(50 days)
The CODAN US Extension Set is indicated to facilitate the infusion of IV fluids from a plastic bag or solution container into the patient.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical device called "Extension Set Light-Safe BC565." This document outlines the regulatory approval of the device and confirms its substantial equivalence to a legally marketed predicate device.
However, the letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment.
The document is purely a regulatory clearance and does not detail the technical performance or validation studies of the device. Therefore, I cannot generate the requested table and information based on the provided text.
§ 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.