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510(k) Data Aggregation

    K Number
    K102077
    Device Name
    MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
    Date Cleared
    2011-01-14

    (175 days)

    Product Code
    Regulation Number
    882.1620
    Why did this record match?
    Applicant Name (Manufacturer) :

    CMA MICRODIALYSIS AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CMA Cerebral Tissue Monitoring System measures intracranial glucose, lactate, pyruvate, glycerol and glutamate 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.
    Device Description
    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 - - Microdialysis Analyzer (CMA 600, ISCUS or ISCUS108) - - -Reagents lactate, pyruvate, glucose, glycerol and glutamate - -Control Samples - Rinsing Fluid - - -Calibrator A The 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. The microdialysis samples are analyzed in the Microdialysis Analyzer for the concentrations of glucose, lactate, pyruvate, glycerol and glutamate, 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.
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    K Number
    K071984
    Device Name
    MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
    Date Cleared
    2008-06-27

    (344 days)

    Product Code
    Regulation Number
    882.1620
    Why did this record match?
    Applicant Name (Manufacturer) :

    CMA MICRODIALYSIS AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CMA Cerebral Tissue Monitoring System measures intracranial glucose, lactate, pyruvate, glycerol and glutamate 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.
    Device Description
    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, glycerol and glutamate - Control Samples l - 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.
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    K Number
    K060554
    Device Name
    CMA CEREBRAL TISSUE MONITORING SYSTEM
    Date Cleared
    2006-05-02

    (62 days)

    Product Code
    Regulation Number
    882.1620
    Why did this record match?
    Applicant Name (Manufacturer) :

    CMA MICRODIALYSIS AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    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.
    Device Description
    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.
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    K Number
    K020285
    Device Name
    CMA CEREBRAL TISSUE MONITORING SYSTEM
    Date Cleared
    2002-10-23

    (268 days)

    Product Code
    Regulation Number
    882.1620
    Why did this record match?
    Applicant Name (Manufacturer) :

    CMA MICRODIALYSIS AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    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.
    Device Description
    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 . - CMA 600 Microdialysis Analyser 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, semipermeable 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 CMA 600 Microdialysis Analyser. 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 CMA 600 showing the local changes in the hypoxic/ischemic state of the brain tissue.
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