FORMULA 418 BILIARY STENT

{0}------------------------------------------------ Cook® Formula 418™ Biliary Stent System D.C.#K051785 K051785 Page 1 of 2 # 510(k) Summary of Safety and Effectiveness Information ## Submitted By: Karen Bradburn, RAC Senior Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, PO Box 489 Bloominaton, IN 47402 812-339-2235 August 16. 2005 #### Device: | Trade Name: | Formula 418 Biliary Stent | |--------------------------|----------------------------------| | Proposed Classification: | Biliary Catheter and Accessories | #### Indications for Use Indicated for use in palliation of malignant neoplasms in the biliary tree. ## Predicate Devices: The Formula 418 Biliary Stent is similar in terms of intended use, principles of operation, materials of construction and technological characteristics to predicate devices reviewed as devices for palliation of malignant neoplasms in the biliary tree. ## Device Description: The Formula 418 Biliary Stent is a balloon-expandable, stainless steel stent which is premounted on the delivery system. The stent will be available in diameters of 3, 4, 5, 6, 7, and 8 mm and lengths of 12, 16, 20, 24 and 30 mm. This device will be supplied sterile and is intended for one-time use. ## Substantial Equivalence: The Formula 418 Biliary Stent is similar to many devices in commercial distribution for palliation of malignant neoplasms in the Biliary tree. These devices include the Bridge FX (Bridge Assurant) Stent Delivery System (D.C. #K011817) stent, the Palmaz Genesis Transhepatic Biliary Stent (D.C. #K021345) and the Lifestent LP SDS Biliary Endoprosthesis (D.C.#K023248). The similar indications for use, principles of operation, technological characteristics and performance testing results of the Formula 418 Biliary Stent {1}------------------------------------------------ KC51785 Page 2 of 2 as compared to the predicate devices support a determination of substantial equivalency. # Test Data: The Formula 418 Biliary Stent was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of: - Deployment Testing 1. - Compression force Testing 2. - Expansion Force Testing 3. - Dimensional Testing 4. - 5. Corrosion Testing - Balloon Performance Testing 6. - Stent Deformation Testing 7. - Tensile Strength Testing 8. - ்ல Magnetic Resonance Imaging (MRI) Testing - Shelf Life Testing 10. - 11. Biocompatibility Testing The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a biliary stent. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings and tail feathers. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 2 3 2005 Ms. Karen Bradburn, RAC Senior Regulatory Affairs Specialist Cook Incorporated P.O. Box 489 BLOOMINGTON IN 47402-0489 Re: K051785 K031783 Trade/Device Name: Cook® Formula™ 418TM Biliary Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: August 5, 2005 Received: August 8, 2005 Dear Ms. Bradburn: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered pror to may 2011-11-11 in accordance with the provisions of the Federal Food, Drug, devices that have boon roomst therefore, market the device, subject to the general controls and Cosmete her (rec) - 1 or imitations described below. The general controls provisions of the provisions of the rice and 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 The Office of Doriet 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, i untilermore, the marcarton 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 - Ms. Karen Bradburn, RAC 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. 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 Section 510(k) premarket notification if the limitation statement described above is added to your labeling. 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 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. 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 (240) 276-0115. Also, please note the regulation 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, onna-Bea Tillman, Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): K051785 Device Name: Cook® Formula™ 418TM Biliary Stent System Indications For Use: The Cook® Formula™ 418™ Biliary Stent is indicated for use in palliation of malignant neoplasms in the biliary tree. Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Nancy C. Brogdon ive. Abdominal. nd Radiological D S10(k) Number Page 1 of 1