The EPAD 2 System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 22, 2019 SafeOp Surgical, Inc. % Jeremy Markovich Senior Manager, Regulatory and Clinical Affairs Alphatec Spine, Inc. 5818 El Camino Real Carlsnad, California 92008 Re: K182542 Trade/Device Name: The EPAD 2 System Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF, PDQ, GXY, GXZ, ETN, IKN Dated: September 14, 2018 Received: September 17, 2018 Dear Jeremy Markovich: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading. 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For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Jay R. Gupta -S For Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K182542 Device Name EPAD 2 System ### Indications for Use (Describe) 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 (NM). Neuromonitoring procedures include intracranial, extracranial, intratemporal, 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. Type of Use (Select one or both, as applicable) | <div> <span> <span style="font-size: 10pt;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |---------------------------------------------------------------------------------------------------------------------------| | <div> <span>□ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92. | I. | SUBMITTER: | SafeOp Surgical, Inc.<br>11350 McCormick Rd, Suite 1003<br>Hunt Valley, MD 21031<br>(410) 891-5708 | |----|------------------------|------------------------------------------------------------------------------------------------------------------------------| | | Contact Person: | Jeremy Markovich<br>Senior Manager, Regulatory and Clinical Affairs<br>Alphatec Spine, Inc.<br>Contact Phone: (760) 431-9286 | | | Date Summary Prepared: | January 23, 2019 | #### II. DEVICE | Trade or Proprietary Name: | EPAD™ 2 System | |----------------------------|---------------------------------------| | Common Name: | Evoked Response Electrical Stimulator | | Classification Name: | Evoked Response Electrical Stimulator | | Regulation Number: | 21 CFR 882.1870 | | Classification: | Class II | | Product Code: | GWF | | Subsequent Code: | GXY, GXZ, PDQ, ETN, IKN | ### III. LEGALLY MARKETED PREDICATE DEVICES | | Primary Predicate: | |--|--------------------| |--|--------------------| | 510(k) | Product Name | Clearance Date | |---------|-------------------------------------------|------------------| | K132616 | EPAD™ (Evoked Potential Assessing Device) | January 24, 2014 | ## Additional Predicates: | 510(k) | Product Name | Clearance Date | |---------|----------------------------------------------------------------------------------------------------------------------|-------------------| | K083124 | Nerve Integrity Monitor 3.0 | February 27, 2009 | | K061639 | Eclipse TCD Neurovascular Workstation Eclipse<br>Neurological Workstation with TCD and vascular<br>Doppler CardioMon | November 1, 2006 | | K110410 | MS-120BK Electric Stimulator Extension Unit | August 4, 2011 | | K162383 | Cadwell Sierra Summit | March 1, 2017 | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows two logos side by side. The first logo is for "atec" and features a green graphic element with the text "tec" in white, all set against a dark blue background. The second logo is for "SafeOp SURGICAL" and includes a stylized human figure with dots on the back, along with the text "SafeOp" in a bold font and "SURGICAL" underneath. ### IV. 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). #### V. INDICATIONS FOR 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. ### VI. TECHNOLOGICAL COMPARISON TO PREDICATES The modified design of the subject device was compared to the predicates in intended use, indications for use, design, function and technology and it was demonstrated that they are substantially equivalent. The technological differences within this 510(k) that were shown to be substantially equivalent to the predicates including the addition of an EMG modality. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the "atec" logo. The logo consists of a green symbol that looks like a stylized letter "a" inside a rounded square. To the right of the symbol, the word "atec" is written in white letters. The background of the logo is a dark blue color. Image /page/5/Picture/1 description: The image contains the logo for SafeOp Surgical. The logo features a stylized human figure with dots on its body, placed within a dark blue circle. To the right of the figure, the text "SafeOp" is written in a bold, dark blue font, with "SURGICAL" written in smaller letters below it. | Table 1: Comparison for Substantial Equivalence | | | | | | | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristic | 510(k) | Predicate Devices | | | | Subject Device | | | | Nerve Integrity<br>Monitor 3.0<br>(K083124) | Eclipse TCD<br>Neurovascular<br>Workstation Eclipse<br>Neurological<br>Workstation with TCD<br>and vascular Doppler<br>CardioMon<br>(K061639) | MS-120BK Electric<br>Stimulator Extension<br>Unit<br>(K110410) | Cadwell Sierra Summit<br>(K162383) | | | Manufacturer | Medtronic Xomed, Inc. | Medtronic Xomed, Inc.<br>(formerly Axon Systems<br>Inc.) | NIHON KOHDEN CORP. | Cadwell Industries, Inc. | SafeOp Surgical, Inc. | SafeOp Surgical, Inc.<br>a subsidiary of Alphatec<br>Holdings, Inc. | | Intended Use/<br>Indications for<br>Use | Intended Use:<br>The NIM 3.0 is<br>intended for locating<br>and identifying<br>cranial and peripheral<br>motor and mixed<br>motor-sensory nerves<br>during surgery,<br>including spinal cord<br>and spinal cord nerve<br>roots. The APS<br>electrode is an<br>accessory intended<br>for providing<br>automatic periodic<br>stimulation to nerves<br>when used with the<br>Medtronic Nerve<br>Monitoring Systems. | The systems are intended<br>for use to monitor sensory<br>and motor pathways and to<br>provide information to<br>determine the state of<br>blood flow in the<br>intracranial and<br>extracranial vascular<br>arteries in adults.<br>The instrument uses<br>electroencephalography<br>(EEG), electromyography<br>(EMG), motor and sensory<br>evoked potentials and<br>nerve potentials and<br>Doppler analysis.<br>Transcranial stimulation<br>techniques for motor<br>evoked potentials are used<br>to assess for acute<br>dysfunction in axonal | When the Low output is<br>selected the MS-120BK is<br>used as a nerve stimulator<br>for surgical procedures<br>and brain mapping during<br>treatment of patients with<br>seizure disorders. When<br>High output is selected the<br>MS-12OBK is used for the<br>intraoperative diagnosis of<br>acute dysfunction in<br>corticospinal axonal<br>conduction brought about<br>by mechanical trauma<br>(traction, shearing,<br>laceration, or<br>compression) or vascular<br>insufficiency. The system<br>is intended for use by<br>qualified medical<br>personnel within a hospital | Cadwell Sierra Summit:<br>Cadwell Sierra Summit is<br>indicated for acquisition,<br>display, storage,<br>transmission, analysis, and<br>reporting of<br>electrophysiological and<br>environmental data<br>including<br>Electromyography (EMG),<br>Nerve Conduction Studies<br>(NCS), Evoked Potentials<br>(EP), and Autonomic<br>Reponses (RR Interval<br>Variability). The Cadwell<br>Sierra Summit is used to<br>detect the physiologic<br>function of the nervous<br>system, and to support the<br>diagnosis of | The EPAD is intended for<br>use in monitoring<br>neurological status by<br>recording somatosensory<br>evoked potentials (SSEP)<br>or assessing the<br>neuromuscular junction<br>(NMJ). | The EPAD 2 system is<br>intended for use in<br>monitoring neurological<br>status by recording<br>somatosensory evoked<br>potentials (SSEP),<br>electromyography (EMG),<br>or assessing the<br>neuromuscular junction<br>(NMJ). Neuromonitoring<br>procedures include<br>intracranial, extracranial,<br>intratemporal,<br>extratemporal, neck<br>dissections, upper and<br>lower extremities, spinal<br>degenerative treatments,<br>pedicle screw fixation,<br>intervertebral fusion cages.<br>rhizotomy, orthopedic<br>surgery, open or | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the Atec logo. The logo features a green square with a stylized white "a" inside. To the right of the square is the word "tec" in white, with a trademark symbol above the "c". The logo has a blue background. Image /page/6/Picture/1 description: The image contains the logo for SafeOp Surgical. The logo features a stylized human figure with dots on the torso and limbs, positioned to the left of the text "SafeOp". Below "SafeOp" is the word "SURGICAL" in a smaller font size. The logo is in a dark blue color. | Indications for NIM 3.0<br>EMG Monitoring<br>Procedures include: | conduction of the<br>corticospinal tract. | or clinical environment.<br>The stimulator is available<br>for use on any patients as<br>determined by the<br>qualified medical<br>personnel. | neuromuscular diseases or<br>conditions. | percutaneous, lumbar,<br>thoracic, and cervical<br>surgical procedures. | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------| | Intracranial,<br>Extracranial,<br>Intratemporal,<br>Extratemporal, Neck<br>Dissections, Thoracic<br>Surgeries, and Upper<br>and Lower<br>Extremities.<br><br>Indications for Spinal<br>procedures which may use<br>NIM 3.0 EMG monitoring<br>include:<br><br>Degenerative<br>Treatments, Pedicle<br>Screw Procedures,<br>Fusion Cages,<br>Rhizotomy,<br>Orthopedic Surgery,<br>Open and<br>Percutaneous Lumbar<br>and Cervical Surgical<br>Procedures, and<br>Thoracic Surgical<br>Procedures. | The system is used in the<br>operating room and critical<br>care areas to provide<br>health care professionals<br>with information to guide<br>surgery and to assess a<br>patient's neurological and<br>vascular status.<br><br>Doppler analysis is not to<br>be used for Obstetrics. | | The listed modalities do<br>include overlap in<br>functionality. In general,<br>Nerve Conduction Studies<br>measure the electrical<br>responses of the peripheral<br>nerve; Electromyography<br>measures the electrical<br>activity of the muscle, and<br>Evoked Potentials measure<br>the electrical activity from<br>the central nervous system.<br>The interface for third-<br>party non-invasive<br>imaging display and<br>control is used to visualize<br>the morphology and<br>location of nerves and<br>muscles, and serves as an<br>aid in confirming the<br>results of the<br>aforementioned<br>modalities.<br><br>Cadwell Sierra Summit is<br>indicated for use by<br>qualified medical<br>practitioners. This device<br>does not provide any<br>diagnostic conclusion<br>about the patient's<br>condition to the user. | | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows two logos side by side. The logo on the left is for "atec" and features a green abstract design within a dark blue square. The logo on the right is for "SafeOp SURGICAL" and features a dark blue silhouette of a person with dots on their body inside a circle, with the text "SafeOp" above the text "SURGICAL". | Regulatory<br>Class/Code | Class II<br>GWF, ETN<br>(882.1870) | Class II<br>GWO, GWS, GWF,<br>GWVE, GWVJ, IKN,<br>IYN, ITX<br>(882.1870) | Class II<br>GYC, GWF<br>(882.1310) | Class II<br>IKN, GWF, JXE,<br>GWJ, GWE, GZP<br>(890.1375) | Class II<br>GWF, GXY, IKN<br>(882.1870) | Class II<br>GWF, GXY, GXZ,<br>PDQ, ETN, IKN<br>(882.1870) | Current Range | 0.01 to 30 mA | Unknown | 0 to 15 mA | 0 to 100 mA | 0 to 100 mA | 0 to 100 mA | |-----------------------------|------------------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------|-----------------------------------------------------------|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------| | 60601-1<br>Compliant | Yes | Yes | Yes | Yes | Yes | Yes | Maximum<br>Current Density | Unknown | Unknown | $46 mA RMS/cm^2$<br>smallest electrode<br>conductive surface area =<br>$0.04 cm^2$ | Unknown | $0.75 mA RMS/cm^2$<br>smallest electrode<br>conductive surface area<br>= $2 cm^2$ | $23.6 mA RMS/cm^2$<br>smallest electrode<br>conductive surface area<br>= $0.0816 cm^2$ | | Operating<br>Modes | Triggered EMG<br>Free run EMG | Triggered EMG<br>Free run EMG<br>Evoked Potentials | When connect to the<br>Neuromaster, the<br>extension unit can output<br>high or low current pulses<br>to measure evoked<br>potentials:<br>(e.g., EEG, EMG, MEP,<br>and SSEP) | Triggered EMG<br>Free run EMG<br>Evoked Potentials | SSEP<br>NMJ | Triggered EMG<br>Free run EMG<br>SSEP<br>NMJ | Compatible<br>Accessories | Surface Electrodes<br>Needle Electrodes<br>Stimulating Probes<br>Cable, Electrode | Surface Electrodes<br>Needle Electrodes<br>Stimulating Probes<br>Cable, Electrode | Surface Electrodes<br>Needle Electrodes<br>Cable, Electrode | Surface Electrodes<br>Needle Electrodes<br>Cable, Electrode | Surface Electrodes<br>Needle Electrodes<br>Cable, Electrode | Surface Electrodes<br>Needle Electrodes<br>Stimulating Probes<br>Cable, Electrode | | Total Amplifier<br>Channels | 1 to 8 | Up to 8 | 16 and 32 when connected<br>to the MEE 1000A<br>through the JB116BK or<br>JB-132BK amplifier | 1 to 12 | Up to 8 | Up to 8 | Biocompatibility<br>of patient<br>contacting<br>accessories<br>(ISO 10993-1) | Yes<br>Tissue/bone/dentin for a<br>limited duration of less than<br>or equal to 24 hours. | Unknown | Unknown | Unknown | Yes<br>Tissue/bone/dentin for a<br>limited duration of less<br>than or equal to 24 hours. | Yes<br>Tissue/bone/dentin for a<br>limited duration of less<br>than or equal to 24 hours. | | Waveform | Monophasic, Rectangular | Biphasic | Multiphasic, Rectangular | Biphasic | Monophasic, Rectangular | Monophasic, Rectangular | | | | | | | | | Pulse Width | 50 to 250 µsec | 50 to 500 µsec | 0.05 msec to 0.3 msec per<br>phase<br>(50 to 300 µsec) | 0.05 to 1 ms<br>(50 to 1000 µsec) | 50 to 300 µsec | 50 to 300 µsec | | | | | | | | | Frequency<br>(Pulse Rate) | 1 to 10 Hz | Unknown | 0.1 to 50 Hz | Up to 50 Hz | 0.1 to 50 Hz | 0.1 to 50 Hz | | | | | | | | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image is a logo for a company called "tec". The logo consists of a green rounded square with a white stylized letter "a" inside of it. To the right of the square is the word "tec" in white letters. The entire logo is set against a dark blue background. Image /page/8/Picture/1 description: The image is a logo for SafeOp Surgical. The logo consists of a stylized human figure with dots on the body, next to the text "SafeOp" in a bold, sans-serif font. Below "SafeOp" is the word "SURGICAL" in a smaller font. The logo is simple and modern, and the use of the human figure suggests a focus on patient safety. Traditional 510(k) Premarket Notification K182542 EPAD™ 2 System {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows two logos side by side. The logo on the left is a dark blue rectangle with a green leaf-like shape and the word "atec" in white. The logo on the right is a human figure with dots on the body and the words "SafeOp SURGICAL" in blue and gray. The logos appear to be for medical or surgical companies. #### VII. PERFORMANCE DATA Nonclinical performance testing demonstrates that the subject EPAD 2 System meets the functional, system, and software requirements. EMC and Electrical Safety Testing of the EPAD 2 System was performed to ensure all functions of the system and its accessories are electrically safe, and comply with recognized electrical safety standards Usability testing was performed to demonstrate that the subject EPAD 2 System presents no adverse effect within the intended environment, and the subject device was therefore found to be substantially equivalent to the predicate. ### Clinical Information Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data. #### VIII. CONCLUSION Based upon the information provided in this 510(k) submission, it has been determined that the subject devices are substantially equivalent to legally marketed devices in regards to indications for use, intended use, design, technology, and performance.