(35 days)
The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
The ACIST Medical Systems Angiographic Injection System Contrast Management Disposable Kits provide the interface between the ACIST Injection System and the Angiographic patient catheter for the delivery of contrast media at a userdetermined variable flow rate that can be instantaneously and continuously varied.
The Contrast Management Disposable Kits are comprised of the following elements:
- Automated Manifold .
- AngioTouch Hand Controller .
- Reusable Syringe Kit * .
- Not affected by this change, but provided with the Contrast Management Disposable Kits is the Reusable Syring Kit.
The provided document K040298 is a 510(k) Summary for the ACIST Angiographic Injection System Contrast Management Disposable Kits. It states that:
- No non-clinical or clinical performance testing was indicated or performed for the determination of substantial equivalence. The device is cleared based on demonstrating substantial equivalence to a predicate device, not on specific acceptance criteria and a study proving those criteria are met.
Therefore, I cannot provide the requested information as it is not present in 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.