(30 days)
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal, Small Organ (prostate), Trans-rectal, Trans-vaginal. Combined modes are: B+M, B+PW.
21336A EV/ER probe has equivalent functionality to the 21370A EV and 21371A ER probes now being used with M2410A; acoustic output for 21336A is within FDA limits. Significant Characteristics of the Modification: new patient contact materials for 21336A EV/ER probe.
This 510(k) summary does not contain information about acceptance criteria or a study proving the device meets those criteria. Instead, it is a submission for an ultrasound probe (21336A) for the M2410A ultrasound imaging system, asserting substantial equivalence to existing predicate devices (21370A and 21371A probes) based primarily on similar functionality and scientific concepts, with the main difference being new patient contact materials. The submission focuses on biocompatibility testing for these new materials, as well as acoustic output being within FDA limits, but it does not detail specific performance acceptance criteria or a study designed to demonstrate them.
Therefore, I cannot provide the requested information from the provided text.
§ 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.