(446 days)
Go Medical Patient Controlled Analgesia Devices, if properly used, are intended to provide a safe and effective means of delivering various analgesic medications to in-patients and out-patients, on both an acute and/or chronic basis. This can be peformed through intravenous (IV) and epidural routes of administration. The device will be available only by prescription and will carry the following legend: "Caution : Federal Law restricts this device to sale by or on the order of a physician". (21 CFR 801.109(b)(1))
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The provided text is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about the acceptance criteria, study details, or performance metrics of the device as it pertains to AI or software algorithms.
Therefore, I cannot answer your request based on the provided input. The document
describes the regulatory approval process for the "Go Medical Patient Controlled Analgesia (PCA) Devices" and confirms its substantial equivalence to a legally marketed predicate device. It does not assess or report on any AI-driven performance or studies related to such.
§ 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).