular form and expanded to impart porosity to the structure. Similar devices have been used clinically since the 1970's with few reported complications or material failures. ePTFE typically is used as a synthetic conduit to replace natural vessels or as a shunt for AV/dialysis access. The mechanical properties of Sulzer Vascutek ePTFE such as strength, suture retention, and handling are substantially equivalent to products currently in commercial distribution. Sulzer Vascutek ePTFE grafts are intended for the creation of subcutaneous conduits for blood access, bypass, or reconstruction of occluded or diseased arterial blood vessels. Typical applications for standard wall grafts include systemic vascular repair, primarily for axillo-femoral bypass and femoral-popliteal reconstruction. Typical applications for thin wall grafts include systemic vascular repair, but not for axillofemoral/bifemoral bypass reconstruction. In vitro testing conducted on the Sulzer Vascutek ePTFE graft line shows it to be substantially equivalent to Impra commercial grafts. Results from animal studies demonstrate that the Sulzer Vascutek standard wall grafts to be equivalent to Impra standard wall grafts. Results from biomaterial testing demonstrate that the Sulzer Vascutek ePTFE grafts are biocompatible and non-toxic. In summary, all testing demonstrates that the Sulzer Vascutek ePTFE graft line to be substantially equivalent to the grafts in commercial distribution by Impra, Division of C.R. Bard for the reconstruction and bypass of diseased or occluded systemic blood vessels and construction of subcutaneous a-v conduits for blood access. | Common name of the Device: | Vascular Graft | |---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------| | Trade name of Proprietary Name: | Sulzer Vascutek ePTFE Vascular Prosthesis | | Submitter and Contact Person: | Edward E. Newton<br>Regulatory Affairs Manager<br>1300 E. Anderson Lane, Austin, TX 78752<br>Phone: (512) 435-3407 Fax: (512) 435-3350 | | Submission Submitted on: | August 20, 1999 | {1}------------------------------------------------ Image /page/1/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping, wavy lines, which are meant to represent the essence of human health and services. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 1 9 1999 Mr. Edward E. Newton Requlatory Affairs Manager Sulzer Carbomedics, Inc. 1300 East Anderson Lane Austin, TX 78752-1793 K992832 Re : Sulzer Vascutek ePTFE Vascular Prosthesis Regulatory Class: II (Two) Product Code: 74 DSY August 20, 1999 Dated: Received: August 23, 1999 Dear Mr. Newton: 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 general controls provisions of the Act include the Act. 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 regulations affecting your device can be found in the Code of Federal Requlations, 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 Requlation (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 assumptions. Failure to comply with the GMP regulation may result in 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 miqht have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {2}------------------------------------------------ ## Page 2 - Mr. Edward E. Newton This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding described in your sio\!, promains 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 requlation (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 Also, please note the regulation entitled, at (301) 594-4639. "Misbranding by reference to premarket notification" (21CFR Other general information on your responsibilities under 807.97) . . 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, for Celia M. Witten, Ph.D., M.D. & exper Ce 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 {3}------------------------------------------------ Page 1 of 1 _ 510(k) Number (if known): __ K992832 Device Name: _ Sulzer Vascutek ePTFE Vascular Prosthesis Indications For Use: Sulzer Vascutek ePTFE grafts are intended for the creation of subcutaneous arteriovenous conduits for blood access, bypass, or reconstruction of occluded or diseased arterial blood vessels. # (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Bree B. Bempere Qe (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K 992832 510(k) Number _ Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)