Search Results

The EVOTECH® ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX® OPA Concentrate Solution and an enzymatic detergent (CIDEZYME XTRA) to achieve cleaning and high level disinfection of heat sensitive (>60°C) semi-critical endoscopes. Manual cleaning of medical devices (endoscopes) is not required prior to placement in the EVOTECH® ECR Endoscope Cleaner and Reprocessor System when selecting those cycles that contain a wash stage. (Manual cleaning of medical devices (endoscopes) is required when selecting the Disinfect only or Disinfect/Alcohol Flush Cycle.)

The EVOTECH® ECR Endoscope Cleaner and Reprocessor is a two-basin The washer/disinfector utilizing an enzymatic detergent and a concentrated high level disinfectant, CIDEX® OPA Concentrate Solution. Both the detergent and high level disinfectant are diluted in the system to in-use concentrations. The EVOTECH® ECR Endoscope Cleaner and Reprocessor is capable of cleaning endoscopes that have not been manually cleaned prior to placing in the system.

Here's a breakdown of the acceptance criteria and study information for the EVOTECH® ECR Endoscope Cleaner and Reprocessor, based on the provided text:

Important Note: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" discussed are largely in reference to meeting established standards and demonstrating performance comparable to previously cleared devices, rather than a novel, bespoke set of criteria for this specific submission's unique functionality. The "study" largely refers to a compilation of previous testing and new verification for the minor modification.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for a device with minor modifications (specifically, DCHP network capability), much of the performance data refers to studies conducted for previous iterations of the device (K040883, K061889, K140977). The "acceptance criteria" are derived from relevant FDA guidance and established standards for endoscope reprocessors.

Ask a specific question about this device

The EVOTECH® ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX® OPA Concentrate and an enzymatic detergent (CIDEZYME GI) to achieve cleaning and high level disinfection of heat sensitive (>60 0C) semi-critical endoscopes. Manual cleaning of medical devices (endoscopes) is not required prior to placement in the EVOTECH® ECR Endoscope Cleaner & Reprocessor when selecting those cycles that contain a wash stage. (Manual cleaning of medical devices (endoscopes) is required when selecting the Disinfect only or Disinfect/Alcohol Flush Cycle.)

The EVOTECH® ECR Endoscope Cleaner & Reprocessor is a two-basin washer/disinfector utilizing an enzymatic detergent and a concentrated high-level disinfectant, CIDEX OPA Concentrate Solution. Both the detergent and high-level disinfectant are diluted in the system to in-use concentrations. The EVOTECH® ECR Endoscope Cleaner & Reprocessor is capable of cleaning endoscopes that have not been manually cleaned prior to placing in the system.

Here's an analysis of the acceptance criteria and study information for the EVOTECH® ECR Endoscope Cleaner & Reprocessor, based on the provided text:

Important Note: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed, standalone clinical study report. Therefore, some information, particularly regarding specifics like effect sizes for human reader studies or detailed ground truth establishment for training sets, is not present because these types of studies (e.g., MRMC studies with human readers, or specific details about training data for an AI algorithm) are not relevant to the evaluation of a mechanical endoscope reprocessor. The device fundamentally automates a physical process, not an interpretive one involving human readers or AI algorithms for diagnostic purposes.

1. Table of Acceptance Criteria and Reported Device Performance

The study that proves the device meets the acceptance criteria is detailed across the "SUMMARY OF NONCLINICAL TESTS" section of the 510(k) summary. These studies were conducted to support the substantial equivalence of the EVOTECH® ECR Endoscope Cleaner & Reprocessor. The summary references prior clearances (K040883, K061889, K991487) which contained data supporting various aspects of the device's performance.

Here's the breakdown of other requested information:

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

• High-Level Disinfection (Simulated Use): Not explicitly stated, but "flexible endoscopes" were contaminated and tested. The data provenance is implied to be laboratory testing rather than real-world clinical data from a specific country.
• Cleaning Efficacy (Simulated Use): Not explicitly stated, but "endoscopes" were contaminated. The data provenance is implied to be laboratory testing.
• Sterility Testing (In-Use): "Endoscopes used in a clinical environment" were reprocessed. The exact number of endoscopes is not specified. Data provenance is "clinical environment," but specific country or retrospective/prospective nature is not detailed.
• Biocompatibility: "An endoscope reprocessed in the EVOTECH® ECR Endoscope Cleaner & Reprocessor" was evaluated. Sample size is at least one endoscope, potentially more for statistical relevance but not specified. Data provenance is laboratory testing.
• Material Compatibility: "Test articles" (materials commonly used in medical devices) were evaluated. The number of test articles is not specified. Data provenance is laboratory testing.
• Cleaning Efficacy (Clinical In-Use): "Endoscopes used in clinical procedures" were processed. Number not specified. Data provenance is "clinical procedures."
• Non-Inferiority Trial (Automated Wash vs. Manual Wash): Not explicitly stated, but implies a comparative study involving multiple endoscopes and conditions. Data provenance is laboratory/simulated environment.
• High-Level Disinfection (In-Use, Contaminated Endoscopes): "Endoscopes" were contaminated. Number not specified. Data provenance is laboratory testing.

Overall Data Provenance: The studies appear to be a mix of simulated-use (laboratory-based) and in-use (clinical environment) testing. The country of origin for the data is not specified in the provided text.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is generally not applicable to the evaluation of an endoscope reprocessor. The "ground truth" for this device's performance is established through objective, measurable laboratory tests (e.g., microbial reduction counts, residual protein/TOC levels, chemical concentration measurements) performed by microbiologists, chemists, and engineers, rather than through expert interpretation of images or clinical cases. Therefore, there were no "experts" in the sense of radiologists or other clinicians establishing ground truth for a test set.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation is based on objective measurements from laboratory and in-use tests, not subjective interpretations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI algorithms or diagnostic tools where human interpretation is involved. The EVOTECH® ECR is a mechanical cleaning and disinfecting device.

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

This is not applicable. The EVOTECH® ECR is not an algorithm or AI system. Its performance evaluation is inherently "standalone" in the sense that its efficacy for cleaning and disinfection is measured directly as a mechanical system.

7. The Type of Ground Truth Used

The ground truth used for these studies was primarily:

• Microbiological Counts: For disinfection studies, the ground truth was the initial and final counts of specific microorganisms (e.g., Mycobacterium terrae) on the endoscopes, determined through standard microbiological assays.
• Chemical/Biochemical Assays: For cleaning efficacy, the ground truth was the quantified level of residual soil (e.g., protein, total organic carbon) on the endoscope surfaces, measured using analytical chemistry techniques.
• Sterility Testing: For sterility, the ground truth was the absence of microbial growth based on culturing methods.
• Chemical Concentration Measurement: For disinfectant effectiveness, the ground truth included verifying minimum effective concentrations of the disinfectant.

8. The Sample Size for the Training Set

This information is not applicable because the device is a mechanical reprocessor, not an AI or machine learning algorithm that requires a "training set."

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

This information is not applicable for the reasons stated above.

Ask a specific question about this device