Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand

K182164 · Ecolab, Inc. · NHV · Mar 29, 2019 · Gastroenterology, Urology

Device Facts

• Record ID: K182164
• Device Name: Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand
• Applicant: Ecolab, Inc.
• Product Code: NHV · Gastroenterology, Urology
• Decision Date: Mar 29, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended 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 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 Story

Disposable polyethersulfone (PES) membrane filter in polypropylene housing; installed at point-of-use (faucets or shower wands) by facility personnel. Operates as a physical barrier to retain bacteria (Brevundimonas diminuta) from EPA-quality drinking water. Used for infection control in clinical settings (hand washing, bathing, equipment cleaning). Provides filtered water output to healthcare providers/patients. Benefits include reduced microbial exposure during clinical procedures. Single-use, sterile-supplied, non-resterilizable; 62-day maximum service life.

Clinical Evidence

Bench testing only. No clinical data. Performance verified via ASTM F838-15 bacterial retention testing (≥ 10^7 organisms/cm²), simulated use cyclic pulse testing, and diffusional flow integrity testing to confirm effectiveness over 62-day service life.

Technological Characteristics

Disposable PES pleated membrane filter in polypropylene housing. Dimensions/form factor: tap attachments or handheld shower wands. Connectivity: none. Sterilization: Gamma irradiation (ISO 11137-1/2). Standards: ASTM F838-15, ISO 10993-1, ISO 11607-1/2, ISO 14971.

Indications for Use

Indicated for use as a microbial retention filter on EPA quality drinking water sources for point-of-use infection control, including superficial wound cleansing, equipment cleaning, surgeon hand washing, and bathing. Suitable for controlling bacteria ≥ size of Brevundimonas diminuta. Not for production of USP sterile water for infusion, injection, or dialysis.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Ecolab POU Water Filters (K173164)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 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.

| Type of Use (Select <i>one</i> or <i>both</i> , as applicable) |
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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.<br>1 Ecolab Place<br>St Paul, MN 55102 USA<br>Establishment Registration Number: 9009921 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Charles Pouliot<br>VP Regulatory Affairs<br>Ecolab Inc.<br>1 Ecolab Place, St Paul, MN 55102 USA<br>Phone: [phone] |
| 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)<br>membrane filter sealed in a white polypropylene housing designed to<br>be installed by facility personnel at point of use locations where the<br>control of bacteria in EPA quality drinking water is desired for hand-<br>washing, bathing, showering and instrument cleaning applications.<br>These filters are designed to be installed as attachments to faucets or<br>as a handheld shower head attached to a water outlet. |
| Indications for Use: | The Ecolab POU Water Filters are intended to operate on EPA quality<br>drinking water sources as a microbial retention filter. Ecolab POU<br>Water Filters are suitable for the control of bacteria equal to or greater<br>in size than Brevundimons diminuta. The POU Filters are suitable for<br>general point of use infection control for procedures such as superficial<br>wound cleansing, cleaning of equipment, washing of surgeon's hands<br>and bathing where the reduction of such microorganisms in the water<br>is desired.<br>The Ecolab POU Filters are not intended for use in the production<br>of USP sterile water for use in infusion, injection or production of<br>fluids 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)<br>Number | K173164 | K182164 |
| Trade Name | Ecolab POU Water Filter | Same as predicate |
| Manufacturer | Ecolab Inc. | Same as predicate |
| Indications for<br>Use | The Ecolab POU Water Filters are intended to operate<br>on EPA quality drinking water sources as a microbial<br>retention filter. Ecolab POU Water Filters are suitable<br>for the control of bacteria equal to or greater in size<br>than Brevundimons diminuta. The POU Filters are<br>suitable for general point of use infection control for<br>procedures such as superficial wound cleansing,<br>cleaning of equipment, washing of surgeon's hands<br>and bathing where the reduction of such<br>microorganisms in the water is desired.<br>The Ecolab POU Filters are <b>not</b> intended for use in the<br>production of USP sterile water for use in infusion,<br>injection or production of fluids for use in dialysis<br>treatments. | There are no differences<br>between the subject<br>device and the predicate<br>device with respect to<br>indications and intended<br>use. |
| Device<br>Description | A disposable Polyethersulfone (PES) membrane filter<br>sealed in a white polypropylene housing designed to<br>be installed by facility personnel at point of use<br>locations where the control of bacteria in EPA quality<br>drinking water is desired for hand- washing, bathing,<br>showering and instrument cleaning applications. These<br>filters are designed to be installed as attachments to<br>faucets or as a handheld shower head attached to a<br>water outlet. | Same as predicate |
| Feed Water<br>Source | Drinking water plumbing at point of use. | Same as predicate |
| Feed Water<br>Quality | Potable Water as defined by the EPA National Primary<br>Drinking Water Regulations (EPA Quality Water) | Same as predicate |
| Useful Life | Up to 31 days depending on model | Up to 62 days |
| Maximum<br>Inlet Pressure | 89.9 psi (6.2 bar gauge): tap filters<br>79.8 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 |
| Filter<br>Element(s) | Polyethersulfone (PES) pleated membrane | Same as predicate |
| Bacteria<br>Reduction | 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<br>(REF) | Description | Max. Use<br>Days | Type | Inlet | Outlet |
|----------------|-------------------------------------------------|------------------|----------------|---------------|--------|
| 6065706 | 62-Day Sterile Tap Filter<br>with Spray Outlet | 62 | Tap | quick connect | Spray |
| 6065707 | 62-Day Sterile Tap Filter<br>with Nozzle Outlet | 62 | Tap | quick connect | Nozzle |
| 6065708 | 62-Day Sterile Shower Wand<br>Filter | 62 | Shower<br>wand | 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.