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510(k) Data Aggregation
(139 days)
The Revital-Ox PAA High Level Disinfectant Chemical Indicator is designed to determine whether the peractic acid concentration in the high-level disinfection (HLD) phase of the chosen reprocessing cycle of the enspire 300 Series AER employing Peracetic Acid (Revital-Ox PAA High Level Disinfectant) is above the minimum effective concentration (MEC) of 850 mg/L.
Revital-Ox PAA High Level Disinfectant Chemical Indicator is a single-use chemical indicator consisting of a polypropylene strip with indicator ink printed in a patch at one end. A clear, germicide-permeable laminate is applied over the reactive patch to protect the strip from damage during handling and to prevent the ink from leaching from the substrate.
One strip is used with each Cleaning and High-Level Disinfection (HLD) and HLD only cycle by placing the strip within the enspire 300 Series Automated Endoscope Reprocessor. At the end of the cycle, if the reactive patch has turned from the starting blue color to grey/tan, it was exposed to > 850 mg/L PAA min. which indicates an effective peracetic acid dose, i.e. 'Pass'.
This document describes the Revital-Ox PAA High Level Disinfectant Chemical Indicator and its performance testing to demonstrate substantial equivalence to a predicate device.
1. Acceptance Criteria and Reported Device Performance
| Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Comparative Sensitivity, Comparative Specificity, Analytic Sensitivity and Analytic Specificity Study | Not explicitly stated in the provided text, but implied to demonstrate correct response to PAA levels. | PASS |
| Post-Processing Stability Study – Outside Processor | Not explicitly stated, but implied to show stability after processing. | PASS |
| Post-Processing Stability Study – Inside Processor | Not explicitly stated, but implied to show stability after processing. | PASS |
| Blind Reader | Not explicitly stated, but implied to demonstrate consistent and accurate interpretation by different readers. | PASS |
| Effects of Contaminants | Not explicitly stated, but implied to demonstrate resistance to common contaminants. | PASS |
| Exposure to Temperature Extremes | Not explicitly stated, but implied to demonstrate performance within expected temperature ranges. | PASS |
| Shelf Life for 16 months | Indicator remains effective for 16 months. (Study "ongoing" for extension). | PASS |
| Open Bottle Stability for 90 days | Indicator remains effective for 90 days after opening. | PASS |
2. Sample Size and Data Provenance
The provided text does not specify the sample sizes used for each test set within the "Performance Testing" section. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts and Qualifications
The document mentions a "Blind Reader" study, which implies human interpretation. However, it does not specify the number of experts used, their qualifications, or their role in establishing ground truth for the device's color change interpretation.
4. Adjudication Method
The document does not describe any specific adjudication method used for the test set interpretation, such as 2+1 or 3+1 concensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this device. This device is a chemical indicator that changes color to signify a concentration level, not an AI-assisted diagnostic tool for human readers.
6. Standalone Performance
The performance testing described, particularly the "Comparative Sensitivity, Comparative Specificity, Analytic Sensitivity and Analytic Specificity Study," implicitly represents a standalone (algorithm only, though in this case, a chemical reaction and visual change) performance evaluation of the chemical indicator's ability to respond to peracetic acid concentrations. The "Blind Reader" study then assesses the human interpretation of this standalone performance.
7. Type of Ground Truth Used
The ground truth for this device's performance would primarily be the measured concentration of peracetic acid (PAA) in the liquid. The chemical indicator is designed to change color when the PAA concentration is above 850 mg/L. Therefore, the ground truth is established by chemical analysis of the PAA concentration in the test solutions or in the effluent from the AER.
8. Sample Size for Training Set
The concept of a "training set" is not applicable to this device. Chemical indicators function based on chemical reactions, not machine learning algorithms that require training data.
9. How Ground Truth for Training Set Was Established
As stated above, a "training set" is not applicable. The device's color change mechanism is an inherent chemical property, not something that is "trained." The ground truth for evaluating its performance is based on precisely controlled and measured concentrations of peracetic acid.
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