NeuroAmp II, NeuroAmp II.5s

{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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. December 30, 2020 Corscience gmbH & Co. KG Stefan Bolleininger Director Regulatory Affairs Hartmannstrasse 65 Erlangen, 91052 De Re: K193159 Trade/Device Name: EEG NeuroAmp II.5s Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWO. GWE. GWJ. OLV. HCC Dated: November 30, 2020 Received: November 30, 2020 Dear Stefan Bolleininger: 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. 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) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K193159 Device Name EEG NeuroAmp II.5s # Indications for Use (Describe) The EEG NeuroAmp II.5s is intended to acquire, display, store and archive the electroencephalographic (EEG) signals from a patient's brain obtained by placing two or more electrodes on the head. It must be used in combination with appropriate software and computer. The EEG NeuroAmp II.5s is also intended to be used to provide stimulation and recording of visual and auditory evoked response potentials with appropriate software, computer, and accessories. The EEG NeuroAmp II.5s can also be used for biofeedback and relaxation purposes of this training task, information for feedback may be derived from the electroencephalographic signals and from as many as eight channels of peripheral physiology measures such as are conventionally used in biofeedback. The EEG NeuroAmp II.5s is intended to be used only by trained professionals who can ensure sound handling practices. The device is intended for use in clinical environments (not surgical or emergency environments) as well as in medical and therapeutic practices. It can be used with patients of all ages but is not designed for fetal use. The device does not draw any diagnostic conclusion. Recorded data of electroencephalogram (EEG) signals or event related potentials (ERPs) need to be interpreted by a clinical expert. The results of such interpretation must be considered only in conjunction with other clinical findings. Type of Use (*Select one or both, as applicable*) | <span> <b> Prescription Use (Part 21 CFR 801 Subpart D) </b> </span> | <span> <b> Over-The-Counter Use (21 CFR 801 Subpart C) </b> </span> | |--------------------------------------------------------------------------------|-------------------------------------------------------------------------------| |--------------------------------------------------------------------------------|-------------------------------------------------------------------------------| **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}------------------------------------------------ | Title | Premarket Notification for EEG NeuroAmp II.5s | |---------------|-----------------------------------------------| | Document Name | NeuroAmp II.5s_510(k).doc | | Issue | 1.3 | | Project | COR035 | | Date | Nov 13th, 2020 | Corscience GmbH & Co. KG # 510(K) SUMMARY # General Information ### 1 Applicant Date: November 13, 2020 Name: Corscience GmbH & Co. KG Hartmannstrasse 65 Address: D-91052 Erlangen Germany Contact person in the U.S .: Address Telephone: E-Mail: Beaverton, OR 97008 818-3139980 bwandernoth@bee-systems.net BEE SYSTEMS INC Dr. Bernhard Wandernoth 7724 SW Nimbus Ave, BLDG 10 S Contact person in Germany: Telephone: FAX: E-Mail: Stefan Bolleininger +49 9131 977986 – 50 +49 9131 977986 - 449 stefan.bolleininger@corscience.de Stetson Bollinger Signature: ## 2 Brand Name EEG NeuroAmp® II (brand name EEG NeuroAmp® II.5s for differentiation to the EEG-biofeedback device EEG NeuroAmp®) ## 3 Common Name or Classification Name EEG/ERP measurement & biofeedback device ## Establishment Registration Number 4 3005488716 ## 5 Facility Address Corscience GmbH & Co. KG Hartmannstrasse 65 D-91052 Erlangen Germany {4}------------------------------------------------ | Title | Premarket Notification for EEG NeuroAmp II.5s | |---------------|-----------------------------------------------| | Document Name | NeuroAmp II.5s_510(k).doc | | Issue | 1.3 | | Project | COR035 | | Date | Nov 13th, 2020 | | | Corscience GmbH & Co. KG | # 6 Device Classification ## 6.1. Classification This is a class II device ### 6.2. Classification panel Panel: Neurology Primary Product Code: GWQ Secondary Product Codes: GWE, GWJ, OLV, HCC ### Regulation Number 6.3. 21 CFR 882.1400 -- Electroencephalograph ## 7 Predicate Devices Descriptions #### 7.1. Names For the EEG measurement functionality Mitsar EEG - primary predicate device Natus Brain Monitor, Embla Dx series # For the EEG-biofeedback (neurofeedback) or peripheral biofeedback functionality EEG NeuroAmp II ### 7.2. Predicate Device Companies Mitsar Co. Ltd, Novorossiyskaya Str. 21-2, 194021 St. Petersburg, Russian Federation Natus Medical Incorporated DBA Excel-Tech Ltd., 2568 Bristol Circle, Oakville, ON L6H5S1, Canada Corscience GmbH & Co. KG, Hartmannstrasse 65, 91052 Erlangen, Germany ### 7.3. Predicate Device 510(k)# Mitsar EEG: K143233 Natus Brain Monitor, Embla Dx series: K180290 EEG NeuroAmp: K073557 {5}------------------------------------------------ | Title<br>Premarket Notification for EEG NeuroAmp II.5s | | | | |--------------------------------------------------------|--------------|-------------------|------------------------| | Document Name<br>NeuroAmp II.5s_510(k).doc | Issue<br>1.3 | Project<br>COR035 | Date<br>Nov 13th, 2020 | | Corscience GmbH & Co. KG | | | | # Device Description 8 The EEG NeuroAmp II.5s is a user-friendly high-performance interface between client and clinician computer. It can be used in two different functionalities: In an EEG/ERP measurement and in an EEG biofeedback (neurofeedback) and/or peripheral biofeedback setting. The figures show the two different settings. Image /page/5/Figure/3 description: The image shows a diagram of a brain-computer interface (BCI) setup. On the left side, a therapist is sitting at a desk with a computer and a screen labeled "Therapist screen". On the right side, a patient is sitting in a chair wearing a cap with electrodes, connected to an EEG NeuroAmp® X23 device. The diagram also shows connections labeled "Video", "Data", and "Audio" between the therapist's computer and the patient's setup, including a speaker and a Sync-Box. Use of the EEG NeuroAmp II.5s and x23 in an EEG/ERP measurement setting Image /page/5/Figure/5 description: The image shows a diagram of a neurofeedback setup. On the left side, a clinician is sitting at a desk with a computer, keyboard, and an EEG NeuroAmp with Impedance Meter. A USB cable connects the NeuroAmp to the computer, and a signal is sent from the NeuroAmp to the client. On the right side, a client is sitting in front of a screen that provides feedback based on their brain activity. Use of the EEG NeuroAmp II.5s in an EEG biofeedback setting {6}------------------------------------------------ | Title | Premarket Notification for EEG NeuroAmp II.5s | |--------------------------|-----------------------------------------------| | Document Name | NeuroAmp II.5s_510(k).doc | | Issue | 1.3 | | Project | COR035 | | Date | Nov 13th, 2020 | | | | | Corscience GmbH & Co. KG | | The EEG NeuroAmp 11.5s device itself contains three function blocks: - 1. EEG amplifier, two channels, interface for 23- or 39-channel EEG recording front-end - 2. Impedance meter function - 3. peripheral channels for additional sensors, ERP synchronization and biofeedback Apart from the EEG-biofeedback functionality, together with the x23/x39 accessories, it is possible to utilize the equipment as an EEG/ERP measurement device. A 23- or 39-channel EEG can be measured with conventional EEG caps, which are not part of the device, according to the standard 10-20 system. The device does not draw any diagnostic conclusions and does not invite the clinician to do so. Recorded data of electroencephalogram (EEG) signals need to be interpreted by a clinical expert. The results of such interpretation must be considered in conjunction with other clinical findings to provide context. There is no therapeutic effect of the EEG NeuroAmp II.5s used in this setting, The NeuroAmp x23/x39 devices are a full 23-/39-channel digital EEG recording front-end with integrated impedance meter. They are an accessory to the EEG NeuroAmp 11.5s and work only in conjunction with it. The cable that connects the x23/x39 devices to the EEG NeuroAmp 11.5s may be up to 3m long allowing for flexibility for the arrangement of the recording environment. The front-connector interfaces directly with all typically available EEG cap systems. Ground, ear electrodes and two additional channels are available at the top panel of the device for convenient connection of standard electrodes. In case of an event related potential (ERP) recording, the ERP task is presented to the client on a second monitor. The Sync-Box is connected to the second screen to record a visual signal for task presentation synchronization and to the audio output. An event button is connected to the Sync-Box to align the clients' reaction to the presented tasks. The following figure shows a schematic of the whole system with all connections. Please note: EEG cap, computer and speakers are not part of the device and must be purchased from external sources. Image /page/6/Figure/10 description: This image shows a diagram of an ERP (Event-Related Potential) experimental setup. The diagram includes components such as a computer with EEG recording software, an EEG NeuroAmp II.5s, an ERP sync device, a computer screen for ERP task presentation, speakers, and an input device. The diagram also shows the connections between these components, including video, audio, USB, Mini-Din8, and digital connections. Schematic of the event related potential (ERP) recording set-up {7}------------------------------------------------ | Title | Premarket Notification for EEG NeuroAmp II.5s | |---------------|-----------------------------------------------| | Document Name | NeuroAmp II.5s_510(k).doc | | Issue | 1.3 | | Project | COR035 | | Date | Nov 13th, 2020 | | | Corscience GmbH & Co. KG | EEG NeuroAmp II.5s provides the following characteristics: - Easy to use ● - Power supply via serial PC-port - . Impedance Meter: - Wide impedance range - Cancellation of electrode galvanic voltages - Cancellation of power line pick-up (notch filters) - Bright easy-to-read LED bar display - Balance display for optimum EEG signal noise reduction - EEG Amplifier . - Low-noise, DC coupled - Fast settling time - High-performance filters for optimum anti-aliasing - Peripheral Sensor Interface ● - Supply of power for active sensors - High performance filters for optimum noise suppression - Stimulation interface for EEG/ERP measurements - Optional peripheral physiological signal sensors as accessories ● - Interface to an optional full 23-/39-channel digital EEG recording front-end ● - Event button for the measurement of event related potentials as optional accessory (ERP ● Sync) - . Peripheral channels for biofeedback (Audio/Visual/Tactile feedback) {8}------------------------------------------------ | Title | Premarket Notification for EEG NeuroAmp II.5s | |--------------------------|-----------------------------------------------| | Document Name | NeuroAmp II.5s_510(k).doc | | Issue | 1.3 | | Project | COR035 | | Date | Nov 13th, 2020 | | Corscience GmbH & Co. KG | | # 8.1. All accessories to be marketed for use with the subject device | Device name | Description | 510(k) number | |----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------| | NeuroAmp x23 | 23-channel EEG recording front-end, works<br>only with EEG NeuroAmp II.5s | No prior clearance | | NeuroAmp x39 | 39-channel EEG recording front-end, works<br>only with EEG NeuroAmp II.5s | No prior clearance | | ERP Sync | Device to record the audio-visual stimuli and<br>patient inputs synchronously with the EEG,<br>used for Event Related Potential<br>measurements, works only with EEG<br>NeuroAmp II.5s | No prior clearance | | Combination sensor | For measurement of heart rate, galvanic skin<br>response (GSR) and skin temperature, works<br>with EEG NeuroAmp and EEG NeuroAmp<br>II.5s | No prior clearance | | Brummi | Tactile feedback device, works with EEG<br>NeuroAmp and EEG NeuroAmp II.5s | No prior clearance | | pIRx3 | Temperature sensor, works with EEG<br>NeuroAmp and EEG NeuroAmp II.5s | K073557 | | Software accessories | Description | 510(k) number | | Cygnet | EEG biofeedback software, works with EEG<br>NeuroAmp and EEG NeuroAmp II.5s | K073557 | | ERPrec | EEG measurement/recording functionality,<br>works only with EEG NeuroAmp II.5s | No prior clearance | | BEE Lab | EEG-biofeedback functionality, works with<br>EEG NeuroAmp and EEG NeuroAmp II.5s | No prior clearance | {9}------------------------------------------------ Title Premarket Notification for EEG NeuroAmp II.5s | Document Name | NeuroAmp II.5s_510(k).doc | |--------------------------|---------------------------| | Issue | 1.3 | | Project | COR035 | | Date | Nov 13th, 2020 | | Corscience GmbH & Co. KG | | ## 9 Indications for Use Statement EEG NeuroAmp® II.5s is intended to acquire, display, store and archive The the electroencephalographic (EEG) signals from a patient's brain obtained by placing two or more electrodes on the head. It must be used in combination with appropriate software and computer. The EEG NeuroAmp® II.5s is also intended to be used to provide stimulation and recording of visual and auditory evoked response potentials with appropriate software, computer, and accessories. The EEG NeuroAmp® 11.5s can also be used for biofeedback and relaxation purposes. For purposes of this training task, information for feedback may be derived from the electroencephalographic signals and from as many as eight channels of peripheral physiology measures such as are conventionally used in biofeedback. The EEG NeuroAmp® II.5s is intended to be used only by trained professionals who can ensure sound handling practices. The device is intended for use in clinical environments (not surgical or emergency environments) as well as in medical and therapeutic practices. It can be used with patients of all ages but is not designed for fetal use. The device does not draw any diagnostic conclusion. Recorded data of electroencephalogram (EEG) signals or event related potentials (ERPs) need to be interpreted by a clinical expert. The results of such interpretation must be considered only in conjunction with other clinical findings. ## Required Components 10 # For EEG measurement functionality: - EEG NeuroAmp II (brand name EEG NeuroAmp II.5s) ● - . Either NeuroAmp x23 or NeuroAmp x39, 23- or 39-channel EEG recording front-end - Software ERPrec ● - User manuals ● Computer, monitor and electrode caps are purchased from other sources Optional accessories - to be obtained from EEG NeuroAmp 11.5s manufacturer - ERP Sync device to record the audio-visual stimuli and patient inputs synchronously with the ● EEG, used for Event Related Potential measurements - . Combination sensor for measurement of heart rate, galvanic skin response (GSR) and skin temperature # For EEG-biofeedback functionality: - EEG NeuroAmp 11.5s - Software Cygnet (optional) - Software BEE Lab (optional) ● - User manuals ● Computer, monitor and electrodes are purchased from other sources Optional accessories - to be obtained from EEG NeuroAmp 11.5s manufacturer - Combination sensor for measurement of heart rate, galvanic skin response (GSR) and skin ● temperature - Tactile feedback device Brummi {10}------------------------------------------------ | Title | Premarket Notification for EEG NeuroAmp II.5s | |-------|-----------------------------------------------| |-------|-----------------------------------------------| | Document Name | NeuroAmp II.5s_510(k).doc | |---------------|---------------------------| | Issue | 1.3 | | Project | COR035 | | Date | Nov 13th, 2020 | Corscience GmbH & Co. KG # 11 Summary Table of Comparisons # 11.1. EEG/ERP measurement functionality | Specification | Subject Device<br>EEG NeuroAmp II.5s | Primary Predicate<br>Device<br>Mitsar EEG<br>K143233 | Predicate Device<br>Natus Brain Monitor<br>K180290 | Discussion on safety<br>and effectiveness | |------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for<br>Use (short<br>version) | Acquire, display, store<br>and archive the electro-<br>encephalographic (EEG)<br>signals from a patient's<br>brain obtained by placing<br>two or more electrodes<br>on the head incl.<br>stimulation and recording<br>of visual and auditory<br>evoked response<br>potentials. | Acquire, display<br>and store the<br>electrical activity of<br>a patient's brain<br>obtained by placing<br>two or more<br>electrodes on the<br>head to aid in<br>diagnosis. | Acquire, display, store<br>and archive<br>electrophysiological<br>signals. Scalp and<br>Intracranial EEG as<br>well as<br>polysomnographic<br>signals. | Both predicates also offer<br>the capability of<br>stimulation and recording<br>of visual and auditory<br>evoked response<br>potentials. | | Common name,<br>Product code,<br>Regulation<br>number | EEG/ERP measurement<br>& biofeedback device,<br>GWQ, GWE, GWJ, OLV<br>& HCC<br>21 CFR 882.1400, 21<br>CFR 882.5050, 21 CFR<br>882.1890 & 21 CFR<br>882.1900 | Electroencephalogr<br>aph<br>GWQ 21 CFR<br>882.1400 | Electroencephalograph<br>GWQ & OLV 21 CFR<br>882.1400 | Codes GWE, GWJ not<br>listed in product 510k of<br>predicate Mitsar EEG but<br>the product fulfills the<br>equal functionality.<br>Thererore, the additional<br>codes are applicable. | | Power supply | Power supply via USB<br>port (galvanic isolation<br>according to IEC 60601-<br>1) | Power supply via<br>USB port | USB port | USB port is the only<br>power source, i.e. as for<br>predicate device no other<br>safety-relevant power<br>sources are to be<br>considered. The galvanic<br>insulation of USB data<br>and power conforms to<br>IEC 60601-1.<br>→ Same or better<br>safety | | Software | ERPrec | EEG Studio | Natus NeuroWorks™/<br>SleepWorks. Data<br>stored in 16-bit<br>resolution only | The ERPrec software<br>stores the data in full<br>resolution without loss. It<br>is better than the<br>predicate devices<br>→ Same or better<br>effectiveness | | Windows 10 and<br>7 compatible | Yes | Windows 7,<br>perhaps also<br>Windows 10 | Yes | Software is fully qualified<br>on actual Windows<br>systems and covers<br>same or more operating<br>systems as predicate<br>device<br>→ Same or better<br>effectiveness | | EEG channels | up to 41 plus 8<br>peripheral channels | 21 + 4<br>active/reference<br>pairs, one auxiliary<br>channel | 40 | More channels<br>→ Same or better<br>effectiveness | | Resolution EEG<br>channels | 24 bit, stored loss-free<br>24bit and full sampling<br>rate | 16 bit | 24 bit (16 bit stored) | Same or higher digital<br>resolution, better<br>resolution in stored data<br>→ Better<br>effectiveness | | Sampling<br>frequency | 1Msample/second gross<br>sampling rate, down<br>sampled to 250 or 500<br>sps. synchronous<br>sampling over all EEG-<br>and peripheral channels | 500 Hz per<br>channel,<br>multiplexed | 256, 512, 1024, 2048,<br>4096<br>256, 512Hz (Embla<br>SDx) | Gross sampling rate much<br>higher than predicate<br>device -> improved anti-<br>aliasing performance. Net<br>sampling rate sufficient for<br>given bandwidth<br>→ Better<br>effectiveness | | Common-Mode<br>Rejection Ratio<br>(CMRR) | >130 dB | at least 100 dB at<br>10 Hz | >106db@60Hz | The CMRR of the subject<br>device is much better than<br>the predicate device.<br>Better CMRR results in<br>better signal quality and<br>immunity against noise.<br>→ Better<br>effectiveness | | Notch filter | <-60 dB at 50 or 60 Hz,<br>optional setting in<br>software. Recording<br>always unfiltered raw<br>signal. | -30 dB at 50(60) Hz | No data | Not relevant, display only | | Input impedance<br>EEG channels | >1000 MOhm | > 200 MΩ | >1000 MOhm | High impedance important<br>for proper recording. Same<br>or better performance as<br>predicate device.<br>→ Same or better<br>effectiveness | | Bandwidth (3dB)<br>and<br>sample rate | DC ... 100Hz/160Hz | 0.16 – 70 Hz | 0.1 Hz – 100 Hz | Subject device has full DC<br>coupling, which allows for<br>recording of slow cortical<br>potentials.<br>→ Better<br>effectiveness | | Impedance<br>measurement<br>EEG electrodes<br>(electrode<br>contact quality) | Yes<br>0 ... 140kΩ | Yes<br>5kΩ – 40kΩ | Yes<br>2.5kΩ, 5kΩ, 10kΩ,<br>25kΩ | Wider range as predicate<br>device. With that, better<br>guidance for technician<br>when mounting the<br>electrodes.<br>→ Better<br>effectiveness | | Input Noise | < 0.01µV/√Hz<br>< 1.0 µV peak toPeak | < 1.5 µV peak to<br>peak | ≤ 2 uV pk-to-pk (0.1Hz<br>to 100 Hz), | Better noise performance.<br>Therefore, better signal-to-<br>noise ratio of recording<br>→ Better<br>effectiveness | | Overvoltage<br>warning | yes | No data | No data | Overvoltage may saturate<br>input amplifier and distort<br>the signal. Subject device<br>has overvoltage warning<br>to prevent this from<br>happening.<br>→ Same or better<br>effectiveness | | Input signal<br>range | 1100mVp-p | 10 - 5000 $\mu$ V | 20mV pk-to-pk, +/-<br>0.3VDC | As the subject device is<br>DC coupled, the signal<br>range equals the offset<br>range. Operation of fully<br>DC coupled device is<br>simpler than AC coupled<br>device as high noise levels<br>may removed by software<br>further down the signal<br>chain<br>-> Better<br>effectiveness | | Maximum<br>Operational DC<br>input voltage<br>electrode offset | ±550mV | ±350 mV (Offset<br>tolerance) | ±300mV | Input offset range of<br>subject device is much<br>higher than predicate<br>device. A large offset<br>range is important to cover<br>offset voltages by<br>electrodes.<br>-> Better<br>effectiveness | | ERP<br>measurement:<br>synchronization<br>mechanism and<br>precision in ms | Active audio and video<br>synchronization with<br>Sync device; Event<br>button, 24 bit trigger..<br>Accuracy/jitter:<br>±1ms/<1ms | Event button<br>No active<br>synchronization<br>Accuracy/jitter:<br>±10ms/<20ms | Integrated 8-bit trigger<br>for synchronizing<br>external events<br>Accuracy/jitter:<br>±10ms/<20ms | Stimulus synchronization<br>of subject device much<br>more precise. Analysis of<br>event-related potentials<br>relies on precision of<br>stimulus synchronization.<br>Subsequent conclusions<br>may be better and safer<br>for patient<br>-> Better<br>effectiveness and<br>safety | | Visual and<br>auditory stimuli<br>for ERP<br>measurement | Stimulus presentation<br>software incorporated in<br>software ERPrec Audio<br>and video sensors for<br>continuous calibration<br>and selftest of the<br>system initial to each<br>recording. | Stimulus<br>presentation<br>software<br>incorporated in<br>software EEG<br>Studio. Audio and<br>video sensors for<br>initial calibration. | no data | Same or better<br>effectiveness | | Measurement of<br>physiological<br>data | Combination sensor,<br>applied to the finger, for<br>heart rate and galvanic<br>skin response (GSR).<br>Skin temperature of the<br>finger can be measured,<br>not absolute values, only<br>trends. No therapeutic<br>effect of sensor. | Multi-purpose<br>inputs for peripheral<br>biosignal<br>acquisition such as<br>heart rate, skin<br>conductance<br>(GSR),<br>temperature,<br>breathing, SpO2.<br>ECG adapter clips<br>supplied, breathing<br>sensor available | SpO2 Pulse Rate,<br>Plethysmogram, PPG | Subject device and<br>software work only with<br>accessories supplied.<br>Therefore mis-reading or<br>false values less likely to<br>occur<br>-><br>Better<br>effectiveness and<br>safety | | Video recording | Possible | Possible | Possible | Same or better<br>effectiveness | | Specification | Subject Device<br>EEG NeuroAmp II.5s | Predicate Device<br>Corscience EEG<br>NeuroAmp<br>K073557 | Comparison of<br>subject device<br>with predicate<br>device based on<br>safety and<br>effectiveness | | | Indications for Use | Biofeedback and relaxation<br>purposes | Biofeedback and<br>relaxation purposes | same | | | Common name,<br>Product code,<br>Regulation number | EEG/ERP measurement &<br>biofeedback device,<br>GWQ, GWE, GWJ, OLV & HCC<br>21 CFR 882.1400, 21 CFR<br>882.5050, 21 CFR 882.1890 &<br>21 CFR 882.1900 | Biofeedback device<br>HCC<br>21 CFR 882.5050 | same or better<br>effectiveness | | | Power supply | Power supply via USB port<br>(galvanic isolation according to<br>IEC 60601-1) | Power supply via USB<br>port (galvanic isolation<br>according to IEC<br>60601-1) | Same<br>→ Same safety | | | Software | Cygnet, BEE Lab | Cygnet, BEE Lab | Same<br>→ same<br>effectiveness | | | Windows 10 and 7<br>compatible | Yes | Yes | Same<br>→ Same<br>effectiveness | | | x23/x39 EEG amplifier<br>interface | Yes | No | Subject device<br>allows to connect<br>additional<br>peripherals<br>→ Same or better<br>effectiveness | | | No. peripheral<br>channels inputs | 8 | 3 | More peripheral<br>channels allow | | | No. peripheral<br>channels outputs | 8 | 1 | for more<br>peripherals<br>attached<br>simultaneously.<br>→ Better<br>effectiveness | | | EEG resolution | 32 bit | 13 bit | Much better | | | Input noise | < 0.01 $">μ$ V/ $Hz$ ; < 1.0 $">μ$ Vp-p | < 1.5 $">μ$ Vp-p | technical | | | Overvoltage warning | yes | yes | performance. The<br>subject device | | | EEG bandwidth | DC ... 100/160Hz | 0.056 ... 70Hz | has full DC | | | Peripheral channel<br>resolution | 24 bit | 13 bit | coupling, which<br>allows the work | | | Peripheral channel | DC ... 100/160Hz | DC ... 70Hz | with slow cortical | | {11}------------------------------------------------ | Title | |-----------------------------------------------| | Premarket Notification for EEG NeuroAmp II.5s | | Document Name | NeuroAmp II.5s_510(k).doc | |--------------------------|---------------------------| | Issue | 1.3 | | Project | COR035 | | Date | Nov 13th, 2020 | | Corscience GmbH & Co. KG | | {12}------------------------------------------------ | Title | Premarket Notification for EEG NeuroAmp II.5s | |--------------------------|-----------------------------------------------| | Document Name | NeuroAmp II.5s_510(k).doc | | Issue | 1.3 | | Project | COR035 | | Date | Nov 13th, 2020 | | Corscience GmbH & Co. KG | | {13}------------------------------------------------ | Title | Premarket Notification for EEG NeuroAmp II.5s | |--------------------------|-----------------------------------------------| | Document Name | NeuroAmp II.5s_510(k).doc | | Issue | 1.3 | | Project | COR035 | | Date | Nov 13th, 2020 | | Corscience GmbH & Co. KG | | # 11.2. EEG-Biofeedback (Neurofeedback) Functionality The EEG NeuroAmp II.5s and its predicate device EEG NeuroAmp (K073557) have the same functionality and similar technical data. The technical data of the EEG NeuroAmp II.5s are superior to those of the EEG NeuroAmp and it has more peripheral channels. In addition, the EEG NeuroAmp II.5s can be equipped to be a 23- or 39-channel EEG recording device by connecting the NeuroAmp x23/x39 accessories. The differences in technical data between the subject and predicate device are listed in the table below. The neurofeedback functionality of both devices is the same. {14}------------------------------------------------ | Title | Premarket Notification for EEG NeuroAmp II.5s | |-------|-----------------------------------------------| |-------|-----------------------------------------------| | Document Name | NeuroAmp II.5s_510(k).doc | |---------------|---------------------------| | Issue | 1.3 | | Project | COR035 | | Date | Nov 13th, 2020 | | Corscience GmbH & Co. KG | | |--------------------------|--| |--------------------------|--| | bandwidth | potentials, higher<br>bandwidth and<br>lower noise. This<br>results in better<br>signal-to-noise<br>ratio and signal<br>quality. Higher<br>resolution and<br>better signal<br>quality allow for<br>better signal<br>processing.<br>-> Better<br>effectiveness | |---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Neurofeedback<br>functionality | Yes | | Biofeedback sensor<br>interface | Yes | {15}------------------------------------------------ | Title | Premarket Notification for EEG NeuroAmp II.5s | |--------------------------|-----------------------------------------------| | Document Name | NeuroAmp II.5s_510(k).doc | | Issue | 1.3 | | Project | COR035 | | Date | Nov 13th, 2020 | | | | | | | | Corscience GmbH & Co. KG | | # 12 Brief Summary of Performance Testing Electrical Safety The EEG NeuroAmp II.5s was tested according to the following standard: IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 ● +A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. (or IEC 60601-1: 2012 reprint) – CB Scheme Results indicate that the EEG NeuroAmp 11.5 complies with the applicable standard. The EEG NeuroAmp II.5s was tested according to the following standards: Electromagnetic Compatibility IEC 60601-1-2: Edition 4.0; 2014-02, 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 – Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs. Results indicate that the EEG NeuroAmp II.5s complies with the applicable standards. Performance Testing The EEG NeuroAmp II.5s was verified for EEG hardware performance in - Bench accordance with internal requirements and the applicable clauses of the following standards: ● IEC 62366-1: 2015, Medical devices - Application of usability engineering to medical devices. . IEC 80601-2-26: 2019, Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs. . IEC 60601-2-40:2016 Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment. Results indicate that the EEG NeuroAmp II.5s complies with its predetermined specifications and the applicable standards. The optional accessories "NeuroAmp x23", "NeuroAmp x39", "ERP Sync", "Combination Sensor" and tactile feedback device "Brumm" have been tested according to ISO 10993-1, IEC 60601-1 and IEC 60601-1-2 and have shown full compliance to these standards. ISO 10993-1 applies only to "Combination Sensor" and "Brummi". ## 13 Conclusions Based on the above, Corscience GmbH & Co. KG concludes, that EEG NeuroAmp II.5s is substantially equivalent to legally marketed predicate devices and effective for its intended use and performs as well as or better than the predicate devices.