(21 days)
For preparing and dispensing I.V. fluids and chemotherapeutic medications from stoppered vials
Not Found
I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The text is a 510(k) clearance letter from the FDA for a device called "Chemo Dispensing Pin," which primarily addresses regulatory approval based on substantial equivalence to a predicate device.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes or data provenance for any test sets.
- Information on the number or qualifications of experts establishing ground truth.
- Adjudication methods.
- Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or human-in-the-loop performance.
- Details of a standalone algorithm performance study.
- The type of ground truth used.
- Sample sizes for a training set or how ground truth for a training set was established.
This document is a regulatory approval notice, not a study report or technical specification outlining performance metrics and validation studies.
§ 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.