(273 days)
The ECOLAB POU Water Filters are intended to operate on EPA quality drinking water sources as a microbial retention filter. ECOLAB POU Water Filters are suitable for the control of bacteria equal to or greater in size than Brevundimons diminuta. The POU Filters are suitable for general point of use infection control for procedures such as superficial wound cleansing, cleaning of equipment, washing of surgeon's hands and bathing where the reduction of such microorganisms in the water is desired.
The POU Filters are not intended for use in the production of USP sterile water for use in infusion, injection of fluids for use in dialysis treatments.
The Ecolab POU Water Filter is a disposable Polyethersulfone (PES) membrane filter sealed in a white polypropylene housing designed to be installed by facility personnel at point of use locations where the control of bacteria in EPA quality drinking water is desired for hand- washing, bathing, showering and instrument cleaning applications. These filters are designed to be installed as attachments to faucets or as a handheld shower head attached to a water outlet.
The request is about a water filter, not an AI/ML medical device. Therefore, questions 2, 3, 4, 5, 8, and 9 are not applicable to this document. The document describes a traditional medical device (water filter) and its performance characteristics, not an algorithm, so terms like "ground truth," "training set," "test set," and "human-in-the-loop" performance are not relevant.
However, I can extract information related to acceptance criteria and performance studies for the Ecolab POU Water Filter based on the provided text.
Here's the information derived from the provided document, addressing the relevant parts of your request:
Device: Ecolab POU Water Filter (K173164)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Target (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Microbial Retention (against Brevundimonas diminuta) | Suitable for control of bacteria equal to or greater in size than Brevundimonas diminuta. | All Ecolab POU Water Filters retained the test organism Brevundimonas diminuta challenge of ≥ 10^7^ organisms/cm² and prevented bacterial grow-through over the service life of each model. This meets the predicate device's > 10^7^ bacteria reduction. |
| Filter Flow Rate (at 3 bar inlet pressure) | Not explicitly stated as an "acceptance criterion" with a specific numerical target, but flow rates are a performance characteristic. | 7-Day tap filter: 6.3 L/min14-Day tap filter: 6.5 L/min31-Day tap filters: 6 L/min |
| Maintenance of Microbial Retention Effectiveness after Cyclic Pulse Testing (Tap Filters) | Maintain microbial retention effectiveness after continuous use repeated shocks of 89.9 psi (6.2 bar) at 151°F (66°C). | Maintained microbial retention effectiveness (as measured by diffusional flow integrity test) after continuous use repeated shocks of 89.9 psi (6.2 bar) at 151°F (66°C). |
| Maintenance of Microbial Retention Effectiveness after Cyclic Pulse Testing (Shower Wand Filters) | Maintain microbial retention effectiveness after continuous use repeated shocks of 79.8 psi (5.5 bar) at 122°F (50°C). | Maintained microbial retention effectiveness (as measured by diffusional flow integrity test) after continuous use repeated shocks of 79.8 psi (5.5 bar) at 122°F (50°C). |
| Sterility | Assure product sterility. | Verified that the gamma irradiation process assures product sterility (according to ISO 11137-1 and ISO 11137-2). |
| Package Integrity (to maintain sterile barrier) | Capable of maintaining a sterile barrier for the labeled shelf life. | Demonstrated that the packaging is capable of maintaining a sterile barrier for the labeled 36-month shelf life (according to ISO 11607-1 and 11607-2). |
| Retention of Functional Characteristics (through shelf life) | Retain functional characteristics through shelf life. | Verified that the filters retain their functional characteristics through 36 months. |
| Biocompatibility | Satisfy biocompatibility requirements for the intended use (cytotoxicity, irritation, sensitization, acute systemic toxicity, material-mediated pyrogenicity). | All biocompatibility testing was conducted in accordance with ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Irritation, Sensitization), and ISO 10993-11 (Acute Systemic Toxicity, Material Mediated Pyrogenicity) under GLP 21 CFR Part 58 Regulations. The document states "Biocompatibility of the Ecolab POU Water Filters was verified," implying successful completion and meeting of criteria for all listed tests. |
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical water filter, not an algorithm. The "performance" assessment is based on the filter's physical and biological filtration capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this physical device, "ground truth" equates to laboratory testing against established standards and known microbial challenges.
- Microbial Retention: The "ground truth" was the Brevundimonas diminuta challenge ≥ 10^7^ organisms/cm², with the effectiveness judged by the absence of bacterial grow-through. This is a direct measurement of the device's capability.
- Sterility: The "ground truth" for sterility was verification against ISO 11137-1 and ISO 11137-2 standards for sterilization processes.
- Package Integrity: The "ground truth" for package integrity was verification against ISO 11607-1 and 11607-2 standards.
- Biocompatibility: The "ground truth" for biocompatibility was verification against ISO 10993 series standards and GLP 21 CFR Part 58 Regulations.
There are no concepts of "training sets" or "ground truth establishment" for a training set as would apply to machine learning models. The tests were performed to directly demonstrate the specified physical and biological performance characteristics of the manufactured device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 29, 2018
Ecolab Inc. Jennifer Willner, RAC Sr. Director Regulatory Affairs One Ecolab Place St. Paul, MN 55102
Re: K173164
Trade/Device Name: Ecolab POU Water Filter Regulation Number: 21 CFR 876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: Class II Product Code: NHV Dated: May 29, 2018 Received: May 30, 2018
Dear Jennifer Willner:
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. 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.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173164
Device Name Ecolab POU Water Filter
Indications for Use (Describe)
The ECOLAB POU Water Filters are intended to operate on EPA quality drinking water sources as a microbial retention filter. ECOLAB POU Water Filters are suitable for the control of bacteria equal to or greater in size than Brevundimons diminuta. The POU Filters are suitable for general point of use infection control for procedures such as superficial wound cleansing, cleaning of equipment, washing of surgeon's hands and bathing where the reduction of such microorganisms in the water is desired.
The POU Filters are not intended for use in the production of USP sterile water for use in infusion, injection of fluids for use in dialysis treatments.
Type of Use (Select one or both, as applicable)X 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/0 description: The image shows the logo for Ecolab. The logo is in blue and features the company name in a bold, sans-serif font. The "O" in Ecolab is replaced with a stylized image of a star or asterisk inside of a circle. There is a registered trademark symbol next to the "B" in Ecolab.
510(k) Summary
| Manufacturer: | Ecolab Inc. | ||
|---|---|---|---|
| One Ecolab Place | |||
| St Paul, MN 55102 USA | |||
| Establishment Registration Number: 9009921 | |||
| Contact: | Jennifer Willner, RAC | ||
| Sr. Director Regulatory Affairs | |||
| Ecolab Inc. | |||
| One Ecolab Place, St Paul, MN 55102 USA | |||
| Phone: 651 250 4348 | |||
| Date Prepared | May 24, 2018 | ||
| Trade Name | Ecolab POU Water Filter | ||
| Classification | Class II | ||
| Regulation Name | Water purification system for hemodialysis | ||
| Regulation Number | 21 CFR 876.5665 | ||
| Product Code | NHV | ||
| Predicate Device | Evoqua Water Technologies, Nosogard Filters, K153784 | ||
| Device Description | The Ecolab POU Water Filter is a disposable Polyethersulfone (PES) | ||
| membrane filter sealed in a white polypropylene housing designed to | |||
| be installed by facility personnel at point of use locations where the | |||
| control of bacteria in EPA quality drinking water is desired for hand- | |||
| washing, bathing, showering and instrument cleaning applications. | |||
| These filters are designed to be installed as attachments to faucets or | |||
| as a handheld shower head attached to a water outlet. | |||
| Indication for Use | The ECOLAB POU Water Filters are intended to operate on EPA quality | ||
| drinking water sources as a microbial retention filter. ECOLAB POU | |||
| Water Filters are suitable for the control of bacteria equal to or greater | |||
| in size than Brevundimons diminuta. The POU Filters are suitable for | |||
| general point of use infection control for procedures such as superficial | |||
| wound cleansing, cleaning of equipment, washing of surgeon's hands | |||
| and bathing where the reduction of such microorganisms in the water | |||
| is desired. | |||
| The POU Filters are not intended for use in the production of USP sterile | |||
| water for use in infusion, injection or production of fluids for use in | |||
| dialysis treatments. | |||
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Image /page/4/Picture/0 description: The image shows the Ecolab logo in blue. The logo consists of the word "ECOLAB" in a bold, sans-serif font. The "O" in Ecolab is a circle with a star-like design inside. There is a registered trademark symbol to the right of the logo.
| Substantial Equivalence Comparison Table | ||
|---|---|---|
| Subject Device | Predicate Device | |
| 510(k) Number | K173164 | K153784 |
| Trade Name | Ecolab POU Water Filter | Nosogard Filters |
| Manufacturer | Ecolab Inc. | Evoqua Water Technologies, LLC. |
| Indications forUse | The ECOLAB POU Water Filters areintended to operate on EPA qualitydrinking water sources as a microbialretention filter. ECOLAB POU WaterFilters are suitable for the control ofbacteria equal to or greater in sizethan Brevundimonas diminuta. ThePOU Filters are suitable for generalpoint of use infection control forprocedures such as superficialwound cleansing, cleaning ofequipment, washing of surgeon'shands and bathing where thereduction of such microorganisms inthe water is desired.The POU Filters are not intended foruse in the production of USP sterilewater for use in infusion, injection orproduction of fluids for use in dialysistreatments | The NOSOGARD line of filters areintended to operate on EPA qualitydrinking water sources as a microbialretention filter. NOSOGARD filters areavailable in models suitable for thecontrol of bacteria equal to or greaterin size than Brevundimonas diminutaand models for microbial removalequal to or greater than Legionellapneumophila. The NOSOGARD issuitable for general point of useinfection control for procedures suchas cleaning, rinsing of equipment,hand washing and bathing where thereduction of such microorganisms inthe water is desired.The Nosogard is not intended for usein the production of USP sterile waterfor use in infusion, injection orproduction of fluids for use in dialysistreatments. |
| DeviceDescription | A disposable Polyethersulfone (PES)membrane filter sealed in a whitepolypropylene housing designed tobe installed by facility personnel atpoint of use locations where thecontrol of bacteria in EPA qualitydrinking water is desired for hand-washing, bathing, showering andinstrument cleaning applications.These filters are designed to beinstalled as attachments to faucetsor as a handheld shower headattached to a water outlet. | A disposable Polyethersulfone (PES)membrane filters sealed in apolypropylene housing designed to beinstalled by facility personnel at pointof use locations where the control ofbacteria in the drinking water supply isdesired for device cleaning,handwashing and bathingapplications. These filters are designedto be installed as attachments tofaucets or as a handheld shower head. |
| Feed WaterSource | SAME | Drinking water plumbing at point ofuse. |
| Feed WaterQuality | SAME | Potable Water as defined by the EPANational Primary DrinkingWaterRegulations (EPA Quality Water) |
| Substantial Equivalence Comparison Table | ||
| Subject Device | Predicate Device | |
| Useful Life | Up to 7 days and 31 days depending on model | Up to 7 days or 31 days or 62 days depending on model |
| Maximum InletPressure | 89.9 psi (6.2 bar): tap filters79.8 psi (5.5 bar): shower wands | 89.9 psi (pounds / square Inch) for all models |
| Sterile Device | SAME | Shipped in sterile condition and package |
| Casing | SAME | Polypropylene |
| Filter | SAME | Polyethersulfone (PES) pleated membrane |
| Element(s) | SAME | |
| BacteriaReduction* | SAME | > 107 |
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Device Description & Summary of Technological Characteristics:
The ECOLAB POU Water Filter is a disposable polyethersulfone (PES) membrane filter sealed in a white polypropylene housing designed to be installed by facility personnel at point of use locations where the control of bacteria in EPA quality drinking water is desired for hand- washing, showering and instrument cleaning applications. These filters are designed to be installed as attachments to faucets or as a handheld shower head attached to a water outlet. The POU water filters are supplied sterile for single use and are not intended to be resterilized.
| Model(REF) | Description | Max. UseDays | Type | Inlet | Outlet |
|---|---|---|---|---|---|
| 6065845 | 7-Day Sterile Tap Filterw/Spray Outlet | 7 | Tap | Quickconnect | Spray |
| 6065846 | 7-Day Sterile Tap Filterw/Nozzle Outlet | 7 | Tap | Quickconnect | Nozzle |
| 6065702 | 31-Day Sterile Tap Filterw/Spray Outlet | 31 | Tap | Quickconnect | Spray |
| 6065703 | 31-Day Sterile Tap Filterw/Nozzle Outlet | 31 | Tap | Quickconnect | Nozzle |
| 6065704 | 31-Day Sterile Shower WandFilter | 31 | Showerwand | ½" NPT | Shower |
| Ecolab POU Filters Models and Maximum Service Life Once Installed | |
|---|---|
The ECOLAB POU Water Filters have the same intended use as the predicate device. The ECOLAB POU Water Filters and the predicate device are constructed of the same materials; both incorporate a 1µm polypropylene prefilter and a 0.2µm polyethersulfone pleated filter membrane. Both products are available in tap filter and shower wand configurations and have the same range of maximum service life from 7 days to 30 days. Both devices are supplied sterile in packaging capable of maintaining a sterile barrier for the labeled shelf life of three years.
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Image /page/6/Picture/0 description: The image shows the Ecolab logo in blue. The logo consists of the word "ECOLAB" in a bold, sans-serif font. The "O" in "ECOLAB" is replaced by a circular graphic with a starburst pattern inside. There is a registered trademark symbol to the right of the word "ECOLAB".
The predicate devices have models suitable for the control of bacteria equal to or greater insize than Legionella peumophila and models suitable for retention of the smaller Brevundimons diminuta bacteria. All ECOLAB POU Water Filters are suitable for retention of the smaller Brevundimons diminuta over the maximum service life of the model.
Non-Clinical Performance Testing
All ECOLAB POU Water Filters retained the test organism Brevundimonas diminuta challenge of ≥ 10′ organisms/cm² and prevented bacterial grow-through over the service life of each model when tested according to ASTM F838-15 Standard Test Method for Deterial Reterial Retention of Membrane Filters.
Filter flow rates at 3 bar inlet pressure are 7-Day tap filter – 6.3 L/min; 14-Day tap filter – 6.5 L/min; 31-Day tap filters - 6 L/min.
Simulated Use Cyclic Pulse Testing demonstrates that the tap filters maintain microbial retention effectiveness, as measured by diffusional flow integrity test, after continuous use repeated shocks of 89.9 psi (6.2 bar) at 151°F (66°C). The shower wand filters maintain microbial retention effectiveness, as measured by diffusional flow integrity test, after continuous use repeated shocks of 79.8 psi (5.5 bar) at 122°F (50°C).
The Ecolab POU Water Filters are provided sterile in sterile packaging. Testing according to ISO 11137-1 and ISO 11137-2, sterilization of health care products, verifies that the gamma irradiation process assures product sterility.
Package testing according to ISO 11607-1 and 11607-2, Packaging For Terminally Sterilized Medical Devices, has demonstrated that the packaging is capable of maintaining a sterile barrier for the labeled 36 month shelf life. Testing also verified that the filters retain their functional characteristics through 36 months.
Biocompatibility Testing Results
Biocompatibility of the Ecolab POU Water Filters was verified according the biocompatibility tests performed on devices after exposure to all manufacturing conditions and gamma sterilization. All biocompatibility testing was conducted in accordance to ISO 10993-5 and under GLP 21 CFR Part 58 Regulations:
| Biological Effect | Applicable EN ISO 10993 Standard |
|---|---|
| Cytotoxicity | Part 5: Tests for Cytotoxicity – In Vitro Methods |
| Irritation | Part 10: Tests for Sensitization and Irritation |
| Sensitization | Part 10: Tests for Sensitization and Irritation |
| Acute Systemic Toxicity | Part 11: Tests for Systemic Toxicity |
| Material Mediated Pyrogenicity | Part 11: Tests for Systemic Toxicity |
§ 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.