(113 days)
IV administration set used to administer fluids from a container to a patient's venous system through a needle or catheter inserted into a vein.
Intravenous Administration Set
This document is a 510(k) clearance letter from the FDA for an "Intravenous Administration Set" (K992266). It does not contain information about acceptance criteria, device performance studies, or AI/software.
Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, not on specific performance data or clinical study results.
§ 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.