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The AutoFuser family of ambulatory infusion pumps with integrated administration set, either separately or as part of a convenience kit, are indicated for general infusion use. Routes of infusion include intravenous, percutaneous, subcutaneous, inter-arterial and epidural, and into intra-operative (soft tissue / body cavity) sites. Within the AutoFuser family are pump models intended for patient-controlled infusion using the integrated bolus button. General infusion uses include continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, perioperative and postoperative surgery.

The AutoFuser pump (Continuous type Silicone Balloon) provides continuous fluid delivery with attached, fixed rate administration set. The pumps are supplied as fixed flow rates. A silicone balloon is used as both the fluid reservoir of the device and the pressure (energy) source. The AutoFuser pump family includes models of the standard AutoFuser with the addition of a Patient Medication Control Module (PCM). The Patient Medication Control Module allows the patient to administer a bolus of fixed volume with a fixed lockout (re-fill) time. The pump is a disposable device intended for single patient use. The pump is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites. The AutoFuser and the AutoFuser PCM pumps are substantially similar to the I-Flow Homepump (Eclipse) C-Series (included in the I-Flow PainBuster kit and the On-Q pain management kit), the Baxter Infuser and Intermate, the McKinley Accufuser, and the B Braun spring pump (used in the Sgarlato pain kit). The AutoFuser and the AutoFuser PCM pumps have fill volumes and flow rates substantially similar to the pumps of the McKinley Medical Accufuser, the I-Flow PainBuster (Homepump Eclipse C-Series), the B Braun spring pump included in the Sgarlato PCIP, and the Baxter Infusor and Intermate pumps. The AutoFuser and AutoFuser PCM pumps and the identified predicate device use either a glass orifice or PVC tubing to control the flow rate. All fluid path materials of the AutoFuser pumps are in conformance with ISO 10993 Part 1.