(256 days)
Intended for barrier protection during procedures of endocavity ultrasound examination and diagnosis to help prevent transfer of microorganism, body fluids and particulate material.
Natural Rubber Latex Ultrasound Transducer Probe Covers
The provided text is an FDA 510(k) clearance letter for a medical device: "Natural Rubber Latex Ultrasound Transducer Probe Covers." This document does not contain information about acceptance criteria or a study proving that an AI/ML powered device meets acceptance criteria.
The submission is for a physical medical device (ultrasound probe covers), not an AI/ML software device. Therefore, the questions regarding AI/ML device performance, ground truth, expert consensus, and training/test sets are not applicable to the content provided.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.