(273 days)
Not Found
No
The device description and performance studies focus on the physical filtration capabilities of the device and do not mention any computational or data-driven processes indicative of AI/ML.
No.
The device is a water filter intended for microbial retention in drinking water for infection control during procedures like superficial wound cleansing, cleaning equipment, and handwashing, but it is explicitly stated that it is "not intended for use in the production of USP sterile water for use in infusion, injection of fluids for use in dialysis treatments," which are typical applications for therapeutic devices. Its primary function is to provide cleaner water for external use or instrument cleaning, not to directly treat a medical condition or restore a biological function.
No
The device is a water filter designed for microbial retention, not for diagnosing medical conditions. It is used to control bacteria in water for purposes like wound cleansing, cleaning equipment, and handwashing, not to identify diseases or their causes.
No
The device description clearly states it is a physical filter made of Polyethersulfone (PES) membrane sealed in a polypropylene housing. It is designed to be installed as an attachment to faucets or shower heads, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to filter water to reduce microorganisms for purposes like hand-washing, bathing, showering, and instrument cleaning. This is a physical process applied to water, not a diagnostic test performed on a biological sample from a patient.
- Device Description: The device is a water filter designed to be attached to faucets or used as a shower head. This aligns with its function as a water treatment device, not a diagnostic tool.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) to diagnose a disease or condition.
- Performance Studies: The performance studies focus on the filter's ability to retain bacteria and maintain its integrity under various conditions, which are relevant to its function as a water filter. There are no studies related to diagnostic accuracy (sensitivity, specificity, etc.) in the context of patient diagnosis.
- Key Metrics: The key metric provided is "Bacteria Reduction," which is a measure of the filter's performance in removing microorganisms from water, not a diagnostic metric.
In summary, the ECOLAB POU Water Filters are designed to improve the microbial quality of water for various uses, not to diagnose medical conditions. Therefore, they do not fit the definition of an In Vitro Diagnostic device.
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 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.
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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
facility personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing: All ECOLAB POU Water Filters retained the test organism Brevundimonas diminuta challenge of >= 10' organisms/cm squared 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.
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 degrees F (66 degrees 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 degrees F (50 degrees 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
Not Found
§ 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 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);
1
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 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 Brevundimonas 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 | The NOSOGARD line of filters are | |
| intended to operate on EPA quality | ||
| drinking water sources as a microbial | ||
| retention filter. NOSOGARD filters are | ||
| available in models suitable for the | ||
| control of bacteria equal to or greater | ||
| in size than Brevundimonas diminuta | ||
| and models for microbial removal | ||
| equal to or greater than Legionella | ||
| pneumophila. The NOSOGARD is | ||
| suitable for general point of use | ||
| infection control for procedures such | ||
| as cleaning, rinsing of equipment, | ||
| hand washing and bathing where the | ||
| reduction of such microorganisms in | ||
| the water is desired. | ||
| The Nosogard is 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 | 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. | A disposable Polyethersulfone (PES) | |
| membrane filters sealed in a | ||
| polypropylene housing designed to be | ||
| installed by facility personnel at point | ||
| of use locations where the control of | ||
| bacteria in the drinking water supply is | ||
| desired for device cleaning, | ||
| handwashing and bathing | ||
| applications. These filters are designed | ||
| to be installed as attachments to | ||
| faucets or as a handheld shower head. | ||
| Feed Water | ||
| Source | SAME | Drinking water plumbing at point of |
| use. | ||
| Feed Water | ||
| Quality | SAME | Potable Water as defined by the EPA |
| National Primary DrinkingWater | ||
| Regulations (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 Inlet | ||
| Pressure | 89.9 psi (6.2 bar): tap filters | |
| 79.8 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 | |
| Bacteria | ||
| Reduction* | 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. Use
Days | Type | Inlet | Outlet |
|----------------|----------------------------------------------|------------------|----------------|------------------|--------|
| 6065845 | 7-Day Sterile Tap Filter
w/Spray Outlet | 7 | Tap | Quick
connect | Spray |
| 6065846 | 7-Day Sterile Tap Filter
w/Nozzle Outlet | 7 | Tap | Quick
connect | Nozzle |
| 6065702 | 31-Day Sterile Tap Filter
w/Spray Outlet | 31 | Tap | Quick
connect | Spray |
| 6065703 | 31-Day Sterile Tap Filter
w/Nozzle Outlet | 31 | Tap | Quick
connect | Nozzle |
| 6065704 | 31-Day Sterile Shower Wand
Filter | 31 | Shower
wand | 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 |