(26 days)
For use with any I.V. set assembled on commercially available I.V. pumps (not equipped with free flow protection), in order to prevent free flow of drugs or I.V. fluids.
Anti Free Flow Valve
This document is a 510(k) clearance letter from the FDA for a medical device called the "Free Flow Safety Device, Model MG 245052," also referred to as an "Anti Free Flow Valve." The letter confirms that the device is substantially equivalent to a legally marketed predicate device.
However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The document is solely a regulatory clearance letter and does not include the detailed technical study information that would typically be part of a 510(k) submission's supporting data.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study proving the device meets them based on the provided input. This document only confirms that the device has received FDA clearance for marketing.
§ 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.