(141 days)
The Denver® Pleurx Peritoncal Catheter Kit (50-8000) is indicated for:
- Intermittent drainage of symptomatic, recurrent, malignant ascites that does not ● respond to medical management of the underlying disease
- Palliation of symptoms related to recurrent malignant ascites ●
- Peritoneal placement only ●
The Denver® Pleurx Drainage Kits (50-7500 and 50-7510) are indicated for use with either the Pleurx Peritoneal Catheter Kit or the Pleural Catheter Kit.
The Pleurx Catheter is silicone catheter that can be thought of as containing three zones: the fenestrated zone which is implanted in the body cavity and used to collect fluid; the cuffed zone, which is placed inside a subcutaneous tunnel; and the externalized zone. which includes a valve that remains closed, except when purposefully accessed for a drainage procedure. The Pleurx Drainage Kit includes a vacuum bottle with drainage line that connects to the Pleurx catheter for removing fluid. It also includes a procedure pack. that includes all the supplies needed to perform the drainage procedure and to replace the dressing over the catheter.
I am sorry, but the provided text does not contain the detailed information needed to answer your request about acceptance criteria and a study proving device performance as it relates to an AI/ML device. The document is a 510(k) summary for the Pleurx Peritoneal Catheter Kit and Drainage Kits, which is a medical device, but it is not an AI/ML device. The document focuses on the substantial equivalence of this device to previously marketed devices, rather than on the performance criteria or studies typical for AI/ML products.
Therefore, I cannot extract information such as:
- A table of acceptance criteria and reported device performance (for an AI/ML model)
- Sample sizes for test sets, data provenance, and ground truth establishment methods for an AI/ML model
- Information about experts, adjudication methods, or MRMC studies for AI/ML performance evaluation
- Standalone algorithm performance or training set details for an AI/ML model.
§ 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.