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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.

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