(62 days)
The CMA Cerebral Tissue Monitoring System measures intracranial glucose, lactate, and pyruvate levels and is intended as an adjunct monitor of trends in these parameters indicating the perfusion status of cerebral tissue local to catheter placement. Because the CMA System values are relative within an individual, these should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide additional data to that obtained by current clinical practice in cases where ischemia or hypoxia is a concern.
The CMA Cerebral Tissue Monitoring System utilizes the principles of "microdialysis," to monitor biochemical markers of ischemia in the brain. The system consists of the following components: CMA 70 Brain Microdialysis Catheters, CMA 106 Pump and Syringe, Perfusion Fluid CNS, Microvials and Microvial Racks, ISCUS Clinical Microdialysis Analyzer or CMA 600 Microdialysis Analyzer and software, Reagents (lactate, pyruvate, glucose), Control Samples, Rinsing Fluid, Calibrator A. The CMA 70 Brain Microdialysis Catheter mimics the function of a blood capillary. Molecules in the interstitial fluid diffuse over the sterile, semi-permeable dialysis membrane of the catheter into the Perfusion Fluid, which is pumped by the CMA 106 Microdialysis Pump. The Perfusion Fluid equilibrates with the surrounding interstitial fluid and is collected in microvials at the outlet of the catheter. The microvials are changed regularly by the appropriate hospital staff and brought to the Microdialysis Analyzer (CMA 600 or ISCUS). The dialysate is analyzed for the concentrations of glucose, lactate and pyruvate, which are well-known markers of tissue ischemia. The data are displayed as trend curves on the screen of the analyzer showing the local changes in the hypoxic/ischemic state of the brain tissue.
The provided text is a 510(k) summary for the CMA Cerebral Tissue Monitoring System. It describes the device, its intended use, and its equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, nor details about training or test sets, ground truth establishment, or expert involvement.
The document states that the functionality for the CMA Cerebral Tissue Monitoring System with ISCUS is equivalent to its predicate device CMA 600 Cerebral Tissue Monitoring System (K020285) in safety and effectiveness. This implies that the current device is being cleared based on its substantial equivalence to a previously cleared device, rather than through a new clinical study demonstrating its performance against specific acceptance criteria.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The information needed for those sections is not present in the 510(k) summary.
§ 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).