(32 days)
THE WEDICAL SOLUTIONS, INC TEMP 3 WARMING CABINET IS DESIGNED TO STORE, REPIDLY HARM AND MAINTAIN TERRERATURE OF I.V. FLUID BAGS AND IRRIGATION BAGS PRIOR TO TICK TO THE IDE.
Not Found
The provided documents are a letter from the FDA regarding a 510(k) premarket notification for a medical device called "TEMP 3" and the "Indications For Use" statement.
This document does not contain information about acceptance criteria, device performance, sample sizes for testing or training, data provenance, expert qualifications, ground truth establishment, or any studies conducted. It is a regulatory notification confirming substantial equivalence to a predicate device for marketing purposes.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details based on 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).