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510(k) Data Aggregation
(231 days)
Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter
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.
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.
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.
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(273 days)
Ecolab POU Water Filter
The ECOLAB POU Water Filters are intended to operate on EPA quality drinking water sources as a microbial retention filter. ECOLAB POU Water Filters are suitable for the control of bacteria equal to or greater in size than Brevundimons diminuta. The POU Filters are suitable for general point of use infection control for procedures such as superficial wound cleansing, cleaning of equipment, washing of surgeon's hands and bathing where the reduction of such microorganisms in the water is desired.
The POU Filters are not intended for use in the production of USP sterile water for use in infusion, injection of fluids for use in dialysis treatments.
The Ecolab POU Water Filter is a disposable Polyethersulfone (PES) membrane filter sealed in a white polypropylene housing designed to be installed by facility personnel at point of use locations where the control of bacteria in EPA quality drinking water is desired for hand- washing, bathing, showering and instrument cleaning applications. These filters are designed to be installed as attachments to faucets or as a handheld shower head attached to a water outlet.
The request is about a water filter, not an AI/ML medical device. Therefore, questions 2, 3, 4, 5, 8, and 9 are not applicable to this document. The document describes a traditional medical device (water filter) and its performance characteristics, not an algorithm, so terms like "ground truth," "training set," "test set," and "human-in-the-loop" performance are not relevant.
However, I can extract information related to acceptance criteria and performance studies for the Ecolab POU Water Filter based on the provided text.
Here's the information derived from the provided document, addressing the relevant parts of your request:
Device: Ecolab POU Water Filter (K173164)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Target (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Microbial Retention (against Brevundimonas diminuta) | Suitable for control of bacteria equal to or greater in size than Brevundimonas diminuta. | All Ecolab POU Water Filters retained the test organism Brevundimonas diminuta challenge of ≥ 10^7^ organisms/cm² and prevented bacterial grow-through over the service life of each model. This meets the predicate device's > 10^7^ bacteria reduction. |
| Filter Flow Rate (at 3 bar inlet pressure) | Not explicitly stated as an "acceptance criterion" with a specific numerical target, but flow rates are a performance characteristic. | 7-Day tap filter: 6.3 L/min |
| 14-Day tap filter: 6.5 L/min | ||
| 31-Day tap filters: 6 L/min | ||
| Maintenance of Microbial Retention Effectiveness after Cyclic Pulse Testing (Tap Filters) | Maintain microbial retention effectiveness after continuous use repeated shocks of 89.9 psi (6.2 bar) at 151°F (66°C). | Maintained microbial retention effectiveness (as measured by diffusional flow integrity test) after continuous use repeated shocks of 89.9 psi (6.2 bar) at 151°F (66°C). |
| Maintenance of Microbial Retention Effectiveness after Cyclic Pulse Testing (Shower Wand Filters) | Maintain microbial retention effectiveness after continuous use repeated shocks of 79.8 psi (5.5 bar) at 122°F (50°C). | Maintained microbial retention effectiveness (as measured by diffusional flow integrity test) after continuous use repeated shocks of 79.8 psi (5.5 bar) at 122°F (50°C). |
| Sterility | Assure product sterility. | Verified that the gamma irradiation process assures product sterility (according to ISO 11137-1 and ISO 11137-2). |
| Package Integrity (to maintain sterile barrier) | Capable of maintaining a sterile barrier for the labeled shelf life. | Demonstrated that the packaging is capable of maintaining a sterile barrier for the labeled 36-month shelf life (according to ISO 11607-1 and 11607-2). |
| Retention of Functional Characteristics (through shelf life) | Retain functional characteristics through shelf life. | Verified that the filters retain their functional characteristics through 36 months. |
| Biocompatibility | Satisfy biocompatibility requirements for the intended use (cytotoxicity, irritation, sensitization, acute systemic toxicity, material-mediated pyrogenicity). | All biocompatibility testing was conducted in accordance with ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Irritation, Sensitization), and ISO 10993-11 (Acute Systemic Toxicity, Material Mediated Pyrogenicity) under GLP 21 CFR Part 58 Regulations. The document states "Biocompatibility of the Ecolab POU Water Filters was verified," implying successful completion and meeting of criteria for all listed tests. |
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical water filter, not an algorithm. The "performance" assessment is based on the filter's physical and biological filtration capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this physical device, "ground truth" equates to laboratory testing against established standards and known microbial challenges.
- Microbial Retention: The "ground truth" was the Brevundimonas diminuta challenge ≥ 10^7^ organisms/cm², with the effectiveness judged by the absence of bacterial grow-through. This is a direct measurement of the device's capability.
- Sterility: The "ground truth" for sterility was verification against ISO 11137-1 and ISO 11137-2 standards for sterilization processes.
- Package Integrity: The "ground truth" for package integrity was verification against ISO 11607-1 and 11607-2 standards.
- Biocompatibility: The "ground truth" for biocompatibility was verification against ISO 10993 series standards and GLP 21 CFR Part 58 Regulations.
There are no concepts of "training sets" or "ground truth establishment" for a training set as would apply to machine learning models. The tests were performed to directly demonstrate the specified physical and biological performance characteristics of the manufactured device.
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