(169 days)
The Syringe with Handi-Fil is part of the contrast delivery system which is designed to mject radiopaque contrast media and/or salıne into the vascular system for Angiographic or CT procedures as prescribed by qualified healthcare professionals
The proposed device is a disposable, single-use syringe, used to deliver radiographic contrast media and/or salme into a patient's vascular system for the purpose of obtaming enhanced diagnostic images The Syringe with Handi-Fil is plastic and consists of the same components as the predicate device The configuration is equivalent to other syringes already marketed by Mallinckrodt The synnge is provided to the customer packaged and sterilized. This submission covers the following devices: 150 ml syringe with Handı-Fil, 200 ml syringe with Handı-Fil.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance tables, study designs (sample sizes, data provenance, expert panels, adjudication methods, MRMC studies, standalone studies), or ground truth establishment. The document is a 510(k) summary for a medical device (Syringe with Handi-Fil) establishing substantial equivalence to a predicate device. It focuses on device description, intended use, and a comparison of features, not on the results of a performance study.
§ 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.