(277 days)
The Vivio System is indicated for low frequency (
The Vivio Unit is an electronic stethoscope containing a membrane, placed on the skin over the carotid artery, that is displaced due to vibrations produced by the arterial pulse waveform and heart sounds associated with the aortic valve opening and closing. An infrared light photo reflector transmits and detects light to/from the membrane and outputs a current relative to the detected light (or membrane movement). Sensor electronics inside the Vivio Unit generate a current to operate the sensor, read the current produced by the sensor and output a voltage relative to the current. Filter electronics condition the sensor signal, process the data and communicate the data to the tablet with the Avicena App. The Vivio Unit is powered by an internal, rechargeable battery.
The provided text describes a 510(k) submission for the Avicena Vivio System, a digital electronic stethoscope. While it outlines the device's intended use, comparison to a predicate device, and compliance with various standards, it does not contain specific acceptance criteria or a study proving the device meets acceptance criteria related to its diagnostic accuracy or clinical performance.
The document explicitly states: "This submission does not include animal or clinical performance testing."
Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets them from the provided text, as such information is not present. The submission focuses on substantial equivalence based on technical characteristics, safety, and non-clinical bench testing.
§ 870.1875 Stethoscope.
(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.