(66 days)
The Paradigm Insulin Pump system is indicated for the continuous delivery of insulin, at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
Medtronic MiniMed Paradigm Insulin Pumps (Model No. MMT-512); Medtronic MiniMed Paradigm Insulin Pumps (Model No. MMT-712); Medtronic MiniMed Paradigm Insulin Pumps (Model Nos. MMT-515, MMT-715)
I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a Medtronic MiniMed Paradigm Insulin Pump System, outlining its substantial equivalence to predicate devices and general regulatory information. It does not include details on specific performance criteria or a study describing how those criteria were met.
§ 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).