(14 days)
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.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.