(224 days)
The Fresenius CAPD stay.safe® Disposable Administration Sets with stay•safe® Connector is indicated for use in end stage acute and chronic renal disease.
The Fresenius CAPD stay•safe® Disposable Administration Sets with stay•safe® Connector consists of a circular housing designed with three, evenly spaced, outlet ports. Individual ports specifically provide for attachment either to the patient, to the peritoneal dialysis solution, or to a drain bag. The outlet port plugs allow the start or stop of solution flow; and prior to use the outlet port for the patient connection is covered with a cap. A knob is turned to different positions to initiate the various treatment steps of the peritoneal dialysis procedure.
The provided text is a 510(k) summary for a medical device called "Fresenius CAPD stay•safe® Disposable Administration Sets with stay•safe® Connector." 510(k) submissions typically focus on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specific acceptance criteria and detailed performance metrics as might be found in a Premarket Approval (PMA) application.
Based on the provided text, here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Met ISO 10993-1 biological requirements for safety screening of materials in indirect contact for greater than 30 days. |
| Pyrogenicity | Tested to a Limulus Amebocyte Lysate (LAL) specification of 0.01 EU/mL. (Implies meeting this specification) |
| Sterility | Sterilized by a method determined and verified to assure an SAL of ≥ 10⁻⁶. (Implies achieving this sterility assurance level) |
| Functional and Physical Properties | Performed prior to product release. (Implies successful completion of these tests.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states "Clinical Data: Not Applicable." The data provenance for the non-clinical tests (biocompatibility, pyrogenicity, sterility, functional/physical) is not specified. It can be inferred that these tests were conducted by the manufacturer, Fresenius Medical Care North America (headquartered in Lexington, MA). The retrospective or prospective nature of these tests is not mentioned, but they are typically conducted as part of the product development and manufacturing process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The study did not involve human interpretation or subjective measurements that would require expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no clinical study involving human interpretation requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a disposable administration set, not an AI-assisted diagnostic or interpretive tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is defined by established scientific standards and specifications:
- Biocompatibility: ISO 10993-1 standards.
- Pyrogenicity: LAL specification of 0.01 EU/mL.
- Sterility: Sterility Assurance Level (SAL) of ≥ 10⁻⁶.
- Functional and Physical Testing: Internal product release specifications.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an algorithm or AI-based device.
9. How the ground truth for the training set was established
Not applicable, as there was no 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.