(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))
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device, specifically "Go Medical Patient Controlled Analgesia Devices (PCA) Devices." It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter confirms that the device is substantially equivalent to a legally marketed predicate device and can therefore be marketed. It outlines regulatory requirements that the manufacturer must adhere to, such as registration, listing, good manufacturing practices, and labeling.
Therefore, I cannot provide the requested information based on the content of this document.
§ 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).