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510(k) Data Aggregation

    K Number
    K232148
    Device Name
    X-Guide Surgical Navigation System
    Manufacturer
    X-Nav Technologies, LLC
    Date Cleared
    2024-02-21

    (217 days)

    Product Code
    QRY, PLV
    Regulation Number
    872.4120
    Why did this record match?
    Applicant Name (Manufacturer) :

    X-Nav Technologies, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The X-Guide® Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures and/or endodontic access procedures. The system provides software to preoperatively plan dental implantation procedures and/or endodontics access procedures and provides navigational guidance of the surgical instruments. The device is intended for use for partially edentulous adult and geriatric patients who need dental implants as a part of their treatment plan. The device is also intended for endodontic access procedures (i.e., apicoectomies and/or access of calcified canals) where a CBCT is deemed appropriate as part of their treatment plan.
    Device Description
    The X-Guide® Surgical Navigation System is a cart mounted mobile system utilizing video technology to track position and movement of a surgical instrument (Dental Hand-Piece) during surgical procedures. The X-Guide® Surgical Navigation System consists of a Mobile Cart, equipped with an LCD Monitor, Boom Arm, Navigation Assembly, Keyboard, Mouse and an Electronics Enclosure. The Electronics Enclosure contains the system power supplies, data processing hardware, and electronics control circuitry for coordinating operation of the X-Guide® Surgical Navigation System. A LCD Monitor, Keyboard, and Mouse serve as the main user interface for the surgeon. The Go-Button serves as an additional form of input by providing virtual buttons that a user can activate by touching them with the surgical instrument tip. The Boom Arm allows the operator to manipulate the Navigation Assembly position for optimal distance and alignment to patterns located with the surgical region (Navi-Zone) for tracking purposes. The Navigation Assembly contains two cameras oriented in a stereo configuration, along with blue lighting for illuminating the patterns and mitigating ambient lighting noise. This electro-optical device is designed to improve dental surgical procedures by providing the surgeon with accurate surgical tool placement and guidance with respect to a surgical plan built upon Computed Tomographic (CT scan) data. The surgical process occurs in two stages. Stage 1 is the pre-planning of the surgical procedure. The dental surgeon plans the surgical procedure in the X-Guide System Planning Software. A virtual implant or endodontic trajectory is aligned and oriented to the desired location in the CT scan, allowing the dental surgeon to avoid interfering with critical anatomical structures during surgery. Once an implant or trajectory has been optimally positioned, the plan is transferred to the X-Guide Surgical Navigation System in preparation for surgery. In Stage 2 the system provides accurate guidance of the dental surgical instruments according to the preoperative plan. As the dental surgeon moves the surgical instrument around the patient anatomy, 2D barcode tracking patterns on the Handpiece Tracker and the Patient Tracker are detected by visible light cameras in a stereo configuration and processed by data processing hardware to precisely and continuously track the motion of the dental handpiece and the surgically-relevant portion of the patient. The relative motion of the dental handpiece and the patient anatomy, captured by the tracking hardware, is combined with patient-specific calibration data. This enables a 3D graphical representation of the handpiece to be animated and depicted in precise location and orientation relative to a 3D depiction of the implant target, along with depictions of the patient anatomy, and other features defined in the surgical plan. This provides continuous visual feedback that enables the dental surgeon to manewer the dental handpiece into precise alignment. During execution of the surgical procedure, the X-Guide® Surgical Navigation System correlates between the surgical plan and the surgeon's actual performance. If significant deviations in navigation between the plan and the system performance occur, the system will alert the user.
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    K Number
    K211701
    Device Name
    X-Guide® Surgical Navigation System
    Manufacturer
    X-Nav Technologies, LLC
    Date Cleared
    2022-02-01

    (243 days)

    Product Code
    QRY, PLV
    Regulation Number
    872.4120
    Why did this record match?
    Applicant Name (Manufacturer) :

    X-Nav Technologies, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The X-Guide® Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures and/or endodontic access procedures. The system provides software to preoperatively plan dental implantation procedures and/or endodontics access procedures and provides navigational guidance of the surgical instruments. The device is intended for use for partially edentulous adult and geriatric patients who need dental implants as a part of their treatment plan. The device is also intended for endodontic access procedures (i.e., apicoectomies and/or access of calcified canals) where a CBCT is deemed appropriate as part of their treatment plan.
    Device Description
    The X-Guide® Surgical Navigation System is a cart mounted mobile system utilizing video technology to track position and movement of a surgical instrument (Dental Hand-Piece) during surgical procedures. The X-Guide® Surgical Navigation System consists of a Mobile Cart, equipped with an LCD Monitor, Boom Arm, Navigation Assembly, Keyboard, Mouse and an Electronics Enclosure. The Electronics Enclosure contains the system power supplies, data processing hardware, and electronics control circuity for coordinating operation of the X-Guide® Surgical Navigation System. A LCD Monitor, Keyboard, and Mouse serve as the main user interface for the surgeon. The Go-Button serves as an additional form of input by providing virtual buttons that a user can activate by touching them with the surgical instrument tip. The Boom Arm allows the operator to manipulate the Navigation for optimal distance and alignment to patterns located with the surgical region (Navi-Zone) for tracking purposes. The Navigation Assembly contains two cameras oriented in a stereo configuration, along with blue lighting the patterns and mitigating ambient lighting noise. This electro-optical device is designed to improve dental surgical procedures by providing the surgeon with accurate surgical tool placement and guidance with respect to a surgical plan built upon Computed Tomographic (CT scan) data. The implant process occurs in two stage 1 is the pre-planning of the surgical implantation procedure. The dental surgeon plans the surgical procedure in the X-Guide System Planning Software. A virtual implant is aligned location in the CT scan, allowing the dental surgeon to avoid interfering with critical anatomical structures during implant surgery. Once an implant has been optimally positioned, the plan is transferred to the X-Guide Surgical Navigation System in preparation for implant surgery. In Stage 2 the system provides accurate guidance of the dental surgical instruments according to the pre-operative plan.
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    K Number
    K192579
    Device Name
    X-Guide Surgical Navigation System
    Manufacturer
    X-Nav Technologies, LLC
    Date Cleared
    2020-02-03

    (137 days)

    Product Code
    PLV
    Regulation Number
    872.4120
    Why did this record match?
    Applicant Name (Manufacturer) :

    X-Nav Technologies, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The X-Guide(R) Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. The device is intended for use for partially edentulous adult and geriatric patients who require dental implants as part of their treatment plan.
    Device Description
    The X-Guide® Surgical Navigation Systemis an electro-optical device designed to aid dental surgical providing the surgeon with accurate surgical tool placement and guidal plan built upon Computed Tomographic (CT scan) data. The system provides the surgeon with a three-dimensional real time video visual aid to indicate dental drill location in space, with 6 degrees of freedom (X, Y,Z, Pitch, Yaw,andRoll) and anaccuracy (RMS) of < 1 mm. Thishelps to improve the Oral Surgeon drilling precision within a patient oral cavity. Since the system is video based, the surgeon is still working in the freehand mode, meaning he/she is always in control of the surgery. The implant process occurs in two stages. Stage 1 is the surgical implantation procedure. The dental surgeon plans the surgical procedure in the Implant Planning Software, XOS®. A virtual implant is aligned to the desired location in the CT scan. allowing the dental surgeon to avoid interfering with critical anatomical structures during implant has been optimally positioned, the plan is transferred to the X-Guide® Surgical Navigation System in preparation for implant surgery. In Stage 2 the system provides accurate guidance of the dental surgical instruments according to the pre-operative plan. As the dental surgeon moves the surgical instrument around the patient anatomy, 2D barcode tracker and the Patient Tracker are detected by visible light cameras in a stereo configuration and processing hardware to precisely and continuously track the motion of the dental handpiece and the surgically-relevant portion of the patient. The relative motion of the dental handpiece and the patient an the tracking hardware, is combined with patient-specific calibration data. This enables a 3D graphical representation of the handpiece to be animated and drientation relative to a 3D depiction of the implant target, along with depictions of the patient anatomy, and other features defined in the surgical plan. This provides continuous visual feedback that enables the dental surgeon to maneuver the dental handpiece into precise alignment.
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    K Number
    K150222
    Device Name
    X-Guide Surgical Navigation System
    Manufacturer
    X-Nav Technologies, LLC
    Date Cleared
    2015-10-08

    (251 days)

    Product Code
    PLV
    Regulation Number
    872.4120
    Why did this record match?
    Applicant Name (Manufacturer) :

    X-Nav Technologies, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The X-Guide(R) Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and intra-operative surgical phase of dental implantation procedures. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. The device is intended for use for partially edentulous adult and geriatric patients who require dental implants as part of their treatment plan.
    Device Description
    The X-Guide® Surgical Navigation System is an electro-ontical device designed to aid dental procedures by providing the surgeon with accurate surgical tool placement and guidance with respect to a surgical plan built upon Computed Tomographic (CT scan) data. The system provides the surgeon with a three visual aid to indicate dental drill location in space, with 6 degrees of freedom (X, Y, Z, Pitch, Yaw, and Roll) and an accuracy (RMS) of < 1 mm. This helps to improve the Oral Surgeon drilling precision within a patient oral cavity. Since the system is still working in the freehand mode, meaning he/she is always in control of the surgery. The implant process occurs in two stages is the preplanning of the surgical implantation procedure. The dental surgeon plans the surgical procedure in the Implant Planning Software. XOS®. A virtual implant is aligned to the desired location in the CT scan, allowing the dental surgeon to avoid interfering with critical anatomical structures during implant surgery. Once an implant has been optimally positioned, the X-Guide® Surgical Navigation System in preparation for implant surgery. In Stage 2 the system provides accurate quidance of the dental surgical instruments according to the pre-operative plan. As the dental surgeon moves the surgical instrument around the patient anatomy, 2D barcode tracking patterns on the Hand Piece Tracker and the Patient Tracker are detected by visible light cameras in a stereo configuration and processed by data processing hardware to precisely and continuously track the motion of the surgically-relevant portion of the patient. The relative motion of the dental handpiece and the patient anatomy, captured by the tracking hardware, is combined with patient-specific calibration data. This enables a 3D graphical representation of the handpieced in precise location and orientation relative to a 3D depiction of the implant target, along with depictions of the patient anatomy, and other features defined in the surgical plan. This provides continuous visual feedback that enables the dental surgeon to maneuver the dental handpiece into precise alignment. Several patient-specific calibrations underpin the quidance system. Hand Piece calibration is performed to determine the geometric relationship between the Hand Piece Tracker and the tip of the surgical instrument.
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