(250 days)
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
| Test/Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| High-Level Disinfection (Simulated Use) | A 6 Log$_{10}$ reduction of Mycobacterium terrae when flexible endoscopes, contaminated with Mycobacterium terrae and artificial soil, were exposed to CIDEX OPA Concentrate In Use solution without cleaning. | |
| Diluted CIDEX® OPA Concentrate at an MEC of 0.055% OPA concentration at 50°C is effective against Mycobacterium terrae in artificial soil. | A 6 Log$_{10}$ reduction of Mycobacterium terrae was achieved. | |
| The diluted CIDEX® OPA Concentrate at an MEC of 0.055% OPA concentration at 50°C was effective against Mycobacterium terrae in artificial soil. | ||
| Cleaning Efficacy (Simulated Use) | Residual soil (protein and total organic carbon - TOC) below a predefined limit of 8.5 ug/cm² after processing in the "wash only" cycle with contaminated endoscopes. | In all instances, the residuals (protein and TOC) were below the predefined limit of 8.5 ug/cm². |
| Cleaning Efficacy (Clinical In-Use, without manual pre-cleaning) | Processing in the EVOTECH® ECR Endoscope Cleaner & Reprocessor reduces residual protein and TOC in all channels and surfaces to less than predefined acceptance criteria. | Processing in the EVOTECH® ECR Endoscope Cleaner & Reprocessor reduced the residual protein and TOC in all channels and surfaces to less than the predefined acceptance criteria. |
| High-Level Disinfection (In-Use, Cleaned Endoscopes) | Not explicitly stated with a numerical criterion for this specific test, but implies effectiveness. | High-level disinfection of cleaned endoscopes was achieved (studied in K061889). |
| High-Level Disinfection (In-Use, Contaminated Endoscopes without manual/automated washing) | A >10$^6$ reduction in M. terrae after processing contaminated endoscopes through the disinfect cycle only. | There was a >10$^6$ reduction in M. terrae. |
| Quantitative Tuberculocidal Testing | Effectiveness of OPAC solution at 0.042% concentration in the presence of 5% fetal bovine serum organic soil load within 5 minutes at 50-52°C. | Effectiveness demonstrated for OPAC solution at 0.042% concentration in the presence of 5% fetal bovine serum organic soil load within 5 minutes at 50-52°C. |
| Sterility Testing (In-Use) | No growth after reprocessing clinically used endoscopes. | Sterility testing demonstrated no growth. |
| Biocompatibility | Residual OPA levels not likely to cause toxic effects in humans. | Analysis indicates that the level of OPA residual remaining on an endoscope is not likely to cause toxic effects in humans. |
| Material Compatibility | Minimal effect on test articles over extended periods of multiple disinfection cycles, similar to predicate device. | Multiple disinfection cycles over extended periods of time resulted in minimal effect on the test articles, similar to the predicate device. |
| Non-Inferiority (Automated Wash vs. Manual Wash) | Washing in the EVOTECH® ECR Endoscope Cleaner & Reprocessor determined to be non-inferior to washing following SGNA procedure. | Washing of endoscopes in the EVOTECH® ECR Endoscope Cleaner & Reprocessor was determined to be non-inferior to washing of endoscopes following the SGNA procedure. |
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.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.