ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X

{0}------------------------------------------------ JUL 29 1999 K991512 Page 1 of 1 # Asahi AM-R Series Dialyzers | Submitter: | Asahi Medical Company, Ltd.<br>9-1, Kanda Mitoshirocho<br>Chiyoda-ku, Tokyo 101-8482<br>Japan | |----------------------------------------|-----------------------------------------------------------------------------------------------| | Date summary was prepared: | April 2, 1999 | | Name(s) of the device: | Asahi AM-R Series Dialyzers | | Identification of predicate device(s): | Asahi AM-R Series Dialyzers | ### Description of the device: Asahi AM-R Series Dialyzers cleared under 510(k) K970650 are designed as reusable, hollow fiber (cuprammonium rayon) membranes which are housed within a plastic casing of styrene butadiene block polymer. #### Intended Use: The AM-R Series Dialyzers are indicated for use in hemodialysis treatment of patients who have chronic renal failure or acute renal failure. Asahi AM-R Dialyzers may be reprocessed for reuse on the same patient. #### Comparison To Predicate: The previously cleared Asahi AM-R Series Dialzyers are being modified to update the dialyzer casings. No other changes to the dialyzers are being made. #### Conclusion: Revisions to the casing dimensions for the AM-R Series dialyzers are demonstrated to have an insignificant impact on the performance of the dialyzers. The indications for use remains unchanged and no new issues of safety or effectiveness are expected to be raised as a consequence of this modification. Therefore the modified AM-R series dialyzers are considered substantially equivalent to the original AM-R series dialyzers. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image is a circular logo for the Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a sphere. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## JUL 29 1999 Asahi Medical Company, Ltd. c/o David L. West, Ph.D. Vice President Quintiles Consulting 15825 Shady Grove Road, Suite 130 Rockville, MD 20850-4008 Re: K991512 Asahi AM-R Series of Dialyzers Dated: April 29, 1999 Received: April 30, 1999 Requlatory Class: II 21 CFR §876.5820/Procode: 78 FJI Dear Dr. West: 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 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), 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 requlations 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 requirements, 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 regult 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), piease 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/dsma/dsmamain.html". Sincerely yours, CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications For Use Statement None assigned as of this time Device Name: 510(k) Number: Asahi AM-R Series Dialyzers Indications for Use: The AM-R Series Dialyzers are indicated for use in hemodialysis treatment of patients who have chronic renal failure or acute renal failure. Asahi AM-R Dialyzers may be reprocessed for reuse on the same patient. ============================================================================================================================================================================== Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (per 21 CFR 801.109) Image /page/2/Picture/8 description: The image shows a simple square shape. The square is formed by four straight lines, creating a closed geometric figure. The lines appear to be of uniform thickness, and the square is oriented with its sides parallel to the horizontal and vertical axes. Over-the Counter Use David A. Bergman (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K991512