eego amplifiers

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. March 30, 2018 eemagine Medical Imaging Solutions GmbH % Gary J. Syring Principal Consultant Ouality & Regulatory Associates, LLC 800 Levanger Lane Stoughton, Wisconsin 53589 Re: K172312 Trade/Device Name: eego amplifiers Regulation Number: 21 CFR 882.1835 Regulation Name: Physiological Signal Amplifier Regulatory Class: Class II Product Code: GWL, GWQ, OMC Dated: July 25, 2017 Received: March 1, 2018 Dear Gary J. Syring: 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, William J. Heetderks -S 2018.03.30 16:43:21 -04'00" 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) K172312 Device Name eego™ amplifiers Indications for Use (Describe) The eego amplifier is intended to be used by or under the direction for acquisition of EEG signals and to transmit them digitally to a computer. The device is intended for use on humans. The device is intended for use in a clinical environment (e.g., hospital, physician's office, etc). The device is not intended for use in life support systems. Type of Use (Select one or both, as applicable) | 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}------------------------------------------------ # K173312 510(k) Summary ## Submitter Information | Submitter's Name: | eemagine Medical Imaging Solutions GmbH | |----------------------|---------------------------------------------------------| | Submitter's Address: | Gubenerstr. 47, Fabrik | | | D-10243, Berlin, Germany | | Submitter's Phone: | Phone: +49 30 29 04 84 04 | | Contact Person: | Frank Zanow, Chief Executive Officer | | | or Ralf Hauffe, PhD, Chief Operations Executive Officer | | Date Summary | | March 29, 2018 # Subject Device Prepared: | Trade Name: | eego™ amplifiers | |----------------------|----------------------------------------------------------------------------------------------------------| | Common Name: | Physiological signal amplifier | | Classification Name: | 21 CFR 882.1835 Physiological signal amplifier<br>Class II | | Product Code: | GWL, amplifier, physiological signal | | Subsequent Code: | GWQ, full-montage standard electroencephalograph<br>OMC, reduced- montage standard electroencephalograph | # Predicate Device | 510(k) Number: | K060374 | |----------------------|-------------------------------| | Trade Name: | REFA, Physiological Amplifier | | Submitter Name: | TMS International BV | | Classification Name: | 21 CFR 882.1835 | | Product Code: | GWL | ### Device Description The eego amplifier is a multi-channel, plastic enclosed EEG amplifier. There are two ranges for the variations of amplifiers (models): - 1. EE-2xx, and - 2. EE-4xx. In total, there are 8 models, as follows: | Model | EEG<br>Channels<br>(Referential) | Sampling rate configuration<br>(down sampling in API software,<br>internal 32 kHz for all) | Power Source | |--------|----------------------------------|--------------------------------------------------------------------------------------------|-------------------------------| | EE-211 | 64 | 2 kHz | Rechargeable battery | | EE-212 | 32 | 2 kHz | | | EE-213 | 16 | 2 kHz | | | EE-221 | 32 | 16 kHz | | | EE-222 | 64 | 16 kHz | | | EE-224 | 32 | 16 kHz | | | EE-411 | 8 | 2 kHz | USB Connection to<br>Computer | | EE-430 | 8 | 0.5 kHz | | {4}------------------------------------------------ The EE-411 and EE-430 amplifiers are built using identical components and share identical internal structure, functionality and performance. The eego amplifier electroencephalography (EEG) input is from commercially available EEG electrodes from the Waveguard™ EEG Cap cleared in K110223. The eego amplifiers support EEG acquisition and storage by: - 1. referential DC input channels, - 2. parallel trigger input channel. Electrode Impedance values can be measured for all referential electrodes, reference and patient ground electrode. Signal sampling rate and gain are set through the user interface of the Software Development Kit (SDK). The EE-2XX series of eego amplifier is powered by a built-in, rechargeable battery. The battery provides a minimum of 4 hours of operation time. The amplifier can be applied for data acquisition with the 12 V battery charger source applied. The USB port supports interface to the computer running the SDK. The EE-4XX series of eego amplifier is powered by the USB port connection to a computer. ### Statement of Intended Use The eego amplifier is intended to be used by or under the direction of a physician for acquisition of EEG signals and to transmit them digitally to a computer. The device is intended for use on humans. The device is intended for use in a clinical environment (e.g., hospital, physician's office, etc). The device is not intended for use in life support systems. ### Summary of Technological Characteristics & Comparison to Predicate The following table provides a comparison the eego amplifiers to the predicate device identified to demonstrate substantial equivalence. | Table 1: Substantial Equivalence Technical Characteristics | | | | |------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | Feature | eego™ amplifiers<br>Subject Device K172312 | REFA Physiological Amplifier<br>Predicate K060374 | Comment | | Intended Use | Used to electrically amplify signals<br>derived from electroencephalogram. | Used to electrically amplify signals<br>derived from various physiological<br>sources, including the<br>electroencephalogram. | Both devices are<br>amplifiers of signals<br>derived from physiologic<br>sources. | | Indications for Use | The eego amplifier is intended to be<br>used by or under the direction of a<br>physician for acquisition of EEG signals<br>and to transmit them digitally to a<br>computer. The device is intended for<br>use on humans. The device is intended<br>for use in a clinical environment (e.g.,<br>hospital, physician's office, etc). The<br>device is not intended for use in life<br>support systems. | The REFA Physiological Amplifier<br>family is intended to be used by or<br>under the direction of a physician<br>for acquisition of EEG, polygraphy<br>and polysomnography signals and<br>transmission of the signals to a PC<br>during recording of neurophysical /<br>physiological research and exams.<br>Polygraphy and Polysomnography<br>may besides EEG, include<br>physiological information such as<br>EMG, ECG, EOG, EGG, PH,<br>Respiration, Temperature and<br>Oxygen Saturation. | Amplifiers are intended<br>for acquisition of EEG<br>signals to a computer. | | Type of use | Prescription Use | Prescription Use | Same | | Modes of Operation | Electroencephalography (EEG) | EEG, EMG, ECG, EOG<br>EGG, PH<br>Respiration, Temperature, | Both acquire EEG signals. | | Table 1: Substantial Equivalence Technical Characteristics | | | | | Feature | eego™ amplifiers<br>Subject Device K172312 | REFA Physiological Amplifier<br>Predicate K060374 | Comment | | | | Oxygen Saturation | | | Environment of Use | Clinical environment<br>(Example: hospital, physician's office,<br>etc) | Clinical environment<br>(Example: hospital, physician's<br>office, etc) | Same | | Data Storage | Yes | Yes | Same | | Electrode<br>impedance<br>measurement | Yes | Yes | Same | | Filter | Low pass filtering in amplifier | Low pass filtering in amplifier | Same | | Patient Contact | No<br>Patient contact is made by the<br>Waveguard™ EEG Cap (K110223). | No<br>Patient contact is made by<br>commercially available electrodes<br>and transducers. | Equivalent | | Sampling rate | EE-2XX Series:<br>Up to 16384 Hz Set through the user<br>interface of the Software Development<br>Kit (SDK) software<br>EE-4XX Series: Up to 2048 Hz | Up to 20000 Hz | Equivalent | | Video | Optional | No | Option to allow video | | Amplifier active<br>shielding technique | Yes<br>(Protects the referential EEG inputs from<br>environmental noise) | Yes | Same | | Amplifier CMRR<br>(referential) | >100 dB | 90 dB | Equivalent | | Amplifier Input<br>Channels | Up to 64 | Up to 64<br>Special mode supports 128 EEG<br>inputs | Equivalent | | Amplifier input<br>impedance<br>(referential) | >109 Ohm | >1012 Ohm | Equivalent for low<br>impedance of<br>physiological signal<br>inputs. | | Amplifier power | EE-2XX Series: Rechargeable<br>integrated battery<br>EE-4XX Series: USB from Computer | AC Mains | DC power source for eego<br>amplifiers. | | Amplifier operating<br>time on battery<br>power | EE-2XX Series: Up to 4 hours | Not Applicable | DC power source for eego<br>amplifiers. | | Amplifier referential<br>DC input channels | Yes<br>8, 16, 32, or 64 channels | Yes<br>16, 32, 64 or 128 channels | Equivalent | | Amplifier trigger<br>input | Yes,<br>EE-2XX Series: Optional 8 bit TTL<br>EE-4XX Series: Optional 2 bit TTL | Yes,<br>Optional 8 bit TTL | Equivalent | | Amplifier trigger<br>input channel | Yes<br>(Parallel) | Yes | Equivalent | | Amplifier USB<br>interface | Yes | Yes | Same | {5}------------------------------------------------ {6}------------------------------------------------ | Table 1: Substantial Equivalence Technical Characteristics | | | |------------------------------------------------------------|--|--| |------------------------------------------------------------|--|--| | Feature | eego™ amplifiers<br>Subject Device K172312 | REFA Physiological Amplifier<br>Predicate K060374 | Comment | |--------------------------|-------------------------------------------------------------|---------------------------------------------------|-------------------------------| | Safety standards applied | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-26<br>IEC 62133 | IEC 60601-1<br>IEC 60601-1-2 | Appropriate standards applied | ## Performance Testing To establish the equivalency of the eego amplifiers, evaluations were conducted to confirm compliance with performance requirements and standards including: - IEC 60601-1:2005 (DIN EN 60601-1:2007), Medical electrical equipment Part 1: General 0 requirements for basic safety and essential performance. - . IEC 60601-1-2:2007, Medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility requirements and tests. - IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic . safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests. - . IEC 60601-2-26: 2012 Medical electrical equipment, Particular requirements for the basic safety and essential performance of electroencephalographs. - IEC 62133 Edition 2.0 2012-12. Secondary cells and batteries containing alkaline or other . non-acid electrolytes - safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications. ### Conclusion The eego amplifiers meet performance requivalent to the predicate device. The intended use and technology of the eego amplifiers are equivalent to the predicate device.