(232 days)
The AU2 Med-I'lo Solution Sct is intended to be used to provide a sterile pathway from the solution source (T.V.bag) to the patient's intravascular catheter. The flow of the solution is accomplisched i by gravity flow.
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This document is a 510(k) clearance letter from the FDA for a medical device called the "AB2 Med-Flo Solution Set." It's a regulatory approval document, not a study report or technical specification document detailing acceptance criteria and performance data.
Therefore, the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is not present in the provided text. The letter only states that the device is "substantially equivalent" to previously marketed devices and can be marketed subject to general controls.
§ 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.