(328 days)
Extension sets are for administering fluids from container to a patient's vascular system through a vascular access device. Used for the removal of particulate matter and elimination of air from infusion fluids while administering. Stopcocks are intended for use to change the direction of fluids through a tubing set. Needleless valve allows the user to add medication into the without the use of a needle.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Flowart" and does not contain the detailed information you requested about acceptance criteria and the study proving the device meets them.
The document primarily focuses on:
- The FDA's determination of substantial equivalence to a predicate device.
- Regulatory requirements and guidelines for the manufacturer.
- The indications for use of the Flowart device (extension sets, stopcocks, needleless valve).
It does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test or training sets.
- Information on data provenance, expert qualifications, or adjudication methods.
- Details about MRMC studies, effect sizes, or standalone algorithm performance.
- The type and establishment of ground truth.
Therefore, I cannot fulfill your request with the information provided.
§ 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.