(313 days)
for use in the infusion of chemotherapy, antibiotherapy, patient controlled analgesia, anti-emetic therapy, parenteral nutrition, and other infusion therapies that require continuous, bolus or intermittent delivery.
MELODIE INFUSION PUMP
This document is a 510(k) premarket notification letter from the FDA regarding the Melodie® Infusion Pump. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets such criteria. It is a regulatory approval letter, not a performance study report.
Therefore, I cannot provide the requested information based on the input.
§ 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).