(256 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 performed through intravenous (IV) and Epidural routes of administration.
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This document is a 510(k) clearance letter for a Patient Controlled Analgesia (PCA) device, not a study report or a document detailing acceptance criteria and performance data. Therefore, the requested information cannot be extracted from the provided text.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976...". This indicates that the device was cleared based on substantial equivalence to a predicate device, rather than through a direct demonstration of meeting specific performance acceptance criteria via a study described in this document.
To answer your questions, one would need access to the actual 510(k) submission (K972158) from GO Medical, which might contain the testing and performance data that supported the claim of substantial equivalence.
§ 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).