(72 days)
The Empower Transfer Set is intended to deliver fluid (contrast media or saline) from a container into a CT power Injector syringe.
The Empower Transfer Set is a disposable set used to transfer contrast media or saline from a container that can be spiked to a CT power Injector syringe.
This document is a 510(k) summary for the E-Z-EM Empower Transfer Set, seeking clearance for a medical device. It does not contain information about studies or acceptance criteria for device performance in the way a clinical or AI performance study would.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on regulatory compliance, device description, and comparison to a predicate device, not on analytical or clinical performance studies with specific acceptance criteria and detailed study designs.
§ 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.