(89 days)
The SafeLine Multidose Vial Adapter is intended for multiple withdrawals of drug solution from standard size drug vial solid stoppers. The spike portion of the SafeLine Multidose Vial Adapter is inserted into the drug vial solid stopper and the drug solution is withdrawn using a blunt plastic cannula connected to a syringe. The fluid is withdrawn into the syringe through the blunt plastic cannula inserted into the injection site portion of the SafeLine Multidose Vial Adapter. The drug solution in the syringe can then be transferred to an I.V. administration set with a pre-slit septum injection site for administration of the drug solution to the patient. The SafeLine Multidose Vial Adapter replaces use of a traditional metal hypodermic needle to provide needlefree access to drug vials. Thus, eliminating the potential for accidental needlestick injury.
The SafeLine™ Multidose Vial Adapter is an additional accessory device for use with McGaw's SafeLine System. It is a single sterile plastic device composed of a pre-slit rubber septum injection site, a standard drug vial spike and a plastic spike tip protector. The SafeLine Multidose Vial Adapter is designed to withdraw drug solution from the solid stopper of standard size drug vials using a blunt plastic cannula attached to a syringe. Thus providing needlefree access of drug vials. As with all of the currently marketed SafeLine devices, the new SafeLine Multidose Vial Adapter is tinted green to signify a needle free SafeLine product.
This is a 510(k) premarket notification for a medical device (SafeLine™ Multidose Vial Adapter), not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and AI-specific metrics (like MRMC studies or training set details) is not applicable to this document.
The document describes a conventional medical device and focuses on demonstrating substantial equivalence to a predicate device based on material composition, functional performance, and microbiological challenge testing.
§ 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.