(22 days)
The VCS Doppler Transceiver is designed for the evaluation of blood flow in uterine arteries.
The VCS Doppler Transceiver is a battery powered pulsed Doppler ultrasound system designed for the evaluation of blood flow in vessels. An 8 MHz Doppler device, which plugs into the transceiver unit, emits a pulsed ultrasonic signal. A varying audible signal is produced when the device is placed upon a vessel within which there is flow. The frequency (i.e., pitch) of the signal is proportional to the blood velocity within the vessel. Distinctive tonal patterns are produced which are indicative of the flow pattern in terms of velocity vs. time. The volume of the tone may be adjusted by the means of a control on the transceiver. Rechargeable batteries power the transceiver. An 8 MHz transmitter in the transceiver periodically drives the ultrasonic transmitting sensor located at the tip of the device. The ultrasonic waves generated by the sensor travel through the tissue just under the device tip in a fairly narrow beam. The waves are then reflected back towards the device whenever they encounter a boundary between tissues of different densities. During the intervals when the unit is not transmitting, the device passes any reflected signals that it receives to a receiving circuit. This circuit amplifies the re-turning echoes, compares their frequency to that of the transmitted signal and converts any frequency differences into an audible tone.
The provided text, KOS2209, is a 510(k) summary for the VCS Doppler Transceiver. It seeks to establish substantial equivalence to predicate devices, not to present a de novo study proving that the device meets specific acceptance criteria through a clinical trial. Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving the device meets them, sample sizes, expert qualifications, or ground truth establishment.
Instead, the document focuses on:
- Device Description: A battery-powered pulsed Doppler ultrasound system for evaluating blood flow.
- Intended Use: Evaluation of blood flow in uterine arteries.
- Predicate Devices: Komen and Associates Mini Doppler II Ultrasound Flow Detector (K915550) and Meadox Medicals, Inc. MS Disposable Rigid Doppler Probe (K930227).
- Technological Characteristics Comparison: States that the VCS Doppler Transceiver has the same device characteristics as the predicate devices, with the exception of the Meadox Medicals device being 20MHz.
- Nonclinical Tests: Electrical Safety testing was conducted to IEC 60601-1 and UL 60601.
- Conclusion: The device does not raise new issues of safety, effectiveness, or performance because it is substantially equivalent to legally marketed predicate devices.
Therefore, it is not possible to fill out the requested table and answer the study-related questions based on this document. This summary outlines a regulatory submission for substantial equivalence based on comparison to existing devices, not a clinical study to prove performance against specific acceptance criteria for a novel device.
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).