(120 days)
The "X" Series PD Catheter is indicated for peritoneal dialysis in adults. It is intended for use in patients who are poor candidates for conventional peritoneal dialysis catheters and are candidates for presternal insertion.
The "X" Series Catheter is indicated for chronic peritoneal dialysis.
The extended length of the “X” Series Catheter makes it especially applicable for peritoneal dialysis patients when it is necessary to locate the skin exit site remote from the usual lower abdominal region. The catheter may be particularly indicated in patients with obesity, floppy abdominal skin folds, urinary or fecal incontinence, chronic yeast intertrigo, intestinal stomas, or in patients who desire to take deep tub baths.
The "X" Series PD Catheter is comprised of a silicone rubber, coiled tip, single polyester cuff abdominal catheter segment that is joined with a titanium double bared connector to a silicone rubber, double polyester cuff subcutaneous extension catheter possessing a preformed tubing arc bend between the two cuffs. The abdominal catheter segment is implanted into the peritoneal cavity. The attached subcutaneous extension piece allows remote location of the catheter skin exit site away from the lower abdominal region.
The catheter will be sold in two kit configurations, as the catheter only with a female luer, clamp, and male luer end cap and titanium connector. The catheter set will also include the addition of a dilator/sheath introducer, guidewire, scalpel, introducer needle, tunneling tool, gauze pads and syringe.
The provided text describes a medical device, the "X" Series PD Catheter, and its substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the context of AI/ML performance.
Instead, the document focuses on:
- Device Description: What the "X" Series PD Catheter is made of and how it's constructed.
- Intended Use and Indications for Use: For peritoneal dialysis, especially in patients with specific conditions like obesity or stomas, where a remote exit site is beneficial.
- Comparison to Predicate Devices: Asserting substantial equivalence in terms of intended use, materials, design, performance, etc.
- Performance Testing (Non-Clinical): A list of physical and material tests performed (e.g., Air Leakage, Gravity Flow, Biocompatibility).
- Regulatory Information: 510(k) summary, classification, product codes, and the FDA's substantial equivalence determination.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, human readers, ground truth establishment, or training/test set sizes because this information is not present in the provided text. The performance testing mentioned (Air Leakage, Liquid Leakage, etc.) are engineering/materials tests for the physical catheter, not a clinical study or AI/ML performance evaluation.
§ 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.