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.

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

The document refers to multiple studies conducted for prior versions of the device, making it difficult to extract a single "test set" and provenance for this specific 510(k). However, based on the descriptions:

• Simulated Use Testing for Disinfection (K040883 & K140977): The number of endoscopes or channels tested for the log reduction of Mycobacterium terrae is not explicitly stated as a number (e.g., "N=X"). Similarly, the provenance (country) is not specified, but these are generally conducted in a controlled lab environment. This would be considered prospective for the original studies.
• In-Use Clinical Testing for Disinfection (K040883): It mentions "endoscopes used in a clinical environment" were reprocessed and sterility tested. No specific number ("N") is provided. The provenance is not specified. This would be prospective data collection.
• Cleaning Efficacy (K061889): Mentions "endoscopes were contaminated" and "clinically used endoscopes" were processed. No explicit sample size (N) is given for either the simulated or clinical cleaning studies. Provenance not specified. This would be prospective data collection for those specific cleaning studies.
• Duodenoscope Cleaning and Disinfection (K152189 summary): Tested Olympus, Pentax, and Fujinon duodenoscopes. The number of each type or total number of endoscopes is not specified. This suggests multiple units were tested to cover device variations. Provenance not specified, likely lab-based prospective studies.

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

The ground truth in these studies is primarily based on microbiological testing (colony counts for Mycobacterium terrae), chemical analysis (residual protein, TOC, OPA), and physical observations (sterility). These types of ground truth are established by laboratory procedures and measurements, not typically by human expert consensus or adjudication in the medical imaging sense. Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth is not directly applicable to this type of device testing, which relies on objective, measurable scientific parameters.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective interpretation, such as image analysis for disease detection. For device performance evaluations like cleaned surfaces, disinfection efficacy, or chemical residue, the "ground truth" is determined by direct measurement against established quantitative thresholds or qualitative observations by trained laboratory personnel/standardized assays, rather than a consensus or adjudication among multiple expert reviewers. So, none in the traditional sense.

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, an MRMC comparative effectiveness study was not done. This type of study (AI assistance for human readers) is relevant for diagnostic AI tools that aid human interpretation. The EVOTECH® ECR Endoscope Cleaner and Reprocessor is an automated cleaning and disinfection device; it does not involve human "readers" or "AI assistance" in its operation or the assessment of its output in a diagnostic context.

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

The device itself is a standalone automated system. The performance data presented (disinfection efficacy, cleaning efficacy, residual levels) directly represent the standalone performance of the EVOTECH® ECR Endoscope Cleaner and Reprocessor as an algorithm-controlled machine, without human intervention during the reprocessing cycle itself (beyond loading and selecting the cycle).

7. The Type of Ground Truth Used

The types of ground truth used were primarily:

• Microbiological Culture/Counts: For disinfection efficacy (e.g., Mycobacterium terrae log reduction, sterility testing).
• Chemical Analysis: For cleaning efficacy (quantification of residual protein, total organic carbon, hemoglobin) and biocompatibility (OPA residual levels).
• Physical Observation/Measurement: For material compatibility (assessing effects on materials).
• Compliance with Standards: For electrical safety and EMC.

8. The Sample Size for the Training Set

This document describes a medical device, not an AI/ML algorithm that requires a "training set" in the conventional machine learning sense for its core function. The software component mentioned (for DHCP network connectivity) would have undergone standard software development, verification, and validation, rather than "training" using a specific dataset. Therefore, the concept of a "training set sample size" as typically understood for AI models is not applicable to this device.

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

As mentioned above, the concept of a "training set" and its associated ground truth is not applicable to this device's regulatory submission, which focuses on hardware and software (for control and networking) function rather than a machine learning model's performance on a training dataset. The "ground truth" for verifying the software related to network connectivity would be established through functional testing against specified requirements and network protocols.

Ask a specific question about this device