(30 days)
Not Found
No
The description focuses on the hardware for EEG acquisition and transmission, with no mention of AI or ML for data analysis or interpretation.
No
The device is used to acquire and transmit electroencephalogram (EEG) data, which is a diagnostic function, not a therapeutic one. It does not provide any treatment or therapy.
No
The device is intended to acquire and transmit EEG data, but no mention is made of it analyzing this data to diagnose a condition.
No
The device description explicitly details hardware components including a bio-potential amplifier, wireless data transmission technology, analog to digital converters, a receiver unit, electrodes, a cap, and a chin-strap. While software is mentioned (driver, API), it is part of a larger system that includes significant hardware.
Based on the provided information, the g.Nautilus PRO is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to acquire and transmit electroencephalogram (EEG) data. EEG measures electrical activity in the brain, which is a physiological signal from the body.
- Device Description: The device is described as a bio-potential amplifier that acquires EEG channels. It works with electrodes placed on the head.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The g.Nautilus PRO does not process or analyze such specimens. It directly measures electrical signals from the body.
Therefore, the g.Nautilus PRO falls under the category of a medical device that measures physiological signals, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
Product codes (comma separated list FDA assigned to the subject device)
GWL, GXY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
On the head
Indicated Patient Age Range
The device can be used for adults, children and infants.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1835 Physiological signal amplifier.
(a)
Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).(b)
Classification. Class II (performance standards).
0
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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
1
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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Michael J. Hoffmann -S
for
Carlos L. Peña. PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) 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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3
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
Sierningstrasse 14
4521 Schiedlberg
| 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 |
| (per 21 CFR section 21 CFR 882.1835) | |
| Cutaneous Electrode | |
| (per 21 CFR section 21 CFR 882.1320) | |
| Product Codes: | GWL, GXY |
| 807.92(a)(3) |
|---|
| -------------- |
| Predicate Device(s) | |
|---|---|
| g.tec medical engineering GmbH | |
| Electro-cap International Inc. | g.Hlamp K123255 |
| Electro-Cap System K112319 |
4
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.
5
807.92(a)(6)
| Technological Characteristics | |||
|---|---|---|---|
| Item | g.tec medical engineering | ||
| GmbH g.HIamp | |||
| K123255 | g.tec medical engineering GmbH | ||
| g.Nautilus PRO | |||
| This Submission | Substantial | ||
| Equivalence | |||
| Comments | |||
| Intended Use | 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 g.Nautilus PRO is intended | ||
| to be used to acquire the | |||
| electroencephalogram (EEG) | |||
| and transmit it wirelessly to a | |||
| computer. | Similar to predicate | ||
| in measuring EEG | |||
| but equivalent in | |||
| safety and | |||
| effectiveness | |||
| EEG/Polygraphic channels | Up to 256 monopolar | Up to 32 monopolar channels. | |
| Different electrode grids | |||
| available providing 8, 16 or 32 | |||
| channels and 32 or 16 channel | |||
| CSP layout on predefined | |||
| positions | Less maximum | ||
| amount of channels | |||
| but equivalent in | |||
| safety and | |||
| 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 |
| scale input range | |||
| but equivalent in | |||
| safety and | |||
| effectiveness | |||
| A/D conversion | 24 Bit SAR | 24 Bit Delta-Sigma | Other A/D |
| technique but | |||
| equivalent in safety | |||
| and effectiveness | |||
| Sampling rate | User selectable (256, ... up to | ||
| 38400 Hz/channel) | User selectable (250, 500 | ||
| Hz/channel) | Less maximum | ||
| sampling rate but | |||
| equivalent in safety | |||
| and effectiveness | |||
| CMRR | >90 dB at 60 Hz | >90 dB at 60 Hz | Same as predicate |
| Noise | 100 MOhm | >100 MOhm | Same as predicate |
| Filters | DC up to 2000 Hz (depending on | ||
| sampling frequency) | DC up to 200 Hz (depending on | ||
| sampling frequency) | Less digital filters | ||
| but equivalent in | |||
| safety and | |||
| effectiveness |
6
| Item | Electro-cap
International Inc.
Electro-cap System
K112319 | g.tec medical
engineering GmbH
g.Nautilus PRO
This Submission | Substantial
Equivalence
Comments |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Intended Use | The Electro-cap is intended for | The g.Nautilus PRO is intended to | Not intended for |
| | | | |
| | use in routine clinical settings
where rapid placement of a
number of EEG electrodes is
desired | be used to acquire the
electroencephalogram (EEG) and
transmit it wirelessly to a
computer. | clinicla settings but
equivalent in safety
and effectiveness |
| Environment of Use | Electrophysiological | Electrophysiological | Same as predicate |
| Where Used | On the head | On the head | Same as predicate |
| Number of possible
electrodes | 2-256 | Different electrode grids available
providing 8, 16 or 32 channels
and 32 or 16 channel CSP layout
on predefined positions | Less number of
possible electrodes
but equivalent in
safety and
effectiveness |
| Size of caps | Various: extra-small to large,
head circumference 26-66 cm
(adults, children, infants) | Various for infants, children
(mini, midi, maxi) and adults
(small, medium, large), head
circumference: 32-62 cm | Similar sizes but
equivalent in safety
and effectiveness |
| Style of caps | Full head cap | Full head cap | Same as predicate |
| Ear slits | Yes | Yes | Same as predicate |
| Performance
requirements | Needs to transmit
electrophysiological signals from
an individual to data collection
device | Needs to transmit
electrophysiological signals from
an individual to data collection
device | Same as predicate |
| Manufacturing method
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
equivalent in safety
and effectiveness |
| Electrode mounts | Polyethylene | POM-C | Other material but
equivalent in safety
and effectiveness |
| Location of wiring | Inside cap | Outside cap | Other location of
wiring but equivalent
in safety and
effectiveness |
| Cable length | 3-5 feet | Up to 25 cm | Shorter cable length
but equivalent in
safety and
effectiveness |
| Type of cables | Standard ribbon cable and lead
wires | Flex-print, material polyimide | Other type of cables
but equivalent in
safety and
effectiveness |
| Type of electrode
connector | D-Sub connector | No connector. Cables go directly
into amplifier | No connector and
therefore better in
safety and
effectiveness |
| Biocompatibility testing | None was conducted | Evaluation done | Better in safety and
effectiveness |
| Type of electrodes | Passive, wet | Active, wet and dry | Better in safety and
effectiveness |
| Reprocessing | Low level disinfection with
IVORY® or PALMOLIVE®.
Sterilization possible via cold
sterilizing solution or cold gas
sterilization process | Cleaning with multistage
enzymatic cleaner of cap and wet
electrodes. Disinfection of cap
and wet electrodes with low level
disinfectant based on
Glucoprotamin. Cleaning of dry
electrodes with cleaning wipe.
Disinfection of dry electrodes | Similar reprocessing
but better in safety
and effectiveness |
7
8
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.