(119 days)
FlowArt® Needle-Free Split Septum Valve: Needle-free valve is intended for use as an accessory to a vascular access device used in Hemodialysis or as an accessory to an Intravascular Administration Set for the administration or withdraw of fluids to a patient through a cannula or needle placed in the vein.
FlowArt® Needle-Free Split Septum Valve
I am sorry, but the provided text only contains an FDA clearance letter for a medical device called "FlowArt® Needle-Free Split Septum Valve" and its indications for use. It briefly describes the device's purpose as an accessory for vascular access devices in hemodialysis or for administering/withdrawing fluids via an intravascular administration set.
This document does not include information about:
- Acceptance criteria or reported device performance in a table format.
- Details of a study proving the device meets acceptance criteria.
- Sample sizes, data provenance, number of experts, adjudication methods, or ground truth details for any test or training sets.
- Information regarding multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
Therefore, I cannot provide a detailed response to your request based on the given input. The document is solely an FDA clearance letter confirming substantial equivalence to predicate devices, not a study report.
§ 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.