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510(k) Data Aggregation

    K Number
    K182662
    Device Name
    NAV PAK Needle, NIM NAV PAK Needle
    Manufacturer
    Boston Endo Surgical Tech,
    Date Cleared
    2019-04-10

    (197 days)

    Product Code
    PDQ, HAW, OLO
    Regulation Number
    874.1820
    Why did this record match?
    Applicant Name (Manufacturer) :

    Boston Endo Surgical Tech,

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BE-ST NAV PAK is indicated for navigated pedicle pilot hole preparation. The BE-ST NAV PAK should only be used with a compatible Medtronic StealthStation® System. The BE-ST NAV NIM® PAK is indicated for navigated pedicle pilot hole preparation, locating, and identifying nerves during surgery, including spinal nerve roots. The BE-ST NAV NIM® PAK should only be used with compatible Medtronic StealthStation® and Medtronic NIM® Systems.
    Device Description
    The BE-ST Navigated PAK Needles are single use surgical instruments composed of stainless steel and plastic. They are sterile packaged. The devices are comprised of three main components: the cannula, stylet assembly, and tracker subassembly. There are two devices in the family: the BE-ST Navigated NIM® PAK Needle and the BE-ST Navigated PAK Needle. The BE-ST Navigated NIM® PAK Needle is an accessory to the Medtronic StealthStation® System and is intended for use as a stimulating accessory to the Medtronic NIM® System. The BE-ST Navigated PAK Needle is an accessory to the Medtronic StealthStation® System. The only significant differences between the two subject devices are the electrical insulation on the cannula and the connection to the NIM® System. The BE-ST Navigated PAK device has the same basic function and navigational capabilities as the BE-ST Navigated NIM® PAK device but is not an accessory to the Medtronic NIM® system and therefore cannot be used for nerve monitoring.
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    K Number
    K180542
    Device Name
    NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe
    Manufacturer
    Boston Endo Surgical Tech,
    Date Cleared
    2018-08-22

    (174 days)

    Product Code
    PDQ, PDO
    Regulation Number
    874.1820
    Why did this record match?
    Applicant Name (Manufacturer) :

    Boston Endo Surgical Tech,

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BE-ST NIM® PAK Needle, Blunt, and Pedicle Probe are indicated for pedicle pilot hole preparation, locating, and identifying cranial and peripheral motor nerves during surgery, including spinal nerve roots.
    Device Description
    The BE-ST NIM® PAK Needle, Blunt, and Pedicle Probe are single use devices composed of stainless steel and plastic and are sterile packaged. The devices are comprised of two main components: the cannula and stylet assembly. Also, in the package are two monopolar cables: a subdermal needle electrode and a connecting cable. The NIM® PAK devices are available in standard "NIM® PAK" or longer "NIM® XPAK" configurations with 3 different types of tips: bevel, trocar or blunt. The blunt tips are only offered for the NIM® XPAK. In addition, there are three (3) NIM Pedicle Probes in lumbar, straight, and thoracic configurations. The BE-ST NIM® product family has a total of four (4) pedicle access needle configurations, three (3) pedicle probe configurations, and one (1) blunt configuration. All configurations are packaged with two (2) accessory monopolar cables. One cable is used to ground the patient and the other cable is used to connect the device to a Medtronic Neural Integrity Monitor (NIM®). The connection to the NIM® allows the subject device to provide stimulation to nerves.
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