Search Results

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

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.

Ask a specific question about this device

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

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.

Ask a specific question about this device

The ORS-3000LD is an equipment cover for the ORS-1075LD Hush-Slush®machine. This is a single use product supplied sterile. This device is intended to be used during various surgeries where slush and/or cold solution is required.

The ORS-1000LD Leak Detection Drape is an equipment cover for the ORS-2000LD Solution Warmer. This is a single use product supplied sterile. This device is intended for use during various surgeries where warm irrigation solution is required.

The ORS Fluid Warming and Slush Drapes are sterile, single-use equipment covers intended for use during various surgeries where warm irrigation, slush and/or cold solution is required. The ORS Fluid Warming drapes consist of a polyurethane film base material manufactured to protect ORS surgical fluid warming consoles. The ORS Surgical Slush drapes consist of a polyurethane film base secured to a polycarbonate disc or plate manufactured to protect ORS surgical slush machines from contamination during various procedures throughout the clinical setting.

The ORS Fluid Warming and Slush Drapes come in a variety of sizes and shapes specifically designed for safe use and proper fit on ORS Fluid Warming Consoles and Slush Machines.

Here's a breakdown of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text.

Important Note: The provided document is a 510(k) Pre-market Notification for a medical device (ORS Fluid Warming and Slush Drapes). It focuses on demonstrating substantial equivalence to predicate devices, particularly regarding a change in packaging. This means the study described is primarily focused on validating the packaging change and its impact on the device's performance, rather than a de novo validation of device performance itself. It does not contain information typically found in studies for AI/algorithm-based medical devices (e.g., MRMC studies, ground truth establishment by experts for AI, training set details). Therefore, many of the requested points related to AI/algorithm performance (e.g., effect size for human readers with AI assistance, independent algorithm performance, expert qualifications for ground truth) are not applicable to this document.

1. Table of Acceptance Criteria and Reported Device Performance

This table summarizes the design verification testing results presented in Table 5-2 of the document.

Note on Temperature Failures: The document explains that although the temperature results for pre-conditioning and gas dwell did not strictly meet the protocol's acceptance criteria, it was determined the criteria were inappropriate for the assessment. The performance was deemed acceptable because temperature penetration into the new packaging was comparable to the incumbent packaging, avoiding an adverse impact on sterility assurance.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set:

  • EO Residuals: ORS-321 (flat pack; 24/case) - Implies testing on a representative sample from this lot size.
  • Seal Strength (various tests): 15 samples for each of the "Pre Seal Current," "Post Seal Current," "Pre Seal New," and "Post Seal New" tests.
  • Sterilization Cycle Comparison: ORS-321 (file pack; 24/case) - Implies representative samples.
  • ISO 11607-1 Transport Challenge & Package Integrity Testing (ORS-301): 3 samples for the initial transport challenge, and 22 samples for each of the dye penetration, bubble emission, and seal strength tests.
  • ISO 11607-1 Transport Challenge & Package Integrity Testing (ORS-321): 3 samples for the initial transport challenge, and 22 samples for each of the dye penetration, bubble emission, and seal strength tests.
  • Packaging Shelf Life Assessment: POU708 & POU709 Header Bags (assessment, not direct testing on specific number of samples for results).
  • Biocompatibility Assessment: POU708 Header Bag (assessment, not direct testing on specific number of samples for results).

• Data Provenance: The document does not specify the country of origin for the data. The testing appears to be internal verification and validation testing performed by Ecolab, Inc., for a 510(k) submission to the FDA (USA). The studies are inherently prospective in nature, as they involve testing conducted specifically to validate a manufacturing or design change (changing the packaging configuration).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This document describes design verification and validation testing for a physical medical device (equipment covers) and a change in its packaging. It does not involve an AI/algorithm where "ground truth" related to expert interpretations (e.g., radiology reads) would be established. Therefore, this section is Not Applicable.

4. Adjudication Method for the Test Set

This document describes physical and chemical testing (tensile strength, dye penetration, sterilization cycle parameters, etc.). "Adjudication methods" like 2+1 or 3+1 are typically used in clinical studies involving multiple human readers for diagnostic interpretation. Therefore, this section is Not Applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was Not Applicable and therefore not done. This type of study is relevant for AI-powered diagnostic devices where human readers' performance with and without AI assistance is evaluated. This document pertains to sterile equipment covers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This document does not involve an algorithm. Therefore, this section is Not Applicable.

7. The Type of Ground Truth Used

For this device and the tests performed, the "ground truth" is established by:

• Engineering specifications and standards: e.g., minimum seal strength, maximum EO residuals, temperature/RH requirements for sterilization, and compliance with ASTM and ISO standards (e.g., ISO 14971, ISO 10993-7, ISO 11607-1, ASTM D4169-14, ASTM F3039-13, ASTM F1929-12, ASTM F2096-11, ASTM F88-09).
• Laboratory measurements and observations: The quantitative results from the tests (e.g., 2.9 mg EO, 15 of 15 passes for seal strength, observed lack of dye penetration).
• Prior predicate device performance: The basis for demonstrating substantial equivalence is that the new packaging performs comparably to the previously cleared packaging, without raising new questions of safety or effectiveness.

This is not a clinical "ground truth" derived from expert consensus, pathology, or outcomes data in the sense used for diagnostic algorithms.

8. The Sample Size for the Training Set

This document does not describe the development or testing of an AI/algorithm, and thus there is no "training set" in this context. Therefore, this section is Not Applicable.

9. How the Ground Truth for the Training Set was Established

As explained above, there is no AI/algorithm and no training set involved. Therefore, this section is Not Applicable.

Ask a specific question about this device

The IntraTemp Solution Warmer (ITW6L) is designed to warm and maintain the temperature of surgical solutions prior to their use.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding the "IntraTemp™ Solution Warmer, Model ITW6L." This document establishes that the device has been found substantially equivalent to a predicate device, allowing it to be marketed.

However, the provided text does not contain the specific information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. These details are typically found in the manufacturer's 510(k) submission summary, which is a separate document detailing the technical and performance data used to support the substantial equivalence claim.

Therefore, I cannot populate the table or answer the specific questions because the necessary information is not present in the provided FDA letter. The letter is an approval notification, not a technical performance report.

Ask a specific question about this device

The ORS pillow drape is a single-use disposable device intended for use as an accessory for ORS Solution Warmers which is designed to hold the optical end of various endoscopes above the warm solution to prevent fogging or wetting of the scope eyepiece.

The following model(s) are included: ORS-400 and ORS-400N

The ORS-400N Scope Pillow™ Warmer Drape is a single-use disposable device provided non-sterile to secondary processors, who then package, label and sterilize the device. The Scope Pillow Warmer Drape is an accessory/equipment drape for use with the ORS-2057 Irrigation Solution Warming System which is designed to both protect ORS surgical fluid warmers from contamination during various procedures as well as hold the optical end of various endoscopes above the warm solution to prevent fogging or wetting of the scope eyepiece.

The drape material is the identical polyurethane film that is used on all standard ORS Warmer Drapes (K021288). A soft polyurethane foam pillow is integrated within the polyurethane drape and has no direct or indirect patient contact. The pillow (endoscope holder) is designed to provide stable positioning of scope(s) during warming and prevents one or more scopes from rolling or tipping while the scope rests in the fluid warmer during the procedure (Figure 5-1).

The ORS-400 and ORS-400N model drapes are identical with the exception of how they are packaged and labeled. The ORS-400 model consists of drapes individually packaged in labeled peel pouches or header bags which are stacked inside a double poly-lined corrugate case with Instructions for Use (IFU) insert and sterilized by an Ecolab subcontractor before it is released for sale. The ORS-400N model consists of the identical drapes which are individually wrapped in a poly tie secured by a product ID label and stacked inside a double poly-lined corrugate case with IFU insert that does not get sterilized before it is released for sale to kit packer customers. The IFU insert differs between the two models in that the ORS-400N contains sterilization instructions for kit packer customers to evaluate their sterilization process as it applies to placing the product in their commercial procedure kits.

NOTE: Both device models are designed and intended to be used by clinical staff in sterile condition.

The provided text describes the acceptance criteria and study for the ORS Scope Pillow Warmer Drape. This device is an accessory designed to protect surgical fluid warmers and hold endoscope eyepieces above warm solution to prevent fogging or wetting.

Here is the requested information:

1. Table of Acceptance Criteria and the Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific sample sizes for the "test set" for each individual requirement. However, it indicates Validation & Verification (V&V) testing was performed, and the results were documented in VVR-14-0002 V&V Summary Report, Project 8 Track, and Packaging Engineering Report # REPT-18430. The nature of the tests (visual inspections, dimensional checks, simulated distribution) suggests that the testing was prospective, conducted specifically for this regulatory submission. Country of origin of the data is not specified, but the submitter is Ecolab, Inc., located in St. Paul, MN, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This device is an equipment cover/accessory, not a diagnostic imaging device. Therefore, the concept of "experts" establishing ground truth for performance metrics (like dimensional requirements, drape integrity, packaging, and labeling) is not applicable in the same way it would be for a medical AI device interpreting images. The assessment appears to be based on engineering specifications and visual inspections rather than expert clinical interpretation. The document does not mention the use of experts in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation of medical data (e.g., radiology reads) where discrepancies need to be resolved. For the performance tests described (visual inspections, dimensional requirements, packaging integrity), this type of adjudication method is not relevant. The document does not suggest any formal adjudication process was used.

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

No MRMC comparative effectiveness study was done. This device is a passive accessory and does not involve AI or human readers for interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No standalone algorithm performance study was done. This device is a physical accessory and does not involve any algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the device's performance is based on its engineering specifications and physical characteristics. For functional and packaging requirements, the ground truth is whether the device meets the predefined dimensional requirements, remains intact, has correct packaging counts, maintains fold integrity, and withstands distribution stress as per the specified methods (e.g., visual inspection, ASTM D4169-09). For labeling, the ground truth is adherence to specific label designs and content. These are objective criteria rather than subjective expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This device is a physical product, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established

As there is no training set for an AI/ML algorithm, this question is not applicable.

Ask a specific question about this device

The ORS drape is a single-use equipment cover intended for use during various surgeries where warm irrigation, slush and/or cold solution is required.

The Non-Sterile ORS Warming and Slush Drapes are single-use equipment covers intended for use during various surgeries where warm irrigation, slush and/or cold solution is required. These equipment drapes consist of a polyurethane film base material manufactured to protect ORS surgical fluid warmers and slush machines from contamination during various procedures throughout the clinical setting.

These equipment drapes come in a variety of sizes and shapes to allow the device to properly fit ORS surgical fluid warmers and slush machines.

The provided text describes a 510(k) summary for "Non-Sterile ORS Warming and Slush Drapes." This submission is for a medical device (equipment cover) and not an AI/ML-driven device. Therefore, many of the requested elements pertaining to AI model performance, expert review, training sets, and statistical studies are not applicable.

However, I can extract the acceptance criteria and performance data as presented for this medical device from the "Performance Data Summary" table (Table 5-2).

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the other requested information, they are not applicable as this is a traditional medical device, not an AI/ML product:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• The document mentions "Representative drapes were chosen to cover all drape types" for functional testing. It also refers to "VVR-14-0002 V&V Summary Report, Project 8 Track" and "PKG 001F" and "REPT-18430" which suggests internal validation and verification testing. Specific sample sizes for each test are not provided in this summary. Data provenance (country of origin, retrospective/prospective) is not mentioned, but is likely internal testing by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not applicable. The "ground truth" for this device is based on physical specifications, visual inspection according to engineering drawings and internal reports, and adherence to ASTM standards for packaging. There is no indication of expert interpretation, as would be required for diagnostic AI devices.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable. The tests involve objective measurements, visual inspections, and adherence to specifications, not subjective expert reviews requiring adjudication.

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 an equipment cover, not a diagnostic AI tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The ground truth for this device's performance relies on adherence to engineering drawings, visual inspection criteria, and industry-standard physical testing methods (e.g., ASTM D4169-09 for distribution testing).

8. The sample size for the training set

• Not applicable. This is not an AI/ML device where a training set is used.

9. How the ground truth for the training set was established

• Not applicable. There is no training set for this device.

Ask a specific question about this device