(13 days)
Embrace Gel is intended for use as an ultrasound coupling media for use with the Embrace™ 3D Ultrasound Tomography System K070477.
Embrace™ Gel Pad is en expandable polymer used to provide a coupling medium between breast tissue and the Embrace™ 3D Ultrasound Tomography System K070477. The gel is prepared just prior to scanning by placing the gel pad in the dome and adding hydrating fluid. The gel pad expands and fills the voids between the probe and breast tissue. After the ultrasound scan is completed, the gel is removed from the dome in one piece.
This document is a 510(k) summary for the Embrace Gel, an ultrasound coupling media. It explicitly states that its function and performance are similar to a predicate device (Aquasonic 100 Ultrasound Trans Gel K802146) and that it is "substantially equivalent".
The document does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or any of the detailed aspects of a study typically associated with AI/software device evaluation (e.g., sample sizes, expert qualifications, ground truth, MRMC studies, standalone performance).
The FDA's review in this case determined that the device is substantially equivalent to a legally marketed predicate device, allowing it to proceed to market. This type of submission for a physical medical device (like an ultrasound gel) typically focuses on material safety, physical properties, intended use, and comparison to existing, already-approved devices, rather than a clinical performance study with statistical endpoints as would be required for a diagnostic AI algorithm.
Therefore, I cannot provide the requested information from the given text as it is not present.
§ 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.