SKATER BILIARY CATHETER

{0}------------------------------------------------ K070610 page 1 of 3 ### Section 5 - 510(k) Summary JUN 2 1 2007 ### 1. Applicant Contact: Trudy D. Estridge, PhD Director of Regulatory Affairs Angiotech Dulles Gateway Center 13921 Park Center Road, Suite 100 Herndon, VA 20171 USA CA voice: 510.742.5301 VA voice: 703.796.8927 Fax: 703.673.0061 Email: testridge@angio.com Date Prepared: March 01, 2007 2. Name of Device: Skater® Biliary Drainage Catheter Common Name: Biliary Catheter Classification Name: Catheter, Biliary, Diagnostic Regulation 21 CFR 876.5010 -- Product Code FGE ### 3. Identification of device(s) to which the submitted claims equivalence: Boston Scientific Corporation, Flexima™ Biliary Catheter, K023870 ### 4. Device Description: The Skater® Biliary Drainage Catheter is made from hydrophilic coated polyurethane. The catheter comes in a pigtail-loop, locking-type end configuration with drainage holes. The catheters are provided in 8 French, 10 French, and 12 French sizes with a length of 40 cm. Accessories include a metal stiffening cannula, a plastic stiffening cannula and a standard luer locking hub. #### 5. Intended Use of the Device: The Skater® Biliary Drainage Catheter is indicated for percutaneous biliary drainage. {1}------------------------------------------------ page 2 of 2 K07061C # Section 5 - 510(k) Summary 6. Technological characteristics of the device in comparison to those of the predicate device(s) | Feature /<br>Technological<br>Characteristics | Boston Scientific<br>Corporation, Flexima™<br>Biliary Catheter<br>K023870<br>(Predicate Device) | Skater® Biliary<br>Drainage Catheter<br>(New Device) | |-----------------------------------------------|----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Designed for the external and<br>internal percutaneous<br>drainage of the biliary system | Intended for percutaneous<br>biliary drainage | | Characteristics | Drainage catheter with metal<br>stiffening cannula, flexible<br>stiffening cannula and luer<br>cap | Drainage catheter with metal<br>and plastic stiffening cannula<br>and female/male luer hub<br>(adapter) | | Sizes (French) | 8, 10, 12, 14 | 8, 10, 12 | | Length (cm) | 35 cm from hub to proximal<br>side of pigtail in curved<br>position | 40 cm from hub to distal tip<br>in curved position | | Lumens | One | One | | Distal end<br>configuration | 12 side holes and one end<br>hole, pigtail. | 8 Fr. - 12 side drainage holes<br>and one end drainage hole,<br>pigtail.<br>10 and 12 Fr. - 11 side<br>drainage holes and one end<br>drainage hole, pigtail. | | Intended anatomical<br>location of distal end | Biliary system | Biliary system | | Proximal end<br>configuration | Standard luer locking hub and<br>stop-cock | Female/male luer hub<br>(adapter) and clip | | Materials | Polyurethane | Polyurethane | | Coating | Hydrophilic | Hydrophilic | {2}------------------------------------------------ page 3 of 3 K070610 ## Section 5 - 510(k) Summary ### 7. Safety and Performance: The Skater® Biliary Drainage Catheter has been tested and compared to the predicate device. Testing included functional, leakage, catheter body tensile strength and elongation, physical dimensions and catheter body to hub tensile strength. All data gathered demonstrates the Skater® Biliary Drainage Catheter comparably to the predicate device. The results of in vitro bench tests and biocompatibility testing demonstrate the safety and effectiveness of the Skater® Biliary Drainage Catheter. #### 8. Conclusion Based on the design, material, function and intended use discussed herein. Angiotech believes the Skater® Biliary Drainage Catheter is substantially equivalent to predicate devices currently marketed under the Federal Food, Drug and Cosmetic Act. {3}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850 N 2 1 2007 Trudy D. Estridge, Ph.D. Director of Regulatory Affairs Angiotech® Dulles Gateway Center 13921 Park Center Road, Suite 100 HERNDON VA 20171 Re: K070610 Trade/Device Name: Skater® Biliary Drainage Catheter Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: June 7. 2007 Received: June 8, 2007 Dear Dr. Estridge: 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 application (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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Image /page/3/Picture/10 description: The image is a circular logo or emblem. The central element is the acronym "FDA" in a stylized font, with the word "Centennial" written below it. Above the acronym, the years "1906-2006" are displayed, indicating a centennial celebration. The entire design is encircled by text and star symbols, forming a complete circular seal. cling and Promoting {4}------------------------------------------------ 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. This letter will allow you to begin 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 one of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/industry/support/index.html Sincerely vours. Nancy C. Brogdon Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the text "page 1 of 1" in a handwritten style. The word "page" is written in lowercase letters, followed by the number "1". The words "of" are written in lowercase letters, followed by the number "1". The text appears to be a page number or a document identifier. ## Section 4 - Indications for Use Statement 510k number if known: KO-70610 Device Name: Skater® Biliary Drainage Catheter Indications for Use: The Skater® Biliary Drainage Catheter is indicated for percutaneous biliary drainage. Prescription Use 2 (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 OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Heal on Sign-Off) vision of Reproductive, Abdomina and Radiological Devices 510(k) Number