(379 days)
A ZyzaTech Portable, V, Z or T Series Reverse Osmosis System and its pretreatment and product water distribution components is intended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from water that is used to dilute dialysis concentrate to form dialysate, and to produce purified water for other purposes such as dialyzer reprocessing and equipment rinse and disinfection.
The ZyzaTech series RO systems purify feed water through reverse osmosis which is the opposite of osmosis. Osmosis is the natural process wherein concentrated and dilute solutions, separated by a semipermeable membrane, flow to equalize concentrations. Solvent will flow from the dilute to the concentrated side of the membrane creating equal levels of concentration. Reverse osmosis is the application of high hydrostatic pressure on the concentrated solution; the direction of flow is reversed so that high solute concentrations flow across a semi-permeable membrane and become dilute concentrations. This results in two streams of water; one that is purer than the feed water, and the other that is higher in concentrates than the feed water. The pure flow is product water. The high concentrate flow is waste water.
The purpose of a pretreatment section of the system is to remove chlorine/chloramines and to condition the feed water supplying the RO unit. Conditioning the feed water can include: boosting the pressure, tempering, removal of particulates and, often, membrane scaling factors, along with volatile inorganic and organic solutes. The pretreatment section can include: feed water booster pumps, a temperature blend valve, chemical feed unit, cartidge filters, multi-media (sediment) filters, water softeners, dealkalizers and carbon filtration tanks.
The RO unit removes dissolved inorganic solutes with a molecular weight greater than 300, bacteria, viruses, endotoxins and particles. The primary elements of a RO unit are: a prefilter, RO pump and RO membranes housed in pressure vessels.
The purpose of a product water distribution section of a system is to deliver product water that meets AAMI standards to the points of use. Additional post-treatment measures are intended to control or eliminate bacteria prior to the points of use, especially in an indirect feed type of system. The product water distribution section can include: a storage tank, distribution repressurization pumps, distribution loop, UV irradiators, ultra and sub-micron filters.
Depending upon the series and model, ZyzaTech water purification systems produce typically from 250 gpd to 42,000 gpd of product water with a range of 17-75 percent recovery rate. Rejection of total dissolved solids (TDS) and monovalent and polyvalent ions is in the range of 95-99% depending upon feed water characteristics. Bacteria and pyrogens are rejected 99%. Organic size cut-off is a molecular weight greater than 300 Dalton.
ZyzaTech's water purification systems produce product water that meets the requirements of the voluntary standard issued by the American National Standard Institute and the Association for the Advancement of Medical Instrumentation: ANSI/AAMI RD5-1992, Hemodialysis Systems.
The provided text describes a 510(k) summary for the ZyzaTech Water Purification Systems, which are intended for use with hemodialysis systems. While the document outlines the device's function, intended use, and general performance claims, it does not contain the detailed study information typically found when evaluating acceptance criteria against specific scientific studies.
The document claims the device meets the voluntary standard ANSI/AAMI RD5-1992, Hemodialysis Systems, but it does not provide the specific acceptance criteria from that standard nor a detailed study report demonstrating compliance.
Therefore, much of the requested information cannot be extracted from the provided text. I will complete what is available and note what is missing.
Acceptance Criteria and Device Performance
The document states that ZyzaTech's water purification systems produce product water that meets the requirements of the voluntary standard ANSI/AAMI RD5-1992, Hemodialysis Systems. While the specific numerical acceptance criteria from that standard are not provided in the input text, the document does report general performance characteristics of the ZyzaTech systems.
| Performance Metric | Acceptance Criteria (from ANSI/AAMI RD5-1992) | Reported Device Performance |
|---|---|---|
| Total Dissolved Solids (TDS) Rejection | Not specified in text | 95-99% (depending on feed water characteristics) for TDS and monovalent/polyvalent ions. |
| Bacteria Rejection | Not specified in text | 99% |
| Pyrogen Rejection | Not specified in text | 99% |
| Organic Size Cut-off | Not specified in text | Molecular weight greater than 300 Dalton |
| Product Water Production Rate | Not specified in text | Typically 250 gpd to 42,000 gpd (depending on series and model) |
| Recovery Rate | Not specified in text | 17-75 percent |
| Compliance with Standards | Not specified in text | Meets the requirements of ANSI/AAMI RD5-1992, Hemodialysis Systems (voluntary standard). |
Study Details (Information Not Available in the Provided Text)
The provided text is a 510(k) summary, which typically summarizes the equivalence to predicate devices rather than providing full study protocols and results for device performance against specific acceptance criteria. Therefore, the detailed study information requested below is not available within the input.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document states general performance characteristics ("typically," "range of," "depending upon") but does not detail specific test sets or studies performed to arrive at these numbers.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not provided. This type of information is relevant for studies involving human interpretation (e.g., medical imaging diagnostics). For a water purification system's performance, ground truth would typically be established through analytical laboratory methods, not expert consensus on interpretations.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. As above, this is typical for studies involving human reviewers and diagnostic interpretations.
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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/Not provided. This is a water purification system, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. This device is a physical water purification system, not an algorithm. Its performance is inherent to its mechanical and chemical processes, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For water purification systems, ground truth is typically established by chemical and microbiological laboratory analysis of water samples before and after purification against established standards (e.g., AAMI RD5-1992 chemical limits, bacterial counts). However, the specific methodology is not detailed in the provided document.
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The sample size for the training set:
- Not applicable/Not provided. The device is a physical system, not a machine learning algorithm that requires a "training set." Its effectiveness is based on engineering design and physical principles.
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How the ground truth for the training set was established:
- Not applicable/Not provided. See the explanation for point 7.
§ 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.