(81 days)
The Primary I.V. Set with Backcheck Valve is used for the delivery of I.V. fluids through the primary line or through the attachment of a secondary line into the backcheck valve. A backcheck valve prevents the intermixing of fluids while the secondary line is running. Then, when the secondary line is emptied, the valve automatically restores flow from the primary container.
Primary I.V. Set with Backcheck Valve
This document is a 510(k) clearance letter from the FDA for a medical device called "Primary I.V. Set with Backcheck Valve." It does not contain information on acceptance criteria, device performance, an associated study, or any of the other specific details requested in the prompt (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information).
The letter simply states that the FDA has reviewed the manufacturer's notification and determined that the device is substantially equivalent to legally marketed predicate devices. It then outlines the regulatory framework and responsibilities for the manufacturer.
§ 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.