(78 days)
The pump is indicated for intravenous, subcutaneous, arterial, enteral, and epidural infusion of antibiotics, analgesics, chemotherapeutic agents and other medications or fluids requiring precisely-controlled infusion rates.
Not Found
This is a 510(k) clearance letter for an infusion pump, which is a hardware device. The questions you're asking are typically relevant to AI/ML (Artificial Intelligence/Machine Learning) powered software as a medical device (SaMD) or AI/ML components of a medical device. This document does not contain information related to AI/ML algorithms, performance studies, or acceptance criteria in the context of AI.
Therefore, I cannot answer the questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided document. The document pertains to the regulatory clearance of a physical medical device (infusion pump) based on substantial equivalence to a predicate device.
§ 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).