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510(k) Data Aggregation

    K Number
    K243520
    Device Name
    Bullsai Confirm
    Manufacturer
    Turing Medical Technologies, Inc.
    Date Cleared
    2025-03-28

    (135 days)

    Product Code
    QQC, OOC
    Regulation Number
    882.5855
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bullsai Confirm provides functionality to assist medical professionals in planning the programming of stimulation for patients receiving approved Abbott deep brain stimulation (DBS) devices.
    Device Description
    Bullsai Confirm is intended to assist medical professionals in planning the programming of deep brain stimulation (DBS) by visualizing the Volume of Tissue Activated (VTA) relative to patient anatomy. It is used to visualize patient-specific information within the patient's anatomy. Integrated magnetic resonance imaging (MRI) and computed tomography (CT) images are uploaded to Bullsai Confirm and can be navigated through in multiple 2D projections and 3D reconstructions. Abbott DBS lead models are positioned in the corresponding artifacts and potential stimulation settings and electrode configurations entered. Bullsai Confirm mathematically combines finite element (FE) based electric field model of the lead with an axon based neural activation model to translate potential stimulation settings and electrode configurations into a visualized VTA field to indicate the shape and the area or volume of anatomy that will be activated by the stimulation. Results, including input image quality assessments, are shared in an output PDF report and visualized in a web-based software interface. Bullsai Confirm is used to do the following: - Import DICOM images from a picture archiving and communication system (PACS), including . MRI and CT DICOM images. - . Import preoperative planning outputs (including tractography, structural ROIs, etc.) from AWS S3 Cloud Storage - . Combine MR images, CT images, and patient specific 3D structures for more detail - Localize graphical compatible DBS lead models (based on preoperative imaging) . - . Visualize VTA fields relative to structures of interest in the patient anatomy or lead position The software provides a workflow for clinicians to: - Create patient-specific stimulation plans for DBS programming . - . Export reports that summarize stimulation plans for patients (PNG screenshot)
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    K Number
    K213930
    Device Name
    Brainlab Elements Guide XT, Guide 3.0
    Manufacturer
    Brainlab AG
    Date Cleared
    2022-04-19

    (124 days)

    Product Code
    QQC
    Regulation Number
    882.5855
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Brainlab Elements Guide XT provides functionality to assist medical professionals in planning the programming of stimulation for patients receiving approved Boston Scientific deep brain stimulation (DBS) devices.
    Device Description
    Brainlab Elements Guide XT is a software application designed to support neurosurgeons and neurologists in Deep Brain Stimulation (DBS) treatments. It enables stimulation field simulation and visualization of the stimulation field model in the context of anatomical images. This functionality can be used to aid in lead parameter adjustment. Brainlab Elements Guide XT is used in combination with other applications that provide functionality for image fusion, segmentation, etc. Guide XT is compatible with selected Boston Scientific leads and implantable pulse generators but does not directly interact with the surgeon. The subject device Brainlab Elements Guide XT consists of multiple software components including the Guide XT 3.0 application that provides the core functionality for stimulation field model creation and visualization in the context of the patient anatomy.
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    K Number
    DEN210003
    Device Name
    SureTune4 Software
    Manufacturer
    Medtronic Neuromodulation
    Date Cleared
    2021-08-23

    (201 days)

    Product Code
    QQC
    Regulation Number
    882.5855
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SureTune4 Software is indicated to assist medical professionals in planning the programming of stimulation for patients receiving approved Medtronic deep brain stimulation (DBS) devices.
    Device Description
    The SureTune4 Software is intended to assist medical professionals in planning the programming of deep brain stimulation (DBS) by visualizing the Volume of Neural Activation (VNA) relative to patient anatomy. It is used to visualize patient-specific information within the patient's anatomy. Integrated preoperative and postoperative magnetic resonance imaging (MRI), Oarm™, and computed tomography (CT) images are uploaded to SureTune4 and can be navigated through in multiple 2D projections and 3D reconstructions. Medtronic DBS lead models are positioned in the corresponding artifacts and potential stimulation settings and electrode configurations entered. The SureTune4 Software mathematically combines finite element (FE) based electric field model of the lead with an axon based neural activation model to translates potential stimulation settings and electrode configurations into a visualized VNA field to indicate the shape and the area or volume of anatomy that will be activated by the stimulation. The SureTune4 software is used to do the following: - TM Import MR, O-arm ", and CT patient images over a DICOM network or from . physical media (hard drive, USB drive, CD, or DVD) - Import DICOM archives from StealthStation TM S7 TM systems with Cranial 3.x . software and StealthStation S8 Cranial software systems, and SureTune4 systems over a DICOM network - Combine MR. O-arm and CT images for more detail . - Superimpose an anatomical atlas to better understand the position of structures of . interest relative to a patient's anatomy - Manually segment structures of interest to highlight particular brain structures . - . Localize graphical Medtronic DBS lead models (based on preoperative imaging) - Enter electrophysiological annotations . - Visualize VNA fields relative to structures of interest in the patient anatomy or . lead position - . Create patient-specific stimulation plans for DBS programming - Generate reports that summarize stimulation plans for patients . - Export patient sessions to SureTune4 XLS spreadsheets (in Microsoft™ Excel format) .
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