(203 days)
The WaterVault Cube Water Treatment System for HemoDialysis is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate.
Organic, inorganic and microbial contaminants are removed from water supplied to hemodialysis clinics for use in the dilution and preparation of dialysate solutions used in hemodialysis machines. The water treatment system includes a means of tempering the water and pretreatment, followed by reverse osmosis, ultrafiltration and UV sterilization. Pretreatment includes water softening to remove hardness and Granular Activated Carbon treatment to remove Chloramines in addition to filament cartridge filters to control particulate solids. Reverse Osmosis utilizes a pressure gradient to reverse the process water diffusion across a semipermeable membrane, concentrating the contaminants which are subsequently rejected as concentrate. Water forced through the membrane known as "Permeate" is then passed through a hollow fiber ultra filter to remove microorganisms, pyrogens and endotoxins. A UV light source that provides a minimum of 30,000 microwatts/cm2 sec limits further bacterial growth in the treated water.
The Water Vault Cube, Water Treatment System for Hemodialysis, underwent nonclinical testing to demonstrate its performance against AAMI (Association for the Advancement of Medical Instrumentation) standards for water used in the preparation of dialysate.
1. Table of Acceptance Criteria and Reported Device Performance
| Component | Acceptance Criteria (AAMI Standard mg/l) | Reported Device Performance (Permeate mg/l) | Meets or Exceeds Acceptance Criteria |
|---|---|---|---|
| Calcium | 2 | 1 | Yes |
| Magnesium | 4 | 1 | Yes |
| Sodium | 70 | 1 | Yes |
| Potassium | 8 | 1 | Yes |
| Fluoride | 0.2 | 0.1 | Yes |
| Chlorine | 0.5 | 0.02 | Yes |
| Chloramines | 0.1 | 0.02 | Yes |
| Nitrate | 2 | 0.1 | Yes |
| Sulfate | 100 | 5 | Yes |
| Copper | 0.1 | 0.01 | Yes |
| Barium | 0.1 | 0.01 | Yes |
| Zinc | 0.1 | 0.02 | Yes |
| Aluminum | 0.01 | 0.01 | Yes |
| Arsenic | 0.005 | 0.005 | Yes |
| Lead | 0.005 | 0.003 | Yes |
| Silver | 0.005 | 0.005 | Yes |
| Cadmium | 0.001 | 0.001 | Yes |
| Chromium | 0.014 | 0.005 | Yes |
| Selenium | 0.05 | 0.005 | Yes |
| Mercury | 0.0002 | 0.0002 | Yes |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The test results are based on a single sample test of a "demonstration unit."
- Data Provenance: The data is retrospective, derived from tests performed on a specific demonstration unit (Osmonics Solorss reverse osmosis unit, Serial Number 96-61650-11). The country of origin is not explicitly stated but implied to be the United States, given the FDA filing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this device is based on quantifiable chemical analysis against established industry standards (AAMI Standards), not expert human assessment.
4. Adjudication Method for the Test Set
Not applicable. The device performance is assessed through direct chemical analysis (quantitative measurements), not through human adjudication.
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 water treatment system, not an AI-powered diagnostic device, so an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone test was performed. The device's performance was evaluated by analyzing the "Permeate" water it produced, independently of any human intervention or interpretation, against the AAMI standards.
7. The Type of Ground Truth Used
The ground truth used is AAMI Standards for water quality in hemodialysis. This is an objective, established standard for chemical contaminant levels.
8. The Sample Size for the Training Set
Not applicable. This device is a physical water treatment system, not a machine learning algorithm that requires a training set. The "design" of the system is based on established water purification principles.
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 ground truth in that context.
§ 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.