(77 days)
A device used to regulate the flow of fluids from a container, such as an I.V. bag, to a patient's vascular system, through a needle or catheter inserted into a vein. For single use.
Stable Flow, I.V. Flow Controller
The provided document is a 510(k) clearance letter from the FDA for a device named "Stable Flow IV Flow Controller." This document primarily indicates that the device has been found substantially equivalent to a predicate device and is cleared for market. It does not contain a detailed study report or specific acceptance criteria and performance data for the device itself.
Therefore,Based on the provided document, I cannot fulfill the request as it asks for information (acceptance criteria, study details, sample sizes, ground truth establishment, MRMC studies, etc.) that is not present in the FDA 510(k) clearance letter.
The letter acknowledges the submission and clarifies the regulatory pathway, but it does not include the technical study details that would typically be found in a study report.
§ 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.