WALSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS

{0} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service NOV - 3 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Boston Scientific Corporation % Ms. Angela Byland Manager, Regulatory Affairs Cardiovascular Two Scimed Place Maple Grove, MN 55311-1566 Re: K961507 Trade/Device Name: WALLSTENT® Tracheobronchial Endoprosthesis Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis Regulatory Class: II Product Code: JCT Dated: April 18, 1996 Received: April 19, 1996 Dear Ms. Byland: This letter corrects our substantially equivalent letter of July 10, 1996. 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 – Ms. Angela Byland 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,  Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health {2} # Indications for Use 510(k) Number (if known): K961507 Device Name: Wallstent® Tracheobronchial Endoprosthesis Indications for Use: The Wallstent® Tracheobronchial Endoprosthesis is intended for use in the treatment of tracheobronchial strictures and fistulas produced by malignant neoplasms. Prescription Use ☑ (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) (Division Sign-Off) Division of General, Restorative, Page 1 of 1 and Neurological Devices 510(k) Number K961507 {3} K961507 p. 1 of 2 # Boston Scientific 510(K) SUMMARY K961507 ## 1. Submitter: Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01545 Telephone: 508-683-4942 Fax: 508-683-5939 Contact: Kathleen Morahan Director Regulatory Affairs Original Date Prepared: April 18, 1996 Revision Date: July 14, 2006 ## 2. Device: Trade Name: Wallstent® Tracheobronchial Endoprosthesis Common Name: Tracheal Prosthesis Classification Name: Tracheal Prosthesis Regulation Number: 878.3720 Product Code: JCT Classification: Class II ## 3. Predicate Device: Boston Scientific Corporation’s Wallstent Tracheobronchial Prosthesis, K934116 Boston Scientific Corporation’s Wallstent Tracheobronchial Prosthesis, K945494 ## 4. Device Description: The Wallstent Tracheobronchial Endoprosthesis is a self-expanding prosthesis constructed of biomedical superalloy and an elastomeric polymer. Smaller diameter models may utilize a radiopaque core. The prosthesis is a braided wire structure which may be covered with an elastomeric polymer in selected models. The outward radial force along with the ends of the device serve to stabilize the prosthesis after implanted. The prosthesis is offered in covered and uncovered version to allow physicians to select the most appropriate models based on their preference and individual patient condition. The stents purpose is to increase or maintain the inner luminal diameter of the tracheobronchial passage. The stent is placed by means of a delivery system. The delivery system is a coaxial tubing assembly which constrains the prosthesis until it is release in a controlled manner. The release of the stent is accomplished by retracting the outer sheath. The prosthesis is packaged constrained on the delivery system ready for placement. The system is sterile and intended for single use only. {4} K96/50 + p. 20+2 # Boston Scientific ## 5. Intended Use: The Wallstent Tracheobronchial Endoprosthesis is intended for us in the treatment of tracheobronchial strictures and fistulas produced by malignant neoplasms. ## 6. Technological Characteristics: This premarket notification deals with modification of the indication for use statement. The design of the Endoprosthesis is the same as that of the predicate devices. ## 7. Performance Data: No modifications to the device were included, therefore bench data was not required. A summary of clinical cases and information from clinical literature is included in the 510(k) submission. ## 8. Conclusion: Boston Scientific Corporation believes the above listed predicate devices and the Wallstent Tracheobronchial Endoprosthesis are substantially equivalent based on design, materials, methods of fabrication and indications for use.