(148 days)
The Medtronic MiniMed Paradigm Model MMT-512, MMT-712, MMT-515 and MMT-715 insulin infusion pumps are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
Not Found
The provided document is a 510(k) clearance letter for an insulin infusion pump. It does not contain information on acceptance criteria, device performance, study details, ground truth, or sample sizes related to a medical device's performance in a study. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and is thus cleared for marketing.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided text.
§ 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).