(85 days)
The Coeur Injector Adaptor / Pressure Jacket is intended to be installed on Liebel-Flarsheim Angiomal* 6000 and Angiomat* Illumena** Contrast Delivery Systems to allow the injectors to be used with the Coeur 150mL A-Series (Angiographic andCT) Syringes (Catalog Numbers: C853-6150 and C853-6159).
The COEUR Injector Adaptor/Pressure Jacket, Model C859-6003 is an accessory intended to be installed on specific contrast delivery systems to allow the use of specific syringes.
The provided text is a 510(k) premarket notification letter from the FDA to COEUR Medical regarding their Injector Adaptor/Pressure Jacket. This document primarily focuses on regulatory approval based on substantial equivalence to a predicate device and does not contain information about the acceptance criteria, study design, or performance metrics of the device as if it were an AI/software as a medical device (SaMD).
Therefore, I cannot provide the requested information as the document does not originate from a study report or clinical trial that would typically outline such details. The FDA letter confirms the device's classification and allows it to be marketed, but it does not detail performance testing against acceptance criteria in the manner described in the prompt.
§ 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.