(198 days)
The Byonyks X-1 APD Cycler is indicated for acute and chronic peritoneal dialysis.
The Byonyks X-1 APD Cycler System includes an Automated Peritoneal Dialysis Cycler and a disposable tubing set. The Byonyks X-1 APD Cycler is intended for acute and chronic peritoneal dialysis. Byonyks X-1 APD Cycler is an automated peritoneal dialysis system that uses a peristaltic pumping mechanism to infuse the dialysate (Dialyzing Solution) into the peritoneal cavity and drain it after the dialysate has dwelled within a patient's peritoneal cavity for a specified amount of time. Byonyks X-1 APD Cycler is a prescription-use-only device and the therapies administered using Byonyks X-1 APD Cycler are prescribed by a physician. The device operates according to a therapy prescription provided by the patient's physician. The device is designed to be used in dialysis clinics, outpatient care areas, and home treatment settings with dialyzing solutions approved for peritoneal dialysis. Dialysate is infused into the patient's peritoneal cavity from a dialysate bag through a surgically implanted catheter which provides a fluid connection to the device's disposable tubing set. The dialysate remains in the peritoneal cavity for the dwell time which is a programmed length of time prescribed by the patient's physician. After the dwell time has elapsed, the fluid is drained from the patient using the device's peristaltic pumping system to extract the fluid from the patient's peritoneal cavity. Peristaltic pumping mechanism of the Byonyks X-1 APD cycler assist the dialysate flow at pre- programmed flowrate up to the volume prescribed by the patient's physicians, device continuously monitors volume of dialysate exchanges along with the fluid pressure external to the cassette of disposable set, fluid pressure detects resistance in dialysate exchanges at which pumping regulates the overall flow.
The Byonyks X-1 APD Cycler System consists of the (i) main control unit (Cycler) and the (ii) disposable set.
The provided 510(k) clearance letter and summary for the Byonyks X-1 APD Cycler focuses on the substantial equivalence of the device to a predicate device, primarily through engineering and bench testing, and does not include an AI/ML component. Therefore, the information required to answer your prompt, such as acceptance criteria for AI/ML performance, study details for AI/ML models (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training data details), is not present in the provided document.
The document details performance testing for the physical cycler device and its disposable set, as well as general medical device requirements like biocompatibility, electrical safety, EMC, and human factors. However, these are evaluations of the hardware and overall system functionality, not specific to an AI/ML algorithm's performance on diagnostic tasks.
Therefore, I cannot populate the table or answer the specific questions related to AI/ML acceptance criteria and performance study details based on the given text.
If this medical device were to incorporate AI/ML, the 510(k) summary would typically include a separate section outlining the AI/ML algorithm, its intended use, performance metrics, and the details of the validation study.
§ 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.