(260 days)
The device is intended 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 dialyzer reprocessing, and equipment rinse and disinfection.
The Biopure Series RO systems purify feed water through reverse osmosis a membrane separation process. In reverse osmosis, pressure is applied to force water through a semipermeable membrane, while leaving impurities on the feed side of the membrane. The membrane allows the solvent (water) to pass through but retains a large percentage of impurities such as dissolved inorganics, organics, bacteria, and pyrogens. The water that passes through the membrane (permeate), has significantly less contamination than the feed water. while the reject stream, which remains upstream of the membrane, has a much higher concentration than the feed stream.
The purpose of a pretreatment to reverse osmosis is to remove chlorinel chloramines and condition the feed water supplying the RO machine. The pretreatment section may include feed water boost pumps, a temperature blend valve, chemical feed unit, sediment/carbon cartridge filters, water softeners, multi media filters, carbon filters and dealkalizers.
The RO unit removes more than 99% of all micro-organisms, pyrogens, particles, and organics with a molecular weight greater than 300, and up to 95% of all dissolved inorganics. The elements of an RO unit include a prefilter, RO pressure pump, and RO membranes.
The purpose of a product water distribution system is to deliver water that meets or exceeds AAMI/ASAIO standards for water treatment equipment and water quality requirements for hemodialysis point of use. Additional product water treatment is intended to control or eliminate bacteria prior to point of use. The product water treatment system may include a storage tank, distribution pump, a distribution loop, UV disinfection, and hot water sanitization.
Depending on the series and model, Biopure water purification systems produce from 300 GPD (gallons per day) to 100 GPM (gallons per minute) at 75% recovery rate. Rejection of total dissolved solids and monovalent ions is in the range of 95%-99% depending on feed water characteristics. Colloids, bacteria, and organics larger than a 200 molecular weight are rejected at greater than 99%.
Biopure water purification systems product water that meets the requirements of ANSI / AAMI RD5-1992, Hemodialysis Systems.
The provided text describes a 510(k) premarket notification for the Biopure Series RO systems, which are water purification systems for hemodialysis. The document focuses on establishing substantial equivalence to legally marketed predicate devices, rather than detailing a specific study to prove the device meets acceptance criteria through rigorous performance testing outlined in the input request.
Therefore, much of the requested information regarding study design, sample sizes, ground truth establishment, expert involvement, and statistical analysis is not present in the provided text. The document primarily focuses on regulatory approval based on technological similarity and intended use.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
The document states that the Biopure water purification systems produce product water that "meets the requirements of ANSI / AAMI RD5-1992, Hemodialysis Systems." ANSI/AAMI RD5-1992 specifies water quality standards for hemodialysis. The text also includes performance claims relevant to these standards:
| Acceptance Criteria (from ANSI / AAMI RD5-1992) | Reported Device Performance |
|---|---|
| Removal of micro-organisms | >99% rejection |
| Removal of pyrogens | >99% rejection |
| Removal of particles | >99% rejection |
| Removal of organics (>300 molecular weight) | >99% rejection |
| Removal of dissolved inorganics | Up to 95% rejection (95%-99% depending on feed water characteristics) |
| Removal of monovalent ions | 95%-99% rejection (depending on feed water characteristics) |
| Removal of colloids | >99% rejection |
| Removal of organics (>200 molecular weight) | >99% rejection |
| Product water output (recovery rate) | 300 GPD to 100 GPM at 75% recovery rate (depending on series and model) |
Note: The document states that the product water meets these requirements, implying these are the acceptance criteria. However, it does not provide a specific study report detailing the results of performance tests against these criteria with specific data tables for each analyte. It provides general performance capabilities of the RO technology.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not specified. The document does not describe a performance study with a distinct test set, sample size, or data provenance. The 510(k) submission is based on substantial equivalence to predicate devices, not on a new, dedicated clinical or performance study of the Biopure system's ability to meet the ANSI/AAMI RD5-1992 requirements.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not specified. This type of information is typically relevant for studies involving human interpretation or subjective assessments (e.g., medical image analysis). For a water purification system, "ground truth" would be established by analytical testing methods adhering to relevant standards (e.g., chemical analysis for purity, microbiological assays for contamination). The document does not describe the methodology for establishing ground truth for any testing, if such testing was performed for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not specified. Adjudication methods are used when multiple experts assess a case. This concept is not relevant to the type of device and regulatory submission described.
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 device is a water purification system, not a diagnostic or AI-assisted medical imaging device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a water purification system, not an algorithm or AI system. Its performance is inherent to its physical and chemical processes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Inferred to be analytical measurements against water quality standards. For a water purification system, the "ground truth" for its performance would be established by laboratory analysis of the treated water, measuring parameters like total dissolved solids, specific ion concentrations, bacterial counts, and pyrogen levels, all compared against the limits specified in ANSI/AAMI RD5-1992. However, the document does not detail the specific ground truth establishment methods used for the Biopure system in the context of this submission. It only states the system "meets the requirements."
8. The sample size for the training set
Not applicable/Not specified. This concept is relevant for machine learning algorithms. For a physical device like a water purification system, there is no "training set" in the computational sense. If manufacturing or calibration data were used, that is not described here.
9. How the ground truth for the training set was established
Not applicable/Not specified. As there is no training set mentioned, this question is not relevant.
§ 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.