(28 days)
This set is used during Peritoneal Dialysis therapy to transfer peritoneal dialysis solution to the patient from the source solution container.
The MiniCap Extended Life PD Transfer Sets are single use, sterile, non-pyrogenic devices for use with Baxter peritoneal dialysis systems. A Transfer Set is connected to a Titanium Adapter that is at the end of an implanted peritoneal catheter. The Transfer Sets stay connected to the patient and allows for the exchange of peritoneal dialysis solution into and out of the peritoneal cavity as prescribed.
The provided document describes the K192705 premarket notification for the "MiniCap Extended Life PD Transfer Sets." The acceptance criteria and the study performed to prove the device meets these criteria are outlined in the "DISCUSSION OF NONCLINICAL TESTS" and "Performance Data" sections.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" alongside "reported device performance" with specific quantitative results. Instead, it states that "All results meet their acceptance criteria." The performance data is described as a list of functional tests performed to ensure proper design and function. The acceptance criteria for these tests are implied to be satisfactory performance without specific pass/fail values mentioned.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Proper design and function for intended use | All functional test results met their acceptance criteria |
| Biocompatibility in accordance with ISO-10993 and FDA Guidance | All biocompatibility tests passed |
| Visual integrity | Visual Inspection passed |
| Pressure integrity in closed position | Initial Pressure Test (clamp in closed position) passed |
| Durability after conditioning | Cycling (Conditioning Step Prior to Pressure Tests) performed successfully |
| Pressure integrity after cycling (closed position) | 8 psi Pressure Test Post Cycling (clamp in closed position) passed |
| Pressure integrity after cycling (open position) | 8 psi Pressure Test Post Cycling (clamp in open position) passed |
| Strength of tubing-to-barb connections | 5 lb Pull of Tubing to Barb Connections passed |
| Absence of cytotoxicity | Cytotoxicity test passed |
| Absence of sensitization | Sensitization test passed |
| Absence of intracutaneous reactivity | Intracutaneous reactivity test passed |
| Absence of acute systemic toxicity | Acute Systemic toxicity test passed |
| Absence of material-mediated pyrogenicity | Material Mediated Pyrogenicity test passed |
| Absence of sub-chronic toxicity | Sub-chronic Toxicity test passed |
| Absence of genotoxicity | Genotoxicity test passed |
| Absence of hemolysis | Hemolysis test passed |
| Acceptable levels of extractables and leachables | Physical or Chemical Information (Extractables & Leachables) assessment passed |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for any of the functional or biocompatibility tests. It also does not explicitly state the provenance of the data (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The document outlines non-clinical testing, which typically involves laboratory testing rather than expert-based ground truth establishment as seen in diagnostic device studies.
4. Adjudication method for the test set
This information is not applicable and is not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple experts are resolving discrepancies in observational data. This document describes non-clinical laboratory testing.
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
A multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This document describes non-clinical testing of a medical device (transfer sets), not a diagnostic algorithm involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical device (transfer sets), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the functional tests, the "ground truth" would be established by predefined engineering specifications and performance standards relative to the device's intended use. For biocompatibility, the ground truth is established by the accepted standards within ISO 10993 and FDA guidance documents, which define what constitutes a biologically safe material for medical device contact. It's based on objective laboratory measurements and analyses, not expert consensus, pathology, or outcomes data in the clinical sense.
8. The sample size for the training set
This is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this device.
§ 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.