(114 days)
The MEDRAD Avanta™ Fluid Management Injection System is indicated for the controlled administration of intravascular radio-opaque contrast media and common flushing solutions to humans during angiographic procedures.
Not Found
This document is a 510(k) premarket notification approval letter from the FDA to Medrad, Inc. for their Avanta Fluid Management Injection System. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. Such information would typically be found in the 510(k) submission itself or in a summary of safety and effectiveness, neither of which is provided here.
Therefore, I cannot fulfill the request for information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details. The provided text only states that the device is substantially equivalent to legally marketed predicate devices for the indications for use.
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.