(81 days)
Peritoneal dialysis connectors are used to connect the peritoneal dialysis catheter to the dialysate line.
Peritoneal dialysis connectors are used to connect the peritoneal dialysis catherer to the dialysate line. Medigroup intends to market titanium connectors for use with their large diameter, low duromoter (Flex Neck™) cathere only. Those connectors have the same intended use, general configuration, and materials as titanium connectors marketed by Accurate Surgical Instruments.
The provided text describes a Premarket Notification (510(k)) for a Peritoneal Dialysis Catheter Connector. This is a medical device submission seeking a determination of "substantial equivalence" to a legally marketed predicate device, rather than a study proving the device meets acceptance criteria in the same way a new, novel device might. Therefore, many of the requested elements for a typical study (like sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone performance evaluation of an AI algorithm) are not applicable in this context.
Here's an interpretation based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission like this, "acceptance criteria" are generally tied to demonstrating substantial equivalence to the predicate device. The performance is shown through functional testing.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (Summary of Testing) |
|---|---|
| Mechanical Integrity: Sufficient strength and durability for its intended use (connecting catheter to dialysate line). | Functional testing performed to demonstrate mechanical integrity, including connector retention. |
| Material Compatibility: Use of medical-grade titanium. | Medical grade titanium used. |
| Sterilization Efficacy: Compatible with 100% ETO sterilization. | 100% ETO sterilization method used. |
| Configuration: Two-piece connector with specific connection method (main body with single, rounded barb; cap over catheter end with screw lock). | Two-piece connector; main body with single, rounded barb; cap over the catheter end with screw lock onto main body. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for the functional testing. It only states "Functional testing has been performed". Data provenance is not applicable as this concerns mechanical device testing, not data generated from patients or populations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for AI/diagnostic studies (e.g., expert labels on images) is not relevant for this type of mechanical device testing. The performance is assessed against engineering specifications and functional requirements.
4. Adjudication method for the test set
Not applicable. There's no indication of multiple human readers or adjudication processes in a medical image/diagnostic context.
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 is a mechanical device, not an AI or diagnostic tool where a MRMC study would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a mechanical medical device, not an algorithm. The "standalone" performance refers to the device's functional testing as described.
7. The type of ground truth used
For this device, the "ground truth" or reference standard for testing would be engineering specifications, functional requirements, and performance characteristics established for similar predicate devices. The testing verifies if the new device meets these pre-defined physical and mechanical criteria.
8. The sample size for the training set
Not applicable. This is a physical device being tested functionally; there is no "training set" in the machine learning sense.
9. How the ground truth for the training set was established
Not applicable. As there's no training set, there's no ground truth for it. The standards for device performance are derived from industry standards and the predicate device's established performance.
§ 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.