(72 days)
An extension set to be used as an extension to the Intravascular administration set to be assul in the IV extension set will connect the administration set to a catheter or needle inserted into a vessel. The IV IV administration bet to a calleless access devices to protect the users from needle stick injuries.
Not Found
This document is a marketing clearance letter from the FDA for a medical device, specifically "Starluck® IV Extension Sets with Needleless Access Devices." It states that the device is substantially equivalent to legally marketed predicate devices and outlines general controls and regulations.
Unfortunately, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is an administrative document related to market approval, focusing on regulatory classification and substantial equivalence, not performance testing details.
Therefore, I cannot provide the requested information based on the provided text.
§ 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.