(231 days)
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.
§ 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.