[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR876.5630]

[Page 362-363]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES--Table of Contents
 
                     Subpart F--Therapeutic Devices
 
Sec. 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.

[[Page 363]]

    (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 (performance standards).