(232 days)
The Deionizer and Carbon Exchange Service for Hemodialysis are intended to be used in a hemodialysis facility according to AAMI standards to supply purified water for use in hemodialysis applications per the requirements of ANSI/AAMI RD62. The exchange tanks can be used for either primary water purification or to supply emergency backup water purification for dialysis. These exchange tanks are components of a larger water treatment system employing adequate pretreatment and post treatment sections. These tanks are not to be used alone.
Upon exhaustion, these tanks will be replaced with other Deionization Tanks containing newly regenerated resin or with new resin altogether, or in the case of Carbon Tanks, with tanks containing fresh virgin carbon.
New Aqua LLC Deionizer and Carbon Filter exchange tanks for Dialysis are FRP tanks filled with high purity DI resins for the Deionizers and acid washed carbon for the carbon filters. Union style connectors are used in conjunction with a molded Noryl head, PVC riser pipe and distributor basket. The tanks are designed to supply AAMI standard water for dialysis through ion exchange. The tanks are based on the AmeriWater Dialysis Deionizer Exchange Tanks K991519.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (AAMI RD62 Standards) | Reported Device Performance |
|---|---|
| Chlorine levels meet AAMI standards | Monitored for performance and meet standards. |
| Chloramine levels meet AAMI standards | Monitored for performance and meet standards. |
| Resistivity levels meet AAMI standards | Monitored for performance and meet standards. |
| TOC reduction to non-detectable limits | Reduction of TOC to non-detectable limits. |
| Overall performance equivalent to predicate | Performance testing demonstrates equivalent performance to predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Four (4) water samples were taken for validation:
- Two raw feed water samples.
- Two treated water samples from the final DI unit.
- Data Provenance: Not explicitly stated, but implies a prospective approach as the system was set up and operated, and samples were drawn from this operational system. The location of the test facility is not specified, but the testing laboratories are named (AmeriWater and Broward Testing Laboratory, LTD).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document does not mention the use of experts to establish ground truth for the test set.
- Instead, ground truth was established by laboratory analysis against established standards (AAMI RD62).
4. Adjudication Method for the Test Set:
- Not applicable as the ground truth was established through laboratory analysis, not expert consensus requiring 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:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study pertains to a water purification device, not an AI or human-in-the-loop diagnostic system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- This question is not applicable. The device is a physical water purification system, not an algorithm. The "standalone" performance assessed was the physical system's ability to purify water.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- The ground truth used was objective laboratory analysis of water samples against the requirements of ANSI/AAMI RD62 standards for chlorine, chloramine, resistivity, and Total Organic Carbon (TOC).
8. The Sample Size for the Training Set:
- Not applicable. This device is a physical water purification system and does not involve AI or machine learning that would require a "training set" in the traditional sense. The "training" in this context would be the design and manufacturing processes ensuring adherence to specifications.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable for the same reasons as point 8.
§ 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.