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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 Its introducer needle is inserted at a right angle into the subcurtaneous tissue of the infusion site and then withdrawn to leave the indwelling catheter in place.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).

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