FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The provided documents are a 510(k) clearance letter and an "Indications For Use" statement for the Cruz® Peritoneal Dialysis Catheter (K964514). These documents do not contain any information regarding acceptance criteria or a study proving device performance against such criteria. They primarily state that the device is substantially equivalent to legally marketed predicate devices and is cleared for marketing.

Therefore, I cannot provide the requested information for acceptance criteria and a study that proves the device meets them based on these documents.

Here's why and what kind of information would be needed:

Acceptance Criteria: Acceptance criteria for medical devices typically involve performance metrics such as safety, effectiveness, biocompatibility, durability, and specific technical specifications (e.g., tensile strength, flow rate). These would be defined by the manufacturer and assessed by testing.
Study Data: A study proving device performance would involve details about:
- Clinical trials or bench testing: Protocols, results, statistical analysis.
- Sample sizes: How many devices were tested or how many patients were enrolled.
- Ground truth: How outcomes were determined (e.g., clinical diagnosis, pathology).
- Expert involvement: If human readers/experts were involved in assessing performance.
- Comparative studies: If the device was compared to a predicate or alternative treatment.

The documents refer to "general controls provisions of the Act" and "Current Good Manufacturing Practice requirements," which are regulatory frameworks for manufacturing quality and safety, but do not detail specific performance criteria or studies.

Summary

Regulation Number and Section

§ 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.