(273 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 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.
§ 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.