g.Nautilus PRO

K171669 · G.Tec Medical Engineering GmbH · GWL · Jul 5, 2017 · Neurology

Device Facts

• Record ID: K171669
• Device Name: g.Nautilus PRO
• Applicant: G.Tec Medical Engineering GmbH
• Product Code: GWL · Neurology
• Decision Date: Jul 5, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1835
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.

Device Story

g.Nautilus PRO is a wireless bio-potential amplifier system for EEG acquisition. It consists of a headset (amplification/digitization unit with integrated electrodes, cap, and chin-strap), a receiver unit connecting via USB to a host PC, and driver/API software. The device captures EEG signals via 8-32 active gel or dry electrodes, converts them to digital format using 24-bit Delta-Sigma ADCs, and transmits data wirelessly (2.4 GHz) to a computer. It features an internal impedance check unit and is battery-powered. The system is operated by clinicians or technicians in clinical settings. The host computer runs software to receive and process the EEG data. The device provides high-resolution signal acquisition, enabling clinicians to monitor and interpret brain activity for diagnostic or research purposes.

Clinical Evidence

Bench testing only. Testing included signal transmission and amplification verification using an external signal generator with sinusoidal signals across various frequencies and amplitudes, documented via Bode plots. Impedance measurement accuracy was verified using test impedances. Noise levels were assessed by short-cutting input channels. Safety was evaluated through battery-powered operation and wireless isolation, ensuring compliance with relevant electrical safety standards.

Technological Characteristics

Battery-powered (3.7V DC) wireless EEG amplifier. 8-32 monopolar channels. 24-bit Delta-Sigma A/D conversion. Sampling rates: 250/500 Hz. CMRR >90 dB at 60 Hz. Noise <0.6 μV RMS. Input impedance >100 MOhm. Active gel or dry electrodes. Wireless 2.4 GHz transmission to USB receiver. Standards: IEC 60601-1, AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-26, IEC 60601-2-40, ISO 14971, IEC 62304, AAMI ANSI ISO 10993-1, AAMI ANSI IEC 62366, IEEE 2010-2012.

Indications for Use

Indicated for acquisition of EEG signals in adults, children, and infants.

Regulatory Classification

Identification

A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).

Predicate Devices

• g.Hlamp (K123255)
• Electro-Cap System (K112319)

Submission Summary (Full Text)

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July 5, 2017

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

g.tec medical engineering GmbH % Alexander Schapovalov Responsible Third Party Official TÜV SÜD America Inc. 1775 Old Highway 8 NW New Brighton, Minnesota 55112-1891

Re: K171669

Trade/Device Name: g.Nautilus PRO Regulation Number: 21 CFR 882.1835 Regulation Name: Physiological Signal Amplifier Regulatory Class: Class II Product Code: GWL, GXY Dated: June 5, 2017 Received: June 5, 2017

Dear Mr. Schapovalov:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# Michael J. Hoffmann -S

for

Carlos L. Peña. PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) K171669

Device Name g.Nautilus PRO

Indications for Use (Describe)

The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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## K171669 510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).

807.92(a)(1)

#### Submitter Information

| g.tec medical engineering GmbH<br>Sierningstrasse 14<br>4521 Schiedlberg<br>Austria |
|-------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------------------|

| Phone: | ++43 (7251) 22240-12 |
|-----------------|----------------------|
| Fax: | ++43 (7251) 22240-39 |
| Contact Person: | Christoph Guger |
| Date: | 25th September 2015 |

| 807.92(1)(2) |
|--------------|
|--------------|

| Trade Name: | g.Nautilus PRO |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Physiological Signal Amplifier |
| Classification Names(s): | Physiological Signal Amplifier<br>(per 21 CFR section 21 CFR 882.1835)<br>Cutaneous Electrode<br>(per 21 CFR section 21 CFR 882.1320) |
| Product Codes: | GWL, GXY |

| 807.92(a)(3) |
|--------------|
|--------------|

| Predicate Device(s) | |
|------------------------------------------------------------------|-----------------------------------------------|
| g.tec medical engineering GmbH<br>Electro-cap International Inc. | g.Hlamp K123255<br>Electro-Cap System K112319 |

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807.92(a)(4)

#### Device Description

g.Nautilus PRO is g.tec's bio-potential amplifier with wireless data transmission technology. The device allows the acquisition of up to 32 EEG (Electroencephalogram) channels with 24 bit resolution. The sampling frequency can be set up to 250 or 500 Hz. g.Nautilus PRO is available with 8-32 channels.

The wireless amplifier is transmitting data to a PC or notebook with 2.4 GHz technology. On the computer a receiver unit is connected with USB. Up to 32 analog to digital converters perform the simultaneous sampling. The sampling frequency can be set to 250 Hz or 500 Hz. Each analog to digital converter is operating with 1.024 MHz and performs a 2048 times oversampling for 500 Hz. A sampling frequency of 250 Hz vields to an over-sampling rate of 4096 with a very high signal to noise ratio. Furthermore, the device has an internal impedance check unit. g.Nautilus PRO works with either active gel or active dry electrodes and comes with an EEG cap with chinstrap. The device is controlled via its driver and application programming interface (API), which is part of the g.tec device service g.NEEDaccess. The device is battery supplied.

The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer. It captures the data, converts it into digital form and passes it on to a host computer running appropriate software. The device can be used for adults, children and infants. The host computer must use Microsoft Windows. g.Nautilus PRO comes with a C Application Programming Interface (C API) which allows to control the device.

The system consists of the charging device, the g.Nautilus PRO Headset (the amplification and digitization unit with EEG electrodes, cap and chin-strap), the receiver unit (with USB connector cable to connect the device to a host computer), the driver and the C API software.

g.Nautilus PRO works in the same manner as the approved and predicate device.

807.92(1)(5)

#### Intended Use(s)

The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.

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### 807.92(a)(6)

| Technological Characteristics | | | |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Item | g.tec medical engineering<br>GmbH g.HIamp<br>K123255 | g.tec medical engineering GmbH<br>g.Nautilus PRO<br>This Submission | Substantial<br>Equivalence<br>Comments |
| Intended Use | The g.Hlamp amplifier is intended<br>to be used to acquire biopotentials<br>and transmit them to a computer via<br>the USB port connection. These<br>biopotentials include for example<br>the electroencephalogram (EEG),<br>electromyogram (EMG),<br>electrooculogram (EOG), and<br>electrocardiogram (ECG). | The g.Nautilus PRO is intended<br>to be used to acquire the<br>electroencephalogram (EEG)<br>and transmit it wirelessly to a<br>computer. | Similar to predicate<br>in measuring EEG<br>but equivalent in<br>safety and<br>effectiveness |
| EEG/Polygraphic channels | Up to 256 monopolar | Up to 32 monopolar channels.<br>Different electrode grids<br>available providing 8, 16 or 32<br>channels and 32 or 16 channel<br>CSP layout on predefined<br>positions | Less maximum<br>amount of channels<br>but equivalent in<br>safety and<br>effectiveness |
| DC channel | All | All | Same as predicate |
| Full scale input range | $\pm$ 250 mV | $\pm$ 187.5 mV to $\pm$ 2.25 V | Configurable full<br>scale input range<br>but equivalent in<br>safety and<br>effectiveness |
| A/D conversion | 24 Bit SAR | 24 Bit Delta-Sigma | Other A/D<br>technique but<br>equivalent in safety<br>and effectiveness |
| Sampling rate | User selectable (256, ... up to<br>38400 Hz/channel) | User selectable (250, 500<br>Hz/channel) | Less maximum<br>sampling rate but<br>equivalent in safety<br>and effectiveness |
| CMRR | >90 dB at 60 Hz | >90 dB at 60 Hz | Same as predicate |
| Noise | <0.5 μV RMS | <0.6 μV RMS | Higher RMS noise<br>but equivalent in<br>safety and<br>effectiveness |
| Power Supply | External IEC 601-1 mains adapter,<br>5V DC | Battery, 3.7 V DC | Other power supply<br>but equivalent in<br>safety and<br>effectiveness |
| Rated power consumption | 20 VA | 0.5 VA | Less power<br>consumption but<br>equivalent in safety<br>and effectiveness |
| Internal Storage | N/A | N/A | Same as predicate |
| Amplifier-PC Interface | USB | Wireless to receiver, USB to<br>computer | Other technique of<br>data transfer but<br>equivalent in safety<br>and effectiveness |
| Other Interfaces | Power on LED | Power on LED | Same as predicate |
| Use standard sensors and<br>electrodes | Electrodes and sensors are not<br>included with the amplifier | Electrodes and cap are included<br>(Ag/AgCl or golden dry<br>electrodes, elastic cap with<br>certain electrode positions) | Electrodes are<br>dedicated to device<br>and therefore better<br>in safety and<br>effectiveness |
| Dimension | 197 (L) x 197 (W) x 90 (H) mm | 80 (L) x 60 (W) x 27 (H) mm | Smaller dimensions<br>but equivalent in<br>safety and<br>effectiveness |
| | | | but equivalent in<br>safety and<br>effectiveness |
| Weight | 1,875 kg | <200 g | Lighter weight but<br>equivalent in safety<br>and effectiveness |
| Isolation | Opto coupler, patient isolation CF<br>type | wireless, patient isolation BF<br>type | Only BF applied<br>part but equivalent<br>in safety and<br>effectiveness<br>considering the<br>intended use |
| Safety standards | IEC60601-1<br>IEC60601-1-2<br>IEC60601-2-25<br>IEC60601-2-26<br>IEC60601-2-40<br>IEC60601-1-4<br>ISO 14971<br>IEC 62304 | IEC 60601-1 / AAMI ANSI<br>ES60601-1<br>IEC 60601-1-2<br><br>IEC 60601-2-26<br>IEC 60601-2-40<br><br>ISO 14971<br>IEC 62304 / AAMI ANSI IEC<br>62304<br>AAMI ANSI ISO 10993-1<br>AAMI ANSI IEC 62366<br>IEEE 2010-2012 | Similar to predicate<br>but equivalent in<br>safety and<br>effectiveness<br>considering the<br>intended use |
| System Components | Amplifier/Digitization<br>AC/DC Adapter<br>USB cable<br>Electrode connector box and<br>connector cable | Amplifier/Digitization/Electrod<br>es/Cap<br>Charging Device + USB cable<br>Receiver + USB cable | Different system<br>components but<br>equivalent in safety<br>and effectiveness |
| Firmware / driver software | Resident / CD | Resident / CD | Same as predicate |
| Digital inputs/outputs | 16 inputs, all patient separated, no<br>outputs | 8 inputs, all patient separated,<br>no outputs | Less digital inputs<br>but equivalent in<br>safety and<br>effectiveness |
| Stimulation unit<br>input/output | Not available | Not available | Same as predicate |
| Patient connection and<br>inputs | 256 monopolar inputs - 256 plugs<br>4 ground inputs - 4 plugs<br>USB – 1 connector<br>DIGITAL IN – 2 connectors<br>HOLD - 1 connector | Receiver:<br>USB – 1 connector<br>DIGITAL IN - 1 connector | No connectors at<br>the applied part and<br>therefore better in<br>safety and<br>effectiveness |
| Type of applied part | CF | BF | Only BF applied<br>part but equivalent<br>in safety and<br>effectiveness<br>considering the<br>intended use |
| Impedance measurement | Performed with 10 Hz | Performed with 10 Hz | Same as predicate |
| Input impedance | >100 MOhm | >100 MOhm | Same as predicate |
| Filters | DC up to 2000 Hz (depending on<br>sampling frequency) | DC up to 200 Hz (depending on<br>sampling frequency) | Less digital filters<br>but equivalent in<br>safety and<br>effectiveness |

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| Item | Electro-cap<br>International Inc.<br>Electro-cap System<br>K112319 | g.tec medical<br>engineering GmbH<br>g.Nautilus PRO<br>This Submission | Substantial<br>Equivalence<br>Comments |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Intended Use | The Electro-cap is intended for | The g.Nautilus PRO is intended to | Not intended for |
| | | | |
| | use in routine clinical settings<br>where rapid placement of a<br>number of EEG electrodes is<br>desired | be used to acquire the<br>electroencephalogram (EEG) and<br>transmit it wirelessly to a<br>computer. | clinicla settings but<br>equivalent in safety<br>and effectiveness |
| Environment of Use | Electrophysiological | Electrophysiological | Same as predicate |
| Where Used | On the head | On the head | Same as predicate |
| Number of possible<br>electrodes | 2-256 | Different electrode grids available<br>providing 8, 16 or 32 channels<br>and 32 or 16 channel CSP layout<br>on predefined positions | Less number of<br>possible electrodes<br>but equivalent in<br>safety and<br>effectiveness |
| Size of caps | Various: extra-small to large,<br>head circumference 26-66 cm<br>(adults, children, infants) | Various for infants, children<br>(mini, midi, maxi) and adults<br>(small, medium, large), head<br>circumference: 32-62 cm | Similar sizes but<br>equivalent in safety<br>and effectiveness |
| Style of caps | Full head cap | Full head cap | Same as predicate |
| Ear slits | Yes | Yes | Same as predicate |
| Performance<br>requirements | Needs to transmit<br>electrophysiological signals from<br>an individual to data collection<br>device | Needs to transmit<br>electrophysiological signals from<br>an individual to data collection<br>device | Same as predicate |
| Manufacturing method<br>cap | Caps sewn | Caps sewn | Same as predicate |
| Electrode metal | Gold plated or Ag/AgCl | Gold plated or Ag/AgCl | Same as predicate |
| Cap material | Spandex | Oeko-Tex certificate | Similar material but<br>equivalent in safety<br>and effectiveness |
| Electrode mounts | Polyethylene | POM-C | Other material but<br>equivalent in safety<br>and effectiveness |
| Location of wiring | Inside cap | Outside cap | Other location of<br>wiring but equivalent<br>in safety and<br>effectiveness |
| Cable length | 3-5 feet | Up to 25 cm | Shorter cable length<br>but equivalent in<br>safety and<br>effectiveness |
| Type of cables | Standard ribbon cable and lead<br>wires | Flex-print, material polyimide | Other type of cables<br>but equivalent in<br>safety and<br>effectiveness |
| Type of electrode<br>connector | D-Sub connector | No connector. Cables go directly<br>into amplifier | No connector and<br>therefore better in<br>safety and<br>effectiveness |
| Biocompatibility testing | None was conducted | Evaluation done | Better in safety and<br>effectiveness |
| Type of electrodes | Passive, wet | Active, wet and dry | Better in safety and<br>effectiveness |
| Reprocessing | Low level disinfection with<br>IVORY® or PALMOLIVE®.<br>Sterilization possible via cold<br>sterilizing solution or cold gas<br>sterilization process | Cleaning with multistage<br>enzymatic cleaner of cap and wet<br>electrodes. Disinfection of cap<br>and wet electrodes with low level<br>disinfectant based on<br>Glucoprotamin. Cleaning of dry<br>electrodes with cleaning wipe.<br>Disinfection of dry electrodes | Similar reprocessing<br>but better in safety<br>and effectiveness |

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The g.Hlamp amplifier is intended to be used to acquire biopotentials and transmit them to a computer via the USB port connection. These biopotentials include for example the electroencephalogram (EEG), electromyogram (EMG), electrooculogram (EOG), and electrocardiogram (ECG). The Electro-cap is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired. Therefore, if the Electro-cap is used together with g.HIamp building up a system, this system can be used to measure EEG as found in clinical settings.

The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.

Therefore both systems, g.Hlamp with Electro-cap compared to g.Nautilus PRO, are intended to be used to measure EEG and transmit them to a computer. The difference in intended use applies only to the way of data transmission to a computer. g.Hlamp with Electro-cap uses a USB cable connection whereas g.Nautilus PRO uses a wireless connection. In both cases the software on the computer indicates if data are lost, so the user can interpret the data correctly. Therefore the wireless connection of g.Nautilus PRO is safe and effective and substantial equivalent to the cable connection of the predicate device.

807.92(b)(1)

The amplifier was tested with an external signal generator which applies sinusoidal signals with different frequencies and amplitudes to the inputs of the amplifier. The correct signal transmission and amplification was determined with Bode plots for each channel. The impedance measurement was tested with test impedances. Noise was tested by short-cutting the input channels. The tests show that the signal quality is appropriate for EEG measurements and that impedance measurements are accurate.

In g.Hlamp, medical safety is realized by isolating the applied part with digital isolators, DC/DC converters and by using a medical power supply unit. In g.Nautilus PRO the medical safety is realized with battery supply and wireless transmission of the data. In both cases the current for impedance measurement is limited to be safe.

807.92(b)(2) Not applicable

#### 807.92(b)(3)

The conclusion is that g.Nautilus PRO and the predicate device amplify sinusoidal signals with varying frequencies and amplitudes in the same way and that the amplifier is working substantial equivalent and as effective as the marketed device. g.Nautilus PRO is using battery supply and wireless transmission and is therefore considered to be safe. The electrodes are safe and effective because they are directly integrated into the device and have the necessary material and diameter.