(278 days)
To allow multiple needleless accesses to an injection vial for the purpose of facilitating the withdrawal or addition of drugs/solutions from or to the vial.
Not Found
The provided text is an FDA 510(k) clearance letter for the "FlowArt® Valve for Vial Access". This document does not contain any information about acceptance criteria for an AI/ML device, nor does it describe a study proving such a device meets acceptance criteria.
The 510(k) is for a physical medical device (a valve for vial access), not an AI/ML software device. Therefore, it does not discuss topics such as sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.
To answer your request, I would need a different document that pertains to the clearance of an AI/ML driven medical device. The current document is irrelevant to the specific questions asked as it focuses on the substantial equivalence of a physical medical device to a predicate device, and the general regulatory requirements for marketing such a device.
§ 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.