(44 days)
The MedSource IV Set is designed to administer parenteral fluids from a container to a vascular system through a needle or catheter inserted into a vein.
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The provided text is a 510(k) premarket notification letter from the FDA regarding a MedSource IV Administration Set. This document is a regulatory approval notice for a medical device and does not contain information about software or AI-powered devices, nor does it detail acceptance criteria, study designs, or performance metrics in the way requested for an AI/ML device.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document is solely focused on the regulatory approval of a physical medical device (an IV administration set) based on substantial equivalence to a predicate device, not on the performance evaluation of an AI/ML algorithm.
§ 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.