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The Tru-Swab™ Stopcock is an accessory to an Intravascular Administration Set used as a secondary sterile injection site for delivery of fluids to a patient's vascular system through a cannula inserted into a vein or artery.

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The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called the "Tru-Swab™ Stopcock." This document primarily addresses the substantial equivalence of the device to a legally marketed predicate device and grants permission for the manufacturer to market it.

It does not contain information about acceptance criteria, device performance studies, sample sizes for test or training sets, expert qualifications, ground truth establishment methods, or comparative effectiveness studies (MRMC studies).

The letter is a regulatory approval document and does not delve into the detailed technical or clinical studies that would typically provide the information requested in your prompt. Therefore, I cannot generate the requested table and study details based on the provided text.

To answer your prompt, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a detailed device description that includes performance data and study methodologies.

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