(217 days)
The Nexus I.V. Vial Access Device is intended for use to aid healthcare professionals in mixing and transferring I.V. fluids / medication from a rubber-stopper medication vial to another device, through a needle-free system that aids in the elimination of needle stick injuries.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a medical device. It does not contain any information about the acceptance criteria or a study that proves the device meets those criteria.
The letter states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This determination is based on the information provided by the manufacturer (Nexus Medical, LLC) in their 510(k) submission, which would include performance data, but that specific data and the acceptance criteria themselves are not detailed in this clearance letter.
Therefore, I cannot answer your request for a table of acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth information based on the provided text.
§ 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.