(98 days)
The SmartSet Insulin Infusion Device is intended for the subcutaneous infusion of medicine, including insulin, from an external infusion pump.
Indication for Use: Intended for the subcutaneous infusion of medicine, including insulin, from an external infusion pump
The SmartSet Insulin Infusion Device is intended for the subcutaneous infusion of medicine, including insulin, from an external infusion pump. Its introducer needle is inserted at a right angle into the subcurtaneous tissue of the infusion site and then withdrawn to leave the indwelling catheter in place. The pump end of the Smart-Set tubing is attached to an external infusion pump. Following the pump manufacturer's instructions, the tubing is primed until medication drips from the connector needle. The SmartSet end of the tubing is aligned with the SmartSet hub and then firmly locked together.
The provided text is a 510(k) summary for the SmartSet Insulin Infusion Device. It explicitly states that "Appropriate information relative to the biocompatibility of the device's components and the sterilization of the finished device, but not clinical study findings, were submitted."
Therefore, based on the provided document, there are no clinical study findings, acceptance criteria, or performance data available to address the requested points. The device's substantial equivalence was determined based on its similarity to a predicate device and non-clinical data (biocompatibility and sterilization).
§ 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.