(567 days)
The V Set is suitable for intravenous infusion of drug solutions and fluids and has been designed to connect multiple infusion lines, functioning in the administration of intravenous fluids from a number of sources into one cannula.
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I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study to prove acceptance, or any of the other specific details requested in your prompt.
The document is a letter from the FDA to Henning Enterprises Europe S.R.L. regarding their "V Set" device. It is a 510(k) premarket notification letter, indicating that the device has been found substantially equivalent to a legally marketed predicate device. It also includes an "Indications for Use Statement" for the V Set.
This type of document typically confirms regulatory clearance but does not contain detailed study results, acceptance criteria, or performance metrics.
§ 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.