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The SideKick Infusion Kit is intended to provide continuous infusion of a local anesthetic directly into an intraoperative (soft tissue / body cavity) site for general surgery for postoperative pain management. Additional routes of administration include percutaneous, subcutaneous, intramuscular and epidural infusion.

The SideKick Infusion Kit is identical to the I-Flow Paragon Infusion Kit with the exception of the SideKick pump and administration set replacing the Paragon pump and administration set. The kit is comprised of a SideKick pump and administration set and various kit components such as catheter, needle, syringe, Y adapter, dressing, tape, gauze and carry case. The SideKick administration set is intended to attach to the kit catheter at the distal end of the set to provide continuous infusion of a local anesthetic directly into the intraoperative site for general surgery for postoperative pain management. The SideKick administration set is a disposable device intended for single patient use. The SideKick pump is reusable. The SideKick is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.

This document describes the SideKick Infusion Kit, an infusion pump kit. Here's an analysis of the acceptance criteria and supporting study information:

1. Acceptance Criteria and Reported Device Performance

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