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510(k) Data Aggregation

    K Number
    K171666
    Device Name
    MPR2 logO DATALOGGER
    Manufacturer
    Raumedic AG
    Date Cleared
    2017-07-06

    (31 days)

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

    Raumedic AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RAUMEDIC® MPR2 is indicated for use by qualified neurosurgeons or neurointensivists for measurement of intracranial pressure, temperature as well as to determine the partial oxygen pressure ptiO2 of the interstitial fluid.
    Device Description
    The MPR2 is a small bedside monitor for measuring, displaying and monitoring of physiological parameters in the human brain which is used only in conjunction with RAUMEDIC ® -catheters. Analog signals can be relayed to a series-connected bedside monitor via its 2 analog outputs. Optionally, the device can be operated in stand-alone mode. The power is supplied by either the internal rechargeable battery or by an external, medically approved wide range wall plug transformer. The MPR2 is a diagnostic device with physiological limit value monitor for measuring, displaying and monitoring the following physiological parameters: oxygen partial pressure (pO2), intracranial pressure (ICP) and brain temperature (T). These parameters are determined exclusively by connecting RAUMEDIC® catheters for single channel ICP measurement or with RAUMEDIC® multi-parameter catheters for combined measurement of ICP, pO2 and temperature (thermistor-based with YSI400 characteristic) or combinations derived from them such as pO2 and temperature. Optionally the pO2 and ICP signals can be relayed via the 2 analog outputs to a bedside monitor with limit value monitoring.
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    K Number
    K130529
    Device Name
    RAUMEDIC-PTO-MONITORING-SYSTEM
    Manufacturer
    RAUMEDIC AG
    Date Cleared
    2013-10-25

    (238 days)

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

    RAUMEDIC AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RAUMEDIC® - PTO-Monitoring-System measures intracranial pressure, temperature and oxygen and is intended as an adjunct monitor of trends in these parameters, indicating the perfusion status of cerebral tissue local to sensor placement. RAUMEDIC® - PTO-Monitoring-System values are relative within an individual, and should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide data additional to that obtained by current clinical practice, in cases where hypoxia or ischemia is a concem. Use of the parenchymal intracranial pressure monitoring kit with bolt is indicated for children who are at least one year old.
    Device Description
    The RAUMEDIC® -PTO-Monitoring-System determines the level and change in intracranial pressure (ICP) by using semi-conductor pressure sensors, in temperature using thermistors, and in partial oxygen pressure ptiO2 using a luminescence optical sensor fibre. The PTO-Monitoring-System consists of intracranial catheters, a cranial bolt kit, the user interface unit (EASY logO), cables to connect the catheters to the EASY logO and cables for the EASY logO to send the measurements to specific patient monitoring units. Three intracranial catheters are provided: NEUROVENT®-PTO, NEUROVENT® TO and NEUROVENT® PTO 2L. The NEUROVENT®-PTO measures three physiological parameters - ICP, temperature and partial oxygen pressure. The application has to be made with a single lumen Bolt (BOLT-KIT PTO). The NEUROVENT -PTO 2L also measures these three parameters, but has to be placed with a multi lumen Bolt (BOLT KIT PTO 2L) or via tunneling process. The NEUROVENT® TO measures two physiological parameters – temperature and partial oxygen pressure. The application has to be made with a single lumen Bolt (BOLT-KIT PTO). The NEUROVENT®-PTO or the NEUROVENT®-TO is implanted in the parenchyma using a BOLT KIT PTO. The NEUROVENT®-PTO 2L is implanted in the parenchyma using a BOLT KIT PTO 2L or using a RAUMEDIC® spliceable tunnelling sleeve CH8 (already cleared for market under 510(k) K112017). For connecting the catheters to the EASY logO two cables – cable PTO and cable LWL - are needed. The cable PTO transfers the electrical signal for ICP and temperature. The cable LWL transfers the optical signal for oxygen pressure. The EASY logO is the user interface that displays the measurements and alerts the user to the status of the intracranial catheters. The EASY logO displays: oxygen partial pressure pO2, intracranial pressure ICP, pulse amplitude ICPA and temperature T. ICP is a pulsatile signal that consists of the ICP average value and a pulsatile ICPA component, which is superimposed over the ICP average value. DATALOGGER cables allows the EASY logO to send the measurements to specific patient monitoring units.
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    K Number
    K120252
    Device Name
    RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM
    Manufacturer
    RAUMEDIC AG
    Date Cleared
    2012-04-11

    (75 days)

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

    RAUMEDIC AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RAUMEDIC®-ICP-TEMP-Monitoring-System is indicated for use by a qualified neurosurgeon for direct measurement of intracranial pressure and temperature in the parenchyma and in the ventricle and cerebrospinal fluid drainage applications. Use of the parenchymal and ventricular intracranial pressure monitoring kit with bolt is contra-indicated in children under one year old. The RAUMEDIC® catheters are MR Unsafe.
    Device Description
    The RAUMEDIC® -ICP-TEMP-Monitoring-System determines the level and change in intracranial pressure (ICP) by using semi-conductor pressure sensors and temperature monitoring using thermistors. The NEUROVENT®-TEMP IFD-S and NEUROVENT®-TEMP IFD-R are indicated for use in ventricular pressure and temperature monitoring and cerebrospinal fluid drainage applications. The NEUROVENT®-P-TEMP is indicated for use in parenchymal pressure and temperature monitoring. The RAUMEDIC® -ICP-TEMP-Monitoring-System is composed of the following elements: - NEUROVENT®-TEMP IFD-S - NEUROVENT®-TEMP IFD-R - NEUROVENT®-P-TEMP - ICP-TEMP-Adapter - ICP-TEMP-Adapter HP / Philips
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    K Number
    K112017
    Device Name
    RAUMEDIC ICP MONITORING SYSTEM
    Manufacturer
    RAUMEDIC AG
    Date Cleared
    2011-10-11

    (89 days)

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

    RAUMEDIC AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RAUMEDIC® -ICP-Monitoring-System ventricular is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. Use of the ventricular intracranial pressure monitoring kit with bolt is contra-indicated in children under one year old. The RAUMEDIC® catheters are MR Unsafe.
    Device Description
    The RAUMEDIC® -ICP-Monitoring-System ventricular is composed of NEUROVENT® components, spliceable tunneling sleeves, and bolt and drill kits. The device is used for intracranial pressure monitoring and cerebrospinal fluid drainage applications, and is implanted in the ventricle using various methods.
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    K Number
    K103206
    Device Name
    RAUMEDIC- ICP-MONITORING SYSTEM
    Manufacturer
    RAUMEDIC AG
    Date Cleared
    2011-03-04

    (123 days)

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

    RAUMEDIC AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RAUMEDIC® -ICP-Monitoring-System is indicated for use in parenchymal pressure monitoring. Use of the parenchymal intracranial pressure monitoring kit with bolt is contra-indicated in children under one year old. The RAUMEDIC® precision pressure catheters are MR Unsafe.
    Device Description
    The RAUMEDIC® -ICP-Monitoring-System determines safely, quickly and accurately the level and change in intracranial pressure (ICP) by using semi-conductor pressure sensors. The Neurovent® - P and Neurovent® - P - C are indicated for use in parenchymal pressure monitoring. Both types of catheters are implanted in parenchyma via a RAUMEDIC® - Bolt Kit CH5. In addition to the catheter a zero point module NPS2 x is needed. "x" depends on the type of patient monitor available in the hospital - there are 20 different references. To the equipment also belongs an ICP-Temp-Cable and a NPS3 pressure display unit. The difference between the Neurovent® - P and the Neurovent® - P - C is that the housing material in the C-version is ceramic instead of titanium. The RAUMEDIC® -ICP-Monitoring-System is composed of the following elements: Neurovent® - P, Neurovent® P C, RAUMEDIC® - Bolt Kit (CH 5), RAUMEDIC® Drill Kit 4,5 mm (CH 5), ICP-TEMP-Cable, NPS2, NPS3.
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