Enobio Wireless EEG

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 2, 2017 Neuroelectrics Barcelona S.L.U. % Deirdre Barrow Senior Consultant, Regulatory Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin. Texas 78746 Re: K162681 Trade/Device Name: Enobio Wireless EEG Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ, GWL Dated: April 21, 2017 Received: April 27, 2017 Dear Deirdre Barrow: 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely. Michael J. Hoffmann -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) K162681 Device Name Enobio Wireless EEG #### Indications for Use (Describe) ENOBIO is an EEG portable monitoring device of 8, 20, 32 channels intended for the use in clinical patient monitoring for use in hospitals and other medical environments. The Enobio is intended to acquire, store, transmit and display electrophysiological signals in wireless mode as an aid in diagnostics. The system digitizes analogue EEG signals collected by a cap with electrodes, amplifies them, and uses WiFi connectivity to transmit the EEG data to a dedicated host computer with the software. This device is intended to be used by trained health-care personnel. It is restricted to sale by or on order of a physician. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### 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. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary # K162681 #### 1. Submission Sponsor Neuroelectrics Barcelona SLU Avenida Tibidabo 47 bis 08035 Barcelona SPAIN Phone number: + 34 932540370 Contact: Ana Maiques Title: CEO # 2. Submission Correspondent Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Cell Phone: +353 86 8733815 Office Phone: (512) 327.9997 Contact: Deirdre Barrow, Senior Consultant, RA Email: project.management@emergogroup.com #### 3. Date Prepared September 21, 2016 #### 4. Device Identification | Trade/Proprietary Name: | ENOBIO WIRELESS EEG | |-------------------------|---------------------------------------------| | Common/Usual Name: | Electroencephalograph | | Classification Name: | Full-Montage Standard Electroencephalograph | | Regulation Number: | 882.1400 & 882.1835 | {4}------------------------------------------------ | Product Code: | GWQ, Full-Montage Standard Electroencephalograph &<br>GWL, Amplifier, Physiological Signal | |-----------------------|--------------------------------------------------------------------------------------------| | Device Class: | Class II | | Classification Panel: | Neurology | ### 5. Legally Marketed Predicate Device | Device<br>Name | 510(k)<br>No. | Product Code | Classification<br>Regulation | Sponsor | |----------------------------|---------------|--------------|--------------------------------------|----------------------| | Nicolet<br>Wireless<br>EEG | K103140 | GWL & GWQ | 21 CFR 882.1835 &<br>21 CFR 882.1400 | Carefusion 209, Inc. | #### 6. Indication for Use Statement ENOBIO is an EEG portable monitoring device of 8, 20, 32 channels intended for the use in clinical patient monitoring for use in hospitals and other medical environments. The Enobio is intended to acquire, store, transmit and display electrophysiological signals in wireless mode as an aid in diagnostics. The system digitizes analogue EEG signals collected by a cap with electrodes, amplifies them, and uses WiFi connectivity to transmit the EEG data to a dedicated host computer with the software. This device is intended to be used by trained health-care personnel. It is restricted to sale by or on order of a physician. # 7. Device Description The Neuroelectrics device, Enobio Wireless EEG, performs electroencephalographic measurements with non-invasive technology. Enobio is a wireless, battery-operated and portable electrophysiology sensor system for the recording of the electroencephalogram (EEG). It has been designed for use in a clinical environment or hospital.. Enobio use must be controlled by specialized medical personnel able to guarantee the correct recording. ENOBIO WIRELESS EEG, consists of three models designated as the 8, 20 and 32 channels. ENOBIO WIRELESS EEG has a sampling rate of 500 SPS, it works in a bandwidth from 0 to 125Hz (DC coupled) and it provides a resolution of 24 bits - 0.05μV. Enobio is capable of acquiring a variety of electrophysiological signals. These signals include EEG, EOG, ECG and EMG. The Enobio system is primarily made up of the following three items: {5}------------------------------------------------ - Necbox (amplifier, transmitter and control box), - the neoprene cap with the electrodes and - the NIC software. The Necbox, which has a data amplifier, connects directly via Wi-Fi to the Neuroelectrics Instrument Controller (NIC) software running on a computer. The EEG data is streamed through the standard Wi-Fi band, and the standard Wi-Fi operating distance range is 10 meters. In all situations the amplifiers store a copy of the data locally to allow for data back-up. This amplifier provides storage and subsequent transmission of data that is not transferred live when the amplifier is in out of range situations. # 8. Substantial Equivalence Discussion The following table compares the ENOBIO WIRELESS EEG to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device. | Manufacturer | Neuroelectrics | Carefusion | Significant Differences | |-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | ENOBIO WIRELESS EEG | Nicolet Wireless EEG | | | 510(k) Number | K162681 | K103140 (predicate) | n/a | | Product Code | GWL & GWQ | GWL & GWQ | Same | | Regulation<br>Number | 882.1835 & 882.1400 | 882.1835 & 882.1400 | Same | | Regulation Name | Amplifier, Physiological<br>Signal & Full-Montage<br>Standard<br>Electroencephalograph | Amplifier, Physiological<br>Signal & Full-Montage<br>Standard<br>Electroencephalograph | Same | | Indications for Use | ENOBIO is an EEG<br>portable monitoring<br>device of 8, 20, 32<br>channels intended for<br>the use in clinical patient<br>monitoring for use in<br>hospitals and other<br>medical environments.<br>The Enobio is intended to<br>acquire, store, transmit | The Nicolet Wireless<br>EEG Amplifier is<br>intended to be used as a<br>front end amplifier to<br>acquire, store, and<br>transmit<br>electrophysiological<br>signals in a wired or<br>wireless mode for the<br>Nicolet Neurodiagnostic | No significant difference as<br>each device acquires,<br>stores, amplifies and<br>transmits EEG signals to<br>host software for<br>neurological applications. | | Manufacturer | Neuroelectrics | Carefusion | Significant Differences | | Trade Name | ENOBIO WIRELESS EEG<br>and display<br>electrophysiological<br>signals in wireless mode<br>as an aid in diagnostics.<br>The system digitizes<br>analogue EEG signals<br>collected by a cap with<br>electrodes, amplifies<br>them, and uses WiFi<br>connectivity to transmit<br>the EEG data to a<br>dedicated host computer<br>with the software.<br>This device is intended to<br>be used by trained<br>health-care personnel. It<br>is restricted to sale by or<br>on order of a physician | Nicolet Wireless EEG<br>system. | | | Mechanism of Action | The Enobio Wireless EEG<br>is a wireless and<br>wearable<br>electrophysiology sensor<br>system for the recording<br>of electroencephalogram<br>(EEG) measurements | The device is intended<br>to be used as a front end<br>Nicolet<br>EEGwireless32/64<br>amplifier with the<br>Nicolet Neurodiagnostic<br>system to record,<br>measure, store, analyze<br>and display cerebral and<br>extra cerebral<br>physiologic data for EEG<br>and Sleep studies with<br>or without synchronous<br>digital video. The device<br>is wearable on the torso<br>or head | No Significant Difference; the differences between them are:<br><br>● The Enobio Wireless EEG is only available in a wireless assembly whilst the Nicolet Wireless EEG is available in a wired and wireless assembly.<br><br>● The associated software systems are obviously proprietary and are therefore different but the fundamental technology of acquiring, storing, amplifying and transmitting EEG signals to host software is very similar between the two | | Manufacturer | Neuroelectrics | Carefusion | Significant Differences | | Trade Name | ENOBIO WIRELESS EEG | Nicolet Wireless EEG | | | Technology<br>Overview | System components:<br>• cap with electrodes<br>• control box<br>(amplifier,<br>transmitter)<br>• software for PC | System components:<br>• patient cable<br>• amplifier, CPU and<br>display monitor,<br>telemetry unit<br>• access point<br>Interface to amplifier:<br>Wired Ethernet<br>(10/100baseT)or<br>Wireless<br>Ethernet (802.11b/g) | devices<br>• The Enobio Wireless EEG<br>is only available in a<br>battery operated<br>configuration whereas<br>the predicate device,<br>Nicolet Wireless EEG,<br>can be battery or AC<br>powered.<br>No significant difference as<br>each device consists of a<br>method of capturing the<br>signal, storing, amplifying<br>and transmitting the signal<br>No significant difference as<br>the predicate device,<br>Nicolet Wireless EEG offers<br>wired or wireless signal<br>transmission to the host<br>computer used to display<br>and manage acquired data.<br>The proposed device,<br>Enobio Wireless EEG, offers<br>wireless signal transmission<br>only. | | | A/D conversion:<br>24 bits | A/D conversion:<br>24 bits | Same | | | Sampling rate:<br>500 Hz | Sampling rate:<br>125, 250, 500, ... 48000<br>Hz | No significant difference as<br>the predicate device,<br>Nicolet Wireless EEG offers<br>the user a choice of<br>sampling rates that the user<br>may select. The proposed<br>device, Enobio Wireless | | Manufacturer | Neuroelectrics | Carefusion | Significant Differences | | Trade Name | ENOBIO WIRELESS EEG | Nicolet Wireless EEG | EEG, provides a fixed<br>sampling rate of 500 Hz<br>included within the range<br>offered by the predicate<br>device. | | Anatomical<br>Location | Worn on the head via a<br>headcap or headband | Worn on the torso<br>and/or via a headcap | No significant difference as<br>the only option available for<br>the proposed device, Enobio<br>Wireless EEG, is a headcap<br>or headband which is<br>included with the options<br>available with the Nicolet<br>Wireless EEG | | Material | ABS 40%c, ABS, gel ,<br>neoprene | Not specified | No significant difference as<br>while a potential difference<br>exists between the devices<br>in terms of patient<br>contacting materials,<br>appropriate<br>biocompatibility testing has<br>been conducted on the<br>proposed device. | | Number of<br>Channels | 8, 20, 32 channels | 32 or 64 channel | No significant difference as<br>the number of channels<br>reflects the simpler nature<br>of the Enobio device.<br>Testing has been conducted<br>to ensure each model<br>performs in accordance<br>with the intended use. | | Temperature<br>Control Range | Use Temperature Range:<br>+5 to 45 °C<br>Storage in Box<br>Temperature Range: -25<br>to +70 °C | Not defined but as the<br>use has been confined<br>to research institutions,<br>clinic, hospital,<br>operating room and<br>epilepsy evaluation | No significant difference as<br>the operating environment<br>is very similar to that of the<br>proposed device therefore<br>the operating range in | | Manufacturer | Neuroelectrics | Carefusion | Significant Differences | | Trade Name | ENOBIO WIRELESS EEG | Nicolet Wireless EEG | | | Pressure Range | Atmospheric Pressure:<br>700 - 1.000 hPa | environments it would<br>be expected to be within<br>the same range as that<br>of the proposed device | terms of temperature,<br>pressure and humidity<br>would be expected to have<br>similar parameters. | | Humidity Range | 15 - 93 % | | | | Sterile | no | no | Same | | Single-Use | no | no | Same | | Shelf Life | 5 years | Unknown | Unknown; predicate device<br>shelf life is not available | | Software<br>Microprocessor | ATSAM4SD32CGWL | Unknown | N/A | | Battery Operated | yes | yes | Same | | AC Powered | no | yes | No significant difference:<br>The Enobio Wireless EEG is<br>only available in a battery<br>operated configuration<br>whereas the predicate<br>device, Nicolet Wireless<br>EEG, can be battery or AC<br>powered | | Complies with ISO<br>10993-1 | yes | yes | Same | | Electrical Safety<br>Testing Passed | yes | yes | Same | # Comparison of Characteristics {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ # 9. Non-Clinical Performance Data As part of demonstrating safety and effectiveness of Enobio Wireless EEG and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Neuroelectrics completed a number of non-clinical performance tests. The Enobio Wireless EEG meets all the requirements for overall design, biocompatibility, and electrical safety, confirming that the design output meets the design inputs and specifications for the device. The Enobio Wireless EEG passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device: {10}------------------------------------------------ - Biocompatibility; ● - ISO 10993-1: 2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing o - O ISO 10993-5: 2009, Biological Evaluation of Medical Devices - Part 5: Test for In Vitro Cytotoxicity - ISO 10993-10: 2010, Biological Evaluation of Medical Devices Part 10: Tests for Irritation O and Delayed-Type Hypersensitivity - . Electrical Performance; - o IEC 60601-1: 2005 + CORR. 1 (2006) + CORR 2 (2007), Medical Electrical Equipment -Part 1 General Requirements for Basic Safety and Essential Performance - o IEC 60601-1-2:2007 (Third Edition), Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests. (General II (ES/EMC)) - IEC 60601-2-26:2012, Medical electrical equipment Part 2-26: Particular requirements o for the basic safety and essential performance of electroencephalographs - o IEC 60601-1-11: 2010, Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests; all applicable requirements were met - o IEC 61000-4-3, Radiated, radio-frequency, electromagnetic field immunity test - . Software verification and validation testing per IEC 62304 and FDA Guidance - . Disinfection testing - Compatibility of electrodes with Enobio Wireless EEG ● - . Product specification compliance tests: - Bandwidth O - O Sampling Rate - Input Referred Noise O - O Dynamic Range - O Operating Hours - o Resolution - Input Impedance o # 10. Clinical Performance Data There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate device, have been on the market for many years with proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device. # 11. Statement of Substantial Equivalence By definition, a device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be {11}------------------------------------------------ demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicate device. The Enobio Wireless EEG, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device, Nicolet Wireless EEG.