(181 days)
The Talon insulin pump infusion set is an administration infusion set intended to be used for subcutaneous infusion of medicine solutions, such as insulin, from an external infusion pump
The Talon infusion sets are connected to a medication reservoir proximally (i.e., a syringe that is placed within an infusion pump, such as an insulin pump) and distally inserted into the subcutaneous tissue of the user. The infusion set attaches to the medication reservoir by means of a female luer connector and is inserted into the patient through an introduction cannula. The 26 gauge indwelling catheter is connected to tubing of various lengths. The materials used for the components include: PVC/polyethylene; polyvinyl chloride; polytetrafluorethylene; stainless steel; polycarbonate; polypropylene; and, trace amounts of silicone as a lubricant. All of these materials are typically used in medical devices.
The provided text does not contain information about acceptance criteria or specific studies detailing device performance against those criteria for the Talon Infusion Set. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance study data.
Therefore, I cannot complete the table or answer the questions based on the provided input. The document primarily describes the device, its intended use, and confirms its 510(k) clearance by the FDA.
§ 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.