FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROSTHESIS

{0}------------------------------------------------ # 984068 #### JAN 7 1999 # 510(k) Summary Flamingo™ WALLSTENT® Esophageal Endoprosthesis ### General Information | Date Prepared: | November 11, 1998 | |-----------------|------------------------------------------------| | Classification: | Class III | | Trade Name: | Flamingo™ WALLSTENT® Esophageal Endoprosthesis | | Submitter: | Schneider (Europe) GmbH | | | Ackerstrasse 6, CH-8180 Bülach, Switzerland | | | Tel. ++41 872 11 11; Telefax ++41 862 05 04 | | Contact: | Thomas Thaler, Ph. D. | | | Director, Clinical and Regulatory Affairs | | | Predicate Device: | ## Device Description: The Flamingo™ WALLSTENT® Esophageal Endoprosthesis is a self expanding prosthesis constructed of biomedical superalloy with an elastomeric polymer covering. The prosthesis is a braided wire structure which is covered with elastomeric polymer over approx. 75 % of it's length. The outward radial force, the conical shape of the stent along with the ends of the device serve to stabilize the placed. The stent's purpose is to increase or maintain the inner lumenal diameter of the esophageal passage or to close tracheo-esophageal fistulae. 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 released in a controlled manner. The release of the stent is accomplished by the sliding of the outer coaxial tube. The prosthesis is packaged constrained on the delivery system ready for placement. The system is sterile and intended for single use only. In summary, Schneider (Europe) GmbH believes the above listed predicate devices and the Flamingo™ WALLSTENT® Esophageal Endoprosthesis are substantially equivalent based on design, materials, methods of fabrication and indications for use. {1}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 7 1999 Thomas Thaler, Ph.D Director, Clinical and Regulatory Affairs Schneider (Europe) GmbH Ackerstrasse 6, P.O. Box CH-8180 Bülach, Switzerland > K984068 Trade Name: Flamingo Wallstent Esophageal Endoprostheses Regulatory Class: III Product Code: ESW Dated: November 12, 1998 Received: November 16, 1998 Dear Dr. Thaler: Re: 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 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 regulations 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 requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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 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. Image /page/1/Picture/9 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of a stylized eagle with three lines representing its wings. {2}------------------------------------------------ Page 2 - Dr. Thomas Thaler 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) 594-4595. 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/dsmamain.html". Sincerely yours, ~Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ K9840668 Premarket Notification for the Flamingo™ WALLSTENT® Esophageal Endoprosthesis 510(k) number (if known): Device name: Indications for Use: Flamingo™ WALLSTENT® Esophageal Endoprosthesis The Flamingo™ WALLSTENT® Esophageal Endoprosthesis is intended to be used for the - palliative treatment of strictures of the esophagus, - including cardia, due to a malignant process - palliative treatment of tracheo-esophageal fistulae due to a malignant process. PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) ## X Prescription OTC lo.colle (Division) Sign-Off Division of General 510(k) Number