(137 days)
For the delivery of blood or blood related solutions by or on the order of a physician or other licensed practitioner.
Not Found
I am sorry, but based on the provided text, there is no information about the acceptance criteria and study proving device performance as requested. The text consists of an FDA 510(k) clearance letter for the "Protos Blood Transfusion Set" and its indications for use. This document confirms the device's substantial equivalence to a predicate device but does not detail performance studies, acceptance criteria, or any of the specific points you've asked for regarding AI/algorithm performance.
§ 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.