VIABIL BILIARY ENDOPROSTHESIS

{0}------------------------------------------------ JUL 21 2004 K041423 Page 1 of 2 # Premarket Notification 510(k) Summary ## Summary of Safety and Effectiveness ## Applicant: W.L. Gore and Associates Inc. 3250 W. Kiltie Lane Flagstaff, AZ 86001 #### Contact: Michael E. Ivey #### Date Prepared: June 25, 2004 ## Trade or Proprietary Name: VIABIL"™ Biliary Endoprosthesis #### Common or Usual Name: Biliary Stent #### Device Predicate: VIABIL™ Biliary Endoprosthesis #### Device Description: The predicate VIABIL "" Biliary Endoprosthesis is a flexible, self-expanding stent with an inner tubular lining that is radially compressed and secured onto the distal end of a delivery catheter. The catheter provides a means for implanting the VIABIL " Biliary Endoprosthesis at the target site in the biliary tract. There are two principle components of the device: the endoprosthesis and the delivery catheter. Two catheter lengths are available: a 40 cm working length catheter for percutaneous delivery of the endoprosthesis, and a 195-cm working length catheter for endoscopic delivery. The endoprosthesis is available in two diameters (8 mm and 10 mm), and four lengths (4 cm, 6 cm, 8 cm, and 10 cm). {1}------------------------------------------------ K041423 Page 2 of 2 # Statement of Intended Use: The VIABIL™ Biliary Endoprosthesis is indicated for the treatment of malignant biliary strictures. # Substantial Equivalence: A variety of tests, assessments, and comparisons demonstrate that the VIABIL™ Biliary Endoprosthesis is substantially equivalent to its predicate in terms of composition, design, intended use, and performance attributes. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 2 1 2004 Mr. Michael E. Ivey Regulatory Affairs Associate W.L. Gore & Associates, Inc. 3450 West Kiltie Lane FLAGSTAFF AZ 86001 Re: K041423 Trade/Device Name: W.L. Gore VIABIL TM Biliary Endoprosthesis Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: June 25, 2004 Received: June 28, 2004 Dear Mr. Ivey: We have reviewed your Section 510(k) premarket notification of intent to market the device we have love 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 ase suited in also there 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 and the limitations described below. 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. The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling: The safety and effectiveness of this device for use in the vascular system have not been established. Furthermore, the indication for biliary use must be prominently displayed in all labeling, including pouch, box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print. {3}------------------------------------------------ Page 2 - Mr. Michael E. Ivey If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to 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 I lease be adermination that your device complies with other requirements of the Act or any I DA has made a dollarions 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); good manufacturing practice requirements as set forth in the quality labeling (21 CFR Part 801); good nation (20); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. The FDA finding of substantial equivalence of your device to a legally marketed predicate device The I Dry Inding of sacoming of your device and permits your device to proceed to the market. This results in a classiniation for marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling. Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling. If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4616. Also, please note (21 CFR Part entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Nustein Ms for Donna-Bea Tillman, Ph.D. Acting Director Office of Device Evaluation Center for Devices and Radiological Health {4}------------------------------------------------ Page__________________________________________________________________________________________________________________________________________________________________________ 510(k) Number: K041423 Device Name: W.L. Gore VIABIL™ Biliary Endoprosthesis FDA's Statement of the Indications For Use for device: The VIABIL™ Biliary Endoprosthesis is indicated for the treatment of malignant biliary strictures. Prescription Use X (Per 21 CFR 801.109) OR Over-the-Counter Use ___________ Smith. Egger --- (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devj 510(k) Number _