(73 days)
An intravascular administration set with needle access to be used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vessel.
IV Extension/Administration Sets with Needle
The provided text pertains to a 510(k) premarket notification for an "IV Extension/Administration Sets with Needle" device (K980994) received by the FDA in 1998. The document is an FDA clearance letter confirming substantial equivalence to a predicate device.
This document does not contain any information regarding acceptance criteria, device performance, study details (sample sizes, data provenance, expert-established ground truth, adjudication methods, MRMC studies, standalone performance), or training set information for an AI/algorithm-based device.
The document is a regulatory clearance letter for a physical medical device (IV administration sets), not a software or AI medical device. Therefore, the questions posed in the prompt about AI/algorithm performance and study methodologies are not applicable to the content provided.
§ 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.