(207 days)
The Plum A+ Infusion Pump is indicated for use in i parenteral, enteral and epidural therablem ramp 13 indicated for use in parenteral, enti epidural the administration of whole blood and blood products.
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I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. The document is solely an FDA 510(k) clearance letter for the Abbott Plum A+ Infusion Pump, indicating that the device is substantially equivalent to legally marketed predicate devices and outlining regulatory controls. It does not contain any technical study details or performance metrics.
§ 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).