CLIRANS T-SERIES HOLLOW FIBER DIALYZERS

{0} p.1/4 SECTION II Summary and Certification DEC 19 1997 # SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE Proprietary Device Name: CLIRANS® T-Series Hollow Fiber Dialyzer Classification Name: Dialyzer, Capillary, Hollow Fiber Common Name: Hollow Fiber Dialyzer ## INTENDED USE The CLIRANS® T-Series Hollow Fiber Dialyzers are devices used as part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. This device is indicated for single and multiple use. ## DESCRIPTION The CLIRANS® T-Series Hollow Fiber Dialyzers consists of cellulose hollow fibers with 9μ wall thickness. Blood is pumped via a roller pump from the artery of the patient into the arterial end of the dialyzer. The blood travels down through the dialyzer fibers where waste products pass through the membrane of the dialyzer into the dialysate, which is constantly circulating through the dialyzer on the outside of the hollow fibers. Blood then exits the venous end of the dialyzer back to the patient. ## SUBSTANTIAL EQUIVALENCE The CLIRANS® T-Series Hollow Fiber Dialyzers submitted in this 510(k) are substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the largest effective surface area dialyzer (CL*M151L) cleared in the CLIRANS® TAF Hollow Fiber Dialyzer 510(k) K854280. 009 {1} K110708 p. 2/4 SECTION II: Summary and Certification ## PRINCIPLE OF OPERATION/TECHNOLOGY The CLIRANS® T-Series Hollow Fiber Dialyzers operate in the following manner. Blood is taken from the artery of a patient and pumped via a roller pump into the arterial end of the dialyzer. The blood travels down through the dialyzer fibers, and waste products then pass through the membrane of the dialyzer into the dialysate which is constantly circulating through the dialyzer on the outside of the hollow fibers. Blood then exits the venous end of the dialyzer, and back into the veins of the patient. ## DESIGN/MATERIALS | Parts | CLIRANS T-Series Hollow Fiber Dialyzer | Cleared CLIRANS TAF Hollow Fiber Dialyzer K854280 | | --- | --- | --- | | Hollow Fiber | Cellulose | Cellulose | | Housing | Acrylonitrile-Styrene copolymer | Acrylonitrile-Styrene copolymer | | Blood Port | Polypropylene | Polypropylene | | Screw ring | Acrylonitrile-Styrene copolymer | Acrylonitrile-Styrene copolymer | | O-ring | Silicone rubber | Silicone rubber | | Adhesive | Polyurethane | Polyurethane | | Blood/Dialysate Port cap | Polyethylene | Polyethylene | {2} 470708 p 3/4 # SECTION II Summary and Certification ## SPECIFICATIONS | Parts | CLIRANS T-Series Hollow Fiber Dialyzer | | | Cleared CLIRANS TAF Hollow Fiber Dialyzer K854280 - Largest Effective Surface Area (CL*M151L) | | --- | --- | --- | --- | --- | | Hollow Fiber | CL*T150L | CL*T175L | CL*T220L | CL*M151L | | Inside Diameter | 200μ | 200μ | 200μ | 220μ | | Wall Thickness | 9μ | 9μ | 9μ | 12μ | | Effective Length | 235mm | 235mm | 235mm | 235mm | | Quantity of Fiber | 10,000pcs | 11,800pcs | 15,000pcs | 9300pcs | | Priming Blood Vol | 101ml | 120ml | 148ml | 115ml | | Eff. Surface Area | 1.5m² | 1.75m² | 2.2m² | 1.5m² | ## PERFORMANCE The performance of the CLIRANS® T-Series Hollow Fiber Dialyzers (T-Series) are substantially equivalent to the performance of the currently marketed largest effective surface area CLIRANS® TAF Hollow Fiber Dialyzer (CL*M151L). The T-Series dialyzers exhibit a somewhat higher clearance and UFR than the M151L which is to be expected with the thinner fiber walls in the T-Series dialyzer. However, none of the data raises any issues of safety or effectiveness. Therefore, the CLIRANS® T-Series Hollow Fiber Dialyzers performance are substantially equivalent to the predicate devices. The following clearance tests were performed demonstrating the substantial equivalence of the CLIRANS® T-Series Hollow Fiber Dialyzers submitted in this 510(k) to the largest effective surface area dialyzer (CL*M151L) cleared in the CLIRANS® TAF Hollow Fiber Dialyzer 510(k) K854280. - Urea - Creatinine - Phosphates - Vitamin B12 - UFR (In Vitro & In Vivo) - Priming Volume 011 {3} p 4/4 SECTION II: Summary and Certification ## ADDITIONAL SAFETY INFORMATION Sterilization conditions have been validated according to the AAMI guidelines to provide a Sterility Assurance Level (SAL) of 10 to the negative sixth. Ethylene oxide residuals will not exceed the maximum residue limits proposed for Part 821 of Title 21 in the Federal register of June 23, 1978 (or as finalized or amended). Manufacturing control test methods include: functional, extraction and sterility tests. Blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing." [External Communicating Devices, Circulating Blood, Prolonged (24 hours-30 days) contact duration]. The blood contacting materials were found to be biocompatible. The expiration dating for the CLIRANS® T-Series Hollow Fiber Dialyzers will be 36 months. This dating period is adopted from legally marketed CLIRANS® TAF Hollow Fiber Dialyzer 510(k) K854280. The sterilization process and packaging materials are the same for these products. Verification testing of aged product consists of package permeability, sterility and shelf life functional testing. ## CONCLUSION The CLIRANS® T-Series Hollow Fiber Dialyzers submitted in this 510(k) are substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the largest effective surface area dialyzer (CL*M151L) cleared in the CLIRANS® TAF Hollow Fiber Dialyzer 510(k) K854280. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness. Date Prepared February 23, 1997 Prepared by Keith M. Smith Senior Regulatory Affairs Specialist Regulatory Affairs Prepared for Terumo Medical Corporation 125 Blue Ball Road Elkton, MD 21921 Phone (410) 392-7375 or (410) 392-7231 Fax (410) 398-6079 012 {4} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 19 1997 Mr. Keith M. Smith Senior Regulatory Affairs Specialist Terumo Medical Corporation Regulatory Affairs Department 125 Blue Ball Road Elkton, Maryland 21921 Re: K970708 CLIRANS® T-Series Hollow Fiber Coventional Dialyzers for Single and Multiple Use Dated: November 26, 1997 Received: November 28, 1997 Regulatory Class: II 21 CFR §876.5820/Product Code: 78 FJI and MSE Dear Mr. Smith: 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 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. 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, 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. This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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/dsmamain.html". Sincerely yours,  Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5} 510(k) Number (if known): Device Name: CLIRANS® T-Series Hollow Fiber Dialyzers ## Indications For Use: The CLIRANS® T-Series Hollow Fiber Dialyzers are devices used as part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. This device is indicated for single and multiple use.  (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K 970708 Prescription Use ☑ (Per 21 CFR 801.109) OR Over-The-Counter Use ☐ (Optional Format 1-2-96)