(134 days)
Not Found
No
The device description and performance studies focus on physical filtration technology and do not mention any AI or ML components.
No.
Explanation: The device is a water filter intended to produce bacteriologically controlled, purified water for general medical uses such as washing hands and equipment, not for direct therapeutic treatment of a disease or condition. The phrase "may aid in infection control" refers to preventing infections through hygienic practices, not treating existing ones.
No
The device is a water filter designed to produce bacteriologically controlled water for washing and cleaning purposes, not for diagnosing medical conditions.
No
The device description clearly states it is a physical water filter utilizing hollow fiber microfiltration technology. It describes hardware components and physical performance testing, not software.
Based on the provided text, the aqua-tools FILT'RAY 2G Disposable Water Filter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the filter is for filtering drinking water to remove bacteria for various purposes like washing, drinking, wound cleansing, and cleaning medical equipment. It is not intended for the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the physical mechanism of filtration (hollow fiber microfiltration) to remove bacteria from water. It does not describe any components or processes related to analyzing biological samples.
- Performance Studies: The performance studies focus on the filter's ability to remove bacteria from water, its durability, biocompatibility, and sterilization. These are typical performance characteristics for a water filter, not an IVD device.
- Key Metrics: The key metrics measured relate to bacterial retention, flow rate, and sterilization, which are relevant to water filtration performance. They do not include metrics like sensitivity, specificity, or accuracy, which are common for IVD devices.
In summary, the device's function is to purify water for various uses, not to perform diagnostic tests on biological samples. Therefore, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
NHV
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing was conducted to characterize the subject FILT RAY 2G Disposable Water Filters and is summarized as follows:
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.,
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with an eagle and text around it. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the text "U.S. FOOD & DRUG ADMINISTRATION" is displayed in blue.
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.
1
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
2
Indications for Use
510(k) Number (if known) K191563
Device Name FILT'RAY2G Diposable Water Filter
Indications for Use (Describe)
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.
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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3
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. Grondin |
| virginie.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
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.
4
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:
5
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.,