(336 days)
Medisystems Peritoneal Dialysis Set product line is indicated for use in compatible peritoneal dialysis procedures. Specific codes are indicated respectively for Continuous Ambulatory Peritoneal Dialysis (CAPD) and Cycler Peritoneal Dialysis.
The Medisystems' Peritoneal Dialysis Sets comprise a number of codes to facilitate peritoneal dialysis procedures. The Medisystems' Peritoneal Dialysis Sets consist of tubing and componentry to allow connection between a container of dialysate solution and the patient's indwelling catheter for instillation into and retention of the dialysate in the peritoneal cavity. The Peritoneal Dialysis Sets then allow exchange of fresh dialysate by providing a means to aseptically drain the used dialysate from the peritoneal cavity into a collection bag for disposal.
The provided text describes a 510(k) submission for Medisystems Peritoneal Dialysis Sets, focusing on substantial equivalence to a predicate device rather than presenting detailed performance studies or specific acceptance criteria with quantifiable metrics. The information available is primarily about the product description, intended use, and manufacturing controls.
As such, many of the requested sections (e.g., sample sizes, expert qualifications, effect size for MRMC studies, standalone performance data) cannot be fully addressed from the given document because the submission does not detail such a "study that proves the device meets the acceptance criteria" in the way one might expect for a diagnostic or AI-driven device. Instead, it relies on demonstrating equivalence through design and material characteristics, and manufacturing quality control.
Here's an attempt to structure the available information per your request, with explicit notes on what information is not present in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (as inferred/stated) | Reported Device Performance |
|---|---|---|
| Safety & Effectiveness | Meet required release specifications (sterility, pyrogenicity, physical testing, visual examination). | Device manufacturing "defined by written and approved procedures that conform to the product design specifications" and documented in "Device Master Records." All finished products are tested and must meet these specifications before distribution. (No specific performance data i.e., rates, values presented). |
| Intended Use | Identical to predicate device: exchange dialysate solution in peritoneal dialysis for kidney failure. | Stated to be identical to the predicate device. (No performance metrics given). |
| Technological Characteristics | Components for access, tubing for instillation/drainage, drain bag for aseptic collection, various codes for different needs. | Stated to be "identical to those of the predicate device." (No performance metrics given). |
| Substantial Equivalence | Equivalent to Fresenius USA's peritoneal dialysis sets. | FDA reviewed and determined the device is "substantially equivalent." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document refers to "all finished products" being tested as part of manufacturing release, implying ongoing quality control rather than a specific test set for a performance study.
- Data Provenance: Not applicable in the context of a clinical performance study. The "data" pertains to internal manufacturing test results.
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 ground truth for this device appears to be based on adherence to engineering and safety specifications (e.g., sterility, pyrogenicity, physical integrity), rather than expert clinical assessment of outcomes or diagnoses.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically used in clinical trials or diagnostic accuracy studies where multiple human readers or AI make assessments that need to be reconciled against a ground truth. The testing described here is manufacturing quality control.
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
- No MRMC comparative effectiveness study was done or mentioned. This type of study is relevant for AI-assisted diagnostic devices, which is not the nature of this submission (a peritoneal dialysis set).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a medical accessory, not an algorithm or AI system.
7. The type of ground truth used
- The "ground truth" for this device's acceptance is based on engineering specifications and established safety standards (e.g., sterility, pyrogenicity, physical integrity as defined by written procedures and design specifications) rather than clinical outcomes, pathology, or expert consensus on a diagnostic task.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training" for the device involves manufacturing processes and quality control.
9. How the ground truth for the training set was established
- Not applicable. As this is not an AI/ML device, there is no "training set" or corresponding ground truth establishment in that context.
§ 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.