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.

Device Description

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 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
1. Impedance meter function
1. 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.

AI/ML Overview

The Corscience EEG NeuroAmp II.5s is an electroencephalograph device that functions for EEG/ERP measurement and biofeedback. The device received 510(k) clearance based on substantial equivalence to predicate devices, demonstrating its safety and effectiveness through performance testing against relevant IEC and ISO standards.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the EEG NeuroAmp II.5s are implicitly defined by its performance against the specified technical requirements, which are shown to be equivalent or superior to predicate devices. The "Discussion on safety and effectiveness" column in the comparative table effectively serves as the acceptance criteria and performance review.

Specification	Acceptance Criteria (from predicate comparison)	Reported Device Performance (EEG NeuroAmp II.5s)
EEG/ERP Measurement Functionality
Indications for Use (short version)	Acquire, display, store, and archive electrical activity of a patient's brain (Mitsar EEG and Natus Brain Monitor also allow stimulation and recording of evoked response potentials).	Acquire, display, store and archive the electroencephalographic (EEG) signals from a patient's brain obtained by placing two or more electrodes on the head incl. stimulation and recording of visual and auditory evoked response potentials.
Common name, Product code, Regulation number	GWQ, 21 CFR 882.1400 (Mitsar EEG); GWQ & OLV, 21 CFR 882.1400 (Natus Brain Monitor)	EEG/ERP measurement & biofeedback device, GWQ, GWE, GWJ, OLV & HCC, 21 CFR 882.1400, 21 CFR 882.5050, 21 CFR 882.1890 & 21 CFR 882.1900
Power supply	Primarily USB port for power, with galvanic isolation (for EEG NeuroAmp, presumed for Mitsar EEG).	Power supply via USB port (galvanic isolation according to IEC 60601-1)
Software	EEG Studio (Mitsar EEG); Natus NeuroWorks™/SleepWorks (Natus Brain Monitor)	ERPrec
Windows 10 and 7 compatible	Windows 7, perhaps also Windows 10 (Mitsar EEG); Yes (Natus Brain Monitor)	Yes
EEG channels	21 + 4 active/reference pairs, one auxiliary channel (Mitsar EEG); 40 (Natus Brain Monitor)	up to 41 plus 8 peripheral channels
Resolution EEG channels	16 bit (Mitsar EEG); 24 bit (16 bit stored) (Natus Brain Monitor)	24 bit, stored loss-free 24bit and full sampling rate
Sampling frequency	500 Hz per channel, multiplexed (Mitsar EEG); 256, 512, 1024, 2048, 4096 (Natus Brain Monitor)	1Msample/second gross sampling rate, down sampled to 250 or 500 sps. synchronous sampling over all EEG- and peripheral channels
Common-Mode Rejection Ratio (CMRR)	at least 100 dB at 10 Hz (Mitsar EEG); >106db@60Hz (Natus Brain Monitor)	>130 dB
Notch filter	-30 dB at 50(60) Hz (Mitsar EEG); No data (Natus Brain Monitor)	<-60 dB at 50 or 60 Hz,optional setting in software. Recording always unfiltered raw signal.
Input impedance EEG channels	> 200 MΩ (Mitsar EEG); >1000 MOhm (Natus Brain Monitor)	>1000 MOhm
Bandwidth (3dB) and sample rate	0.16 – 70 Hz (Mitsar EEG); 0.1 Hz – 100 Hz (Natus Brain Monitor)	DC ... 100Hz/160Hz
Impedance measurement EEG electrodes (electrode contact quality)	Yes, 5kΩ – 40kΩ (Mitsar EEG); Yes, 2.5kΩ, 5kΩ, 10kΩ, 25kΩ (Natus Brain Monitor)	Yes, 0 ... 140kΩ
Input Noise	< 1.5 µV peak to peak (Mitsar EEG); ≤ 2 uV pk-to-pk (0.1Hz to 100 Hz) (Natus Brain Monitor)	< 0.01µV/√Hz; < 1.0 µV peak toPeak
Overvoltage warning	No data (Mitsar EEG and Natus Brain Monitor)	yes
Input signal range	10 - 5000 µV (Mitsar EEG); 20mV pk-to-pk, +/- 0.3VDC (Natus Brain Monitor)	1100mVp-p
Maximum Operational DC input voltage electrode offset	±350 mV (Offset tolerance) (Mitsar EEG); ±300mV (Natus Brain Monitor)	±550mV
ERP measurement: synchronization mechanism and precision in ms	Event button, No active synchronization, Accuracy/jitter: ±10ms/<20ms (Mitsar EEG); Integrated 8-bit trigger, Accuracy/jitter: ±10ms/<20ms (Natus Brain Monitor)	Active audio and video synchronization with Sync device; Event button, 24 bit trigger.. Accuracy/jitter: ±1ms/<1ms
Visual and auditory stimuli for ERP measurement	Stimulus presentation software incorporated, Audio and video sensors for initial calibration (Mitsar EEG); No data (Natus Brain Monitor)	Stimulus presentation software incorporated in software ERPrec Audio and video sensors for continuous calibration and selftest of the system initial to each recording.
Measurement of physiological data	Multi-purpose inputs for peripheral biosignal acquisition (Mitsar EEG); SpO2 Pulse Rate, Plethysmogram, PPG (Natus Brain Monitor)	Combination sensor, applied to the finger, for heart rate and galvanic skin response (GSR). Skin temperature of the finger can be measured, not absolute values, only trends. No therapeutic effect of sensor.
Video recording	Possible (Mitsar EEG and Natus Brain Monitor)	Possible
EEG-Biofeedback (Neurofeedback) Functionality
Indications for Use	Biofeedback and relaxation purposes (EEG NeuroAmp)	Biofeedback and relaxation purposes
Common name, Product code, Regulation number	Biofeedback device, HCC, 21 CFR 882.5050 (EEG NeuroAmp)	EEG/ERP measurement & biofeedback device, GWQ, GWE, GWJ, OLV & HCC, 21 CFR 882.1400, 21 CFR 882.5050, 21 CFR 882.1890 & 21 CFR 882.1900
Power supply	Power supply via USB port (galvanic isolation according to IEC 60601-1) (EEG NeuroAmp)	Power supply via USB port (galvanic isolation according to IEC 60601-1)
Software	Cygnet, BEE Lab (EEG NeuroAmp)	Cygnet, BEE Lab
Windows 10 and 7 compatible	Yes (EEG NeuroAmp)	Yes
x23/x39 EEG amplifier interface	No (EEG NeuroAmp)	Yes
No. peripheral channels inputs	3 (EEG NeuroAmp)	8
No. peripheral channels outputs	1 (EEG NeuroAmp)	8
EEG resolution	13 bit (EEG NeuroAmp)	32 bit
Input noise	< 1.5 µVp-p (EEG NeuroAmp)	< 0.01 µV/ √Hz ; < 1.0 µVp-p
Overvoltage warning	Yes (EEG NeuroAmp)	yes
EEG bandwidth	0.056 ... 70Hz (EEG NeuroAmp)	DC ... 100/160Hz
Peripheral channel resolution	13 bit (EEG NeuroAmp)	24 bit
Peripheral channel bandwidth	DC ... 70Hz (EEG NeuroAmp)	DC ... 100/160Hz

2. Sample size used for the test set and data provenance

The document does not describe a clinical study with a "test set" of patient data for the device to be evaluated. The performance testing conducted was:

Electrical Safety: Bench testing according to IEC 60601-1.
Electromagnetic Compatibility: Bench testing according to IEC 60601-1-2 and IEC 60601-2-26.
Performance Testing (Hardware): Bench testing in accordance with internal requirements and applicable clauses of IEC 62366-1, IEC 80601-2-26, and IEC 60601-2-40.

The accessorizes were also tested to ISO 10993-1, IEC 60601-1 and IEC 60601-1-2.

Therefore, there is no mention of sample size or data provenance in terms of patient data.

3. Number of experts used to establish the ground truth for the test set and their qualifications

This information is not applicable as there was no test set of patient data requiring expert ground truth establishment. The device capabilities were verified through technical bench testing against established engineering standards and specifications.

4. Adjudication method for the test set

This information is not applicable as there was no test set of patient data requiring adjudication.

5. Multi-reader multi-case (MRMC) comparative effectiveness study

No MRMC study was performed or described. The study focused on technical equivalence and performance against predicate devices and standards, not on human reader performance with or without AI assistance. The device does not draw any diagnostic conclusion and requires interpretation by a clinical expert.

6. Standalone (i.e. algorithm only without human-in-the-loop performance) study

No standalone performance study of an algorithm was conducted or described. The device is a hardware system for acquiring, displaying, storing, and archiving EEG signals, with capabilities for biofeedback and evoked response potentials. It's explicitly stated that the device "does not draw any diagnostic conclusion" and "Recorded data... need to be interpreted by a clinical expert."

7. Type of ground truth used

The "ground truth" for evaluating the EEG NeuroAmp II.5s was based on:

Adherence to international electrical safety and EMC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26, ISO 10993-1 for accessories).
Compliance with device-specific performance standards for electroencephalographs and evoked response equipment (IEC 80601-2-26, IEC 60601-2-40).
Comparison of technical specifications against legally marketed predicate devices (Mitsar EEG K143233, Natus Brain Monitor K180290, EEG NeuroAmp K073557) to demonstrate substantial equivalence and often superior performance.

8. Sample size for the training set

This information is not applicable as the device is a medical measurement instrument and not an AI/ML algorithm that requires a training set of data.

9. How the ground truth for the training set was established

This information is not applicable as there was no training set of data.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K193159

Device Name EEG NeuroAmp II.5s

Indications for Use (Describe)

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)
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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

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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

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TitlePremarket Notification for EEG NeuroAmp II.5s
Document NameNeuroAmp II.5s_510(k).doc	Issue1.3	ProjectCOR035	DateNov 13th, 2020
Corscience GmbH & Co. KG

Device Description 8

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

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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
1. Impedance meter function
1. peripheral channels for additional sensors, ERP synchronization and biofeedback

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

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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)

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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, worksonly with EEG NeuroAmp II.5s	No prior clearance
NeuroAmp x39	39-channel EEG recording front-end, worksonly with EEG NeuroAmp II.5s	No prior clearance
ERP Sync	Device to record the audio-visual stimuli andpatient inputs synchronously with the EEG,used for Event Related Potentialmeasurements, works only with EEGNeuroAmp II.5s	No prior clearance
Combination sensor	For measurement of heart rate, galvanic skinresponse (GSR) and skin temperature, workswith EEG NeuroAmp and EEG NeuroAmpII.5s	No prior clearance
Brummi	Tactile feedback device, works with EEGNeuroAmp and EEG NeuroAmp II.5s	No prior clearance
pIRx3	Temperature sensor, works with EEGNeuroAmp and EEG NeuroAmp II.5s	K073557
Software accessories	Description	510(k) number
Cygnet	EEG biofeedback software, works with EEGNeuroAmp and EEG NeuroAmp II.5s	K073557
ERPrec	EEG measurement/recording functionality,works only with EEG NeuroAmp II.5s	No prior clearance
BEE Lab	EEG-biofeedback functionality, works withEEG NeuroAmp and EEG NeuroAmp II.5s	No prior clearance

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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.

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

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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 DeviceEEG NeuroAmp II.5s	Primary PredicateDeviceMitsar EEGK143233	Predicate DeviceNatus Brain MonitorK180290	Discussion on safetyand effectiveness
Indications forUse (shortversion)	Acquire, display, storeand archive the electro-encephalographic (EEG)signals from a patient'sbrain obtained by placingtwo or more electrodeson the head incl.stimulation and recordingof visual and auditoryevoked responsepotentials.	Acquire, displayand store theelectrical activity ofa patient's brainobtained by placingtwo or moreelectrodes on thehead to aid indiagnosis.	Acquire, display, storeand archiveelectrophysiologicalsignals. Scalp andIntracranial EEG aswell aspolysomnographicsignals.	Both predicates also offerthe capability ofstimulation and recordingof visual and auditoryevoked responsepotentials.
Common name,Product code,Regulationnumber	EEG/ERP measurement& biofeedback device,GWQ, GWE, GWJ, OLV& HCC21 CFR 882.1400, 21CFR 882.5050, 21 CFR882.1890 & 21 CFR882.1900	ElectroencephalographGWQ 21 CFR882.1400	ElectroencephalographGWQ & OLV 21 CFR882.1400	Codes GWE, GWJ notlisted in product 510k ofpredicate Mitsar EEG butthe product fulfills theequal functionality.Thererore, the additionalcodes are applicable.
Power supply	Power supply via USBport (galvanic isolationaccording to IEC 60601-1)	Power supply viaUSB port	USB port	USB port is the onlypower source, i.e. as forpredicate device no othersafety-relevant powersources are to beconsidered. The galvanicinsulation of USB dataand power conforms toIEC 60601-1.→ Same or bettersafety
Software	ERPrec	EEG Studio	Natus NeuroWorks™/SleepWorks. Datastored in 16-bitresolution only	The ERPrec softwarestores the data in fullresolution without loss. Itis better than thepredicate devices→ Same or bettereffectiveness
Windows 10 and7 compatible	Yes	Windows 7,perhaps alsoWindows 10	Yes	Software is fully qualifiedon actual Windowssystems and coverssame or more operatingsystems as predicatedevice→ Same or bettereffectiveness
EEG channels	up to 41 plus 8peripheral channels	21 + 4active/referencepairs, one auxiliarychannel	40	More channels→ Same or bettereffectiveness
Resolution EEGchannels	24 bit, stored loss-free24bit and full samplingrate	16 bit	24 bit (16 bit stored)	Same or higher digitalresolution, betterresolution in stored data→ Bettereffectiveness
Samplingfrequency	1Msample/second grosssampling rate, downsampled to 250 or 500sps. synchronoussampling over all EEG-and peripheral channels	500 Hz perchannel,multiplexed	256, 512, 1024, 2048,4096256, 512Hz (EmblaSDx)	Gross sampling rate muchhigher than predicatedevice -> improved anti-aliasing performance. Netsampling rate sufficient forgiven bandwidth→ Bettereffectiveness
Common-ModeRejection Ratio(CMRR)	>130 dB	at least 100 dB at10 Hz	>106db@60Hz	The CMRR of the subjectdevice is much better thanthe predicate device.Better CMRR results inbetter signal quality andimmunity against noise.→ Bettereffectiveness
Notch filter	<-60 dB at 50 or 60 Hz,optional setting insoftware. Recordingalways unfiltered rawsignal.	-30 dB at 50(60) Hz	No data	Not relevant, display only
Input impedanceEEG channels	>1000 MOhm	> 200 MΩ	>1000 MOhm	High impedance importantfor proper recording. Sameor better performance aspredicate device.→ Same or bettereffectiveness
Bandwidth (3dB)andsample rate	DC ... 100Hz/160Hz	0.16 – 70 Hz	0.1 Hz – 100 Hz	Subject device has full DCcoupling, which allows forrecording of slow corticalpotentials.→ Bettereffectiveness
ImpedancemeasurementEEG electrodes(electrodecontact quality)	Yes0 ... 140kΩ	Yes5kΩ – 40kΩ	Yes2.5kΩ, 5kΩ, 10kΩ,25kΩ	Wider range as predicatedevice. With that, betterguidance for technicianwhen mounting theelectrodes.→ Bettereffectiveness
Input Noise	< 0.01µV/√Hz< 1.0 µV peak toPeak	< 1.5 µV peak topeak	≤ 2 uV pk-to-pk (0.1Hzto 100 Hz),	Better noise performance.Therefore, better signal-to-noise ratio of recording→ Bettereffectiveness
Overvoltagewarning	yes	No data	No data	Overvoltage may saturateinput amplifier and distortthe signal. Subject devicehas overvoltage warningto prevent this fromhappening.→ Same or bettereffectiveness
Input signalrange	1100mVp-p	10 - 5000 $\mu$ V	20mV pk-to-pk, +/-0.3VDC	As the subject device isDC coupled, the signalrange equals the offsetrange. Operation of fullyDC coupled device issimpler than AC coupleddevice as high noise levelsmay removed by softwarefurther down the signalchain-> Bettereffectiveness
MaximumOperational DCinput voltageelectrode offset	±550mV	±350 mV (Offsettolerance)	±300mV	Input offset range ofsubject device is muchhigher than predicatedevice. A large offsetrange is important to coveroffset voltages byelectrodes.-> Bettereffectiveness
ERPmeasurement:synchronizationmechanism andprecision in ms	Active audio and videosynchronization withSync device; Eventbutton, 24 bit trigger..Accuracy/jitter:±1ms/<1ms	Event buttonNo activesynchronizationAccuracy/jitter:±10ms/<20ms	Integrated 8-bit triggerfor synchronizingexternal eventsAccuracy/jitter:±10ms/<20ms	Stimulus synchronizationof subject device muchmore precise. Analysis ofevent-related potentialsrelies on precision ofstimulus synchronization.Subsequent conclusionsmay be better and saferfor patient-> Bettereffectiveness andsafety
Visual andauditory stimulifor ERPmeasurement	Stimulus presentationsoftware incorporated insoftware ERPrec Audioand video sensors forcontinuous calibrationand selftest of thesystem initial to eachrecording.	Stimuluspresentationsoftwareincorporated insoftware EEGStudio. Audio andvideo sensors forinitial calibration.	no data	Same or bettereffectiveness
Measurement ofphysiologicaldata	Combination sensor,applied to the finger, forheart rate and galvanicskin response (GSR).Skin temperature of thefinger can be measured,not absolute values, onlytrends. No therapeuticeffect of sensor.	Multi-purposeinputs for peripheralbiosignalacquisition such asheart rate, skinconductance(GSR),temperature,breathing, SpO2.ECG adapter clipssupplied, breathingsensor available	SpO2 Pulse Rate,Plethysmogram, PPG	Subject device andsoftware work only withaccessories supplied.Therefore mis-reading orfalse values less likely tooccur->Bettereffectiveness andsafety
Video recording	Possible	Possible	Possible	Same or bettereffectiveness
Specification	Subject DeviceEEG NeuroAmp II.5s	Predicate DeviceCorscience EEGNeuroAmpK073557	Comparison ofsubject devicewith predicatedevice based onsafety andeffectiveness
Indications for Use	Biofeedback and relaxationpurposes	Biofeedback andrelaxation purposes	same
Common name,Product code,Regulation number	EEG/ERP measurement &biofeedback device,GWQ, GWE, GWJ, OLV & HCC21 CFR 882.1400, 21 CFR882.5050, 21 CFR 882.1890 &21 CFR 882.1900	Biofeedback deviceHCC21 CFR 882.5050	same or bettereffectiveness
Power supply	Power supply via USB port(galvanic isolation according toIEC 60601-1)	Power supply via USBport (galvanic isolationaccording to IEC60601-1)	Same→ Same safety
Software	Cygnet, BEE Lab	Cygnet, BEE Lab	Same→ sameeffectiveness
Windows 10 and 7compatible	Yes	Yes	Same→ Sameeffectiveness
x23/x39 EEG amplifierinterface	Yes	No	Subject deviceallows to connectadditionalperipherals→ Same or bettereffectiveness
No. peripheralchannels inputs	8	3	More peripheralchannels allow
No. peripheralchannels outputs	8	1	for moreperipheralsattachedsimultaneously.→ Bettereffectiveness
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. Thesubject device
EEG bandwidth	DC ... 100/160Hz	0.056 ... 70Hz	has full DC
Peripheral channelresolution	24 bit	13 bit	coupling, whichallows 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, higherbandwidth andlower noise. Thisresults in bettersignal-to-noiseratio and signalquality. Higherresolution andbetter signalquality allow forbetter signalprocessing.-> Bettereffectiveness
Neurofeedbackfunctionality	Yes
Biofeedback sensorinterface	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.

Regulation Number and Section

§ 882.1400 Electroencephalograph.

(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).