(60 days)
The Reliance Medical Bi-Phasic Infiltrator indication for use is: General surgical fluid irrigation and infiltration.
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study design, sample sizes, expert qualifications, or ground truth establishment. The document is a 510(k) clearance letter from the FDA for a device called "Bi-Phasic Infiltrator," indicating it is substantially equivalent to a legally marketed predicate device for general surgical fluid irrigation and infiltration. It does not contain the detailed study information you are requesting.
§ 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).