(134 days)
The aqua-tools FILT'RAY 2G Disposable Water Filter is intended to filter EPA (Environmental Protection Agency in USA) quality drinking water. By retaining bacteria, the filters may aid in infection control. The filters produce water that is suitable for washing and drinking, superficial wound cleansing (minor cuts, scrapes, or abrasions), cleaning of equipment used in medical procedures and washing of surgeon's hands. The filters are not intended to provide water that can be used as a substitute for USP grade sterile water.
The FILT'RAY 20 Disposable Water Filters are intended to produce bacteriologically controlled, purified water for general medical uses (e.g., washing of surgeon's hands, surgical instruments, and cleansing). These devices retain bacteria including opportunistic waterborne pathogenic microorganisms via a hollow fiber microfiltration technology with a corresponding pore size of 0.1 µm nominal / 0.2 µm absolute. This microfiltration technology ensures that the purified water will meets the criteria of bacteriologically controlled water that presents a higher bacteriological quality than the water of the distribution network by retaining bacteria, including Legionella spp., L. pneumophila. Pseudomonas aeruginosa and other opportunistic waterborne pathogenic microorganisms. Of note, the subject FILT'RAY 20 devices do not contain latex, nor tissues or by-product animal origins, nor derived of blood or any substance considered as a medicine. The subject FILT' RAY 20 devices are provided sterile and are designed to be used for 1 month up to 4 months after initial connection and depending on the specific model.
This document is a 510(k) submission for the aqua-tools FILT'RAY 2G Disposable Water Filters. It describes the device, its indications for use, and the performance data that demonstrates its substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Microbial Retention (Brevundimonas diminuta) | Bacterial load greater than 10^7 CFU/cm² retained (per ASTM F838-15a) | Brevundimonas diminuta not found in filtrates for all tested filters. |
| Bacteriostatic Agent Effectiveness (External Surface Contamination) | Reduce external surface contamination by >99.9% | Reduced external surface contamination by >99.9% for Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus, and MRSA. Ageing had no impact on efficacy. |
| Silver Ion Presence in Filtered Water | Below quantification limit and in compliance with WHO guidelines | 7 log reductions |
| Flow Rate | Adequate flow for use at water pressures from 1 to 5 bar | Adequate flow for use at water pressures from 1 to 5 bar. |
| Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity) | Safe for use in medical devices (passing results per ISO 10993-1 guidance) | Passed all tests, indicating safety for use in medical devices. |
| Sterility Assurance Level (SAL) | 10^-6 | Achieved SAL of 10^-6 with a minimum dose of 25kGy (per ISO 11137-1 and 11137-2). |
| Shelf Life (Packaging Integrity and Sterilizing Grade Performance) | Acceptable after sterilization, transportation simulation, and accelerated aging | All results passed acceptance criteria; packaging integrity and sterility acceptable after testing; device remains sterile and produces bacteriologically-controlled water for up to 3 years. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample sizes (number of filters) used for each specific test described in the "Performance Data" section. However, it indicates that testing was conducted on "all tested filters" for microbial retention and "new filters and on aged filters" for bacteriostatic agent effectiveness. "All filter models" were subjected to flow rate testing.
The data provenance is from non-clinical performance testing (bench testing) and specifically refers to a "manufacture the housing components" for the bacteriostatic agent. The origin of the data is not specified by country, but it's likely from the manufacturer's internal testing or contract labs. It is retrospective in the sense that the testing was performed on the finished device before submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to this document. The device in question is a water filter, and its performance criteria are objective, based on physical and microbiological measurements (e.g., bacterial retention, chemical concentration, temperature, pressure, flow rate). There is no "ground truth" established by human experts in the way that it would be for an AI diagnostic device evaluating medical images. The ground truth for performance claims is established by adherence to recognized standards (e.g., ASTM F838-15a, ISO 22196, ISO 11737-1, ISO 11137-1).
4. Adjudication Method for the Test Set
This section is not applicable. Since the performance of the water filter is assessed through objective laboratory tests against pre-defined standards, there is no need for expert adjudication of results.
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
This section is not applicable. The device is a physical water filter, not an AI diagnostic device. Therefore, no MRMC study involving human readers and AI assistance was performed.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This section is not applicable. The device is a physical water filter and does not involve any algorithms or AI for its function.
7. The Type of Ground Truth Used
The "ground truth" for the performance of this device is established through:
- Objective laboratory measurements and adherence to recognized international and national standards/protocols. Examples include:
- Bacterial retention: ASTM F838-15a
- Antibacterial activity: ISO 22196
- Silver ion limits: World Health Organization (WHO) guidelines
- Sterility: ISO 11737-1, 11737-2, ISO 11137-1, ISO 11137-2
- Biocompatibility: FDA Guidance on the "Use of International Standard ISO 10993-1"
These standards define the expected performance metrics and the methods to verify them.
8. The Sample Size for the Training Set
This section is not applicable. As a physical water filter, this device does not use machine learning or AI, and therefore does not have a "training set" in the computational sense. The design and manufacturing processes are informed by engineering principles, materials science, and regulatory requirements.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reason as point 8.
§ 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.