(69 days)
The BioSonic UC-70 Sterilizable Instrument Cassette (The Cassette) is used for the ultrasonic cleaning and subsequent steam sterilizing (autoclaving) of contaminated dental/medical instruments in a 132°C gravity cycle for 12 minutes.
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This document is a 510(k) premarket notification decision letter from the FDA for a dental/medical device, the BioSonic UC-70 Sterilizable Instrument Cassette. It primarily addresses the regulatory approval of the device and does not contain information about specific acceptance criteria, study methodologies, or performance metrics in the way your request describes for a typical medical device validation study (e.g., software or diagnostic test performance).
The letter states that the device is "substantially equivalent" to predicate devices, which means it has the same intended use, technological characteristics, and safety and effectiveness. The "Indications For Use" provided describe how the device is intended to be used, not performance criteria it must meet.
Therefore,Based on the provided text, I cannot extract the information required for your request. The document is an FDA 510(k) clearance letter, which confirms substantial equivalence but does not detail acceptance criteria, device performance metrics, study designs, sample sizes, or ground truth methodologies.
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).