(38 days)
The NOA III Enteral Nutrition Pump is designed to deliver programmed doses of enteral nutrition solutions at selected rates. The pump is designed to be used in hospital and home care environments. The pump can be used in stationary and ambulatory ways.
The NOA III Enteral Nutrition System includes: Infusion Pump, Battery Charger.
The provided text is a 510(k) premarket notification letter from the FDA to Caesarea Medical Electronics Limited regarding their NOA III Enteral Nutrition Pump. It does not contain any information about acceptance criteria or a study that proves the device meets those criteria.
The document states that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices. This determination is based on the information provided by the manufacturer in their submission, but the letter itself does not detail the specific performance studies or acceptance criteria.
Therefore, I cannot provide the requested information based on the input text. The document is primarily an approval letter, not a device performance report.
§ 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).