(229 days)
The Infusion Sets with Precision Filter for Single Use is indicated for the delivery of fluids from a container to a patient's vascular system for short term infusions only.
The Precision Infusion Filter for Single Use is intended to be used with administration sets for removal of particulate matter during the administration of fluids or medications.
The Extended Infusion Sets for Single Use is intended to be used in I.V. therapy when an extended fluid path is requirement for administration.
The purpose of this submission was to introduce new products into interstate commerce. This is a bundled submission which includes Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use and Extended Infusion Sets for Single Use.
Infusion Sets with Precision Filter for Single Use is indicated for the delivery of fluids from a container to a patient's vascular system under the action of gravity. The proposed devices are comprised of protective cap, closure-piercing device, air vent, drip chamber, precision filter, flexible tubing, injection site, flow regulator, clamp, conical fitting, burette and needle tube. The devices are provided sterile and single use.
Precision Infusion Filter for Single Use is intended to be used with administration sets or extension sets for removal of particulate matter during the administration of fluids or medications. The proposed devices are comprised of protective Cap and precision filter. The devices are provided sterile and single use.
Extended Infusion Sets for Single Use is intended to be used in I.V. therapy when an extended fluid path is requirement for administration. The proposed devices are comprised of protective Cap, flexible tubing, conical fitting and precision filter. The devices are provided sterile and single use.
This document describes various infusion sets and filters, but it does not describe a study involving an AI device. The document is for a 510(k) premarket notification for medical devices (infusion sets and filters), focusing on demonstrating substantial equivalence to predicate devices, not on AI performance. Therefore, I cannot provide an answer based on 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.