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.

Device Description

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.

AI/ML Overview

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	<1.0 µg/L (below quantification limit)
Maximum Operating Temperature and Pressure	Withstand 5 bar pressure and 70°C for 30 minutes, and retain bacteria at >7 log reductions	Withstood 5 bar pressure and 70°C for 30 minutes, and achieved >7 log reductions of bacteria.
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.

Summary

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October 25, 2019

aqua-tools Virginie Grondin Medical Devices Quality and Regulatory Affairs Manager 26 Rue Charles Edouard Jeanneret 78300 POISSY FRANCE

Re: K191563

Trade/Device Name: FILT'RAY 2G Disposable Water Filters Regulation Number: 21 CFR§ 876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: NHV Dated: September 17, 2019 Received: September 23, 2019

Dear Virginie Grondin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Carolyn Y. Neuland, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191563

Device Name FILT'RAY2G Diposable Water Filter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable):

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image is a logo for Aqua-Tools. The logo features a series of blue and green circles that fade from dark blue to light green. Below the circles is the text "aqua-tools" in a sans-serif font, with the word "aqua" in lowercase and "tools" in uppercase. Below that is the text "INFECTION CONTROL SOLUTIONS" with "INFECTION CONTROL" in a larger font than "SOLUTIONS".

510(K) SUMMARY

I. SUBMITTER

Company Name:	aqua-tools
Contact Person :	Ms. Virginie S. Grondinvirginie.grondin@aqua-tools.com
Date Prepared:	May 28th, 2019
II.	DEVICE
Trade Name:	FILT'RAY 2G Disposable Water Filters
Common Name:	System, Water purification, General medical use
Device Classification:	21 CFR 876.5665, Product code NHV
Classification Name:	Water purification system for hemodialysis
Device Class:	Class II
Panel:	Gastroenterology/Urology

III. PREDICATE DEVICES

Primary Predicate Device:	Pall-Aquasafe TM Water Filters (K153434) 21 CFR 876.5665, Class II, NHV
Additional Predicate Devices:	Evoqua Nosogard Filters (K153784) Nephros, Inc. S100 Point of Use Filters (K153084)

IV. DEVICE DESCRIPTION

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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.

V. INDICATIONS FOR USE

The aqua-tools FILT' RAY 20 Disposable Water Filter is intended to be used 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.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH VI. THE PREDICATE DEVICE

The subject and predicate devices have identical or similar indications for use and yield water that is suitable for drinking and washing. The subject FILT'RAY 20 Disposable Water Filter device is also similar in its system configuration (e.g., shower, faucet, in-line filters), use specifications (use life, pressure rating, water source/network), and in other significant design and technological features. The subject and predicate devices utilize the same fundamental technology that consists of a sterilizing grade filter1 membrane that has been validated to retain and remove microorganisms in the water supply. The characteristics of the subject device and the predicate device were assessed and compared via performance testing, as described below. Any minor differences between the subject and predicate devices do not raise new questions of safety or effectiveness. Rather, these differences can and were evaluated through performance testing to determine substantial equivalence.

PERFORMANCE DATA VII.

Non-clinical performance testing was conducted to characterize the subject FILT RAY 2G Disposable Water Filters and is summarized as follows:

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Microbial Retention

The ability of the subject FILT'RAY 20 Disposable Water Filter to retain a bacterial load greater than 107 colony-forming units (CFU)/cm² was captured via performance bench testing per ASTM F838-15a: Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration. This standard testing was used on water filters that have underwent worst case use. The Brevundimonas diminuta test microorganism was not found in any of the filtrates for all tested filters.

Evaluation of Bacteriostatic Agent Effectiveness

The addition of a silver ion-based bacteriostatic agent into the material used to manufacture the housing components was evaluated per ISO 22196: Measurement of antibacterial activity on plastics and other non-porous surfaces. These tests were performed on new filters and on aged filters. Per the results of these tests, this agent allows to reduce the external surface contamination by more than 99.9% for Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus and Methicillin Resistant Staphylococcus aureus (MRSA). Ageing of the samples had no impact on the efficacy of the treated samples.

Silver Ion Testing

The presence of any silver-based ions in the water filtered through the FILT RAY 20 Disposable Water Filters was quantified via inductively coupled plasma mass spectrometry (ICP/MS) and found to be less than the quantification limit (i.e., <1.0ug/L) and are in compliance with the World Health Organization (WHO) guidelines without risk to health.

Maximum Operating Temperature and Pressure Rating

Testing was conducted at up to 5 bar as well as up to 70℃ (for a continuous period of 30 minutes) to ensure that the subject filters were able to not only withstand these conditions, but also adequately retain bacteria at a greater than 7 log reductions after filtration of water at these conditions.

Flow Rate Testing

All filter models were subjected to a flow rate/pressure test with water pressures varying from 1 to 5 bar (on the filter input) and were found to have adequate flow for use at these various inputs.

Sterilizing grade filter is defined in "American standard Test Method ASTM F838-15a and in FDA - Guidance for Industry - Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice" as a filter ability to sustain a bacterial challenge of 107 CFU of Brevundimonas diminuta per cm2 of filtration surface.

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Biocompatibility

The subject FILT'RAY 20 Disposable Water Filter device is proposed to be used for washing, drinking, superficial wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon's hands. Therefore, given the intended use, nature and degree of tissue contact and exposure duration during clinical use, the subject device is considered a surface device, contacting breached or compromised surfaces repeatedly for limited duration of contact (< 24 hour-exposure duration is considered as worst-case cumulative patient-contacting hours, even though there is potential for repeat use of the same or a new device during its intended use. Therefore, per the FDA Guidance on the "Use of International Standard ISO 10993-1," the following tests for biocompatibility evaluation of the subject FILT'RAY 20 Disposable Water Filter device have been performed: cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, and material mediated pyrogenicity testing. The NAMSA tests reports indicate that it is safe for use in medical devices, as evidenced by the passing results of cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, and material mediated pyrogenicity testing, which are required for this classification.

Sterilization Testing

The FILT'RAY 20 Disposable Water Filters are available sterile with a use life of 1-month (31 days), 2-month (62 days), 3-month (93 days) and 4-month (124 days). Bioburden was assessed per ISO 11737-1 and 11737-2, and sterilization was conducted per ISO 11137-1, parts 1 and 2. The VDMax® method was utilized to characterize a minimum dose of 25kGy to ensure a sterility assurance limit (SAL) of 10-6

Shelf Life Testing

The packaging and sterilizing grade performance for the subject FILT'RAY 20 Disposable Water Filters was conducted via 3-year accelerated aging tests and a 2 years and 9 months real-time aging test. Packaging integrity testing was performed. All results passed the acceptance criteria, and the packaging integrity (and sterility) was determined to be acceptable after sterilization, transportation simulation, and accelerated aging testing. Therefore, the subject FILT RAY 20 Filters remain sterile and produce bacteriologicallycontrolled water with an expiration date of up to 3 years.

VIII. CONCLUSIONS

Comparison of the indications for use, technical characteristics, as well as performance of the subject and predicate water filters provided in the 510(k) submission, is sufficient to demonstrate substantial equivalence. The information contained in this 510(k) demonstrates that the FILT' RAY 20 Disposable Water Filters are as safe and effective as the predicate device. With identical indications for use and similar technological characteristics that were evaluated by performance testing, the aqua-tools FILT RAY 2G Disposable Water Filters are substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.