(84 days)
Not Found
The device consists of two parts; the spike assembly and the Miser fluid administration set. The spike assembly is inserted into a container of contrast media. The Miser is then attached to the spike assembly. The distal end (fixed male luer) of the Miser is attached to a manifold port (or stopcock with syringe). The stopcock on the spike assembly is opened to allow the contrast to flow into the Miser's burette chamber. The burette is filled to approximately the 10 ml level and then the contrast flow stopped by closing the stopcock on top of the burette. As contrast is withdrawn from the Miser, the level within the burette will remain at approximately the same level until the contrast in the container is depleted. The shut-off disc within the burette prevents air from entering the system when the contrast container becomes empty. The stopcock below the burette may be opened to allow the contrast contained within the proximal tubing to be aspirated.
The contrast manager is attached to a manifold port or a three way stopcock. A control syringe is connected to the manifold or stopcock on the opposite side from the indwelling catheter. Opening the port between the contrast manager and the syringe allows the syringe to aspirate contrast media. The port between the syringe and catheter is opened and the contrast can be injected into the catheter. This process can be repeated until the contrast is expended.
The provided text is a 510(k) summary for the Merit Medical Contrast Management System. It describes the device, its function, and some safety considerations. However, it does not contain information about acceptance criteria, device performance studies, sample sizes for test or training sets, ground truth establishment, expert involvement, or MRMC studies.
The document is an old 510(k) summary from 1996, and the type of information typically requested in your prompt (especially regarding AI/ML device evaluations) was not standard or relevant for this type of medical device at that time.
Therefore, I cannot fulfill your request with the provided input. The document is for a Contrast Management System, which is a hardware device for managing contrast media in a clinical setting, not an AI/ML-based diagnostic or prognostic device.
If you have a document for an AI/ML medical device, I would be happy to help you extract the requested information.
§ 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.