(84 days)
The Aquaboss® EcoRO I, EcoRO I HT, EcoRO Dia II and EcoRO Dia II HT are complete water treatment systems centered around reverse osmosis units of varying output which include recommended pretreatment components such as carbon filtration, backwash filters, softeners, and temperature blending valves and recommended post treatment such as final filtration intended for hemodialysis applications. The Aquaboss water treatment systems are to be used at dialysis clinics or hospitals. The Aquaboss® EcoRO I, EcoRO I HT, EcoRO Dia II and EcoRO Dia II HT are intended to remove organic and inorganic substances and microbial contaminants from water. The treated water will then be used to prepare and dilute dialysate concentrate to form dialysate and/or rinse dialyzers for multiple uses and/or to prepare dilute solutions for reprocessing procedures in multiple-use dialyzers. The water treatment systems are designed to meet current AAMI/ISO and Federal (U.S.) standards.
The Aquaboss® EcoRO Dia I + II (HT) Series Water Treatment System for Hemodialysis is a complete water purification system and consists of a reverse osmosis (RO) and pro-treatment. This product is an accessory device that is intended for use within the Hemodialysis facility to remove organic and inorganic substances and microbial contaminants from tap water used to dilute Dialysate concentrate to form Dialysate. This system has been designed to produce purified water as prescribed by AAMI ANSI ISO 13959: 2009 Water for hemodialysis and related therapies and provide adequate flow of the feed (tap) water and compliance with the existing drinking water standards. In order to optimize the performance of the RO system, the following items for pre-treatment can be utilized: - Softeners 1) - Backwash filters 2) - 3) Organic Bed Service Carbon 4) Raw Water Temperature Blending Value Aquaboss® EcoRO Dia I + II (HT) operates on the reverse osmosis principle. Reverse Osmosis describes a process involving a pressure operated cross filtration system. The water high pressure tangentially to a semi permeable membrane. As it is the case with normal filtration the system is cleaned by allowing one component (water) of the mixture to be separated to pass through the membrane with almost no hindrance whereas the other components (dissolved and non-dissolved water contents) are held back to leave the fitration unit in the concentrate flow. This is a separation process in the molecular sector which does not change the components being separated either chemically, biologically or thermally.
The provided document describes a 510(k) summary for the Aquaboss® EcoRO Dia I + II (HT) Series Water Treatment System for Hemodialysis. This type of regulatory document focuses on demonstrating substantial equivalence to predicate devices already on the market, rather than a clinical study evaluating the device's performance against specific acceptance criteria in a human-in-the-loop or standalone setting.
Therefore, the information requested in points 2-9 regarding sample sizes, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, ground truth types, and training set details generally do not apply or are not explicitly stated in the context of this 510(k) submission. These are typical requirements for clinical studies of AI/ML-powered diagnostic or prognostic devices, which this water treatment system is not.
The device's performance is assessed against recognized consensus standards for water purification systems rather than clinical endpoints or diagnostic accuracy.
Acceptance Criteria and Reported Device Performance
The core "acceptance criteria" for this device, as stated in the document, are its ability to produce water that meets specific industry standards for hemodialysis. The "reported device performance" section summarizes the non-clinical testing performed to demonstrate this compliance and substantial equivalence to predicate devices.
| Acceptance Criteria (from AAMI/ISO Standards and Federal Regulations) | Reported Device Performance (Summary of Testing) |
|---|---|
| Produces purified water as prescribed by AAMI ANSI ISO 13959: 2009 Water for hemodialysis and related therapies. | • Membrane performance (flux, rejection) demonstrated equivalence with predicate devices. |
| • Microbiological stability for bacterial counts and endotoxins according to AAMI AISI ISO standard 13959:2009. | |
| Produces purified water as prescribed by AAMI ANSI ISO 11663:2009 Quality of dialysis fluid for hemodialysis and related therapies. | • Not explicitly re-stated in the "Assessment of non-clinical performance data" section, but the overall conclusion affirms compliance with AAMI/ISO standards. |
| Produces water meeting AAMI ANSI ISO standard 23500:2011 (Quality of dialysis fluid for hemodialysis and related therapies). | • Microbiological stability for bacterial counts and endotoxins according to AAMI AISO ISO standard 23500:2011. |
| • Chemical and heat disinfection testing. | |
| Compliance with existing drinking water standards. | • Implied by the overall system design and purpose, but no specific test data for "drinking water standards" is listed in the summary of non-clinical tests. |
| Electrical safety. | • Electrical safety testing according to IEC 61010; ANSI/UL61010 (External test laboratory). |
| Electromagnetic compatibility. | • Electromagnetic compatibility testing according to IEC 6061-1-2 (External test laboratory). |
| Functional safety. | • Functional safety (according to ISO 14971). |
| Ergonomics and usability. | • Ergonomics and usability (IEC 62366 & Risk management according to ISO 14971). |
| Maintenance and reliability. | • Maintenance and reliability (Long term market performance Europe and SEA). |
| Biocompatibility of product contact materials. | • Leachable and extractable testing (Biocompatibility External Test laboratory and predicate devices). |
| • Biocompatibility testing of extract from the hydraulic flow path of product contact material (specific to heat disinfection). |
Further Details Regarding Studies (Points 2-9):
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Sample size used for the test set and the data provenance: This device is a water purification system, not an AI/ML-powered diagnostic tool. The "test set" refers to the specific units of the Aquaboss® EcoRO Dia I+II (HT) water purification units, equipped with Software 1.04, that underwent various non-clinical performance tests. The document doesn't specify a "sample size" in terms of number of test units beyond generally referring to "units." The data provenance is internal and external test laboratories, with some long-term market performance data from Europe and SEA (Southeast Asia). This is a non-clinical submission, not involving human subjects.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a water purification system is established by objective measurements against established chemical, physical, and microbiological standards (e.g., AAMI/ISO). It does not involve human expert interpretation of data in the same way as an imaging or diagnostic AI device.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept pertains to resolving discrepancies among expert interpretations in diagnostic studies. Here, the "ground truth" is determined by direct measurement and compliance with pre-defined standards.
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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 type of study is for evaluating observer performance with diagnostic aids. The device is a water treatment system, not a diagnostic tool that assists human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The "performance" described is inherently standalone, as it refers to the device's ability to purify water. The device operates automatically and its output (purified water) is measured directly against standards. There isn't an "algorithm only" performance separate from the physical system. The software validation is mentioned as part of the overall system testing: "Validation and Verification of Software including all options for single and double staged RO systems as well as HT (hot disinfection of RO membranes and ring main) in system integration testing as well as alarm and error testing. (Internal software and performance tests)".
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the performance tests is objective, quantitative measurements of water quality parameters (e.g., bacterial counts, endotoxins, conductivity, flux, rejection, leachable substances) against the limits defined by AAMI ANSI ISO 13959: 2009 and AAMI ANSI ISO 23500:2011, and other relevant electrical/safety standards (IEC 61010, ANSI/UL61010, IEC 6061-1-2, ISO 14971, IEC 62366).
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The sample size for the training set: Not applicable. This device is not an AI/ML system that requires a "training set" in the computational sense. Its design and performance are based on established engineering principles of reverse osmosis and water purification, validated through physical testing against specified standards.
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How the ground truth for the training set was established: Not applicable, as there is no training set.
§ 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.