(95 days)
Diasend is intended for transmitting data from home monitoring devices such as glucose meters and insulin pumps to a server data base.
Diasend is a system for transmitting of data from patients home monitoring devices and consists of a transmitter, a server database and a website available for the care provider and the patient.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted. The document is a 510(k) summary and FDA clearance letter for the Aidera Diasend System, which describes its intended use and classification but does not include details on performance studies or validation.
§ 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).