(444 days)
to be used as an interface between (an) Angiographic, CT, or MR Syringe(s) and a needle catheter for the purpose of delivering diagnostic fluids (such as contrast media and saline) to the vascular system.
Disposable, 330psi Extension Lines
This document is a 510(k) summary for a medical device (Disposable 330psi Extension Lines) and does not contain the type of acceptance criteria and study information requested. The document is a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information based on the provided text. The document does not describe:
- Acceptance criteria or reported device performance in a table format.
- Sample sizes, data provenance, or details about test sets.
- The number or qualifications of experts, nor adjudication methods.
- Any multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- The type of ground truth used.
- Sample size or ground truth establishment for a training set.
This information would typically be found in a separate clinical or non-clinical study report submitted as part of the 510(k) premarket notification, not in the FDA's substantial equivalence determination letter.
§ 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.