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510(k) Data Aggregation

    K Number
    K182542
    Device Name
    The EPAD 2 System
    Manufacturer
    SafeOp Surgical, Inc.
    Date Cleared
    2019-02-22

    (158 days)

    Product Code
    GWF, ETN, GXY, GXZ, IKN, PDQ
    Regulation Number
    882.1870
    Why did this record match?
    Applicant Name (Manufacturer) :

    SafeOp Surgical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EPAD 2 system is intended for use in monitoring neurological status by recording somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMJ). Neuromonitoring procedures include intracranial, extracranial, intratemporal, extratemporal, neck dissections, upper and lower extremities, spinal degenerative treatments, pedicle screw fixation, intervertebral fusion cages, rhizotomy, orthopedic surgery, open or percutaneous, lumbar, thoracic, and cervical surgical procedures.
    Device Description
    The EPAD 2 System consists of the EPAD 2 Headbox and power supply, a tablet computer, electrodes, stimulating probe or clip and cables. The Headbox is responsible for the stimulation and acquisition of signals for the intraoperative neurophysiologic monitoring (IONM) functions. The Headbox contains onboard firmware and is mounted on the operating room (OR) bed by clipping it to the bed side bar. The EPAD application provides the primary graphical user interface and controls for the EPAD II System. The application runs on a touchscreen tablet mobile device which connects wirelessly or via a wired USB cable to the Headbox. The application serves as the interface to the EPAD Headbox, enabling both user input (e.g., patient and procedure information, adjustment of stimulus and acquisition parameters) and display of output (e.g., display of acquired waveforms, data, messages and alerts to the clinician).
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    K Number
    K132616
    Device Name
    EPAD
    Manufacturer
    SAFEOP SURGICAL, INC.
    Date Cleared
    2014-01-24

    (156 days)

    Product Code
    GWF, GXY, IKN
    Regulation Number
    882.1870
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAFEOP SURGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EPAD is intended for use in monitoring neurological status by recording somatosensory evoked potentials (SSEP) or assessing the neuromuscular junction (NMJ).
    Device Description
    The EPAD system consists of the following components/accessories: EPAD Headbox EPAD Headbox Power Supply EPAD Tablet Computer (includes power supply and USB cable) Stimulator Left Blue Cable Assembly (110 inches) Stimulator Right Yellow Cable Assembly (110 inches) Acquisition Left Red Cable Assembly (91 inches) Acquisition Right White Cable Assembly (92 inches) Stimulator Left Blue Short Cable Assembly (67 inches) Stimulator Right Yellow Short Cable. Assembly (67 inches) Acquisition Left Red Short Cable Assembly (44 inches) Acquisition Right White Short Cable Assembly (72 inches) Adapter Cable for EPAD Headbox (for leakage current testing) Upper Limb Electrodes package Lower Limb Electrodes package The EPAD Headbox contains a complete data acquisition system that has built-in amplifiers, analog to digital converters, and digital signal processors. User interface is via tablet touchscreen computer provided with the EPAD System and running the Android operating system. The EPAD software application is preloaded onto the tablet. Data can be transferred to an external computer for archiving purposes. Communication between the EPAD Headbox and tablet is via Bluetooth wireless or USB connection. Electrode cables are provided for left and right stimulation and left and right acquisition, color coded for correct connection to the EPAD Headbox: Custom cutaneous electrodes for stimulus and acquisition are provided by SafeOp for use with the EPAD. A total of 11 electrodes are applied for full patient monitoring (upper and lower limbs). The SafeOp electrodes are wet qel, single patient use, disposable, and biocompatible for short term (<24 hours) use on intact skin.
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