(306 days)
Purify water used in hemodialysis treatment in dialysis centers/facilities having multiple treatment stations. Purify water used in hemodialysis treatment in hospital intensive care units, critical care units, pediatric intensive care units, and other acute care applications within a hospital setting.
Water purification system for hemodialysis. The typical customized system is configured with booster pump, multimedia filtration, water softener, carbon filter, reverse osmosis, storage tank, ultra-filtration, deionization tanks, audible and visual alarms, and other components that purify water as a function of feed water quality and required capacity. The system product water complies with the AAMI Standard RD62:2001, Water Treatment Equipment for Hemodialysis Applications.
The provided text describes a water purification system for dialysis and its compliance with relevant standards. Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Parameter) | Reported Device Performance |
|---|---|
| AAMI Standard RD62:2001 (Water Treatment Equipment for Hemodialysis Applications) | Complied with requirements |
| USP: Total Organic Carbon (TOC) | Complied with requirements |
| Contaminant levels in product water | Met customer's requirements for purified water (by comparing with maximum permitted levels) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: A "sample of the product water produced by the system is taken" after installation. The exact number of samples or the duration of sampling is not specified.
- Data Provenance: The water samples are analyzed by an "independent laboratory." The country of origin of this data is not explicitly stated, but given the submission is to the FDA in the USA, it's likely the testing occurred within the USA or by a lab recognized by US standards. The testing is prospective in the sense that it's conducted after the installation of the system to verify its performance in a real-world setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a water purification system, and the ground truth for its performance is established through laboratory analysis of water quality against predefined chemical and physical parameters, not through expert human interpretation of medical images or data.
4. Adjudication Method for the Test Set
Not applicable. The "ground truth" (compliance with standards) is determined by laboratory analysis and comparison to AAMI and USP standards, not by human adjudication of differing opinions.
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 not a diagnostic device involving human readers or AI assistance in a medical interpretation context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical water purification system, not an algorithm. Its performance is measured by the quality of the water it produces.
7. The Type of Ground Truth Used
The ground truth used is based on objective standards and laboratory measurements:
- Compliance with AAMI Standard RD62:2001 for Water Treatment Equipment for Hemodialysis Applications.
- Compliance with USP (United States Pharmacopeia) standards for Total Organic Carbon.
- Comparison of measured contaminant levels to maximum permitted levels for purified water.
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning or AI that would require a "training set." It's a manufactured system whose performance is validated post-installation.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 876.5665 Water purification system for hemodialysis.
(a)
Identification. A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.(b)
Classification. Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.