(140 days)
The Animas Corporation R1000 Series Insulin Pump is intended to provide subcutaneous delivery of insulin at programmable basal and bolus rates for the daily management of Type 1 and certain instances of Type 2 diabetes mellitus. The pump is indicated for use in diabetics who have good personnal hygiene, who have established control over their blood glucose and who do not have unpredictable or large variations in blood glucose levels.
The Animas Corporation R1000 Series Insulin Pump is intended to provide subcutaneous delivery of insulin at programmable basal and bolus rates for the management of diabetes mellitus in insulin dependent patients.
This device is intended for home use and is a prescription device.
Not Found
This 510(k) summary for the Animas Corporation R1000 Series Insulin Pump does not contain the information required to populate the acceptance criteria table or describe a study proving the device meets acceptance criteria.
The provided text focuses on regulatory approval, intended use, and substantial equivalence to predicate devices, rather than presenting detailed performance data or a specific study designed to demonstrate compliance with acceptance criteria.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.
§ 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).