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510(k) Data Aggregation

    K Number
    K082565
    Device Name
    MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-200
    Manufacturer
    Date Cleared
    2009-02-12

    (161 days)

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

    MICROSURGEON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MicroSurgeon Microwave Tissue Ablation Device is intended to be used for the surgical ablation of soft tissue.
    Device Description
    The MicroSurgeon Microwave Tissue Ablation device model MTAD-200 is intended to be used by the physician for the ablation of soft tissue by the induction of thermal necrosis in the targeted tissue. The ablation occurs by direct application of microwave energy to the targeted tissue by use of a sterile hand held Disposable Patient Probe (DPP). Lesion sizes ablated by the system are determined by preset values within the system algorithm. The MTAD-200 allows the physician to use a minimally invasive procedure that is an alternative to surgical removal of solid tissue anomalies. It is to be used in conjunction with the clinician's knowledge of the patient as well as the results of a physical examination along with clinical findings as deemed pertinent. The MTAD-200 system is not to be used by untrained and unqualified users in a manner other than that for which it is labeled. The systems Microwave Generator Subsystem (MWGS) generates an RF 2.45GHz signal which is delivered to the Disposable Patient Probe DPP via related controlled electronics, and provides for required patient galvanic isolation. The MWGS component of the MTAD-200 was designed for exclusive use of, and to generate microwave energy to the patient disposable probe cited above. The one time use sterile DPP Hand-piece incorporates a Tip that is inserted directly into the tissue for localized energy delivery, and acts as a microwave radiator in a bipolar mode; thus near-field radiated energy is contained within a limited field with no currents flowing into the patient (as opposed to uni-polar RF Radiators in which current flows thru the patient's body). Two independent Thermo-sensors (provided for further redundancy of the system) located at the tip of the DPP are used to provide for localized temperature measurement during the ablation process. The CPS utilizes these temperature measurements to control the delivery of energy in order to achieve the desired ablation. The CPS, running a Microsoft Windows Operating System, provides for profile programming onto a patient data file; provides user interface and controls the MWGS unit based on predetermined settings. All MWGS functionality and temperature measurements are processed and displayed by this unit, and utilized to achieve a desired ablation. Additionally, it stores all relevant patient information and measured parameters for the procedure.
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    K Number
    K070023
    Device Name
    MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-100
    Manufacturer
    Date Cleared
    2007-08-15

    (224 days)

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

    MICROSURGEON, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MicroSurgeon Microwave Soft Tissue Ablation Device is intended to be used for the surgical ablation of soft tissue.
    Device Description
    The MicroSurgeon Microwave Soft Tissue Ablation device model MTAD-100 is intended to be used by the physician for the ablation of soft tissue by the induction of thermal necrosis in the targeted tissue. The ablation occurs by direct application of microwave energy to the targeted tissue by use of a sterile hand held Disposable Patient Probe (DPP). Lesion sizes ablated by the system are determined by preset values within the system algorithm. The MTAD-100 allows the physician to use a minimally invasive procedure that is an alternative to surgical removal of solid tissue anomalies. It is to be used in conjunction with the clinician's knowledge of the patient as well as the results of a physical examination along with clinical findings as deemed pertinent. The MTAD-100 system is not to be used by untrained and unqualified users in a manner other than that for which it is labeled. The systems Microwave Generator Subsystem (MWGS) generates the RF 2,45GHz signal which is delivered to the DPP via related controlled electronics. It has an RF port for connecting an insulated coaxial cable from the DPP, a port for connecting a temperature measuring interface data cable from the DPP, and an RS232 port for connecting the system Control Processing Subsystem (CPS). Additionally the MWGS provides for required patient galvanic isolation, and is mounted to a Portable Transport Console with a caster base for easy transport in the hospital environment, The MWGS component of the MTAD-100 was designed for exclusive use of, and to generate microwave energy to the patient disposable probe cited above. The one time use sterile DPP Hand-piece incorporates a Tip that is inserted directly into the tissue for localized energy delivery, and acts as a microwave radiator in a bipolar mode; thus near-field radiated energy is contained within a limited field with no currents flowing into the patient (as opposed to uni-polar RF Radiators in which current flows thru the patient's body). Two independent Thermo-sensors (provided for further redundancy of the system) located at the tip of the DPP are used to provide for localized temperature measurement during the ablation process. The CPS utilizes these temperature measurements to control the delivery of energy in order to achieve the desired ablation. The CPS, running a Microsoft Windows Operating System, provides for procedure profile programming onto a patient data file; provides user interface and controls the MWGS unit based on predetermined settings. All MWGS functionality and temperature measurements are processed and displayed by this unit, and utilized to achieve a desired ablation. Additionally, it stores all relevant patient information and measured parameters for the procedure.
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