(31 days)
The BAXJECT II Needleless Transfer Device is intended for transferring and mixing drugs contained in two vials into a syringe.
BAXJECT II is a dual sided needleless transfer device designed for transferring and mixing drugs contained in two vials into a syringe. The double-sided device has a vial holder on each end. Siliconized plastic piercing spikes are designed for easy penetration into the rubber stopper of standard 20mm vials. A deployable tube reduces the potential for foaming during reconstitution of powdered materials. The device filters air passing into the system to relieve vacuum. A standard luer connector with embedded product filter allows for the mixed drug to be transferred into a syringe.
The provided text is a 510(k) Premarket Notification for the Baxter BAXJECT II Needleless Transfer Device. This type of document focuses on establishing substantial equivalence to a predicate device and does not contain information about clinical studies with acceptance criteria, performance metrics, or details typically found in AI/ML device studies.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC comparative effectiveness studies. The document describes a medical device for transferring and mixing drugs, not an AI/ML-driven diagnostic or prognostic tool.
§ 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.