(231 days)
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No
The document describes a physical water filter and its performance in retaining bacteria. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No.
The device is a water filter intended for infection control by reducing microorganisms in water used for general purposes like handwashing, bathing, and cleaning equipment, not for direct therapeutic treatment of a disease or condition.
No
The device is a water filter designed to remove bacteria from water, not to diagnose a condition or disease in a patient. Its purpose is infection control by providing clean water.
No
The device description clearly states it is a physical filter made of Polyethersulfone (PES) membrane sealed in a polypropylene housing, designed to be installed as attachments to faucets or shower heads. This is a hardware device.
Based on the provided information, the Ecolab POU Water Filters are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to filter water for procedures like wound cleansing, equipment cleaning, hand washing, and bathing. This is a physical process of removing microorganisms from water, not a diagnostic test performed on a biological sample (like blood, urine, or tissue) to diagnose a disease or condition.
- Device Description: The device is a physical filter designed to be attached to water outlets. It doesn't involve any reagents, assays, or analysis of biological samples.
- Performance Studies: The performance studies focus on the filter's ability to retain bacteria and maintain flow rate and integrity under stress. These are performance characteristics of a water filter, not diagnostic accuracy metrics.
- Key Metrics: The key metric is "Bacteria Reduction: Greater than 107", which describes the filter's efficiency in removing bacteria from water, not a diagnostic measurement.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Ecolab POU Water Filters do not fit this definition. They are a water filtration device for infection control purposes.
N/A
Intended Use / Indications 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 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.
Product codes (comma separated list FDA assigned to the subject device)
NHV
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.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
facility personnel / point of use locations
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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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.
1
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
2
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 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 Place
St Paul, MN 55102 USA
Establishment Registration Number: 9009921 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Charles Pouliot
VP Regulatory Affairs
Ecolab Inc.
1 Ecolab Place, St Paul, MN 55102 USA
Phone: (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 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. |
| Indications 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 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. |
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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 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 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. | There are no differences | |
| between the subject | ||
| device and the predicate | ||
| device with respect to | ||
| indications and intended | ||
| use. | ||
| Device | ||
| Description | 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. | Same as predicate | |
| Feed Water | ||
| Source | Drinking water plumbing at point of use. | Same as predicate |
| Feed Water | ||
| Quality | Potable Water as defined by the EPA National Primary | |
| Drinking Water Regulations (EPA Quality Water) | Same as predicate | |
| Useful Life | Up to 31 days depending on model | Up to 62 days |
| Maximum | ||
| Inlet Pressure | 89.9 psi (6.2 bar gauge): tap filters | |
| 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 | ||
| Element(s) | Polyethersulfone (PES) pleated membrane | Same as predicate |
| Bacteria | ||
| 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
(REF) | Description | Max. Use
Days | Type | Inlet | Outlet |
|----------------|-------------------------------------------------|------------------|----------------|---------------|--------|
| 6065706 | 62-Day Sterile Tap Filter
with Spray Outlet | 62 | Tap | quick connect | Spray |
| 6065707 | 62-Day Sterile Tap Filter
with Nozzle Outlet | 62 | Tap | quick connect | Nozzle |
| 6065708 | 62-Day Sterile Shower Wand
Filter | 62 | Shower
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.