(150 days)
The ACCU-CHEK Spirit Insulin Infusion Pump is intended for the subcutaneous continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician.
The ACCU-CHEK Spirit Insulin Infusion Pump is an external, portable insulin pump designed for continuous delivery of insulin. The design allows the delivery of 0.1 to 25.0 units of U100 insulin per hour in basal rates and up to 25.00 units of U100 insulin per meal or meal bolus.
The provided text does not contain specific acceptance criteria, study details, or performance metrics for the ACCU-CHEK Spirit Insulin Infusion Pump.
The document is a 510(k) summary and FDA clearance letter, which primarily focuses on establishing substantial equivalence to predicate devices rather than presenting detailed performance studies with acceptance criteria.
The only statement related to device performance is a general claims that "Testing of the ACCU-CHEK Spirit demonstrated that the device meets the resuirements for its intended use. The data also demonstrates that the ACCU-CHEK Spirit is substantially equivalent to the predicate devices." No specific criteria or reported performance values are given.
Therefore, I cannot provide the requested table and detailed information about the study as the necessary data is not present in 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).