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510(k) Data Aggregation
(237 days)
The System 83 Revolve® Endoscope Washer/Disinfector is designed for the high-level disinfection of one or two flexible submersible endoscopes that are used in the gastrointestinal and pulmonary tracts. Flexible endoscopes that undergo bedside cleaning, are manually cleaned, and then exposed to the wash/disinfect cycle of the System 83 Revolve® may be high-level disinfected when the validated disinfection cycle of the System 83 Revolve® corresponds with the labeled contact conditions of the high-level disinfectant.
The System 83 Revolve® Endoscope Washer/Disinfector is an automated, computer controlled, electro-mechanical system intended to wash and high-level disinfect one or two submersible flexible endoscopes utilizing a detergent and FDA cleared high-level disinfectant validated by Wassenburg Medical.
The System 83 Revolve® utilizes a processing chamber and the perform washing, disinfection, rinsing, and alcohol flush of an endoscope to render a high-level disinfected endoscope. The System 83 Revolve® is capable of automated detergent dispensing and transfer of disinfectant solution between the reservoir and processing chamber. Following disinfection, the endoscopes and channels are automatically rinsed with potable water that is filtered through a water filtration system that contains a 0.1 micron bacteria filter and the rhannels are then flushed with air. A semi-automated air/alcohol flush must be completed at the end of the cycle. At completion, the operator prints out the endoscope reprocessing information with a printer.
Built-in sensors detect fluid levels, fluid flow, and the operating states of the components within System 83 Revolve". The system contains a Touchscreen (Graphical User Interface), a Barcode Scanner, an LED Indicator Strip that displays the process status, and a reprocessing chamber lid operation that is hands free.
The provided text is a 510(k) summary for a medical device (System 83 Revolve® Endoscope Washer/Disinfector), which is a premarket notification for a Class II medical device. This type of document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than detailed performance study results of an AI algorithm or a standalone diagnostic device.
Therefore, the information typically requested for AI-driven diagnostic devices (such as a table of acceptance criteria vs. reported device performance for an AI, sample sizes for training/test sets for AI, expert qualifications, ground truth establishment methods for AI, or MRMC studies for AI assistance) is not present in this document. This document is about an endoscope washer/disinfector, an electromechanical system, not an AI or diagnostic imaging device.
Based on the provided document, here's what can be extracted regarding acceptance criteria and performance:
The document describes the acceptance criteria and performance for the endoscope washer/disinfector itself, ensuring it functions correctly and is safe, rather than evaluating an AI's diagnostic performance.
1. A table of acceptance criteria and the reported device performance
The document provides two tables:
- Table 2. New Testing: This table outlines testing performed for the subject device to ensure it meets safety and software standards. These are not performance metrics like sensitivity/specificity but rather compliance with engineering and software standards.
- Table 3. Testing performed for Predicate Device: This table lists performance testing conducted on the predicate device, which the subject device aims to be substantially equivalent to. The results from the predicate device's testing are used to support the subject device's equivalence.
Table 2. New Testing (for Subject Device: System 83 Revolve® Endoscope Washer/Disinfector)
| Testing | Acceptance Criteria | Pass/Fail |
|---|---|---|
| Electrical Safety Conformance | Meets requirements per: UL 61010-1:2012 Ed.3+R:06Jun2023 - Electrical Equipment for Measurement, Control, and Laboratory Use; Part 1: General Requirements CSA C22.2#61010-1:2012 Ed.3+U1;U2;A1;U3 - Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use Part 1: General Requirements IEC 61010-2-040:2021 Ed.3 - Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 2 - 040: Particular Requirements for Sterilizers and Washer-Disinfectors Used to Treat Medical Materials CSA C22.2#61010-2-040:2021 Ed.3 - Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 2 - 040: Particular Requirements for Sterilizers and Washer-Disinfectors Used to Treat Medical Materials | Pass |
| EMC Testing | IEC 60601-1-2 ed 4.1 (2020-09) - Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests | Pass |
| Software Validation | Meets requirements per: BS EN 62304, 2006+A1:2015 - Medical Device Software - software life cycle processes | Pass |
| Cybersecurity | Meets requirements per: AAMI TIR57, 2016(R)2019 - Principles of medical device security - risk management | Pass |
Table 3. Testing performed for Predicate Device (Used to support SE of Subject Device)
| Performance Testing | Description | Acceptance Criteria | Pass/Fail |
|---|---|---|---|
| Simulated use testing | High-level disinfection validation of representative worst case endoscopes under worst case simulated use conditions | ≥6 Log reduction of M.terrae at all inoculated sites | Pass |
| In-use testing | High-level disinfection validation of representative worst case endoscopes and valves under in-use conditions | <1 CFU at all processed test sites | Pass |
| Alcohol and detergent line disinfection | Disinfection of the alcohol and detergent injection lines | ≥6 Log reduction of M.terrae | Pass |
| Toxicological evaluation of residues and rinsing validation | The safety of residual chemicals remaining on endoscopes after high level disinfection was evaluated. The testing was conducted in accordance with ISO 10993-5:2009 | Reactivity grade of 2 or less | Pass |
| Channel volume flushing | Flushing validation testing of representative worst case endoscopes under worst case simulated use conditions | Satisfy endoscope manufacturer's manual flushing requirements | Pass |
| Water filtration system validation | Validation testing under worst case simulated use conditions | <10 CFU per 100 mL | Pass |
| In-line Disc filter validation | Validation testing under worst case simulated use conditions | ≥99% efficient at removing particles ≥250μm | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of an AI algorithm, but rather describes "testing" for the electromechanical device.
- Sample size: Not explicitly stated in terms of number of endoscopes or tests for each specific performance test (e.g., how many endoscopes were tested for simulated use or in-use testing). It refers to "representative worst case endoscopes."
- Data provenance: Not mentioned. It's for an endoscope reprocessing device, so data would likely come from laboratory testing rather than patient data. The document does not specify retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable as this is not an AI diagnostic device that relies on expert ground truth for image interpretation or similar. The "truth" in this context is the successful disinfection or functionality of the device, measured by objective microbiological and engineering criteria.
4. Adjudication method for the test set
Not applicable for this type of device testing.
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 as this is not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the electromechanical device itself, not a separate AI algorithm's standalone performance. The device's "standalone" performance is what is evaluated through the listed tests.
7. The type of ground truth used
The ground truth for the predicate device's performance (and implicitly for the subject device through substantial equivalence) is based on:
- Microbiological assay results: e.g., "≥6 Log reduction of M.terrae" and "<1 CFU at all processed test sites."
- Chemical/Toxicological assessments: e.g., "Reactivity grade of 2 or less."
- Engineering and functional requirements: e.g., "Satisfy endoscope manufacturer's manual flushing requirements," "Water filtration system validation," "In-line Disc filter validation."
- Compliance with electrical, EMC, software, and cybersecurity standards.
8. The sample size for the training set
Not applicable as this is not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable as this is not an AI model that requires a training set.
In summary: The provided document is a regulatory submission for an electromechanical medical device. It demonstrates safety and effectiveness through adherence to engineering standards and performance comparable to a predicate device, as proven by various physical and chemical tests, not through the evaluation of an AI algorithm's diagnostic performance on patient data. Therefore, many of the requested points related to AI/diagnostic studies are not applicable to this specific regulatory filing.
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