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510(k) Data Aggregation
(105 days)
Advantage Plus Pass-Thru Endoscope Reprocessing System tests, washes, disinfect and rinses endoscopes, such as fiberoptic and video endoscopes between patient uses. The Advantage Plus Pass-Thru system is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes and related accessories. Manual cleaning of endoscopes is required prior to disinfection in the Advantage Plus Pass-Thru System.
The Advantage Plus Pass-Thru Endoscope Reprocessing System uses Rapicide PA High Level Disinfectant to provide high level disinfection of endoscopes when used according to the directions for use. The system uses Intercept Plus Detergent in its washing cycle at a concentration of 0.5%.
Rapicide PA Test Strips are used after the disinfection cycle to ensure that the used disinfectant is above the minimum recommended concentration (MRC) of 850 ppm peracetic acid; this ensures that the disinfectant was above MRC during the entire disinfection cycle. Rapicide PA should be used under the following contact conditions -Contact Time: 5 minutes Temperature: 30°C MRC: 850ppm
The Advantage Plus Pass-Thru is an electro-mechanical Automatic Endoscope Reprocessor (AER) intended to high-level disinfect pre-cleaned endoscopes and their related accessories by exposing them to a peracetic acid based disinfectant – Rapicide PA disinfectant solution (cleared under 510k – K082988).
The subject device is closely related to its predicate the Advantage Plus Endoscope Reprocessing System cleared in 510k – K082988 and K102996 but differs in that it is designed in a "pass-thru" configuration. The subject device is intended to be built into a wall which separates 'clean' and 'dirty' sides. It provides the ability to load an endoscope from the dirty side and unload the disinfected endoscope from the clean side, thus preventing potential mix-up between high level disinfected and contaminated endoscopes.
Contaminated endoscopes are placed in the subject device from the 'dirty' side and appropriate connections to the endoscope channels are made. The system is designed to test for proper channel connectivity, channel blockages and leaks in the outer endoscope sheath. After the endoscope passes these tests, the system proceeds to the washing cycle with Intercept Plus detergent, and the highlevel disinfection cycle. In the high-level disinfection cycle, Rapicide PA HLD is diluted by the incoming water to a minimum concentration of 850 ppm of peracetic acid. The system measures and maintains the temperature of this disinfectant solution to ensure that it is above the minimum recommended temperature of 30℃ for Rapicide PA for effective High Level Disinfection to occur. Following the 5 minute disinfectant contact time, the user takes a sample to test for MRC (850 ppm of peracetic acid). Once the MRC test passes, the disinfectant is emptied from basin and drained out of the AER. The endoscope is then rinsed, dried and removed from the 'clean side' of the AER.
The provided text describes the regulatory submission for the "Advantage Plus Pass-Thru Automated Endoscope Reprocessing System" (K172677). The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study involving human readers or expert consensus for AI performance.
Therefore, much of the requested information regarding AI-specific criteria, human expert involvement, ground truth establishment for training and test sets, and MRMC studies, is not applicable or not present in this document. This submission pertains to a medical device for high-level disinfection of endoscopes, not an AI/ML-driven diagnostic or image-analysis device.
However, I can extract the acceptance criteria and performance for the non-clinical performance tests that were conducted to demonstrate substantial equivalence of this device.
Here's the information based on the provided text:
Acceptance Criteria and Reported Device Performance
The device is an Automated Endoscope Reprocessor (AER) intended for high-level disinfection. The performance testing conducted was to demonstrate its physical and microbiological effectiveness in this context.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Simulated-Use Testing (Demonstrates high-level disinfection with Rapicide PA HLD and Intercept Plus detergent) | Achieve 6-log reduction of the test organism in each endoscope channel and endoscope exterior. | Pass |
| Clinical In-Use Testing (Demonstrates high-level disinfection after patient/clinical use) | Demonstrate no viable organisms remain after reprocessing. | Pass |
| Water-Line/Self-Disinfection Cycle Testing (Evaluation of bactericidal effectiveness of the self-disinfection cycle and biofilm analysis) | Survivors after the SDC must be ≤ 10 CFU of test organism per 100 mL. Absence of biofilm formation following self-disinfection cycle. | Pass |
| Rinse Residual Testing (Evaluation of residual levels of Rapicide PA and Intercept Plus) | Any chemistry residuals must be equal to or lower than the lowest reported LD50 exposure with a 10-fold safety margin. | Pass |
| Material Compatibility (Demonstrates system compatibility with Rapicide PA HLD and Intercept Plus Detergent) | Acceptance criteria included dimensional and weight changes <5%, visual observations and FTIR spectra. | Pass |
| Critical Parameter/Component Functionality Testing (Demonstrates consistent and reliable delivery of physical process parameters) | All critical process parameters must achieve and maintain required specifications. | Pass |
Since this is a submission for an endoscope reprocessing system rather than an AI/ML device, the following points are not applicable or not mentioned in the document:
2. Sample size used for the test set and the data provenance:
* Not applicable for AI/ML data sets. The "test set" here refers to the number of reprocessing cycles or endoscope samples tested in the described performance studies. The exact number of cycles/samples for each test type (Simulated-Use, Clinical In-Use, etc.) is not explicitly stated in this summary, nor is the country of origin or whether the data was retrospective/prospective in the context of an AI/ML clinical study. The studies are described as "Performance bench testing" and "Clinical In-Use Testing," implying a prospective experimental design for product validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable. Ground truth for an AI/ML system, especially relating to expert consensus, is not relevant to the validation of an endoscope reprocessing device. The "ground truth" in this context is based on quantifiable microbiological reduction (e.g., 6-log reduction of test organisms, absence of viable organisms) and chemical residual levels, measured by laboratory methods, not human expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable. Adjudication methods are typically used to resolve discrepancies in human expert labeling or diagnoses for AI/ML ground truth, which is not relevant here.
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. This pertains to the evaluation of AI assistance for human readers, which is outside the scope of this device's function.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
* Not applicable. The "performance" of this device is its ability to disinfect endoscopes, and its "standalone" performance is what these non-clinical tests evaluate – the device working as intended without human intervention in the disinfection process itself, beyond loading/unloading and initiation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* The ground truth for this device's performance relies on microbiological testing results (e.g., colony-forming unit (CFU) counts of test organisms to determine log reduction, confirmation of no viable organisms, biofilm analysis) and chemical analyses (e.g., measurement of chemical residuals, verification of minimum recommended concentration, material properties). It is not based on expert consensus, pathology, or patient outcomes data in the sense of a diagnostic device.
8. The sample size for the training set:
* Not applicable. This device is an electro-mechanical system, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
* Not applicable. As above, there is no AI/ML training set.
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