(110 days)
- For aspiration or iniection of medical from inverted multidose vials and bags
- For use as part of a program to reduce the occurrence of needle stick injuries and the associated transmission of blood bome pathogens such as HIV and HBV.
- For use up to 24 hours, or in accordance with current guidelines of IV therapy.
- For use with standard luer taper connections.
- For singe patient use.
The CDC Vial and Bag Access Pin are adapters which pierce a rubber stoppered drug vial and/or bag and allows access to the contents. The CDC Vial and Bag Access Pins will be available with and without a 2-way luer activated check valve or with an extension line. The luer activated check valve or extension line is used to prevent loss of medication during aspiration or injection from inverted vials or bags. The 0.45 micron air vent is used to eliminate air and particulates in the vial or bag contents during aspiration. The CDC Vial and Bag Access Pin are provided sterile and non-pyrogenic in sealed single unit pouches.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or a study that employs AI or machine learning.
The document describes a medical device called "CDC Vial and Bag Access Pins," its features, intended use, and a nonclinical test summary concerning biocompatibility. It concludes by stating the device's safety, effectiveness, and substantial equivalence to a legally marketed predicate device.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving a device meets them, especially with components related to AI, machine learning, expert reviews, or comparative effectiveness studies.
§ 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.