(436 days)
The [ SURE™ ] probe cover is intended to be placed on Ultrasound Probes used in natural body orifices such as vagina to facilitate cleaning and sanitization of the probe.
SURE ™ Latex Ultrasonic Probe Cover
This document is a 510(k) clearance letter from the FDA for a medical device called "SURE™ Latex Ultrasonic Probe Cover". It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.
The letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It discusses regulatory compliance, not performance metrics derived from a study.
Therefore, I cannot provide the requested information based on this document.
§ 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.