(259 days)
Used to control flow rate of IV Solution or medication to patient.
Not Found
I apologize, but the provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for medical devices named "TUTODROP 1" and "TUTODROP 2." This document primarily indicates that the devices have been found substantially equivalent to previously marketed devices.
It does not contain the type of detailed study information, acceptance criteria, or performance data that would allow me to answer your specific questions regarding device acceptance criteria and a study proving device performance. The purpose of this letter is regulatory clearance, not a technical report of a study.
Therefore, I cannot provide the requested information from the given input.
§ 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.