(89 days)
The PVR-100 / Vasogram is a noninvasive medical device used in conjunction with other devices such as: continuous-wave Doppler ultrasound, treadmill testing, and ultrasonic imaging techniques for vascular studies of the limbs and digits. Use of the PVR-100 / Vasogram in this manner allows the physician to noninvasively diagnosis extremity arterial and venous disorders, and receive, record, and produce a visual display of local arterial compliance.
The PVR-100 / Vasogram is a noninvasive medical device.
This looks like a 510(k) submission summary for a medical device (PVR-100/Vasogram II). The provided text does not contain the detailed information required to answer your request about acceptance criteria and a study proving the device meets them.
Specifically, the text is a letter from the FDA acknowledging receipt and review of the 510(k) submission and stating that the device is substantially equivalent to legally marketed predicate devices. It also outlines the intended use of the device.
To answer your request, I would need to find sections of the 510(k) submission itself that describe:
- The specific performance characteristics tested.
- The acceptance criteria for those characteristics.
- Details of the study (clinical or bench) conducted to demonstrate performance.
- The statistical methods used, sample sizes, ground truth establishment, etc.
Therefore, based solely on the provided text, I cannot complete your request.
If you have access to the full 510(k) submission for the PVR-100/Vasogram II, please provide the relevant sections describing the performance data and acceptance criteria.
§ 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.
(a)
Identification. A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.(b)
Classification. Class II (performance standards).