(83 days)
Indicated as a single use, sterile device for use in I.V. therapy when an extended fluid path is required for administration.
Environment of use: Hospital, Emergency Medical Services, Home care settings wherever I.V. fluid administration may be indicated.
The Custom Assemblies Extension Set is a tubing set with various connectors, and accessories, such as drip chambers, infusion line filters, clamps, integral check valves, spikes, Y-site injection sits used as an extension of a fluid pathway for I.V. administration.
The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) submission for a medical device (Extension set/Intravascular Administration Set), focusing on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria.
Therefore, I cannot extract the requested information from the provided text.
§ 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.