MODIFICATION TO: LIFESTENT VALEO BILIARY STENT SYSTEM

{0}------------------------------------------------ # AUG 2 4 2005 KC52132 Page 1 of 2 # 510(k) Summary ### 1. Submitter's Name and Address: Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614 ### 2. Contact: Kevin Drisko Sr. Regulatory Manager Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614 Phone: 949-250-2416 FAX: 949-250-3630 E-Mail: kevin_drisko@edwards.com ### 3. Date Prepared: August 4, 2005 ### 4. Device Trade Name: LifeStent Valeo Biliary Stent System # 5. Device Common Name: Biliary Stent # 6. Device Classification Name: Biliary Catheter (78 FGE), Class II ### 7. Predicate Devices: LifeStent SDS/XL SDS Billary Stent Systems (K023308, K033212, K040550, K041032) LifeStent Turbo Biliary Stent System (K050627) {1}------------------------------------------------ K052132 Page 2 of 2 # 510(k) Summary (continued) # 8. Device Description: The LifeStent Valeo consists of a balloon expandable stent that is provided on an over the-wire catheter that acts as a delivery system. The stent is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging tumor. The flexible. balloon expandable stent is made by laser cutting an open lattice design into a stainless steel tube. The stent is supplied mounted onto a PTA balloon catheter, inserted percutaneously to the diseased site and expanded by balloon inflation. The subject device is supplied in lengths of 17/18mm, 26mm, 36 mm and diameters of 6mm, 7mm, 8mm, 9mm and 10mm. # 9. Intended Use: The LifeStent Biliary Stent Systems are indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree. # 10. Technological Characteristics: Comparisons of the subject and predicate devices show that the technical characteristics such as materials, performance properties, biocompatibility, method of sterilization, and packaging are identical or substantially equivalent. ### 11. Performance Data: Edwards Lifesciences completed bench testing such as deployment testing, dimensional testing, balloon performance testing, stent deformation testing as well as tensile testing on applicable joints of the delivery system. The results indicate that the system performed in a manner substantially equivalent to the predicate devices cited in item 7 above. # 12. Conclusion: Since the LifeStent Valeo has the same intended use, similar materials, similar performance properties, packaging and sterilization methods, it may be considered substantially equivalent to the predicate device cited in item 7 above. {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 stylized eagle with three stripes forming its body and two wavy lines below, representing water. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Public Health Service .. ... Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 2 4 2005 Mr. Kevin Drisko Senior Manager, Regulatory Affairs Edwards Lifesciences LLC One Edwards Way IRVINE CA 92614 Re: K052132 K032132 Trade/Device Name: Edwards Lifesciences LifeStent Valeo Biliary Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: August 4, 2005 Received: August 11, 2005 Dear Mr. Drisko: We have reviewed your Section 510(k) premarket notification of intent to market the device indicati We have reviewed your section 510(x) promained is substantially equivalent (for the indications for referenced above and nave decommiou the are devices marketed in interstate commence use stated in the enclosure) to legally marketed predicate and anyance ante devices that use stated in the enclosure) to regally maneted pressed Device Amendments, or to devices that the encond Carmer of Carmer of Carmer of Carmer of Carmer of Carmer of Carmer of prior to May 26, 1976, inc chacinent and of the Federal Food, Drug, and Cosmetic have been reclassified in accordance with the previsions to the general controls provisions of the Act (Act). You may, ulciclore, market me accessor controls provisions of the Act include Act and the innuallons described below. "The general over the practice, labeling, and prohibitions against misbranding and adulteration. The Office of Device Evaluation has determined that there is a reasonable likelihood that this device The Office of Device Evaluation has decifical in the proposed labeling and that such use could cause will be used for an intended use not rechance 113(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 Furnermore, the indication for omary ass france, and other promotional materials, in close pouch, box, and catter lasse, of a similar point size, and in bold print. {3}------------------------------------------------ # Page 2 - Mr. Kevin Drisko If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classifica (seculove) the ting major regulations affecting your device and be found may be subject to additions, 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 Prease be advised that FDA s issumed of a sassamming of the requirements of the Act or any FDA hia statutes and regulations administered by other Federal agencies. You must comply with all Federal statutes and regulations administered by one registration and listing (21 CFR Part 807); the Act s requirements, merading, but not miring practice requirements as set forth in the quality labeling (21 CFR 1 art 801); good management of any from the electronic product radiation Systems (QB) regulation (Ls 531-542 of the Act); 21 CFR 1000-1050. The FDA finding of substantial equivalence of your device to a legally marketed predicate device The FDA Initing Of substantial equivalerice and permits your device to proceed to the market. This results in a classification for your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling. Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Please note that the above mooning manufactions 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 If you desire specific information about the Office of Compliance at (301) 594-4616. Also, please note (21 CFR Fart 801), prease contact in Offication' compremarket notification'' (21 CFR Part 807.97). Ine regulation other general information on your responsibilities under the Act from the Division I ou may obtain other golleral nifonal, 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, Nancy C. brogdon for Donna-Bea Tillman, Ph. Director Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Page__________________________________________________________________________________________________________________________________________________________________________ 510(k) Number: K052132 Device Name: Edwards Lifesciences LifeStent Valeo Biliary Stent System FDA's Statement of the Indications For Use for device: The Edwards Lifesciences LifeStent Valeo Biliary Stent Systems are indicated for use in the The Edwards Ellebolen strictures (neoplasms) in the biliary tree. Prescription Use V (Per 21 CFR 801.109) OR Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________ Nancy C. Boydon (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number