(88 days)
The Ultra Sets are designed for drainage and infusion of PD solution during a peritoneal dialysis exchange.
The Y-shaped design of the set enables patients to initially drain the dialysis solution from the peritoneum into the attached drain bag and then to fill new dialysis solution from a solution container into the patient's peritoneum. The plastic Y-shaped configuration serves as a junction for three lengths of tubing. The first length of tubing is the patient connector and connects to the patient's transfer set via a luer lock connection. The second length of tubing has a spike connector for connection to the new solution container and an occlusion clamp which is utilized during the solution exchange. The third length of tubing has a empty drain bag and an occlusion clamp for collection of spent dialysate during the dialysis exchange.
I'm sorry, but without a clear description of the "acceptance criteria" and "device performance" in the provided text, I cannot generate the requested table and study information. The provided text is a 510(k) summary for a medical device (Peritoneal Dialysis Y-Set) and discusses its equivalence to predicate devices, safety testing (biological, sterilization, pyrogen), and functional testing, but it does not explicitly define acceptance criteria or specific device performance metrics in a quantitative way that would allow for the construction of the requested table.
The text focuses on demonstrating the device's safety and substantial equivalence to previously cleared devices through adherence to established standards and guidelines, rather than presenting a study with specific performance acceptance criteria and results against those criteria.
§ 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.