(30 days)
GraviTech™ is a single use, disposable gravity-driven flow regulator used in conjunction with I.V. administration sets and extension sets for controlling the flow rate of I.V. solutions into the human body.
GraviTech™ Primary Sets are for use in controlling the infusion rate of I.V. fluids from the solution bag to a patient catheter, which is inserted into a human vein.
GraviTech™ Extension Sets are intended for use in conjunction with commonly used I.V. primary sets for controlling the infusion rate of I.V. fluids into the human body.
GraviTech™ is a single use, disposable gravity-driven flow regulator used in conjunction with I.V. administration sets and extension sets for controlling the flow rate of I.V. solutions into the human body.
The provided text is a 510(k) premarket notification letter from the FDA to IV Medical, Incorporated regarding their GraviTech™ Flow Controller Primary Set/GraviTech™ Flow Controller Extension Set. This document does not contain information about acceptance criteria or a study proving the device meets those criteria.
The 510(k) clearance process primarily establishes substantial equivalence to a legally marketed predicate device, rather than requiring the submission of detailed performance studies against specific acceptance criteria in the same way a PMA (Premarket Approval) would.
Therefore, I cannot provide the requested information based on the given 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.