(40 days)
The CODAN Chemospike is a transfer pin system for the safe preparation and withdrawal of medication and cytotoxic agents. It is designed to prevent the withdrawar of modication aring reconstitution of the drug in the vial and withdrawal of the drug from the vial.
CODAN Chemospike
I am sorry, but the provided text is a letter from the FDA to a medical device manufacturer (CODAN US Corporation) regarding the substantial equivalence of their "CODAN Chemospike" device to a predicate device. This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies that would allow me to populate the requested table and answer the study-related questions.
The document primarily focuses on regulatory approval based on substantial equivalence, which is a different type of assessment than a performance study with detailed acceptance criteria.
§ 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.