(231 days)
THIS DEVICE IS USED AS AN ACCESSORY FOR WHICH CAN BE CONNECTED TO A FEMALE LUER CONNECTOR, ie; WINGED INFUSION SET OR AN I.V. SET, FOR INFUSION OF MEDICATION TO A PATIENT. IT IS STERILE , DISPOSABLE & "ONE-DIRECTIONAL FLUID FLOW DEVICE".
Not Found
This document is a marketing clearance letter from the FDA for a medical device, the "Exel Injection Plug W/Cap." It confirms that the device is substantially equivalent to a predicate device and can be marketed.
The document does NOT contain information about acceptance criteria, study details, or device performance metrics for the Exel Injection Plug W/Cap.
Therefore, I cannot provide the requested table and information as it is not present in the provided text. The letter primarily focuses on regulatory approval based on substantial equivalence, rather than a detailed performance study.
§ 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.