(90 days)
FlexiCap Disconnect Cap with Povidone-Iodine Solution (5C4456): This device is intended for use in the treatment of patients with renal failure to isolate the Luer patient line connector of the Baxter APD (Automated Peritoneal Dialysis) disposable set during temporary disconnections and during the dwell phase of therapy.
MiniCap with Povidone-Iodine Solution (5C4466P): This device is a plastic disconnect cap for peritoneal dialysis and contains povidone-iodine intended to protect the female Luer connector of the Baxter transfer set.
FlexiCap Disconnect Cap with Povidone-Iodine Solution (FlexiCap) is a single use device that connects to the patient line connector of the Baxter Automated Peritoneal Dialysis (APD) set and is designed to isolate the line during temporary disconnections and the dwell phase of peritoneal dialysis therapy sessions. The FlexiCap consists of a molded low density polyethylene cap which contains a polyurethane foam sponge and 10% povidone-iodine (PVP-I) solution.
MiniCap with Povidone-Iodine Solution (MiniCap) is a single use device that connects to a Baxter transfer set and is designed to isolate the line between peritoneal dialysis therapy sessions. The MiniCap consists of a molded low density polyethylene cap which contains a polyurethane foam sponge and 10% Povidone-Iodine (PVP-I) solution.
This document is a 510(k) premarket notification for two devices: the FlexiCap Disconnect Cap with Povidone-Iodine Solution and the MiniCap with Povidone-Iodine Solution, both manufactured by Baxter Healthcare Corporation.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "All tests met the acceptance criteria" for both devices, but it does not specify the quantitative acceptance criteria themselves. It only lists the types of tests performed.
| Test Name | Acceptance Criteria (Not specified) | Reported Device Performance |
|---|---|---|
| Torque-On Test | (Not specified) | Met acceptance criteria |
| Leak Test | (Not specified) | Met acceptance criteria |
| Iodine Efficacy Test | (Not specified) | Met acceptance criteria |
| Cytotoxicity | (Not specified) | Met acceptance criteria |
| Irritation/Intracutaneous | (Not specified) | Met acceptance criteria |
| Sensitization | (Not specified) | Met acceptance criteria |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for each specific test (Torque-On, Leak, Iodine Efficacy, Biocompatibility tests). It mentions "non-clinical tests" and "bench tests."
The data provenance is from non-clinical bench testing conducted by Baxter Healthcare Corporation. No information on country of origin for data or whether it's retrospective or prospective is provided for the non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the tests described are non-clinical bench tests (e.g., Torque-On, Leak, Iodine Efficacy, Biocompatibility). These types of tests do not typically involve human experts establishing ground truth in the same way clinical studies or image interpretation tasks would. The "ground truth" for these tests would be defined by the physical or chemical standards and specifications against which the devices are measured.
4. Adjudication method for the test set
This information is not applicable as the tests described are non-clinical bench tests. Adjudication methods like 2+1 or 3+1 are typically used in studies where human interpretation or consensus is required (e.g., clinical trials, image reading).
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
This information is not applicable. This document describes the substantial equivalence of medical devices (disconnect caps for peritoneal dialysis) based on non-clinical performance and biocompatibility data, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is entirely outside the scope of this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The devices are physical medical products and do not involve any algorithms or AI for standalone performance evaluation.
7. The type of ground truth used
For the non-clinical tests (Torque-On, Leak, Iodine Efficacy), the ground truth is based on pre-defined technical specifications and performance standards. These standards would dictate what constitutes an acceptable torque value, an acceptable leak rate, or an effective iodine concentration/release.
For Biocompatibility tests (Cytotoxicity, Irritation/Intracutaneous, Sensitization), the ground truth is established against standardized biological evaluation criteria, specifically ISO-10993 Part 1 and FDA Blue Book Memorandum #G95-1. These standards define the acceptable biological responses for device materials in contact with the body.
8. The sample size for the training set
This information is not applicable. The devices are physical products, not AI models that require a training set. The "training" in this context refers to manufacturing and quality control processes to meet specifications, not an algorithmic training set.
9. How the ground truth for the training set was established
This information is not applicable. As these are physical medical devices and not AI algorithms, there is no "training set" in the context of machine learning. The focus is on ensuring the manufactured products consistently meet established design specifications and performance criteria through quality control and testing processes.
§ 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.