(29 days)
The Acist Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
The Acist® Angiographic Injection System delivers contrast media to a catheter at a userdetermined variable flow rate that can be instantaneously and continuously varied. The system is comprised of the following elements: Injector Head, Control Panel, Power Supply, AC Power and Interconnect Cables. Not affected by this change, but provided with the system are the sterile disposable components. These are contained in two separate kits (D-1000 and H-1000) and include the Hand Controller, Contrast Syringe, and the valving to provide the interface between the system and the angiographic patient catheter.
I am sorry, but after reviewing the provided document, I cannot find the specific information regarding acceptance criteria and a study that proves the device meets those criteria. The document appears to be a 510(k) summary for the Acist Angiographic Injection System, Model CL100H, focusing on its substantial equivalence to a predicate device and its indications for use.
The document does not contain:
- A table of acceptance criteria and reported device performance.
- Details on sample sizes used for test sets, data provenance, or the number/qualifications of experts for ground truth.
- Information about adjudication methods, MRMC comparative effectiveness studies, or standalone algorithm performance.
- The type of ground truth used, sample size for the training set, or how ground truth for the training set was established.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.
§ 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.