(98 days)
UPT Series Medical Reverse Osmosis Water Treatment System is intended to be used to remove organic and inorganic contaminants from a tap water supply to dilute a dialysate concentrate for hemodialysis treatments, as well as for use for dialyzer reprocessing and dialysis equipment disinfecting and rinsing.
This System is strictly for multi patient use, such as for a dialysis clinic or hospital serving multiple patients with a Central Water Purification System and is intended for use only with conventional hemodialysis treatments. It is not intended for use with high-flux, CRRT, or any other form of dialysis.
The UPT Series Medical Reverse Osmosis Water Treatment System is an accessory device that is intended for use with hemodialysis applications and is intended to remove orqanic and inorganic substances and microbial contaminates from tap water used to dilute dialysis concentrate to form dialysate. The UPT Series Medical Reverse Osmosis Water Treatment System will produce water as prescribed by the Association for the Advancement of Medical Instrumentation (AAMI) Standard ANSI/AAMI/ISO 13959:2014 Water for Hemodialysis and Related Therapies provided adequate flow rate of the feed (tap) water and compliance with existing drinking water standards and proper pre-treatment.
The provided document is a 510(k) premarket notification decision letter and summary for a water purification system. It does not contain information about software or AI, and therefore does not have the kind of performance data, study designs, or ground truth information typically associated with AI/ML device submissions.
The document discusses the UPT Series Medical Reverse Osmosis Water Treatment System, which is a physical device intended to remove contaminants from tap water for hemodialysis. The criteria and "study" proving its acceptance are based on its ability to produce water meeting known standards, rather than statistical performance metrics of an AI model.
Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (Reference) |
|---|---|
| Produces water as prescribed by AAMI Standard ANSI/AAMI/ISO 13959:2014 Water for Hemodialysis and Related Therapies | "The UPT Series Medical Reverse Osmosis Water Treatment System will produce water as prescribed by the Association for the Advancement of Medical Instrumentation (AAMI) Standard ANSI/AAMI/ISO 13959:2014 Water for Hemodialysis and Related Therapies provided adequate flow rate of the feed (tap) water and compliance with existing drinking water standards and proper pre-treatment." (Page 3) and "As compared with the predicate devices, K051620 and K041663, the UPT Series Medical Reverse Osmosis Water Treatment System will produce water that will meet the minimum water quality requirements as specified by Association for the Advancement of Medical Instrumentation (AAMI) standard ANSI/AAMI/ISO 13959:2014, Water for Hemodialysis and Related Therapies" (Page 5) |
| Water treatment equipment functionality as per ANSI/AAMI/ISO 26722:2014 | "and ANSI/AAMI/ISO 26722:2014, Water Treatment Equipment for Hemodialysis Applications and Related Therapies, when used as directed." (Page 5) |
| Electrical safety and EMC compliance | "EN/IEC 61000-4-2 Electrostatic Discharges", "EN/IEC 61000-4-3 Radiated Fields and Transients / Burst", "EN/IEC 61000-4-4 Electrical Fast Transients / Burst", "EN/IEC 61000-4-8 Magnetic Field", "UL Approved / Recognized for safety", "All pumps used are UL recognized (UR) and CSA Approved for safety" (Page 5) |
| Water contact materials | "FDA-NSF Compliant" (Page 4) |
| Safety Features (e.g., diversion to drain on high conductivity, alarms) | "100% Diversion to drain above product conductivity set-point", "Low Supply Pressure Alarm", "High Product Water Conductivity Alarm", "High Supply Water Temperature Shut Down", "Power Disturbance Alarm", "Remote Alarm (Nurses Station)" (Page 4) |
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of an AI/ML device. The "study" refers to the device's ability to consistently output water meeting specific AAMI standards. The evaluation likely involved testing physical prototypes or production units to verify their functionality and water quality output under various operating conditions. No specific sample size or provenance for such testing is mentioned, as it is a device performance verification, not a data-driven model evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" here is objective water quality standards (AAMI/ISO standards) and functional safety requirements, not expert consensus on medical images or clinical outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation of data.
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 purification system, not an AI/ML medical device where human reader performance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm with standalone performance. Its performance is the physical output of purified water meeting specified quality metrics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is established regulatory and industry standards for water quality used in hemodialysis:
- ANSI/AAMI/ISO 13959:2014: Water for Hemodialysis and Related Therapies
- ANSI/AAMI/ISO 26722:2014: Water Treatment Equipment for Hemodialysis Applications and Related Therapies
- Electrical Safety Standards: EN/IEC 61000 series, UL, CSA approvals.
These are objective, quantitative standards for the physical and chemical properties of the water produced, and the safety of the equipment.
8. The sample size for the training set
Not applicable. This device is not an AI/ML model that undergoes training.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML model that undergoes training using a ground truth dataset.
§ 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.