(86 days)
The EVOTECH™ 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°C) 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 of mystical devices (endoscopes) is required when selecting the Disinfect only or Disinfect/Alcohol Flush Cycle.)
The EVOTECH™ Endoscope Cleaner and Re-processor was cleared under the Premarket Notification process (K040883) found substantially equivalent on March 15, 2005. Subsequent to that the EVOTECH ECR was granted a cleaning claim in Premarket Notification K061899 (found substantially equivalent on October 26, 2006). The system is designed to clean and disinfect endoscopes. The system performs tests to check for connection of endoscopes, for leaks in endoscopes, and for blockage of lumens. The device will clean and high-level disinfect endoscopes and provides for automated alcohol flush of the lumens. The system also has a self-disinfection cycle that can be selected (recommended to be performed every 5 days) to prevent the build up of biofilm in fluid pathways.
The provided text is a 510(k) summary for a Special 510(k) submission for the EVOTECH™ Endoscope Cleaner and Reprocessor. This type of submission is for modifications to a previously cleared device that do not affect the safety or effectiveness. As such, it does not typically include new clinical studies or detailed performance data against acceptance criteria for cleaning and high-level disinfection, but rather verification that the modifications do not negatively impact these established performances.
Therefore, many of the requested items (e.g., acceptance criteria, detailed device performance, sample sizes for test/training sets, expert qualifications, MRMC studies) are not applicable to this specific type of submission and the information provided.
However, I can extract information related to the modifications and the non-clinical tests performed to ensure they did not impact the device's original performance.
Here's a breakdown of what can be extracted and what is not provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from modifications) | Reported Device Performance (from modifications) |
|---|---|
| Disinfectant dispenser material compatibility with CIDEX OPA Concentrate Solution | Material was compatible. Did not impact performance. Met specification for dispensing volume and reproducibility. |
| Spray arm guard not impacting rotation or spray pattern | Did not impact rotation or affect spray pattern. |
| MEC Monitor performance equivalent to previous device | Data indicate performance is equivalent to the previous device. |
| Lid motor control preventing opening during operation | Changes implemented to prevent lid opening during operation. |
| Software validation for changes made | Software was validated for the changes made. |
| Risk analysis of changes not implicating a change to performance with respect to cleaning and high-level disinfection claims | Non-clinical testing was not done since risk analysis did not implicate a change. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document focuses on demonstrating that modifications did not impact existing performance, rather than re-proving the device's primary function with new detailed studies. The "non-clinical tests" mentioned are specific to verifying the modifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. This submission is not likely to involve expert ground truth for image interpretation or diagnosis. The "ground truth" for the non-clinical tests would have been the established specifications and performance parameters for each modified component.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Adjudication methods are typically for clinical studies with subjective assessments. The tests described are objective engineering verifications.
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
- Not applicable/Not provided. This is an endoscope cleaning and reprocessing device, not an AI-assisted diagnostic tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is a hardware device with associated software, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the verification of modifications, the "ground truth" was based on:
- Engineering specifications and compatibility testing: For material compatibility, dispensing volume, and reproducibility of the disinfectant dispenser.
- Functional performance standards: For spray arm rotation/pattern, MEC monitor equivalence, and lid motor control safety.
- Software validation protocols.
8. The sample size for the training set
- Not applicable/Not provided. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
§ 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.