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510(k) Data Aggregation

    K Number
    K032149
    Device Name
    RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR
    Manufacturer
    RITA MEDICAL SYSTEMS INC
    Date Cleared
    2003-09-09

    (57 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    RITA MEDICAL SYSTEMS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RITA® System (RF generator and electrosurgical devices) supplies energy for use in electrosurgery and is indicated for use in percutaneous, laparoscopic, or intraoperative coagulation and ablation of soft tissue, including: - the partial or complete ablation of non-resectable liver lesions and - . the palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard pain therapy.
    Device Description
    The Model 1500X Electrosurgical RF Generator is designed to provide monopolar radiofrequency (RF) energy. The RF Generator is a 250 W electrosurgical generator specifically designed for use with RITA electrosurgical devices. It can read multiple temperature sensors and includes impedance and power monitoring to assist the physician in monitoring and controlling the ablation. To use the system, the RF Generator is plugged into the wall outlet via the Power Cord. The electrosurgical device is connected to the RF Generator via the Main Cable. The Dispersive Electrode is placed on the appropriate location of the body and is connected to its port on the RF Generator. Once the system is successfully powered up, the user can set the parameters of the ablation such as the mode of operation, the ablation time, the target temperature, and the power delivery level. With the electrosurgical device placed in the tissue to be ablated and its electrodes deployed, RF power can be turned on. The system parameters are continuously monitored and displayed on the RF Generator. If the measured parameters are outside the acceptable limits, the RF energy delivery automatically stops and a message appears on the liquid crystal display (LCD). The RF energy delivery also automatically ceases once the ablation is completed based on the initial user-defined parameters. RF energy can be stopped at any time by pressing the RF ON/OFF switch.
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    K Number
    K031926
    Device Name
    RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR AND ACCESSORIES (E.G., RITA THERMO PAD AND CABLE ADAPTER)
    Manufacturer
    RITA MEDICAL SYSTEMS INC
    Date Cleared
    2003-07-17

    (24 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    RITA MEDICAL SYSTEMS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RITA® System (RF generator and electrosurgical devices) supplies energy for use in electrosurgery and is indicated for use in percutaneous, laparoscopic, or intraoperative coagulation and ablation of soft tissue, including: - . the partial or complete ablation of non-resectable liver lesions and - the palliation of pain associated with metastatic lesions involving . bone in patients who have failed or are not candidates for standard pain therapy.
    Device Description
    The Model 1500X Electrosurgical RF Generator is designed to provide monopolar radiofrequency (RF) energy. The RF Generator is a 150/200 W electrosurgical generator specifically designed for use with RITA electrosurgical devices. It can read multiple temperature sensors and includes impedance and power monitoring to assist the physician in monitoring and controlling the ablation. To use the system, the RF Generator is plugged into the wall outlet via the Power Cord. The electrosurgical device is connected to the RF Generator via the Main Cable. The Thermo Pad is placed on the appropriate location of the body and is connected to its ports on the RF Generator via a cable adapter. Once the system is successfully powered up, the user can set the parameters of the ablation such as the mode of operation, the ablation time, the target temperature, and the power delivery level. With the electrosurgical device placed in the tissue to be ablated and its electrodes deployed, RF power can be turned on. The system parameters are continuously monitored and displayed on the RF Generator. If the measured parameters are outside the acceptable limits, the RF energy delivery automatically stops and a message appears on the liquid crystal display (LCD). The RF energy delivery also automatically ceases once the ablation is completed based on the initial user-defined parameters. RF energy can be stopped at any time by pressing the RF ON/OFF switch.
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    K Number
    K031257
    Device Name
    RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR
    Manufacturer
    RITA MEDICAL SYSTEMS INC
    Date Cleared
    2003-05-02

    (11 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    RITA MEDICAL SYSTEMS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RITA® System (RF generator and electrosurgical devices) supplies energy for use in electrosurgery and is indicated for use in percutaneous, laparoscopic, or intraoperative coagulation and ablation of soft tissue, including: - the partial or complete ablation of non-resectable liver lesions and . - the palliation of pain associated with metastatic lesions involving . bone in patients who have failed or are not candidates for standard pain therapy.
    Device Description
    The Model 1500X Electrosurgical RF Generator is designed to provide monopolar radiofrequency (RF) energy. The RF Generator is a 150/200 W electrosurgical generator specifically designed for use with RITA electrosurgical devices. It can read multiple temperature sensors and includes impedance and power monitoring to assist the physician in monitoring and controlling the ablation. To use the system, the RF Generator is plugged into the wall outlet via the Power Cord. The electrosurgical device is connected to the RF Generator via the Main Cable. The Dispersive Electrode is place on the appropriate location of the body and is connected to its port on the RF Generator. Once the system is successfully powered up, the user can set the parameters of the ablation such as the mode of operation, the ablation time, the target temperature, and the power delivery level. With the electrosurgical device placed in the tissue to be ablated and its electrodes deployed, RF power can be turned on. The system parameters are continuously monitored and displayed on the RF Generator. If the measured parameters are outside the acceptable limits, the RF energy delivery automatically stops and a message appears on the liquid crystal display (LCD). The RF energy delivery also automatically ceases once the ablation is completed based on the initial user-defined parameters. RF energy can be stopped at any time by pressing the RF ON/OFF switch.
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    K Number
    K030936
    Device Name
    RITA CLIPS FOR INFUSION PUMPS
    Manufacturer
    RITA MEDICAL SYSTEMS INC
    Date Cleared
    2003-04-01

    (7 days)

    Product Code
    MRZ
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    RITA MEDICAL SYSTEMS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RITA® Clips are used with Harvard 2 Syringe Pump to increase the syringe holding capacity of the Pump from two to five syringes to allow one Harvard 2 Syringe Pump to supply local delivery of saline through multiple irrigation ports of one RITA® Electrosurgical Device of the RITA® System. The RITA System is intended for use in percutaneous. laparoscopic, or intraoperative coagulation and ablation of soft tissue, including the partial or complete ablation of non-resectable liver lesions.
    Device Description
    The RITA® Clips are a syringe holder accessory to the Harvard 2 Syringe Pump to accommodate five (5) 20-cc syringes.
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