(129 days)
Extension sets are for administering fluids from container to a patient's vascular system through a vascular access device.
Needleless valve allows the user to add medication into the without the use of a needle.
Power Injection Rating and Flowrate (400 psi and 10 mL/sec).
Not Found
The provided text is related to an FDA 510(k) clearance for a medical device called "FlowArt," an intravascular administration set. This document is a clearance letter and does not contain information about acceptance criteria or specific studies that prove the device meets those criteria.
Therefore, I cannot provide the requested information based on the input text. The text does not include:
- A table of acceptance criteria and reported device performance.
- Sample size, data provenance, number of experts, or adjudication methods for a test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
- Information on standalone algorithm performance.
- The type of ground truth used.
- Sample size or ground truth establishment for a training set.
The document primarily focuses on the regulatory clearance process and general controls for medical devices.
§ 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.