(115 days)
The EvoTech™ System, a washer/disinfector, is indicated for use with highlevel disinfectant CIDEX® OPA Concentrate and an enzymatic detergent (CIDEZYME GI) to achieve cleaning and high level disinfection of heat sensitive (>60℃) semi-critical endoscopes. Manual cleaning of medical devices (endoscopes) is not required prior to placement in the EvoTech System when selecting those cycles that contain a wash stage. (Manual cleaning is required when selecting the Disinfect Only or Disinfect/Alcohol Flush Cycles.)
The EvoTech™ System 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 System is capable of cleaning endoscopes that have not been manually cleaned prior to placing in the EvoTech System.
Here's a summary of the acceptance criteria and study details for the EvoTech™ System based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Cleaning (Simulated and In-Use Studies): Residual soil (protein and Total Organic Carbon - TOC) below a predefined limit. | In all instances, residuals were below the predefined limit of 8.5ug/cm². |
| Cleaning (Non-inferiority to manual cleaning): The washing of endoscopes in the EvoTech System to be non-inferior to washing following SGNA procedures. | The washing of endoscopes in the EvoTech System was determined to be non-inferior to washing of endoscopes following the SGNA procedure. |
| Cleaning (Clinically used endoscopes): Residual protein and TOC in all channels and surfaces to be less than predefined acceptance criteria. | Processing in the EvoTech System reduced the residual protein and TOC in all channels and surfaces to less than the predefined acceptance criteria. |
| High-Level Disinfection: A >10⁶ reduction in Mycobacterium terrae when endoscopes were contaminated with ≥8.5ug/cm² protein and >10 cfu/mL M. terrae. | After processing the contaminated endoscopes through the disinfect cycle only in the EvoTech System, there was a >10⁶ reduction in M. terrae. |
Study Details:
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Sample sizes for the test set and data provenance:
- Cleaning Studies (Simulated Use): Specific numbers are not provided, but it states "Both simulated use and in-use studies were completed." Endoscopes were "contaminated" for these tests. Data provenance is not specified but implies laboratory testing.
- Cleaning Studies (In-Use/Clinical): Specific numbers are not provided, but it states "Endoscopes used in clinical procedures were processed through the 'wash only' cycle." This indicates prospective, clinical data. Data provenance (country of origin) is not specified.
- High-Level Disinfection Study: Specific numbers are not provided, but it states "Endoscopes were contaminated with Mycobacterium terrae imbedded in soil." This implies laboratory testing.
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Number of experts used to establish the ground truth for the test set and their qualifications:
- This information is not provided in the given text. For the cleaning and disinfection studies, the ground truth was based on quantitative measures of residual soil (protein, TOC) and microbial reduction, not expert consensus in the traditional sense of image interpretation.
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Adjudication method for the test set:
- Adjudication methods (e.g., 2+1, 3+1) are typically relevant for qualitative assessments or disagreements in expert interpretation. Since the ground truth for cleaning and disinfection was based on quantitative measurements (ug/cm² and cfu/mL reduction), an adjudication method is not applicable and therefore not mentioned.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- This is a device for endoscope reprocessing, not an AI or diagnostic imaging device. Therefore, an MRMC study and effects on human reader improvement with AI assistance are not applicable and no such study was described.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is a standalone device (automated endoscope reprocessor) where its performance is evaluated directly without human intervention in the core reprocessing function. The studies described are essentially standalone performance evaluations of the EvoTech System's ability to clean and disinfect effectively.
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The type of ground truth used:
- Cleaning Studies: Quantitative measurement of residual protein and Total Organic Carbon (TOC) (ug/cm²).
- High-Level Disinfection Study: Quantitative measurement of microbial reduction (colony-forming units per milliliter - cfu/mL reduction for Mycobacterium terrae).
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The sample size for the training set:
- This information is not applicable as the EvoTech System is an automated physical device, not a machine learning algorithm that requires a "training set" in the context of data-driven model development.
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How the ground truth for the training set was established:
- This information is not applicable for the same reason as point 7.
§ 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.