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The MiniMed 407C Infusion Pump is indicated for infusion of medications For USC. The Ministration, at set and variable rates, for therapies including chemotherapy, antibiotic therapy, and controlled analgesia.

The 407C cxtcmal pump is a syringe-reservoir, rate-programmable pump designed for infusion of medication appropriately labeled for subcutancous administration, at set and variable rates, as prescribed by the user's physician. The 407C is restricted to sale by or on the order of a physician. It is is, not intended nor indicated for the delivery of blood or blood products. The principal modifications described in this, submission are: 1) The device is indicated for use with medication labeled for subcutancous administration. 7) A Low Reservoir Alert feature has been incorporated that will sound when the reservoir plunger reaches the point where approximately 0.200 ml of medication remains. 3) A 'Take a Break' Bolus feature has been added to deliver a bolus before disconnecting from the pump to help the patient remain above the minimum therapeutic lovel of the medication for the duration of the break. 4) Three lockout levels have been incorporated so that some for etturns will not be accessible to the patient. 5) The Bolus feature and the 'Take a Break' Bolus feature can be turned on and off. 6) A Suspend/Storage Mode has been incorporated in which no recurring alcrt will remind the user of that condition. 7) The medication concentration feature has been eliminated. The medication rate will be adapted by delivery rate of the pump only. 8) The square wave bolus and dual wave bolus have bolus have been climinated. A normal bolus can be administered. 9) The temporary basal rate feature has been eliminated. 10) Forty-cight basal rates have been replaced by a single rate. 11) The Auto Off and Audio Dolus features have been climinated. 12) The LCD has been revised so that the word RATE will replace BASAI., PROG will replace SET, and ML will replace U for the anount of medication displayed. 13) Two new icons, a low reservoir icon and a lock icon, have been incorporated.

The provided text does not contain information about acceptance criteria and a study proving device performance in the format requested. The document is a 510(k) summary for the MiniMed Model 407C Infusion Pump, focusing on its substantial equivalence to predicate devices and its intended use. It describes modifications to the device and makes a general statement about safety and effectiveness, but it does not detail specific acceptance criteria or report on a study designed to meet them.

Therefore, I cannot extract the requested information from the provided text.

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