(444 days)
An angiographic syringe is a device that consists of a syringe which is used to inject contrast material into the heart, great vessels, and coronary arteries during angiographic or CT procedures.
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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment for a medical device. The document is an FDA 510(k) clearance letter for the "Medline Angiographic Control Syringe," which states that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance and indications for use but does not include any performance study data or acceptance criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this document.
§ 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.