(220 days)
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.
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This document is a 510(k) clearance letter from the FDA for Peritoneal Dialysis Catheters and Adapters (K993149). It indicates that the device has been found substantially equivalent to legally marketed predicate devices. However, this document does not contain specific acceptance criteria, device performance data, details of a study proving the device meets acceptance criteria, sample sizes, ground truth information, expert qualifications, or details about comparative effectiveness studies.
Therefore, I cannot fulfill your request as the provided text lacks the necessary information.
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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)
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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
§ 876.5630 Peritoneal dialysis system and accessories.
(a)
Identification. (1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments.
(3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles.
(4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or “cycler systems”) or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or “reverse osmosis” systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.
(b)
Classification. Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.