(29 days)
The intended use of the Belmont Hyperthermia Pump is to raise the temperature of the thoracic or peritoneal cavity to the desired target temperature by continuously lavaging the cavity with circulating warmed sterile solution, according to a protocol to be selected by the physician.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Belmont Hyperthermia Pump). This document does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the format you've requested. It primarily focuses on the regulatory clearance of the device based on its substantial equivalence to predicate devices, rather than detailed performance study results against specific criteria.
Therefore, I cannot extract the information required to populate your table and answer your questions.
§ 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).