(271 days)
The Cenorin 610 and Cenorin 610HT Washer-Pasteurizer/High Level Disinfectors are intended for cleaning and high level disinfection of semi-critical and non-critical medical devices using thermal disinfection by full immersion pasteurization.
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The provided document is a 510(k) clearance letter from the FDA for a medical device called "Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector."
**This document does not contain any information about acceptance criteria, device performance metrics, sample sizes, expert ground truth establishment, or any details related to a study proving the device meets acceptance criteria. It is a regulatory clearance document, indicating the device has been found substantially equivalent to legally marketed predicate devices.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving device performance from the provided text. The document is about a washer-pasteurizer, not an AI/ML powered device, and thus the acceptance criteria would be very different (e.g., sterilization effectiveness, temperature control accuracy, cycle times, etc.) which are not detailed here.
§ 880.6991 Medical washer.
(a)
Identification. A medical washer is a device that is intended for general medical purposes to clean and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors.” The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.