FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS

{0}------------------------------------------------ Koi 2242 Page 1 of 2 # AUG 1 6 2001 ### Fresenius Hemodialysis Single Use Arterial Bloodline Sets with Alternate Pump Segment Material "Special" 510(k) Premarket Notification Section II: General Device Summary | Proprietary Name: | Fresenius Hemodialysis Single Use Arterial<br>Bloodline Sets | |------------------------------------|----------------------------------------------------------------| | Common Name: | Blood Tubing Set, with or without Anti-<br>regurgitation Valve | | Product Code/Classification Panel: | 78FJK/Gastroenterology-Urology | | Classification: | Class II per §876.5820. | #### Establishment Registration ### Manufacturing Facility Address: Erika de Reynosa, S.A. de C.V. Brecha E-99 Parque Industrial Revnosa, Mexico C.D. Reynosa, Tamps FDA Establishment Registration Number: 8030665 Sterilization Site: Cosmed of Texas 1175 Isuzu Parkway Grand Prairie, TX 75050 FDA Establishment Registration Number: 1650907 #### Submitter Information ### Submitter's Name and Address: Fresenius Medical Care North America 95 Hayden Avenue Lexington, MA 02420 FDA Establishment Registration Number: 1225714 "Special 510{k)" Submission {1}------------------------------------------------ K012242 Page 2 of 2 ### Fresenius Hemodialysis Single Use Arterial Bloodline Sets with Alternate Pump Segment Material "Special" 510(k) Premarket Notification Section II: General Device Summary #### Contact Information: Arthur E. Eilinsfeld, Director of Regulatory Affairs Telephone: (781) 402-9068 Fax: (781) 402-9635 Alternate Contact: Lorraine Calzetta Patrovic ,Senior Regulatory Affairs Specialist Telephone: (781) 402-9785 Fax: (781) 402-9635 ### Summary of Safety and Effectiveness The 510(k) Summary of Safety and Effectiveness is provided in Appendix 1- Summary of Safety and Effectiveness. ### Performance Standards No applicable performance standards have been issued under section 514 of the Food, Drug and Cosmetic Act for Blood Tubing Sets with and without Anti-regurgitation Valves. #### Compliance with ANSI/AAMI RD17-1994 . The Fresenius Hemodialysis Arterial Blood Tubing Sets have been designed to meet the requirements for Hemodialyzer Blood Tubing as specified in ANSI/AAMI RD17-1994. #### Predicate Device The predicate device for the Fresenius Single use Arterial Bloodline Sets with Alternate Pump Segment Material is: - Fresenius Hemodialysis Blood Tubing Sets cleared under K971313 (10/27/97) . - Fresenius Combi Sets® cleared under #K962081 (11/01/96) and #K000451 . (05/09/00). {2}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 1 6 2001 Mr. Arthur E. Eilinsfeld Director, Regulatory Affairs Fresenius Medical Care North America 95 Hayden Avenue LEXINGTON MA 02420 Re: K012242 Fresenius Single Use Arterial Bloodline Sets with Alternate Pump Segment Material Dated: July 13, 2001 Received: July 17, 2001 Regulatory Class: II 21 CFR §876.5820/Procode: 78 FJK Dear Mr. Eilinsfeld: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the We have reviewed your Section 210(x) noursalion of this. It is enclosure) to to in the enclosure) to in the enclosures and the device is substantially equivalent (of the matement date of the Medical Device Amendmants, or to devices marketed in interstate continetee provisions of the Federal Food, DTug, and Cometic Act (Act.). You may, that have been reclassified in accordance with the provisions of the that have been reclassined in acconcal controls provisions of the Act. The general controls provisions of the Act therefore, market the device, subject on the general concess good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class III (Prematet Approval) it may be subject If your device is classified (See above) nine chile) elass if (Special Obin the Code of Federal Regulations, to such additional controls. Existing major regulations areemes compliance with the Current Good Manufacturing I itte 21, Parts 800 to 693. A substanty equiration (QS) for Medical Devices: General regulation (21 CFR Party of C Practice requirements, as set form in the Quality of Son Rogation (FDA) will verify such assumptions. Failure 820) and mat, through periodic QS mspection. In egulatory action. In addition, FDA may publish further announcements to comply with the User regulation in regulatory ations on are to your premarket notification submission increase concerning your device in the Pederal Regiser. Trease notes with to the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding I his letter will and you to begally 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 If you desire specific advice to your de raze on our nabeing regarant (30 l) 594-4639. Additionally, for questions on the promotion diagnosite devices), please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation and advertising of your device, premarket notification" (21CFR 807.97). Other general information on your entified, "Misoraning by relection of the Division of Small Manufacturers Assistance at its toll-free number (800) 16300130011003 and its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.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 (s) Image /page/2/Picture/16 description: The image shows a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus. The image is simple and clean, with a focus on the department's name and symbol. {3}------------------------------------------------ K01-242 Page 1 of 11 ## Fresenius Hemodialysis Single Use Arterial Bloodline Sets with Alternate Pump Segment Material "Special" 510(k) Premarket Notification Section II: General Device Summary ### Indications for Use/Intended Use The Fresenius Single use Arterial Bloodline Sets are intended for use as the The Fresentus Single use Archar Birdinas They are intended for single use only extractiploreal blood circuit daning nomoundly and high flux negative pressure hemodialyzer equipment. The Indications for Use statement is provided in Appendix 2- Indications for Use Statement. Nancy C. Broadon (Division Sign-Off Division of Reproductive, Abdordi and Radiological D 510(k) Number **Prescription Use** (Per 21 CFR 801.109) (Per 21 CFR 801.109)