(143 days)
The PSI Model 1200 ambulatory infusion pump is a multifunction pump designed to manage a wide variety of intravenous fluid profiles.
The PSI Model 1200 is a small portable ambulatory infusion pump intended for hospital, clinic and home care use. It uses dedicated disposables and related accessories.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The text describes a 510(k) summary for the "Model 1200 Ambulatory Infusion Pump" and focuses on establishing its substantial equivalency to existing legally marketed devices. It details the device's description, intended use, and technological characteristics, but it does not include performance metrics, study designs, sample sizes, expert qualifications, or ground truth methodologies that would be needed to answer your request.
Therefore, I cannot provide a response with the requested information based on the input given.
§ 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).