(267 days)
The intended use of the i3 Membrane Water Filters i3 ONE, i3 TWO connect, i3 TWO direct is to filter EPA quality drinking water. The i3 Membrane Water Filters retain bacteria, which may aid in infection control. The filters produce water that is appropriate for washing and drinking, superficial wound cleansing (minor cuts, scrapes and abrasions), cleaning of equipment used in medical procedures and washing of surgeon's hands. The i3 Membrane Water Filters are not intended to provide water that can be used as a substitute for USP grade sterile water.
The i3 Point-of-Use Water Filters are supplied sterile and 100% integrity tested. The membrane within the filter cartridge is rated and validated at 0.2 µm to remove bacteria and particles in the water supply. This membrane reduces bacteria with more than 7 log levels per square centimeter filtration area. This represents the bacterial retention, the core element of infection prevention. Furthermore, a bacteriostatic additive is present in the outer housings parts of the filter, which prevents retrograde contamination of the filter. In addition, the inlet of the tap water filter is inclined to prevent the water from hitting the siphon. This also prevents retrograde contamination from the siphon, which would be caused by rising aerosols from the direct impact of the water jet. The Water Filters are designed to be used for a maximum of 50 days following initial connection. Suspending use does not extend filter life. The i3 ONE / i3 TWO connect / i3 TWO direct Water Filters are intended to be used within the healthcare environment such as hospitals, nursing homes, health care facilities or clinical settings where immunecompromised patients may be exposed to waterborne microorganisms originating from the water supply. The i3 Membrane Water Filters are disposable and designed for the use on tap or the shower.
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the absence of information related to AI/ML devices as the text concerns water filters:
This document describes a medical device submission for water filters (i3 ONE, i3 TWO connect, i3 TWO direct), not an AI/ML device. Therefore, many of the requested categories related to AI/ML performance, such as test sets, ground truth establishment, expert adjudication, MRMC studies, standalone algorithm performance, and training set information, are not applicable and are absent from the provided text.
1. A table of acceptance criteria and the reported device performance
Since this is not an AI/ML device, the "acceptance criteria" are generally related to the physical, chemical, and microbiological performance of the water filters. The document describes several performance tests against established standards and criteria, rather than specific numerical "acceptance criteria" in a table format. However, the reported performance is presented in relation to the requirements for such devices.
| Acceptance Criterion (Inferred from testing) | Reported Device Performance and Related Information |
|---|---|
| Microbial Retention: | |
| Bacterial retention of membrane filters | - Examined following ASTM F 838 - 15a. |
- Showed very good retention performances with reductions of bacterial count of more than 10^7 colony-forming units (CFU)/cm² filter area.
- All filters passed integrity test prior to and after bacterial retention test.
- (Filter Retention in comparison table): > 10^7 CFU/cm²; > 10^10 CFU/device (matching predicate). |
| Bacteriostatic Additive Efficacy: | |
| Prevention of retrograde contamination | - Reduces retrograde contamination by more than 99.5% for Pseudomonas aeruginosa even after 8 weeks of use. - Achieved 99.5% protection against retrograde contamination for Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Acinetobacter baumannii, and Staphylococcus aureus. |
| Silver Migration: | |
| Acceptable levels of silver ion migration | - Silver-based ions found to be more than 10 times less according to the suggestion of the Environmental Protection Agency. |
| Maximum Operating Temperature & Pressure: | |
| Withstand thermal disinfection | - Tested at up to 5 bar and up to 70°C (for 30 minutes continuous period). - Filters passed integrity tests after these conditions. |
| Flow Rate: | |
| Guaranteed function at various pressures | - Tested at 1, 2, 3, 4, and 5 bar (approx. 15, 30, 45, 60, and 75 PSI) static water pressure. - Intended use guaranteed at each of these pressures. |
| Sterilization: | |
| Sterility and shelf life | - Available sterile with a shelf life of 50 days. - Bioburden and sterilization validation assessed and conducted successfully.
- Sterilization dose of 25 kGy for SAL 10^-6 substantiated. |
| Shelf Life: | |
| Maintenance of integrity and sterility over time | - Tested by a 5-year accelerated test. - 5-year real-time aging test started in 2019.
- Packaging passed peel, dye, and bubble tests.
- Filter confirmed sterile after a 5-year life.
- Further integrity tests of the filter carried out. |
| Biocompatibility: | |
| Compatibility with biological systems | - Biocompatibility review performed for all three filter types using ISO 10993-1 and subsequent ISO 10993 series standards. - Concluded that the products are biocompatible. |
| Additional Tests (Passed product specifications): | |
| Mechanical integrity and chemical resistance | - Burst Pressure Testing - Durability Testing
- Transport Testing
- Drop Testing
- Chlorine Testing for chemical disinfection
- Wipe Disinfection Testing |
| Risk Management: | |
| Acceptable risk profile | - Hazards assessed under ISO 14971. - No risk deemed unacceptable; overall risk profile low (risks mitigated under design control and ASTM testing). |
The following questions are not applicable to the submitted device (water filter) as it is not an AI/ML product. The document does not contain information on these aspects.
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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)
- This is not an AI/ML device. The "test set" refers to the tested filter samples, but specific sample sizes for each test are not detailed in the summary. The tests are non-clinical performance and lab-based.
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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 an AI/ML device. Ground truth for the performance of a physical device like a water filter is established through standardized laboratory testing (e.g., CFU counts, integrity tests, material analysis) rather than expert consensus on medical images or patient data.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not an AI/ML device. Adjudication methods are relevant for ambiguous cases in human interpretation, which is not applicable here.
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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 an AI/ML device. MRMC studies are for evaluating diagnostic performance with human readers, typically in imaging.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not an AI/ML device. This refers to algorithm-only performance, which isn't applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this device, "ground truth" is based on the results of standardized physico-chemical and microbiological laboratory tests (e.g., bacterial count reduction as per ASTM F 838 - 15a, material analysis for silver migration, physical stress tests).
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The sample size for the training set
- Not an AI/ML device. There is no training set mentioned or applicable.
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How the ground truth for the training set was established
- Not an AI/ML device. Not applicable.
§ 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.