(15 days)
An intravascular administration set intended to administer fluids from a fluid container (I.V. bag) to a patient's vascular system through a needle or catheter inserted into a vein.
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I'm sorry, but this document contains a medical device approval letter from the FDA, and it does not include the detailed information about acceptance criteria, study design, or performance metrics that you are requesting. This letter is a regulatory document stating that the device, "SelectFlow Intravascular Administration Set," has been found substantially equivalent to legally marketed predicate devices and can therefore be marketed.
To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a 510(k) summary with performance data. This document primarily focuses on the regulatory approval status.
§ 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.