(81 days)
The SmartSite® Vented Vial Access Device is intended for use by healthcarc professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies for reconstitution or dispensing of medication. The SmartSite® Vented Vial Access Device is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.
The SmartSite® Vented Vial Access Device (Vented VAD) is a stand-alone, single use, multiple-dose device with a SmartSite® Needle Free Valve and a 0.2 micron hydrophobic air-venting filter for use with rubber-stopper vials. The device is intended for use when reconstituting Ivophilized drugs and/or when dispensing medications, particularly hazardous drugs such as chemotherapeuties.
I am sorry, but the provided text does not contain specific acceptance criteria or details of a study that proves the device meets such criteria. The document is a 510(k) summary for the SmartSite® Vented Vial Access Device, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than reporting on specific performance studies with detailed acceptance criteria.
While it mentions "performance data indicate that the SmartSite® Vented Vial Access Device meets specified requirements and is substantially equivalent to the predicate devices," it does not elaborate on what those specific requirements or the performance data entail. Therefore, I cannot extract the information required for your request.
§ 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.