(12 days)
The Pressure, Volume and Pressure-Volume catheters are intended for use with the CFL 512 in conjunctions with a pressure interface module during catheterisation laboratory procedures where the quantitative assessment of Left Ventricular function is desired. Refer to the CFL 512 User Manual for a detailed description of the need for pressure and volume measurements in the clinical setting.
Not Found
I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for a medical device (CD Leycom Pressure/Volume Catheter) which primarily establishes substantial equivalence to a predicate device for marketing purposes. It does not contain details of performance studies, sample sizes, ground truth establishment, or expert evaluations.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).