(45 days)
The Integra Mobius™ Multi-Modality Monitoring System is intended as an adjunct monitor for displaying and recording parameters such as Intracranial Pressure (ICP), Intracranial Temperature (ICT), Cerebral Blood Flow (CBF), Cerebral Perfusion Pressure (CPP), Cerebrovascular Resistance (CVR), Partial Pressure Brain Tissue Oxygen (PbtO2) and other parameters from primary source bedside monitors for the purpose of treating patients with neurological disorders.
The Integra Mobius™ System data is presented both continuously and as trends to be used in concert with other clinical parameters, not as the sole basis for diagnosis.
The Integra Mobius™ Multi-Modality Monitoring System is a neurological monitoring system that records and displays information that is electronically communicated from primary source monitors such as the Integra LICOX Brain Tissue Oxygen Monitoring System, Multi Parameter Monitor (MPM), NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring System and other bedside systems. The Integra Mobius™ System is also capable of recording data from the primary source bedside monitors on to an internal hard drive.
The Integra Mobius™ System will allow the received data to be displayed and stored in real time and analyzed offline with commercially available data analysis software packages. Collecting information in a common computing structure will allow application of "multimeasurement" concepts to applications in neurological monitoring. The Integra Mobius™ System is designed to be used as an adjunct to conventional vital sign monitoring.
The Integra Mobius™ Multi-Modality System consists of a computer platform (PC), an interface module for connection to the monitoring devices, software to record, display and archive the data and multimedia content to assist the user in carrying out a monitoring protocol.
The provided text is a 510(k) summary for the Integra Mobius™ Multi-Modality Monitoring System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with defined acceptance criteria.
§ 882.1620 Intracranial pressure monitoring device.
(a)
Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.(b)
Classification. Class II (performance standards).