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 Ecolab 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.

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.

AI/ML Overview

This document describes the 510(k) premarket notification for the Ecolab POU Water Filter, which is a medical device. The document focuses on demonstrating substantial equivalence to a predicate device, rather than a de novo approval or an AI/ML powered device. As such, many of the requested criteria related to AI/ML device testing (e.g., training set size, human-in-the-loop studies, multi-reader multi-case studies, expert adjudication) are not applicable to this submission.

However, I can extract the information relevant to this medical device's performance and the testing conducted to support its claims.

Device Name: Ecolab POU Water Filter

Regulation Number: 21 CFR § 876.5665 (Water Purification System for Hemodialysis)

Product Code: NHV

Predicate Device: Ecolab POU Water Filters, K173164

Purpose of Submission: To demonstrate substantial equivalence of new Ecolab POU Water Filter models with a longer useful life (up to 62 days) to previously cleared 31-day models.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Functional Claim)	Reported Device Performance
Microbial Retention: Control of bacteria equal to or greater in size than Brevundimons diminuta. Prevention of bacterial grow-through over service life.	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 (up to 62 days) when tested according to ASTM F838-15.
Flow Rate (62-Day Tap Filters):	7 L/min at 3 bar gauge inlet pressure.
Flow Rate (62-Day Shower Filter):	11 L/min at 3 bar gauge inlet pressure.
Simulated Use Cyclic Pulse Testing (Tap Filters): Maintain microbial retention effectiveness after continuous use and repeated shocks.	Maintained microbial retention effectiveness (as measured by diffusional flow integrity test) after continuous use and repeated shocks of 6.2 bar gauge at 66°C.
Simulated Use Cyclic Pulse Testing (Shower Wand Filters): Maintain microbial retention effectiveness after continuous use and repeated shocks.	Maintained microbial retention effectiveness (as measured by diffusional flow integrity test) after continuous use and repeated shocks of 5.5 bar gauge at 50°C.
Sterility: Provided sterile in sterile packaging throughout its stated shelf life.	Verified by testing according to ISO 11137-1 and ISO 11137-2 (gamma irradiation process). Packaging testing according to ISO 11607-1 and 11607-2.
Biocompatibility: Materials are safe for use and free of harmful extractable or leachable chemicals.	Biocompatibility testing (previously provided in K173164) demonstrated safety.
Material Composition:	Polyethersulfone (PES) membrane, polypropylene housing, polypropylene prefilter.
Maximum Inlet Pressure:	Tap filters: 89.9 psi (6.2 bar gauge). Shower wands: 79.8 psi (5.5 bar gauge).
Useful Life (New Models):	Up to 62 days (specific models: 6065706, 6065707, 6065708).

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes for each test conducted (e.g., number of filters tested for bacterial retention, flow rates, or cyclic pulse testing). It refers to "All Ecolab POU Water Filters" undergoing the Brevundimons diminuta challenge.

Data Provenance: The tests appear to be conducted by the manufacturer (Ecolab) in a laboratory setting, likely in the US, as the company is based in St. Paul, MN, USA. The data is prospective, generated specifically for this 510(k) submission to demonstrate the performance of the new filter models.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable to the testing of a water filter's physical and microbial retention properties. The "ground truth" here is established by standardized test methods (e.g., ASTM F838-15) and laboratory measurements, not by human expert consensus or clinical interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This type of adjudication is relevant for studies involving human interpretation (e.g., radiologists interpreting medical images), not for objective physical and microbial performance testing of a water filter.

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

Not applicable. This device is a water filter, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical water filter, not an algorithm. The performance is "standalone" in the sense that the filter itself is tested, but there is no algorithm involved.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the device's performance is established by:

Standardized Test Methods: Specifically, ASTM F838-15 Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration for microbial retention.
Physical Measurements: Flow rates, pressure tolerance, and other engineering specifications.
Sterilization and Packaging Standards: ISO 11137-1, ISO 11137-2, ISO 11607-1, ISO 11607-2.
Biocompatibility Standards: ISO 10993-1.

These are objective, reproducible, and quantitative measurements based on established scientific and engineering principles, not subjective expert consensus or clinical outcomes data in the usual sense.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 29, 2019

Ecolab, Inc. Charles Pouliot VP Regulatory Affairs Healthcare 1 Ecolab Place St. Paul, MN 55102-2739

Re: K182164

Trade/Device Name: Ecolab POU Water Filter Regulation Number: 21 CFR§ 876.5665 Regulation Name: Water Purification System for Hemodialysis Regulatory Class: II Product Code: NHV Dated: February 27, 2019 Received: March 1, 2019

Dear Charles Pouliot:

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.

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.

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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,

Carolyn Y. Neuland -S

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) K182164

Device Name Ecolab POU Water Filter

Indications for Use (Describe)

The Ecolab 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.

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/1 description: The image shows the Ecolab logo. The logo is in blue and features the word "ECOLAB" in a bold, sans-serif font. The "O" in Ecolab is replaced with a stylized image of a starburst or a stylized flower. The logo is simple and modern.

510(k) Summary

Manufacturer:	Ecolab Inc.1 Ecolab PlaceSt Paul, MN 55102 USAEstablishment Registration Number: 9009921
Contact:	Charles PouliotVP Regulatory AffairsEcolab Inc.1 Ecolab Place, St Paul, MN 55102 USAPhone: (651) 250-2876
Date Prepared:	March 28, 2019
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:	Ecolab POU Water Filters, K173164
Device Description:	The Ecolab POU Water Filter is a disposable Polyethersulfone (PES)membrane filter sealed in a white polypropylene housing designed tobe installed by facility personnel at point of use locations where thecontrol 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 oras a handheld shower head attached to a water outlet.
Indications for Use:	The Ecolab POU Water Filters are intended to operate on EPA qualitydrinking water sources as a microbial retention filter. Ecolab POUWater Filters are suitable for the control of bacteria equal to or greaterin size than Brevundimons diminuta. The POU Filters are suitable forgeneral point of use infection control for procedures such as superficialwound cleansing, cleaning of equipment, washing of surgeon's handsand bathing where the reduction of such microorganisms in the wateris desired.The Ecolab POU Filters are not intended for use in the productionof USP sterile water for use in infusion, injection or production offluids for use in dialysis treatments.

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Image /page/4/Picture/1 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 in the upper right corner of the logo.

Substantial Equivalence Comparison Table
	Predicate Device	Subject Device
510(k)Number	K173164	K182164
Trade Name	Ecolab POU Water Filter	Same as predicate
Manufacturer	Ecolab Inc.	Same as predicate
Indications forUse	The Ecolab POU Water Filters are intended to operateon EPA quality drinking water sources as a microbialretention filter. Ecolab POU Water Filters are suitablefor the control of bacteria equal to or greater in sizethan Brevundimons diminuta. The POU Filters aresuitable for general point of use infection control forprocedures such as superficial wound cleansing,cleaning of equipment, washing of surgeon's handsand bathing where the reduction of suchmicroorganisms in the water is desired.The Ecolab POU Filters are not intended for use in theproduction of USP sterile water for use in infusion,injection or production of fluids for use in dialysistreatments.	There are no differencesbetween the subjectdevice and the predicatedevice with respect toindications and intendeduse.
DeviceDescription	A disposable Polyethersulfone (PES) membrane filtersealed in a white polypropylene housing designed tobe installed by facility personnel at point of uselocations where the control of bacteria in EPA qualitydrinking water is desired for hand- washing, bathing,showering and instrument cleaning applications. Thesefilters are designed to be installed as attachments tofaucets or as a handheld shower head attached to awater outlet.	Same as predicate
Feed WaterSource	Drinking water plumbing at point of use.	Same as predicate
Feed WaterQuality	Potable Water as defined by the EPA National PrimaryDrinking Water Regulations (EPA Quality Water)	Same as predicate
Useful Life	Up to 31 days depending on model	Up to 62 days
MaximumInlet Pressure	89.9 psi (6.2 bar gauge): tap filters79.8 psi (5.5 bar gauge): shower wands	Same as predicate
Sterile Device	Shipped in sterile condition and package	Same as predicate
Casing	Polypropylene	Same as predicate
FilterElement(s)	Polyethersulfone (PES) pleated membrane	Same as predicate
BacteriaReduction	Greater than 107	Same as predicate

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Image /page/5/Picture/1 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 stylized with a starburst design in the center. There is a registered trademark symbol to the right of the word.

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, bathing, showering and instrument cleaning applications. These filters are designed to be installed as attachments to faucets (Tap) or as a handheld shower wand) 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
6065706	62-Day Sterile Tap Filterwith Spray Outlet	62	Tap	quick connect	Spray
6065707	62-Day Sterile Tap Filterwith Nozzle Outlet	62	Tap	quick connect	Nozzle
6065708	62-Day Sterile Shower WandFilter	62	Showerwand	1/2" NPT	Shower

Ecolab POU Filter Models and Maximum Service Life Once Installed

The subject Ecolab POU Water Filters have the same intended use as the predicate device and are constructed of the same materials. Both the subject and predicate devices incorporate a polypropylene prefilter and polyethersulfone pleated filter membranes and utilize the same manufacturing processes. Biocompatibility testing (previously provided in K173164) demonstrates that all materials are safe for use in this application and are free of harmful extractable or leachable chemicals.

Subject devices are available in tap spray and nozzle outlet filter and shower wand filter configurations and have a useable maximum service life of up to 62-Days. Devices are supplied sterile in packaging capable of maintaining a sterile barrier for the labeled shelf life of twelve months.

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 Summary

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 Determining Bacterial Retention of Membrane Filters.

The 62-Day tap nozzle and spray filters, and shower filter flow rates at 3 bar gauge inlet pressure are 7L/min and 11L/min respectively.

Simulated Use Cyclic Pulse Testing demonstrates that the tap filters maintain microbial retention effectiveness, as measured by diffusional flow integrity test, after continuous use and repeated shocks of 6.2 bar gauge at 66°C. The 62-Day shower wand filters maintain microbial retention effectiveness, as measured by diffusional flow integrity test, after continuous use and repeated shocks of 5.5 bar gauge at 50°C.

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Image /page/6/Picture/1 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 stylized with a starburst design in the center. There is a registered trademark symbol next to the "B" in Ecolab.

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 was provided in the predicate filing K173164. The sterilization method and parameters used to sterilize the subject device are identical to the predicate.

Package testing according to ISO 11607-1 and 11607-2, Packaging For Terminally Sterilized Medical Devices, was provided previously in the predicate filing K173164. The subject packaging system is identical to the predicate.

Risk Assessment Summary

Hazards associated with design and development, verification and validation, and all manufacturing and sterilization processes, and use of the Ecolab POU Water Filters have been assessed under ISO 14971 and documented in the risk management file and related documents. The full product life cycle is also considered in the risk management plan.

The results of the residual risk assessment conclude that no additional actions are necessary with risk reduction and control actives having been completed. No risk was deemed unacceptable and the overall risk profile of the device was deemed to be low as all risks are mitigated under design control and ASTM testing.

Summary of Standards Utilized in the Design and Performance Evaluation of the subject Ecolab POU Water Filters

ASTM F838-15, 2015 Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration
ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
. ISO 11137-1:2006 Sterilization of health care products- radiation - part 1: requirements for development, validation and routine control of a sterilization process for medical devices
. ISO 11137-2:2013 Sterilization of health care products - radiation - part 2: Establishing the sterilization dose
ISO 11137-3:2006 Sterilization of health care products - radiation - Part 3: Guidance On Dosimetric Aspects ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements For Materials, Sterile Barrier Systems And Packaging Systems
ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation Requirements For Forming, Sealing And Assembly Processes
. ISO 13485: 2012 Medical devices – Quality Management Systems
ISO 14971: 2012 Medical Device – Application of risk management to medical devices

Summary of Substantial Equivalence:

The subject 62-Day Ecolab POU Water Filters are substantially equivalent to the predicate 31-Day Ecolab POU Water Filters (K173164) in their intended use, technical characteristics and performance as verified by non-clinical testing.

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.