(317 days)
The Animas ezManager Plus is indicated for use as an accessory to the Animas IR1000 insulin pump and a number of commercially available blood glucose meters to download data from these devices to a patient's or a physician's personal computer where it may be displayed, printed, and saved. The Animas ezManager Plus is also indicated for the management of diabetes by calculating an insulin or carbohydrate dose based on physician prescribed settings and user entered data.
The Animas ezManager Plus diabetes management software is intended for a Microsoft Windows based personal computer or a Palm handheld organizer. The ezManager Plus allows the user to download, view, print, and save data from a number of commercially available glucose meters and the Animas IR1000 Insulin Infusion Pump. It also calculates an insulin or carbohydrate dosage based physician prescribed settings and data entered by the user. This software was developed using a Borland Delphi integrated development environment using an MS Access database structure and ActiveX Data Objects database connections. The synchronization dynamic library is totally compliant with the Palm Operating System (OS) Conduit requirement and was developed using Microsoft Visual C++ and the Palm OS Software Development Kit.
The provided text is a 510(k) summary for the Animas ezManager Plus, an insulin pump and glucose meter management software. It describes the device, its intended use, and its comparison to predicate devices, ultimately leading to a finding of substantial equivalence by the FDA. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert involvement, or ground truth establishment.
Therefore, I cannot fulfill your request for the specific details outlined in your prompt based on the provided text. The document focuses on regulatory approval based on substantial equivalence to existing devices, rather than detailed performance study results.
§ 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).