(286 days)
This device is an integral part of blood collection (intravenously) used in connection with luer adapter for collection of whole blood into tubes.
Not Found
This document is a 510(k) premarket notification decision letter from the FDA for the "EXEL Vaculet Blood Collection Set". It is an administrative document and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot fulfill your request based on the provided text. The document confirms that the device is substantially equivalent to a predicate device, which is a regulatory determination, not a 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.