PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY

{0}------------------------------------------------ ## Premarket Notification (510(k)) Summary | 510(k) Number: | K012066 | |---------------------------|-----------------------------------------------------------------------------------------------| | Product Name: | Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology (Biliary Indication) | | Common Name: | biliary stent | | Class: | Class II, 21 CFR 876.5010 | | Submitter's Name: | Sulzer IntraTherapeutics Inc.<br>651 Campus Drive<br>St. Paul, MN 55112 | | Official Contact: | Maria Brittle<br>Regulatory Affairs Manager<br>Telephone: 651-697-2018<br>Fax: 651-697-4808 | | Summary Preparation Date: | June 29, 2001 | This summary is provided in compliance with section 513(I)(3)(A) of the Act and summarizes the safety and effectiveness information contained in this premarket notification submission for a modification to the Protégé™ Self-expanding Nitinol StarPort™ Delivery Technology. The Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology is intended as a palliative treatment of malignant neoplasms in the biliary tree. The Protégé™ stent is a self-expanding nitinol (nickel-titanium alloy) stent provided in multiple lengths, (20, 30, 40, 50, 60, 70 and 80 mm) and diameters (6, 7, 8 and 9 mm). The stent is electropolished. The stent is premounted on an 80 or 120 cm working length, 0.035" over-thewire delivery catheter designed for transhepatic access. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency in the biliary ducts. The disposable StarPort Delivery Technology system is comprised of an inner and outer sheath, which are locked together with a safety lock. The modified Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology, is substantially equivalent to the currently marketed Protége™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology (K003040) in intended use, materials, technological characteristics and performance. A stent retainer feature has been added to enhance the smoothness of deployment and additional ports for enhanced contrast injection. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Bockville MD 20850 AUG 0 1 2001 Ms. Maria E. Brittle Regulatory Affairs Manager Sulzer IntraTherapeutics, Inc. 651 Campus Drive ST. PAUL MN 55112 K012066 Re: > ProtégéTM Self-Expanding Nitinol Stent with StarPort™ Delivery Technology (Biliary Indication) Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: June 29, 2001 Received: July 2, 2001 Dear Ms. Brittle: 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 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. {2}------------------------------------------------ Page 2 – Ms. Maria E. Brittle 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 requirements, as set forth in the Quality System Regulation (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 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. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification if the limitation statement above is added to your labeling, as described. 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. 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/dsma/dsmamain.html". Sincerely yours, Bernard E. Statland, M.D., Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Page 1 of 1 510(k) Number (if known): K012066 Device Name: Protégé™ Self-Expanding Nitinol Stent with StarPort™ Delivery Technology (Biliary Indication) FDA's Statement of the Indications For Use for device: The Protégé™ Self-Expanding Nitinol Stent with StarPort™ Delivery Technology (Biliary Indication) is intended as a palliative treatment of malignant neoplasms in the biliary tree. Prescription Use V OR (Per 21 CFR 801.109) Over-The-Counter Use David L. Segerson