(137 days)
The Olympic Medical Lectromed Cerebral Function Monitor System is intended to be used by a variety of clinicians to acquire and utilize EEG signals, when used in conjunction with other clinical data, in intensive care areas, Operating Room, Emergency Room, and clinical research lab:
- to monitor the state of the brain .
- for determination of, and long-term monitoring of, the neurological status of patients that may have suffered an hypoxic-ischemic event.
- for monitoring of neurological status to assist in the clinical management and treatment of the patient by observing how the treatment affects the neurological status as shown by the CFM.
- to assist in the prediction of neurological outcome -
- to monitor and record frequency and intensity of seizures to assist in management of anti-convulsive therapy.
- to assist in the prediction of severity of Hypoxic-Ischemic Encephalopathy and long-term outcome in infants who have suffered an hypoxic-ischemic event.
The Olympic Medical Lectromed Cerebral Function Monitor System consists of three modules. A header amplifier module is used to connect the patient electrode leads to a plug-in module that produces three outputs that may be monitored or recorded on a 2-channel strip-chart recorder. The three outputs are cerebral function (activity), impedance, and raw EEG.
I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) summary for the Olympic Medical Lectromed Cerebral Function Monitor System, focusing on:
- Device classification and name
- Company information
- Intended use
- Predicate devices
- Device description
- Safety and Standards (mentioning BS EN 60601-1-1 and BS EN 60601-1-2: 1993)
- FDA's substantial equivalence letter
- Indications for Use statement
There is no section detailing specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity, or technical benchmarks) or any study results demonstrating that the device meets such criteria. The document asserts compliance with general safety standards and substantial equivalence to predicate devices, but lacks the detailed performance study information you requested.
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).