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    K Number
    K240296
    Device Name
    Tulsa Pro System (Pad-105)
    Manufacturer
    Profound Medical, Inc.
    Date Cleared
    2024-05-09

    (98 days)

    Product Code
    PLP
    Regulation Number
    876.4340
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TULSA-PRO ® is indicated for transurethral ultrasound ablation (TULSA) of prostate tissue.
    Device Description
    Not Found
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    K Number
    K231378
    Device Name
    Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0
    Manufacturer
    Insightec, Ltd.
    Date Cleared
    2023-10-30

    (171 days)

    Product Code
    PLP
    Regulation Number
    876.4340
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Exablate Prostate System is indicated for endorectal MR-Guided Focused Ultrasound (MRgFUS) ablation of Prostatic Tissue.
    Device Description
    The Exablate 2100 / 2100V1 Type 3.0 Prostate System (Trademark Name: Exablate Prostate System) is a high intensity Magnetic Resonance ("MR") image- guided focused ultrasound (MRgFUS) system intended for endorectal use that delivers focused ultrasound energy into the prostate in a minimally invasive manner by utilizing an endorectal probe transducer. The Exablate Prostate System combines a multiple-channel phased-array Focused Ultrasound (FUS) transducer probe and magnetic resonance imaging ("MRI") in a closed- loop treatment for the thermal procedure of Prostatic Tissue while monitoring the procedure in real time. The Exablate Prostate System is designed to work in conjunction with FDA cleared 1.5T and 3.0T MRI scanners with phased array torso cardiac coils that is used for guidance and procedure monitoring and control feedback. The Exablate Prostate System is fully integrated with the MRI scanner used to provide MR images of the patient's anatomy and prepare an appropriate procedure plan. Measured tissue temperature changes provide feedback on the procedure dose in the targeted area and its surroundings, allowing real- time monitoring to achieve safe and effective outcomes. The intended users for the Exablate Prostate System are trained and certified physicians and/or technicians (clinicians) who are seeking to offer patients an incisionless, focal, and MR guided and controlled prostate tissue ablation and have successfully completed the Insightec Exablate training to operate the device. The Exablate Prostate System platform is intended to ablate prostatic tissue with focused ultrasound and operates in conjunction with FDA cleared compatible MRI scanners for the purposes of real time procedure planning, MR based guidance of the focused ultrasound energy to the target region, MR thermal imaging and ablation monitoring. The procedure effect of the Exablate Prostate System is achieved by accurately guiding the focus of the ultrasound energy to the target region. The energy is then repeatedly transmitted to the target until the desired outcome is achieved. The targeted area is defined based on MR images taken during the procedure, while patient is in procedure position. The procedure is constantly monitored in a real-time closed-loop MR thermal feedback. Once the targeting is complete, the outcome is confirmed with adequate post-procedure MR imaging sequences.
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    K Number
    K230692
    Device Name
    TULSA-PRO System
    Manufacturer
    Profound Medical Inc.
    Date Cleared
    2023-09-20

    (191 days)

    Product Code
    PLP
    Regulation Number
    876.4340
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TULSA-PRO is indicated for transurethral ultrasound ablation (TULSA) of prostate tissue.
    Device Description
    The TULSA-PRO system combines real-time Magnetic Resonance (MR) imaging and MR thermometry with transurethral directional ultrasound and closed-loop process control software to deliver precise thermal ablation of physician prescribed prostate tissue. The system consists of both hardware and software components. The subject device includes a modification to the device software that is described below. The hardware components and treatment workflow description are identical to the predicate device. The physician inserts two catheters, one transurethral and another transrectal, into the patient before he is moved into the MR bore. The transurethral catheter consists of an Ultrasound Applicator (UA) which delivers energy from within the prostate tissue, heating it to thermal coagulation. The transrectal catheter is an Endorectal Cooling Device (ECD) which does not emit any energy and cools the rectal wall adjacent to the prostate. Both catheters have fluid flowing inside throughout the treatment. The physician uses the TULSA-PRO console to robotically position the Ultrasound Applicator in the prostate and plan the treatment by contouring the prescribed tissue intended for ablation on real-time high-resolution cross-sectional MR images of the prostate. These features provide the physician with the ability and the control to customize the treatment plan to minimize thermal impact to critical structures surrounding the prostate including the external urethral sphincter, rectum and neurovascular bundles. The treatment begins based upon the physician starting the thermal ablation in the software. The TULSA-PRO closed-loop process control software reads real-time MR thermometry measurements and adjusts automatically and dynamically the frequency and power of ultrasound provided by each ultrasound transducer, and rotation rate of the Ultrasound Applicator, to deliver precise ablation of the prescribed prostate tissue defined by the physician in the treatment plan. Software Modification: An optional feature called Thermal Boost is available in the software during the treatment delivery phase of the treatment workflow. The Thermal Boost feature is useful when the prostate is large and the treatment radius is >15mm for any active ultrasound element. In such cases, heat may not reach the prostate boundary due to prostate size or if tissue perfusion is preventing the heat from reaching the target boundary. The physician has a choice to use the Thermal Boost feature on the corresponding ultrasound transducer. When this feature is turned on, the treatment boundary temperature can reach ≤63 degrees or ≤65 degrees depending on the treatment radius. Thermal Boost does not change the ablation plan prescribed by the physician. Whether Thermal Boost is turned on or off, the tissue heating and monitoring principle of operation of the TDC software do not change. Following completion of the ablation process, the two catheters are removed from the natural orifices of the patient.
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    K Number
    K211858
    Device Name
    TULSA-PRO System
    Manufacturer
    Profound Medical Inc.
    Date Cleared
    2022-09-06

    (447 days)

    Product Code
    PLP
    Regulation Number
    876.4340
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TULSA-PRO® is indicated for transurethral ultrasound ablation (TULSA) of prostate tissue.
    Device Description
    The TULSA-PRO system combines real-time Magnetic Resonance (MR) imaging and MR thermometry with transurethral directional ultrasound and closed-loop process control software to deliver precise thermal ablation of physician prescribed prostate tissue. The system consists of both hardware and software components. The transurethral ultrasound ablation (TULSA) treatment is delivered completely within the MR bore. A real-time MRI interface is used by closed-loop features of the TULSA-PRO system: real-time MRI prostate temperature measurements are processed by TULSA-PRO software which communicates with TULSA-PRO hardware, thereby controlling frequency, power and rotation rate of ultrasound to ablate physician prescribed prostate tissue with a high degree of precision. The physician inserts two catheters, one transurethral and another transrectal, into the patient before he is moved into the MR bore. The transurethral catheter consists of an Ultrasound Applicator (UA) which delivers energy from within the prostate tissue, heating it to thermal coagulation. The transrectal catheter is an Endorectal Cooling Device (ECD) which does not emit any energy and cools the rectal wall adjacent to the prostate. The modified ECD component provides users with a rectal bubble removing feature, and is manufactured using a 3-D printed technology. Both catheters have fluid flowing inside throughout the treatment to thermally protect the urethra and rectum, in order to minimize the potential of any thermal damage to either the urinary or rectal pathways. The physician uses the TULSA-PRO console that was cleared under K191200 to robotically position the Ultrasound Applicator in the prostate and plan the treatment by contouring the prescribed tissue on real-time high-resolution crosssectional MR images of the prostate. These cleared features provide the physician with the ability and the control to customize the treatment plan to minimize thermal impact to critical structures surrounding the prostate including the external urethral sphincter, rectum and neurovascular bundles. The treatment begins based upon the physician's instructions by enabling the software to initiate thermal ablation. The TULSA-PRO closed-loop process control software reads real-time MR thermometry measurements and adjusts automatically and dynamically the frequency, power and rotation rate of ultrasound provided by each UA transducer, to deliver precise ablation of the prescribed prostate tissue. The software controls automated. continuous and robotic rotation of the transurethral UA by 360 degrees in sync with the process-controlled delivery of thermal heating to all the required regions of the prostate. Following completion of the ablation process, the two catheters are removed from the natural orifices of the patients.
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    K Number
    K212150
    Device Name
    Exablate Prostate System
    Manufacturer
    Insightec, Inc
    Date Cleared
    2021-11-23

    (137 days)

    Product Code
    PLP
    Regulation Number
    876.4340
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Exablate Prostate System is indicated for endorectal MR-Guided Focused Ultrasound (MRgFUS) ablation of Prostatic Tissue.
    Device Description
    The proposed Exablate 2100 / 2100V1 Type 3 Prostate System (Trademark Name: Exablate Prostate System) is a high intensity Magnetic Resonance ("MR") image- guided focused ultrasound (MRgFUS) system intended for endorectal use that delivers focused ultrasound energy into the prostate in a minimally invasive manner by utilizing anendorectal probe transducer. The Exablate Prostate System combines a multiple-channel phased-array Focused Ultrasound (FUS) transducer probe and magnetic resonance imaging (“MRI”) in a closed-loop treatment for the thermal procedure of Prostatic Tissue while monitoring the procedure in real time. The Exablate Prostate System is designed to work in conjunction with FDA cleared 1.5Tand 3.0T MRI scanners with phased array torso cardiac coils that is used for guidance andprocedure monitoring and control feedback. The Exablate Prostate System is fully integrated with the MRI scanner used to provide MR images of the patient's anatomy and prepare an appropriate procedure plan. Measured tissue temperature changes provide feedback on the procedure dose in the targeted area and its surroundings, allowing real-time monitoring to achieve safe and effective outcomes. The intended users for the Exablate Prostate System are trained and certified physicians and/or technicians (clinicians) who are seeking to offer patients an incisionless, focal, and MR guided and controlled prostate tissue ablation and have successfully completed the Insightec Exablate training to operate the device. The Exablate Prostate System platform is intended to ablate prostatic tissue with focused ultrasound and operates in conjunction with FDA cleared compatible MRI scanners for the purposes of real time procedure planning, MR based guidance of the focused ultrasound energy to the target region, MR thermal imaging and ablation monitoring. The procedure effect of the Exablate Prostate System is achieved by accurately guiding the focus of the ultrasound energy to the target region. The energy is then repeatedly transmitted to the target until the desired outcome is achieved. The targeted area is defined based on MR images taken during the procedure, while patient is in procedure position. The procedure is constantly monitored in a real-time closed-loop MR thermal feedback. Once the targeting is complete, the outcome is confirmed with adequate post-procedure MR imaging sequences.
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    K Number
    K202286
    Device Name
    Tulsa-Pro System
    Manufacturer
    Profound Medical Inc
    Date Cleared
    2020-09-16

    (35 days)

    Product Code
    PLP
    Regulation Number
    876.4340
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    Matched: '876.4340'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TULSA-PRO® is indicated for transurethral ultrasound ablation (TULSA) of prostate tissue.
    Device Description
    The TULSA-PRO® system combines real-time Magnetic Resonance (MR) imaging and MR thermometry with transurethral directional ultrasound and closed-loop process control software to deliver precise thermal ablation of a customized volume of physician prescribed prostate tissue. The system consists of both hardware and software components. Transurethral ultrasound ablation (TULSA) treatment ablates prostate tissue using inbore real-time MRI treatment planning, monitoring, visualization, and active temperature feedback control. The closed-loop features of the TULSA-PRO® software use a real-time MRI interface to process MRI prostate temperature measurements, and communicate with the TULSA-PRO® hardware, thereby controlling frequency, power and rotation rate of ultrasound to ablate physician prescribed prostate tissue with a high degree of precision. The physician inserts two catheters, one transurethral and another transrectal, into the patient before he is moved into the MR bore. The transurethral catheter consists of an Ultrasound Applicator (UA) which delivers energy from the urethra outwards into the prostate tissue, heating it to thermal coagulation. The transrectal catheter is an Endorectal Cooling Device (ECD) which does not emit any energy and cools the rectal wall adjacent to the prostate. Both catheters have fluid flowing inside throughout the treatment to thermally protect the urethra and rectum, in order to minimize the potential of any thermal damage to either the urinary or rectal pathways. The physician uses the TULSA-PRO® console to robotically position the UA in the prostate and plan the treatment by contouring the prescribed tissue on real time high-resolution crosssectional MR images of the prostate. These features provide the physician with the ability and the control to customize the treatment plan to minimize thermal impact to critical structures surrounding the prostate including the external urethral sphincter, rectum and neurovascular bundles. The treatment begins based upon the physician's instructions by enabling the software to initiate thermal ablation. The TULSA-PRO® closed-loop process control software reads real-time MR thermometry measurements and adjusts automatically and dynamically the frequency, power and rotation rate of ultrasound provided by each UA transducer, to deliver precise ablation of the prescribed prostate tissue. The software controls automated, continuous and robotic rotation of the transurethral UA by 360 degrees in sync with the process-controlled delivery of thermal heating to all the intended regions of the prostate. Following completion of the ablation process, the two catheters are removed from the natural orifices of the patients.
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    K Number
    K191200
    Device Name
    TULSA-PRO System
    Manufacturer
    PROFOUND MEDICAL INC.
    Date Cleared
    2019-08-15

    (101 days)

    Product Code
    PLP
    Regulation Number
    876.4340
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    Matched: '876.4340'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TULSA-PRO System is indicated for transurethral ultrasound ablation (TULSA) of prostate tissue.
    Device Description
    The TULSA-PRO system combines real-time Magnetic Resonance (MR) imaging and MR thermometry with transurethral directional ultrasound and closed-loop process control software to deliver precise thermal ablation of a customized volume of physician prescribed prostate tissue. The system consists of both hardware and software components. Transurethral ultrasound ablation (TULSA) treatment ablates prostate tissue using in-bore real-time MRI treatment planning, monitoring, visualization, and active temperature feedback control. The closed-loop features of the TULSA-PRO software use a real-time MRI interface to process MRI prostate temperature measurements, and communicate with the TULSA-PRO hardware, thereby controlling frequency, power and rotation rate of ultrasound to ablate physician prescribed prostate tissue with a high degree of precision. The physician inserts two catheters, one transurethral and another transrectal, into the patient before he is moved into the MR bore. The transurethral catheter consists of an Ultrasound Applicator (UA) which delivers energy from the urethra outwards into the prostate tissue, heating it to thermal coagulation. The transrectal catheter is an Endorectal Cooling Device (ECD) which does not emit any energy, and cools the rectal wall adjacent to the prostate. Both catheters have fluid flowing inside throughout the treatment to thermally protect the urethra and rectum, in order to minimize the potential of any thermal damage to either the urinary or rectal pathways. The physician uses the TULSA-PRO console to robotically position the UA in the prostate and plan the treatment by contouring the prescribed tissue on realtime high-resolution cross-sectional MR images of the prostate. These features provide the physician with the ability and the control to customize the treatment plan to minimize thermal impact to critical structures surrounding the prostate including the external urethral sphincter, rectum and neurovascular bundles. The treatment begins based upon the physician's instructions by enabling the software to initiate thermal ablation. The TULSA-PRO closed-loop process control software reads real-time MR thermometry measurements and adjusts automatically and dynamically the frequency, power and rotation rate of ultrasound provided by each UA transducer, to deliver precise ablation of the prescribed prostate tissue. The software controls automated, continuous and robotic rotation of the transurethral UA by 360 degrees in sync with the process controlled delivery of thermal heating to all the intended regions of the prostate. Following completion of the ablation process, the two catheters are removed from the natural orifices of the patients.
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    K Number
    K172721
    Device Name
    FOCAL ONE
    Manufacturer
    EDAP Technomed, Inc.
    Date Cleared
    2018-06-07

    (272 days)

    Product Code
    PLP
    Regulation Number
    876.4340
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Focal One device is indicated for transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue.
    Device Description
    The Focal One® is an evolution from the previous generation device, designed by EDAP: Ablatherm Integrated Imaging (K153023) and Ablatherm Fusion (K172285). The Focal One® consists of the Focal One® module with a software control system, an endorectal dynamic focusing probe, a leg holder, a set of single use disposables and a coupling liquid pouch. The Focal One® module consists of a motorized and manual endorectal dynamic focusing probe positioning unit, a RF amplifier to power the transducer, a computer to control device operation, a cooling system to cool Ablasonic (coupling liquid) and built-in safety features. It also allows the user to control the treatment while providing different user interfaces: two dual touch-screens, mouse, keyboard and printer. The Focal One® energy is delivered via an endorectal dynamic focusing probe, which includes an imaging system. The high-energy ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the focal area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The endorectal dynamic focusing probe is attached to a support, enabling movements in the longitudinal, transverse, vertical and angular directions, and in rotation. A coupling liquid pouch (Ablasonic®) included in the FocalPak disposable kit, attached to a stand, maintained at a controlled temperature flows continuously (via a peristaltic pump) into the balloon to preserve the rectal wall from heating associated with the treatment. The module is mounted on four multidirectional wheels allowing an easy positioning of the device in the treatment room.
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    K Number
    K172285
    Device Name
    Ablatherm Fusion
    Manufacturer
    EDAP TECHNOMED, INC.
    Date Cleared
    2017-10-03

    (67 days)

    Product Code
    PLP
    Regulation Number
    876.4340
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ablatherm® Fusion device is indicated for transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue.
    Device Description
    The device is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. The system consists of the following main sub-assemblies: Therapy Control Module, Endorectal Probe, and consumable Ablapak. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated.
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    K Number
    K160942
    Device Name
    Sonablate
    Manufacturer
    SonaCare Medical, LLC
    Date Cleared
    2016-12-21

    (260 days)

    Product Code
    PLP
    Regulation Number
    876.4340
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sonablate® is indicated for transrectal high intensity focused ultrasound (HIFU) ablation of prostatic tissue.
    Device Description
    Not Found
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