PERITONEAL DIALYSIS CATHETERS AND ADAPTERS

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the edge. In the center of the seal is a stylized image of an eagle with three parallel lines forming its body and wings. The eagle's head is facing left, and its tail feathers are depicted as wavy lines. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 2 8 2000 Mr. Mahesh Agarwal President Medionics International, Inc. 114 Anderson Avenue Markham, Ontario CANADA L6E 1A5 Re: K993149 R995143 Peritoneal Dialysis Catheters and Adapters Dated: March 30, 2000 Received: March 31, 2000 Requiatory Class. Il 21 CFR §876.5630/Procode: 78 FJS ## Dear Mr. Agarwal: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have deeminess We have revelled your Ooklyn of or use stated in the enclosure) to legally marketed predicate devices uevice is substantially equivalent (for the models of the Medical Device Amendments, or to device that the Medical (1972) that the have been reclassified in accordance with the Federal Food, Drug, and Cosmell Act (Act). You may, therefore, nave been reclassined in accordance with and provisions of the Act. The general controls provisions of the Actions of the Actions manted the bottor, buyes to the generes, 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 if your device (ood above) and other and editions affecting your device can be found in the Code of Federal Regulations, Title 21, Such additional controls. EAsting major regalations and 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 requirements, as act form in the God 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 premakel notification submission does not affect any obligation you might the reductions 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 ir you doile opportion and the for your content of Compliance at (301) 594-4591. 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, "Mishranding by reference to promarket notification" (21CFR 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) 443-5597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html". Sincerely yours, Daniel G. Schultz, M.D Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure(s) {1}------------------------------------------------ STO(K) NUMBER (IF KNOWN) : K993149 Peritoneal Dialysis Catheters And Adapters DEVICE NAME : INDICATIONS FOR USE: Peritoneal Dialysis Catheters and Adapters are access devices used for providing peritoneal dialysis treatment for patients suffering from End Stage Renal Disease (ESRD). Their main function is to allow the bi-directional flow of peritoneal dialysis solution in a consistent manner, without requiring extraordinary effort or causing discomfort. > (PLEASE DO NOT MRITE BELOW THIS LINE-CONTINUE ON ANOTH IF NEEDED.) Concurrence of CORH, Office of Device Evaluation Prescription Use (Per 21 CFR 801.109) \$\frac{V}{}\$ OR Over-The-Cour (Optional I (Per 21 CFR 801.109) (Division Sign-Off) Division of Reproductive, Abdominal, ENT. and Radiological Devices 510(k) Number. K993149