(50 days)
This product will be used to detect blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.
The LifeDop is a hand-held, battery powered, audio Doppler device used for blood flow detection in veins and arteries: The product includes sterilizable detachable ultrasound transducer probe and user replaceable batteries. The user interface includes an on/off button, volume control, single 2-1/4" speaker and battery. The product is housed in custom injection molded housings. Patient contact materials are ABS and Ploycarbonate injection molded plastic.
The provided text is a 510(k) summary for the Summit Doppler Systems, Inc. STN Probe. It describes the device, its intended use, and claims substantial equivalence to a previously cleared predicate device (LifeDop Doppler Ultrasound System -- w/ 8.0 MHz CW PV Probe K024197).
Crucially, the document states "None provided" for Clinical Testing. This means no acceptance criteria or study data demonstrating the device meets such criteria are present in this submission. The basis for clearance is solely substantial equivalence to a predicate device, assuming similar features, materials, and intended use.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about a study proving the device meets acceptance criteria, as this information is explicitly stated as not provided in the submitted material.
§ 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.