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Intended use: The Avoset Infusion Pump is a single-channel, volumetric infusion is delivered at continuous rate, and/or with an intermittent bolus, and/or with a patient bolus and/or with taper. Indication of use: Routes: Parenteral (intra-arterial, intra-venous, subcutaneous, perineural, epidural) and enteral infusions Fluids: IV medication (including fluids), Total Parenteral Nutrition (TPN), enteral medication and nutrition, lipids, epidural medication. Program Types (specific uses): The pump delivers in one of four program types: a continuous rate of infusion, and/or an intermittent bolus, and/or with patient-controlled intermittent doses, and/or with tapering. Patient Population: Pediatric: infants, children, and adolescents and adult patients. Intended Environments. Intended to be used in clinical environment including, home, plane and ground transportation. Users: licensed health care professional and lay users The dedicated Administration Sets for the Avoset Infusion Pump are intended for single-patient use and single-use only. Set configurations are: (i) Enteral; (ii) Epidural and (iii) General purpose for the routes: intra-arterial, intravenous, subcutaneous, perineural. The Avoset Programming Tool is intended to be used with a computer to create a treatment-based protocol that is boaded onto the pump. The programming tool is intended for use by professional users.

The Avoset Infusion system (pump and accessories) covered by this submission is the Avoset infusion pump, an ambulatory pump intended for controlled infusion at rates between 0.1-300 mL/h at a continuous rate, and/or with an intermittent bolus, and/or with a patient bolus and/or with taper, in the hospital and home environments for pediatric and adult patients. The Avoset infusion pump weighs 365 grams, has 89 parts, and allows infusion from (i) bags; (ii) syringes; and (iii) non collapsible medication reservoirs. The device also contains an optional module (referred to as "Insight Tool"). The module receives data from the pump and uses it for (i) fleet management and (ii) treatment monitoring applications to ensure patient has completed the treatment. This module does not impact or pass data into the pump. The dedicated Avoset Administration Sets are sterile (apart of the Enteral sets) and intended for singlepatient use and single-use only.