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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

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