(170 days)
The NIS is a needle-less device intended as an intravascular administration set accessory for the delivery of drugs and fluids. The NIS device may aid in the prevention of needle stick injuries.
The NIS is a needle-less device intended as an intravascular administration set accessory for the delivery of drugs and fluids.
The provided text is a 510(k) premarket notification letter from the FDA to Nexus Medical, L.L.C. regarding their Nexus Injection Site, NIS-8 device. This document confirms the device's substantial equivalence to a legally marketed predicate device and outlines regulatory requirements.
Crucially, this document does not contain any information about acceptance criteria or specific study results for the device's performance.
Therefore, I cannot provide the requested table or answer the questions related to studies, sample sizes, ground truth, or expert involvement based on the provided text. The letter focuses solely on the regulatory approval process and not on the technical performance data that would typically be included in a premarket submission.
§ 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.