(93 days)
This Infiltration Pump is used to cause a flow of fluid from an IV bag into patient in a manner controlled manually by a health care professional. The Klein Pump is not intended to be used as an IV infusion pump.
Not Found
The provided text is an FDA 510(k) clearance letter for the Klein Surgical Infiltration Pump, Model KIP-II. It does not contain any information regarding acceptance criteria, device performance studies, or details about ground truth, sample sizes, or expert qualifications as requested in the prompt.
This type of FDA letter confirms that the device is substantially equivalent to a predicate device and can be marketed, but it does not typically include the detailed study results that would be found in a comprehensive submission document or scientific publication. Answering the prompt would require information not present in the provided text.
§ 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).