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510(k) Data Aggregation
(860 days)
System 83 Plus™ Washer/Disinfector is designed for the simultaneous high level disinfection of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts. Flexible endoscopes that are precleaned and manually cleaned, and then exposed to the washing /disinfection cycle of the System 83 Plu s™, may be high level disinfected when the disinfection cycle corresponds to the System 83 Plus™ validated contact conditions of the high level disinfectant.
Note: The System 83 Plus™ device includes two models.
· The System 83 Plus™ 2 has one processing chamber that can process 1 to 2 flexible endoscopes at a time .
· The System 83 Plus™ 9 has two processing chambers that can process 1 to 2 flexible endoscopes at a time in each independently operated processing chamber for a total of up to 4 endoscopes simultaneously.
The System 83 Plus™ is an automated, computer controlled, electro-mechanical system intended to wash and high-level disinfect one or two submersible flexible endoscopes (per bay) utilizing a detergent and FDA cleared high-level disinfectant validated by CUI. The System 83 Plus™ device family includes two models. The System 83 Plus™ 2; a model with one processing chamber, which can process one to two flexible endoscopes at a time. The System 83 Plus™ 9: a model with two processing chambers which can asynchronously reprocess up to 2 endoscopes per bay (total of up to 4 endoscopes).
The System 83 Plus™ utilizes a processing chamber and the immersion method to perform washing, disinfection, rinsing, and alcohol flush of an endoscope to render a high level disinfected endoscope. The System 83 Plus™ 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 channels 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 temperature, fluid flow, and the operating states of the components within System 83 Plus™.
The provided text is a compilation of FDA documents related to the 510(k) premarket notification for the "System 83 Plus Washer/Disinfector." It describes the device, its intended use, comparison to a predicate device, and a summary of non-clinical testing performed to demonstrate its safety and effectiveness.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Simulated use testing (High-level disinfection) | ≥6 Log reduction of M.terrae at all inoculated sites | Pass |
| In-use testing (High-level disinfection) | <1 CFU at all processed test sites | Pass |
| Alcohol and detergent line disinfection | ≥6 Log reduction of M.terrae | Pass |
| Toxicological evaluation of residues and rinsing validation | Reactivity grade of 2 or less | Pass |
| Channel volume flushing | Satisfy endoscope manufacturer's manual flushing requirements | Pass |
| Water filtration system validation | <10 CFU per 100 mL | Pass |
| In-line Disc filter validation | ≥99% efficient at removing particles ≥250µm | Pass |
| Electrical safety testing | UL 60601-1:2003 standard for safety | Complies |
| Electromagnetic compatibility testing (EMC) | IEC 60601-1-2:2001 + A1:2004 standard for EMC | Complies |
| Software verification and validation testing | Not explicitly numeric, but implies meeting FDA guidance for software in medical devices | Conducted and documentation provided as recommended by FDA guidance |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific numerical sample sizes (e.g., number of endoscopes, number of runs) for each performance test. It uses terms like "representative worst case endoscopes" and "worst case simulated use conditions" for several tests.
- Sample Size: Not explicitly stated as a number for individual tests.
- Data Provenance: The document implies the tests were conducted by or on behalf of Custom Ultrasonics, Inc. (the submitter) as part of their 510(k) submission. There is no information about the country of origin of the data collectors or whether the studies were retrospective or prospective, though 510(k) testing is typically prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
The document does not provide any information about:
- The number of experts used.
- The qualifications of those experts.
- How ground truth was established for the performance tests.
For this type of device (washer/disinfector), "ground truth" for disinfection performance would typically be established through microbiological assays (e.g., plating, colony counting) to determine bacterial reduction, rather than expert human interpretation in the sense of a medical image analysis.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method. Given the nature of the testing (microbiological, chemical, engineering performance), adjudication by multiple human experts is unlikely to be relevant in the same way it would be for, say, a diagnostic AI device analyzing medical images. The acceptance criteria are objective and measurable (e.g., log reduction, CFU count).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI devices that assist human readers in interpreting medical images or data. The System 83 Plus Washer/Disinfector is an automated reprocessing device, not a diagnostic AI system involving human interpretation of complex medical cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The performance testing described ("Simulated use testing," "In-use testing," etc.) represents a "standalone" or "device-only" performance evaluation. The device itself performs the high-level disinfection process without human intervention during the active cycle. The tests evaluate the device's ability to meet the specified disinfection and other performance criteria independently.
7. The Type of Ground Truth Used
The ground truth for the performance testing is based on objective, quantitative measurements related to disinfection efficacy and device performance. Specifically:
- Microbiological assays: For disinfection testing (simulated use, in-use, alcohol/detergent line), the ground truth is established by measuring the reduction of microbial load (e.g., M. terrae counts, CFU counts).
- Chemical analysis: For toxicological evaluation of residues, ground truth is based on reactivity grades consistent with ISO standards.
- Physical measurements/compliance: For channel volume flushing, water filtration, and disc filter efficiency, ground truth is based on meeting specified flow rates, filtration efficiency percentages, or industry standards.
- Engineering standards compliance: For electrical safety and EMC, ground truth is compliance with recognized industry standards (UL 60601-1, IEC 60601-1-2).
8. The Sample Size for the Training Set
The document does not mention a training set. This is because the System 83 Plus Washer/Disinfector is an electro-mechanical device with software logic, not an AI/machine learning device that requires a "training set" in the conventional sense (i.e., for learning from data to make predictions). The software verification and validation refer to traditional software development and testing, not AI model training.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for an AI model, this question is not applicable. The device's "ground truth" is based on established engineering principles, microbiological science, and regulatory standards for medical device performance and safety.
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