(50 days)
For use by patients at home and clinicians in a medical office setting to communicate with devices that utilize Paradigm pump compatible RF telemetry (i.e. MMT-511). MMT-7304 is intended for use in downloading device information when commanded by MMT-7311 operating on a PC and MMT-7304 is connected in line with the PC's serial port.
The Medtronic MiniMed Communication System is a data transfer system consisting of a hardware component designated by Medtronic MiniMed model number 7304 and a software component designated by model number 7311. The system is designed for use with Medtronic MiniMed infusion pump (model 511). The hardware component of the ComLink consists of a radio-frequency (RF) transceiver enclosed in a plastic housing and one female RS-232 compatible serial communications port. Data is downloaded via RF telemetry to transfer data from the pump to a personal computer. The Converts RF signals into RS-232 compatible electrical pulses, which are sent through a serial port to the PC.
The provided text is a 510(k) summary for the Medtronic MiniMed ComLink Communication System. It describes the device, its intended use, and compares it to a predicate device. However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the other specific details requested in your prompt.
A 510(k) summary primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device. While this involves ensuring the new device is safe and effective, the detailed study design, performance metrics, and statistical analyses that would typically be found in a comprehensive clinical or performance study report are not part of this summary document.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based only on the input provided. The requested information is simply not present in this 510(k) submission.
§ 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).