(44 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Fetal (CWD - N)
Peripheral Vascular (CWD - N)
The system consists of a main body and one probe. The nominal 2 or 3 MHz probes are designed for fetal applications. The nominal 5 or 8MHz probes are designed for peripheral vascular applications.
The provided text is related to an FDA 510(k) premarket notification for the "DigiDop Ultrasound System." This document discusses the substantial equivalence of the device to legally marketed predicate devices and outlines its intended uses and transducer types. It is not an AI/ML device and therefore does not include:
- Acceptance criteria and reported device performance related to AI/ML.
- Sample sizes, data provenance, number of experts for ground truth, or adjudication methods for test sets.
- Multi-reader multi-case comparative effectiveness studies or standalone algorithm performance.
- Ground truth types or sample sizes/ground truth established for training sets.
The document is purely a regulatory approval for a medical device that uses ultrasound technology to detect fetal heartbeats and for peripheral vascular diagnosis. It does not involve any artificial intelligence or machine learning components.
§ 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.