MODIFICATION TO VIABAHN ENDOPROSTHESIS

{0}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure, with three curved lines representing its wings or body. The bird is positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and is arranged around the circumference of the circle. NOV 3 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 W.L. Gore & Associates, Inc. % Mr. Timothy W. Capehart Regulatory Affairs Associate 3450 West Kiltie Lane P.O. Box 2400 Flagstaff, Arizona 86003 Re: K023811 Trade/Device Name: The GORE VIABAHN'" Endoprosthesis Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis Regulatory Class: II Product Code: JCT Dated: November 14, 2002 Received: November 15, 2002 Dear Mr. Capehart: This letter corrects our substantially equivalent letter of December 10, 2002. 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 (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 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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set {1}------------------------------------------------ Page 2 - Mr. Timothy W. Capehart 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 continue 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) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours. Reto Thumme rk N lelker Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ 510(k) Number (if known) : K023811 The GORE VIABAHN® Endoprosthesis Device Name : Indications for Use: : The GORE VIABAHN® Endoprosthesis is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms. . . (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use | <div> <span></span> </div> | |----------------------|----------------------------| | (Per 21 CFR 801.109) | | (Division Sign-Off) | Division of General, Restorative | Counter Use __________ | |----------------------------------|------------------------| | and Neurological Devices | | | 510(k) Number | LC 023511 | |---------------|-----------| |---------------|-----------| {3}------------------------------------------------ # Tab D Premarket Notification 510(k) Summary #### Summary of Safety and Effectiveness Page 1 of 2 #### Applicant: W.L. Gore & Associates, Inc. 3450 West. Kiltie Lane P.O. Box 500 Flagstaff, AZ 86002-0500 #### Contact Timothy W Capehart #### Date Prepared November 13, 2002 Rev: August 28, 2006 Trade or Proprietary Name VIABAHN™ Endoprosthesis #### Common or Usual Name Tracheal Endoprosthesis Classification Name Tracheal Prosthesis #### Device Predicates VIABAHN™ Endoprosthesis #### Device Description The VIABAHN™ Endoprosthesis is a self-expanding implantable endoprosthesis that is compressed and secured on the distal end of a catheter delivery system. The catheter delivery system provides a means for implanting the endoprosthesis at a target location VIABAHN™ is a Trademark of W.L. Gore & Associates. {4}------------------------------------------------ 023811 p. 20+2 ### Summary of Safety and Effectiveness Page 2 of 2 ## Device Description (cont'd) within the tracheobronchial tract. The endoprosthesis consists of a fluoropolymeric tube with a within the factor over its external surface. The catheter delivery system is configured with radiopaque markers and is designed for use with guidewires. The device has been modified in several particulars in order to improve manufacturability. The I he device has been mountented. The fundamental scientific principles underlying its function remain unchanged. # Statement of Intended Use The VIABAHN™ Endoprosthesis is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms. #### Substantial Equivalence A variety of tests, assessments, and comparisons demonstrate that the VIABAHN™ Endoprosthesis is substantially equivalent to its predicate in terms of composition, design, intended use, and performance attributes.