(185 days)
This device is intended for use with Flex-Neck catheters and Ash Advantage catheters in the event one of two situations described below should occur:
- Extender Application
In some patients, the external portion of the PD catheter may be too short for them to comfortably use. For example, obese patients may need an extender kit to be able to work with the external part of the catheter. Other patients may require the external end of the catheter to be more centrally located than it normally might be. - Repair Application
If a peritoneal dialysis catheter develops a fracture in the external portion, the catheter must be trimmed to eliminate the fracture. Doing so, by definition, will shorten the catheter and may make it impractical or difficult or even unsuitable for use. Rather than replace the entire catheter, it is desirable to retain the catheter by extending the external part of the catheter with new tubing.
In either situation, this device enables qualified medical staff to extend and/or repair the external part of an existing Flex-Neck catheter or Ash Advantage catheter by adding a 20 cm long tube to the existing and /or remaining catheter tubing.
This device consists of four components per kit, a double male connector, a catheter connector, a cap and a 20cm long silicone tube, to be assembled in an aseptic manner by qualified personnel.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Demonstrate mechanical integrity | Functional testing performed successfully |
| Demonstrate retention | Functional testing performed successfully |
2. Sample size used for the test set and data provenance:
The document does not explicitly state the sample size used for the test set. It only mentions that "Functional testing has been performed." The data provenance (e.g., country of origin, retrospective or prospective) is also not specified.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
This information is not provided in the document. The testing appears to be purely functional/mechanical rather than involving expert assessment of diagnostic accuracy.
4. Adjudication method for the test set:
Not applicable, as the testing described is functional/mechanical and does not involve human interpretation or adjudication.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a physical medical accessory (catheter extender/repair kit), not an AI-assisted diagnostic or interpretive tool. Therefore, an MRMC study related to human reader performance with or without AI is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical device, not an algorithm. The testing described is for the device's mechanical integrity and retention, which is inherently "standalone" in that it tests the device itself.
7. The type of ground truth used:
The ground truth for the functional testing appears to be based on engineering specifications or performance standards for mechanical integrity and retention, rather than expert consensus, pathology, or outcomes data typically used for diagnostic devices.
8. The sample size for the training set:
Not applicable. This device is a physical medical accessory. There is no mention of a "training set" in the context of an algorithm or AI.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set for an algorithm described, there is no ground truth establishment for a training set.
§ 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.