(344 days)
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
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| High-Level Disinfection Efficacy | Achievement of a 6 Log$_{10}$ reduction of Mycobacterium terrae when flexible endoscopes are exposed to the CIDEX® OPA Concentrate in-use solution. | Simulated Use Testing: A 6 Log$_{10}$ reduction of Mycobacterium terrae was achieved when flexible endoscopes, contaminated with spores and artificial soil, were exposed to CIDEX® OPA Concentrate In Use solution without prior manual cleaning. The diluted CIDEX® OPA Concentrate at a Minimum Effective Concentration (MEC) of 0.055% OPA at 50°C was shown to be effective against Mycobacterium terrae in artificial soil. |
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.
§ 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.