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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.

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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.

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The EvoTech System, a washer / disinfector, is indicated for use with the high level disinfectant CIDEX® OPA Concentrate, (MEC of 0.055%, minimum temperature of 50°C for a contact time of 5 minutes) for reprocessing heat sensitive (

The EvoTech™ System is a two-basin washer / disinfector utilizing a concentrated high-level disinfectant (CIDEX® OPA Concentrate – K032959) that is diluted within the system to an In-Use concentration. The system performs a leak test, a block test, pre-rinse, wash, disinfect, rinse, and alcohol flush on the endoscope being reprocessed. The disinfection temperature is 50-55°C. The In-Use disinfectant is discarded after each use by the system.

The provided document describes the safety and effectiveness summary for the EvoTech™ Integrated Endoscope Disinfection System. This device is a washer/disinfector intended for reprocessing flexible endoscopes.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

In Use Testing: "Sterility testing demonstrated no growth" when endoscopes used in a clinical environment were reprocessed in the EvoTech System without manual cleaning. This implies successful high-level disinfection. |
| Biocompatibility/Residual Levels | The level of OPA residual remaining on an endoscope should not cause toxic effects in humans. | Analysis indicated that "the level of OPA residual remaining on an endoscope is not likely to cause toxic effects in humans." |
| Material Compatibility | Minimal effect on materials commonly used in medical devices after multiple disinfection cycles over extended periods. | "Multiple disinfection cycles over extended periods of time resulted in minimal effect on the test articles. The effects seen were similar to those seen with the predicate device for the high level disinfectant - CIDEX OPA Solution K991487." |
| Predicate Equivalence | Device demonstrates substantial equivalence to the legally marketed predicate device (Medivators DSD-91 Disinfector K914145). | The overall conclusion states: "The data presented and the equivalence demonstrated to the predicate device support the claim of substantial equivalency for the EvoTech System." The material compatibility effects were explicitly stated to be similar to the predicate device. |

2. Sample size used for the test set and the data provenance

• Sample Size for Simulated Use Testing: Not explicitly stated how many endoscopes or samples were used for the Mycobacterium terrae reduction study.
• Sample Size for In Use Testing: Not explicitly stated how many clinical endoscopes were used for the sterility testing.
• Sample Size for Biocompatibility Testing: Not explicitly stated how many endoscopes were tested for OPA residual levels.
• Sample Size for Material Compatibility: Not explicitly stated how many material samples or endoscope types were tested.
• Data Provenance: The document does not specify the country of origin for the data. The data appears to be from laboratory and "in-use" (clinical environment) studies conducted for regulatory submission. It is prospective in nature as it details studies conducted to support the device's efficacy and safety.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not applicable to this type of device submission. The efficacy of a washer/disinfector is typically established through microbiological testing (e.g., Log reduction) and chemical analysis, not through expert consensus on diagnostic images or clinical assessments by a panel of human experts.
• The "ground truth" for disinfection efficacy is objective microbiological results (e.g., bacterial culture, spore count reduction).

4. Adjudication method for the test set

• This information is not applicable as there is no human interpretation or subjective assessment that would require an adjudication method. The testing involves objective measurements like microbial counts, chemical residue levels, and material degradation.

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 is relevant for diagnostic imaging AI systems where human readers interpret medical images. The EvoTech™ System is a medical device for reprocessing flexible endoscopes, not an AI for image interpretation.

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

• This question is not applicable in the context of the EvoTech™ System. While the system automates the disinfection process, it's a physical device and not a standalone algorithm in the sense of an AI performing a diagnostic task. The "performance" of the device is its ability to effectively disinfect, which is evaluated through the studies described. The device itself operates "without human-in-the-loop" once programmed for a cycle, but it doesn't involve an "algorithm only" in the AI sense.

7. The type of ground truth used

• Microbiological Ground Truth: For disinfection efficacy, the ground truth was established by demonstrating a specific reduction in a test microorganism (Mycobacterium terrae) and by showing "no growth" in sterility testing of clinically used endoscopes.
• Chemical Analysis Ground Truth: For biocompatibility, the ground truth was derived from chemical analysis to quantify OPA residuals and assess their potential toxicity.
• Material Science Ground Truth: For material compatibility, the ground truth involved assessing the physical and structural integrity of materials after exposure to the reprocessing cycles.

8. The sample size for the training set

• This concept is not applicable to a medical device like the EvoTech™ System, which is a physical washer/disinfector rather than an AI or machine learning algorithm that requires a "training set" of data.

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

• This question is not applicable as there is no "training set" for this type of device.

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CIDEX® OPA Solution is a high level disinfectant for reprocessing heat sensitive medical devices, for which sterilization is not suitable, and when used according to the Directions for Use.

Manual Processing: High Level Disinfectant at a minimum of 20℃ (68°F): CIDEX® OPA Solution is a high level disinfectant when used or reused, according to the Directions for Use, at or above its Minimum Effective Concentration (MEC) as determined by CIDEX® OPA Solution Test Strips, with an immersion time of at Jeast 12 minutes for a reuse period not to exceed 14 days.

Automatic Endoscope Reprocessors that can be set to 25°C: High Level Disinfectant at a minimum of 25°C (77°F): CIDEX® OPA Solution is a high level disinfectant when used or reused in a legally marketed automatic endoscope reprocessor (that can be set to 25°C) according to the Directions for Use, at or above its Minimum Effective Concentration (MEC) as determined by CIDEX® OPA Solution Test Strips, with an immersion time of at least 5 minutes for a reuse period not to exceed 14 days.

Minimum Effective Concentration (MEC): 0.3%.

Note: If your AER cannot be set to a minimum of 25°C please follow the time and temperature stated in Indications for Use, Manual Processing.

CIDEX® OPA Solution is formulated to contain 0.55% w/v of ortho-phthalaldehyde. The resultant solution contains a corrosion inhibitor, chelating agents, and a dye in a phosphate buffer. ortho-Phthalaldehyde is chemically related to glutaraldehyde in that they are both aldehydes. The mechanism of ortho-phthalaldehyde is postulated to be similar to glutaraldehyde and is based on powerful binding of the aldehyde to the outer cell wall of the organism.

The provided document describes the 510(k) summary for CIDEX® OPA Solution, a liquid chemical germicide, and its efficacy testing. Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Note: The document specifies the efficacy testing was performed with reused CIDEX® OPA Solution at concentrations at or below the MEC of 0.3% for a 5-minute cycle at 25°C. The "acceptance criteria" here are inferred from the types of efficacy and safety tests mandated for such devices to obtain market clearance.

2. Sample size used for the test set and the data provenance

The document does not explicitly state the specific "sample size" in terms of number of devices or number of tests for the efficacy studies. It mentions efficacy testing was performed using a disinfection cycle of 5 minutes at 25°C with reused CIDEX® OPA Solution, and data was generated on the microbiological efficacy.

The data provenance is not explicitly detailed regarding its country of origin. The submission is a 510(k) to the FDA, implying the tests were conducted to meet US regulatory requirements, likely by or for the manufacturer (Advanced Sterilization Products, located in Irvine, CA). The studies appear to be prospective as they were conducted specifically to demonstrate the product's efficacy for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. For a liquid chemical germicide, the "ground truth" for efficacy is typically based on standardized microbiological testing protocols against specified microorganisms, rather than expert judgment on individual "cases" in the way an AI model for medical imaging would.

4. Adjudication method for the test set

This information is not applicable and not provided for this type of device and study. Adjudication methods like 2+1 or 3+1 are relevant for studies involving human interpretation of data, typically in diagnostic imaging or clinical trials where multiple readers assess outcomes and discrepancies need to be resolved. This document describes efficacy testing of a chemical disinfectant.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools that involve human interpretation. CIDEX® OPA Solution is a disinfectant, and its efficacy is determined through laboratory microbiological testing, not human reader performance.

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

Yes, the efficacy testing described is implicitly a standalone performance evaluation of the chemical disinfectant itself. The "algorithm" here is the chemical formulation and its interaction with microorganisms under specific conditions (5 minutes at 25°C, 0.3% MEC). There is no "human-in-the-loop" once the disinfection cycle is initiated; the chemical acts independently.

7. The type of ground truth used

The ground truth used for this study is based on microbiological efficacy against target organisms (sporicidal and mycobactericidal activity) measured in laboratory settings according to established disinfectant testing standards. This is equivalent to "outcomes data" in a very specific sense, where the outcome is the inactivation or killing of microorganisms.

8. The sample size for the training set

This information is not applicable and not provided. CIDEX® OPA Solution is a chemical disinfectant, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of AI. The formulation and testing of the disinfectant are based on chemical principles and empirical biological studies.

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

This information is not applicable as there is no "training set" for a chemical disinfectant. The efficacy (ground truth) is established through standardized laboratory microbiological testing protocols.

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