(84 days)
The syringe is intended for single use by healthcare professionals to dispense fluids to the body and monitor the pressure of those fluids.
The Atrion Medical QL™ Fluid Dispensing Syringe consists of a plastic syringe with a screw-type plunger and a locking lever and rotating palm grip that control the plunger, a manometer to measure pressure and a connecting tube.
The provided documents discuss the Atrion Medical QL™ Fluid Dispensing Syringe, a medical device. There is no information in these documents about any AI/ML components or studies related to acceptance criteria for such components. The submission is a traditional 510(k) for a physical medical device.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as these concepts are not applicable to the content provided.
§ 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.