(93 days)
Decanting device intended for the aseptic dispensing of solutions from IV containers. For use in Docalining at 100 minumedication from a vial to an IV fluid administration device.
Not Found
I am sorry, but the provided text from the FDA 510(k) letter for the Medline Vial Decanter does not contain the specific information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a device performance study.
The document is a clearance letter indicating that the device is substantially equivalent to a legally marketed predicate device. It defines the device, its regulation number, and product code, and states its indications for use. It also provides general information about FDA regulations but does not include details about a performance study with specific acceptance criteria or results.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or other study-related details based on the information given.
§ 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.