(106 days)
The Dragon Heart Intravascular Administration Set is a device intended to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein.
Not Found
This looks like a 510(k) clearance letter for an Intravascular Administration Set, not a study describing the acceptance criteria and performance of a device, especially not one that would involve AI or expert readers.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document is a regulatory approval letter from the FDA stating that the "Dragon Heart Intravascular Administration Set" is substantially equivalent to legally marketed predicate devices, meaning it has met the regulatory requirements for marketing. It does not contain information about:
- A table of acceptance criteria and reported device performance.
- Sample size for a test set or data provenance.
- Number of experts or their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study or human reader improvement.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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.