SIDEKICK INFUSION KIT

• K Number: K990425
• Device Name: SIDEKICK INFUSION KIT
• Manufacturer: I-FLOW CORP.
• Date Cleared: 1999-04-23 ( 71 days)
• Product Code: FRN
• Regulation Number: 880.5725
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: K984146 , K923875 , K980558 , K982946 , K896422 , K944692 , K982256
• Predicate For: N/A

Intended Use

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.

Device Description

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.

AI/ML Overview

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

Acceptance Criteria (Operational Specification)	Reported Device Performance (Flow Rate Performance Data)
Residual Volume:

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).