(62 days)
The Medtronic MiniMed Paradigm Model 511 Insulin Pump is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
Not Found
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets without AI assistance. The document is a 510(k) clearance letter for the Medtronic MiniMed Paradigm Model 511 Insulin Pump, which confirms its substantial equivalence to a predicate device. It does not include details about device performance studies, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.
§ 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).