(57 days)
Easy Care and Tubing Sets are used to provide peritoneal dialysis fluid exchanges for patients suffering from End Stage Renal Disease (ESRD). Their main function is to allow the bi-directional flow of peritoneal dialysis solution in and out of the peritoneal cavity of the patient by means of gravity.
Not Found
This looks like a 510(k) clearance letter for a medical device (K994218 Easy Care and Tubing Sets), rather than a study report or clinical trial. Therefore, the document does not contain the detailed information required to describe acceptance criteria and associated study results. The letter confirms that the device is "substantially equivalent" to a legally marketed predicate device (K910173/C), implying that it meets the same safety and effectiveness standards, but it doesn't provide specific performance metrics or details of a study that would explicitly prove it.
Here's why the requested information cannot be extracted from the provided text:
- No Acceptance Criteria or Reported Performance: The letter only states substantial equivalence. It does not list specific performance metrics (e.g., accuracy, sensitivity, specificity, flow rates, durability) or the numerical results achieved by the device against such criteria.
- No Study Details: There is no mention of a specific study, clinical trial, or independent testing to demonstrate performance. The 510(k) process often relies on existing data or performance characteristics of a predicate device, rather than requiring a new, comprehensive clinical study for every submission, especially for Class II devices.
- No Sample Sizes, Data Provenance, Expert Qualifications, or Adjudication Methods: These are all details typically found in a study report, which is not provided here.
- No MRMC or Standalone Performance: Again, these are specific study types and performance measures that would be reported in a detailed study, not a regulatory clearance letter.
- No Ground Truth Information: Ground truth establishment, whether for a test or training set, is part of a study design and is not included in this type of regulatory document.
- No Training Set Sample Size or Ground Truth Establishment: These pertain to the development and validation of an algorithm or model, which is not applicable to the "Easy Care and Tubing Sets," as these appear to be physical medical devices (peritoneal dialysis tubing) rather than an AI/software device.
In summary, the provided document is a regulatory clearance letter, not a scientific study report. Therefore, it does not contain the specific information requested about acceptance criteria, study design, or performance metrics.
§ 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.