(56 days)
The Spectris MR Injection System with Communicator ™ is a syringe-based fluid delivery System intended to be used for the specific purpose of injecting intravenous contrast media during Magnetic Resonance Imaging applications. It is intended to be used for intravenous access for diagnostic studies in Magnetic Resonance Imaging. The Communicator connection provides an imaging system interface. Properly trained healthcare professionals are intended to operate this device.
Medrad Spectris MR Injector with Communicator™ Option is a syringe-based fluid delivery system.
The document provided is an FDA clearance letter and an Indications for Use statement for the Medrad Spectris MR Injector with Communicator™ option. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria related to its performance in a clinical or analytical setting.
Therefore, I cannot provide the requested information from the provided text. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, and not on detailed performance study results against specific acceptance criteria.
§ 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.