(96 days)
Administration of blood and blood by-products.
Fenwal markets a broad range of intravascular administration sets for administration of I.V. solutions or blood involving hundreds of different sets marketed. While the design of these sets differs for each particular application, they are all based on a common basic design involving polyvinyl chloride extruded tubings, with attendant extruded or injection molded connecting parts of other thermoplastics (such as acrylic, ABS, nylon, and similar polymers) plus latex and synthetic rubber injection sites.
This document is a 510(k) summary for Fenwal's Blood Component Recipient and Infusion Sets. It does not contain a study evaluating the performance of the device against specific acceptance criteria.
Instead, this document focuses on demonstrating substantial equivalence to previously cleared predicate devices (K881321 and K811078).
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them, because such a study is not part of this 510(k) submission. The submission states: "Since this 510(k) notification is only being submitted to obtain a number under Fenwal, the safety and effectiveness for these products have not changed." This implies that the design and performance characteristics are identical to the predicate devices, and a separate study for this 510(k) was not deemed necessary for safety and effectiveness, as long as it is proven to be substantially equivalent.
§ 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.