eVox System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and 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. December 13, 2017 Evoke Neuroscience, Inc. % Marinela Gombosev Executive VP Operations and Marketing Evoke Neuroscience 200 Valencia Dr. Suite 109 Jacksonville, North Carolina 28546 # Re: K171781 Trade/Device Name: eVox System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWO. GWJ Dated: November 10, 2017 Received: November 13, 2017 # Dear Ms. Gombosev: 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. 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); {1}------------------------------------------------ and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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, # Michael J. Hoffmann -S Carlos L. Peña. PhD. MS for 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) K171781 Device Name eVox System Indications for Use (Describe) The eVox System is intended for the acquisition, display, and storage, of electrical activity of a patient's brain including electroencephalograph (EEG) and event-related potentials (ERP) obtained by placing two or more electrodes on the head to aid in diagnosis. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 20px;">☑</span> | |----------------------------------------------|-----------------------------------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | □ | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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SUBMITTER Evoke Neuroscience 200 Valencia Drive, Suite 109 Jacksonville NC 28546 United States David Hagedorn, PhD, CEO, CSO Phone: (917) 261-6096 Fax: (855) 386-5397 # CONTACT PERSON Marinela Gombosev, EVP Operations and Marketing Evoke Neuroscience, Inc. 200 Valencia Drive, Suite 109 Jacksonville NC, 28546 United States Cell Phone: (949) 584-7331 Office Phone: (949) 330-7216 Fax: (855) 386-5397 Email: 510k@evokeneuroscience.com ## DATE PREPARED June 6, 2017 #### DEVICE II. Trade/Proprietary Name: eVox System Common/Usual Name: EEG System, EEG Amplifier Classification Name: Electroencephalograph Classification Regulation: 882.1400 Product Code: GWQ, GWJ Device Class: Class 2 {4}------------------------------------------------ # Classification Panel: Neurology #### III. PREDICATE DEVICES | Legally Marketed Device(s) | 510(k) # | Clearance Date | |----------------------------|----------|----------------| | Mitsar-EEG | K143233 | 8-13-2015 | | COGNISION EEG | K141316 | 2-13-2015 | | Nicolet EDX System | K112052 | 3-15-2012 | #### IV. DEVICE DESCRIPTION The eVox System is intended for the acquisition, display, and storage, of electrical activity of a patient's brain including electroencephalograph (EEG) and event-related potentials (ERP) obtained by placing two or more electrodes on the head to aid in diagnosis The medical system includes the "eVox System" amplifier device, accessories, and a computer (laptop computer or tablet device with internal battery and power cord). The hardware and ancillary components used in conjunction with the eVox System include an EEG cap, the eVox Amplifier, a charging kit (that consists of a USB cable, clip kit, and wall adapter), a Subject Response Device and a Base Station laptop computer. The software on the Base Station laptop computer is intended for device functioning. The eVox System consists of two software components: - . Base Station laptop computer software: pre-loaded Evoke software EVO-002-400-BIATS. - . Firmware running on the eVox Amplifier PN SW-MSP430. The Base Station laptop is running on a Windows Operating System and is paired with the eVox Amplifier with Bluetooth wireless technology. The Evoke software runs on the Base Station computer and has a graphic user interface that allows the clinician to set up a patient and create a new patient record, conduct a study to collect EEG and ERP data, view live EEG and ERP data on the Base Station monitor, and export recorded data to a file. Firmware for the eVox System resides on the eVox Amplifier. The purpose of the eVox amplifier firmware is to acquire electrophysiology data from the patient and transmit it to the Base Station. The Amplifier operational mode is controlled wirelessly via the Evoke software. In addition to 19 channels of EEG recording the device includes a mode to measure the cap electrode impedances. This is useful for determining if the electrodes are making a good electrical connection with the scalp at each electrode location. The primary software outputs are EEG and ERP data files. These data files are written as floating point numbers in binary format, which represent the electrical potential on each of the 19 EEG channels in microvolts. {5}------------------------------------------------ The eVox System amplifier device does not come in direct contact with patients. Accessories that contact patients, such as the EEG electrode cap, are the same as used with legally marketed devices or are comprised of the same materials as legally marketed accessories. The eVox System is intended for prescription use in any healthcare, medical, or athletic or sports clinics, or outside of medical facilities such as in the sports arena under the supervision of a physician. Also, investigations can be performed outside of healthcare facilities, as long as they are led by qualified medical personnel. The device is not sterile. The device is intended for use by qualified medical personnel only and qualifies for exemption per 21 CFR 801 Subpart D «Prescription devices». #### V. INDICATIONS FOR USE The eVox System is intended for the acquisition, display, and storage, of electrical activity of a patient's brain including electroencephalograph (EEG) and event-related potentials (ERP) obtained by placing two or more electrodes on the head to aid in diagnosis. #### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES The following table compares the technological characteristics of the eVox System to those of the predicate devices in order to demonstrate substantial equivalence. {6}------------------------------------------------ Technological Comparison | Trade Name | eVox System | MITSAR-EEG | COGNISION™ | Nicolet EDX 2 Viking Software | Comments | |--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510 (k) Number | K171781 | K143233 | K141316 | K112052 | | | Product codes | GWQ, GWJ, | GWQ | GWJ<br>Additional: OMC, OLT, | GWJ<br>Additional:<br>OLT, GWF, GZP, IKN, JXE, GWE | Product contains multiple product<br>codes which are generally required<br>for a complete system.<br>The eVox System and the Mitsar –<br>EEG device share the product code:<br>GWQ: Full Montage System<br>The eVox System, the COGNISION<br>system and Nicolet EDX system<br>share the product code:<br>GWJ: Evoked response auditory<br>stimulator | | Indications for Use | The eVox System is<br>intended for the<br>acquisition, display, and<br>storage, of electrical<br>activity of a patient's brain<br>including<br>electroencephalograph<br>(EEG) and Event-related<br>Potentials (ERP) obtained<br>by placing two or more<br>electrodes on the head to<br>aid in diagnosis. | The device Mitsar-EEG is<br>intended to acquire,<br>display and store the<br>electrical activity of a<br>patient's brain obtained<br>by placing two or more<br>electrodes on the head<br>to aid in diagnosis. | The COGNISION system is for<br>use by qualified clinical<br>professional in private practice<br>offices or small clinical settings<br>for the acquisition, display,<br>analysis, storage, reporting and<br>management of<br>electroencephalograph (EEG)<br>and auditory evoked potentials<br>(AEP) information. | The Nicolet EDX is intended for the<br>acquisition, display, analysis,<br>reporting and management of<br>electrophysiological information<br>from the human nervous and<br>muscular system including Nerve<br>Conduction (NCS).<br>Electromyography (EMG), Evoked<br>Potentials (VEP), Auditory (AEP)<br>Somatosensory Evoked Potentials<br>(SEP), Electroretinography (ERG)<br>Electrooculography (EOG), P300,<br>Motor Evoked Potential (MEP). The | | | Trade Name | eVox System | MITSAR-EEG | COGNISION™ | Nicolet EDX 2 Viking Software | Comments | | | | | | Nicolet EDX with Viking Software<br>may be used to determine<br>automatics responses to physiologic<br>stimuli by measuring the change in<br>electrical resistance between two<br>electrodes (Galvanic Skin Response<br>and Sympathetic Skin Response).<br>Autonomic testing also includes<br>assessments of RR interval<br>variability. The Nicolet EDX with<br>Viking Software is used to detect<br>the physiologic function of the<br>nervous system, for the location of<br>neural structures during surgery<br>and to support the diagnosis of<br>neuromuscular disease or<br>condition. | | | | | | | The listed modalities do not include<br>overlap in functionality. In general,<br>Nerve Conduction Studies measure<br>the electrical responses of the<br>nerve; Electromyography measures<br>the electrical activity of the muscle<br>and Evoked Potential measure<br>electrical activity from the Central<br>Nervous System.<br>The Nicolet EDX with Viking<br>Software is intended to be used by<br>a qualified healthcare provider. | | | Principle of<br>Operation | The eVox System device is<br>used for acquisition of<br>physiological signals using<br>two or more channels of<br>electroencephalography | The Mitsar EEG consists<br>of biosignal amplifier,<br>USB cable, USB dongle<br>and software. The<br>medical system includes | The COGNISION EEG/EP System<br>is a combination device for<br>reduced montage recording<br>and display of<br>electroencephalographic (EEG) | The Nicolet EDX system with Viking<br>Software (Viking EDX) is designed<br>for the acquisition, display, analysis,<br>reporting and management of<br>electrophysiological information | The eVox System has a principle of<br>operation that closely matches that<br>of its predicates. All devices use<br>skin coupling methods, either<br>through electrodes or sensors | | Trade Name | eVox System | MITSAR-EEG | COGNISION™ | Nicolet EDX 2 Viking Software | Comments | | | (EEG) from the scalp. It<br>consists of an eVox<br>amplifier, a laptop<br>computer (base station),<br>a patient EEG cap, subject<br>response button, ear<br>buds, and a charging cord.<br>The eVox amplifier and<br>software provide a means<br>to:<br>a) initiate a study, track<br>user EEG and ERP data<br>and enter text or<br>questionnaire<br>information,<br>b) acquire and save<br>signals to the memory<br>of the device,<br>c) transmit signal data<br>from the device,<br>d) Visually inspect the<br>acquired signal.<br>e)Manage Event-<br>related Potentials | "Mitsar EEG" device and<br>computer (stationary PC<br>with uninterruptible<br>power supply (UPS) or<br>laptop with internal<br>battery). The Mitsar EEG<br>device is an amplifier<br>which receives patient<br>EEG data from a patient<br>EEG cap or EEG<br>electrodes. | and evoked potentials (EP) test<br>data.<br>The system uses elastic bands<br>to accurately position 10<br>electrode pods around the<br>head.<br>EEG signal amplification,<br>conditioning, and A/D<br>conversion is performed by<br>electronic circuits closely<br>coupled to the electrode pods<br>through short flexible printed<br>wires.<br>The headset is connected by a<br>cable to a handheld control unit<br>and data acquisition box (HCU).<br>The HCU communicates via a<br>wireless data link to a Windows<br>PC to stream EEG data.<br>Software on the PC is used to<br>setup the tests and view and<br>evaluate the resultant test data<br>using standard EEG/EP display<br>methods. | from the human nervous and<br>muscular systems.<br>The system is designed to perform<br>nerve conduction studies (NCS),<br>needle electromyography (EMG)<br>testing, evoked potential (EP)<br>testing, and intra-operative<br>monitoring (IOM). The system can<br>also perform multi-modality<br>recording through Multi-mode<br>programs (MMP). Viking EDX<br>provides a variety of tests spanning<br>the various modalities. | which transmits patient EEG and<br>ERP from the surface of the scalp to<br>an amplifier.<br>The connection between the<br>amplifier and electrodes is a wired<br>connection for the devices.<br>All devices convert the analog data<br>into digital data which is then<br>transmitted to a base station or<br>computer.<br>Once transmitted to the base<br>station, the devices display and<br>store the data on the base station<br>and allow the user to export the<br>data to a file. | | Patient population | All age groups | All age groups | Adults | Unknown | | | Use environment | Intended for use in any<br>healthcare, medical, or<br>athletic or sports clinics,<br>or outside of medical<br>facilities such as in the<br>sports arena under the<br>supervision of a physician.<br>Also, investigations can be | Intended for use in<br>functional diagnostics<br>wards and departments<br>at out-patient clinics,<br>hospitals, health<br>research institutes,<br>health centers and other<br>medical institutions. | Physicians' Offices | Physicians' Offices | | | Trade Name | eVox System | MITSAR-EEG | COGNISION™ | Nicolet EDX 2 Viking Software | Comments | | | performed outside of<br>healthcare facilities, as<br>long as they are led by<br>qualified medical<br>personnel. | Also, investigations can<br>be performed outside of<br>healthcare facilities, as<br>long as they are led by<br>qualified medical<br>personnel. | | | | | Safety class | Class II | Class II | Class II | Class II | | | Biocompatibility | Per ISO 10993-1 | Per ISO 10993-1 | Per ISO 10993-1 | Per ISO 10993-1 | | | Intended Use | The eVox System is<br>intended for the<br>acquisition, display, and<br>storage, of electrical<br>activity of a patient's brain<br>including<br>electroencephalograph<br>(EEG) and Event-related<br>Potentials (ERP) obtained<br>by placing two or more<br>electrodes on the head to<br>aid in diagnosis. | The Mitsar-EEG is<br>intended to acquire,<br>display and store the<br>electrical activity of a<br>patient's brain by placing<br>two or more electrodes<br>on the head to aid in<br>diagnosis. | The COGNISION system is a<br>combination device for reduced<br>montage recording and display<br>of electroencephalograph (EEG)<br>and evoked potentials (EP) test<br>data. | The Nicolet EDX with Viking<br>Software (Viking EDX) is intended<br>for the acquisition, display, analysis,<br>reporting and management of<br>electrophysiological information<br>from the human nervous and<br>muscular systems. The system is<br>designed to perform nerve<br>conduction studies (NCS), needle<br>electromyography (EMG) testing,<br>evoked potential (EP) testing, and<br>intra-operative monitoring (IOM).<br>The system can also perform multi-<br>modality recording through Multi-<br>mode programs (MMP).Viking EDX<br>provides a variety of tests spanning<br>the various modalities. | | | ERP Stimulus<br>Modality | Auditory; Visual | None | Auditory | Auditory; Visual | | | System<br>Components | eVox System consists of : | "Mitsar EEG" consists of | COGNISION™ consists of:<br>• Head Set | CareFusion Nicolet EDX 2 Viking<br>Software consists of: | | | Trade Name | eVox System | MITSAR-EEG | COGNISION™ | Nicolet EDX 2 Viking Software | Comments | | | • an eVox amplifier,<br>• a laptop computer<br>(base station),<br>• a patient EEG cap,<br>• subject response<br>button, ear buds,<br>• and a charging cord. | • biosignal amplifier,<br>• computer<br>(stationary PC with<br>uninterruptible<br>power supply (UPS)<br>• or laptop with<br>internal battery)<br>• USB cable,<br>• USB dongle<br>• and software. | • Auditory stimulator<br>• Handheld Control Unit<br>(HCU) including Interface<br>Software<br>Connecting Headset cable<br>between the headset and<br>the handheld control unit | • EDX Console<br>• Electrical stimulators<br>• Auditory Stimulator<br>• Trigger input/output<br>• LED google interface Control<br>Panel<br>• Amplifier<br>• Computer Monitor<br>• Keyboard,<br>Mouse<br>• Printer | | | ERP Paradigm<br>(Auditory and<br>Visual Stimuli) | P300 Oddball<br>- Single Stimulus<br>- Single Deviant<br>- 2 Deviant<br>- Active and Passive | None | P300 Oddball<br>- Single Stimulus<br>- Single Deviant<br>- 2 Deviant<br>- Active and Passive | P300 Oddball<br>- Single Stimulus<br>- Single Deviant<br>- 2 Deviant<br>- Active and Passive | | | ERP Task<br>Response | User Buttons | User Buttons | User Buttons | User Buttons | | | Skin Coupling | Custom Electrode Band<br>and Gel | Custom Electrode Band<br>and Gel | HydroDot Biosensor | Discrete Electrode Wires | The eVox system, Mitsar EEG, and<br>Nicolet EDX use the same method<br>of utilizing a conductive gel<br>between electrode and the skin<br>The COGNISION system uses<br>HydroDot Biosensor. | | Trade Name | eVox System | MITSAR-EEG | COGNISION™ | Nicolet EDX 2 Viking Software | Comments | | Sterile | No | No…