(30 days)
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
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.
The provided document, K171669, is a 510(k) premarket notification for the g.Nautilus PRO device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria through a clinical study as might be done for a novel or higher-risk device. Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance, ground truth, expert consensus, MRMC studies, or training/test sets is not typically found or required in a 510(k) summary for a physiological signal amplifier unless clinical performance is a new claim or a significant change in the intended use.
The document focuses on demonstrating technical equivalence and safety and effectiveness compared to predicate devices through technical specifications and adherence to standards.
However, I can extract the following information relevant to the device's technical performance and how it meets its intended use, framed within the context of a 510(k) submission:
Device: g.Nautilus PRO (Physiological Signal Amplifier for EEG)
Intended Use (from the document): The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
1. Acceptance Criteria and Reported Device Performance
The "acceptance criteria" in a 510(k) context for this type of device are primarily compliance with technical specifications comparable to predicate devices and adherence to relevant safety standards. The document doesn't present these as explicit "acceptance criteria" in a table with performance targets for a clinical study, but rather as comparative technical specifications to demonstrate substantial equivalence.
Here's a table comparing the g.Nautilus PRO (This Submission) against its primary predicate device, g.HIamp K123255, based on the "Technological Characteristics" table provided. The "Substantial Equivalence Comments" indicate how the new device's performance is deemed acceptable (i.e., "equivalent in safety and effectiveness") despite differences.
| Item | Predicate: g.HIamp K123255 | g.Nautilus PRO (Reported Performance) | Acceptance/Equivalence Comments |
|---|---|---|---|
| Intended Use | Acquire biopotentials (EEG, EMG, EOG, ECG) via USB. | Acquire EEG wirelessly. | Similar to predicate in measuring EEG. Equivalent in safety and effectiveness. (The document states: "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.") |
| EEG/Polygraphic Channels | Up to 256 monopolar | Up to 32 monopolar channels | Less maximum amount of channels but equivalent in safety and effectiveness. |
| DC Channel | All | All | Same as predicate. |
| Full Scale Input Range | ± 250 mV | ± 187.5 mV to ± 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 | <0.5 μV RMS | <0.6 μV RMS | Higher RMS noise but equivalent in safety and effectiveness. |
| Power Supply | External IEC 601-1 mains adapter, 5V DC | Battery, 3.7 V DC | Other power supply but equivalent in safety and effectiveness. |
| Rated power consumption | 20 VA | 0.5 VA | Less power consumption but equivalent in safety and effectiveness. |
| Internal Storage | N/A | N/A | Same as predicate. |
| Amplifier-PC Interface | USB | Wireless to receiver, USB to computer | Other technique of data transfer but equivalent in safety and effectiveness. |
| Other Interfaces | Power on LED | Power on LED | Same as predicate. |
| Use standard sensors and electrodes | Electrodes and sensors are not included with the amplifier. | Electrodes and cap are included (Ag/AgCl or golden dry electrodes, elastic cap with certain electrode positions). | Electrodes are dedicated to device and therefore better in safety and effectiveness. |
| Dimension | 197 (L) x 197 (W) x 90 (H) mm | 80 (L) x 60 (W) x 27 (H) mm | Smaller dimensions but equivalent in safety and effectiveness. |
| Weight | 1.875 kg | <200 g | Lighter weight but equivalent in safety and effectiveness. |
| Isolation | Opto coupler, patient isolation CF type | Wireless, patient isolation BF type | Only BF applied part but equivalent in safety and effectiveness considering the intended use. |
| Safety standards | IEC60601-1, IEC60601-1-2, etc. | IEC 60601-1 / AAMI ANSI ES60601-1, IEC 60601-1-2, etc. | Similar to predicate but equivalent in safety and effectiveness considering the intended use. |
| System Components | Amplifier/Digitization, AC/DC Adapter, USB cable, etc. | Amplifier/Digitization/Electrodes/Cap, Charging Device + USB cable, etc. | Different system components but equivalent in safety and effectiveness. |
| Firmware / driver software | Resident / CD | Resident / CD | Same as predicate. |
| Digital inputs/outputs | 16 inputs, all patient separated, no outputs | 8 inputs, all patient separated, no outputs | Less digital inputs but equivalent in safety and effectiveness. |
| Stimulation unit input/output | Not available | Not available | Same as predicate. |
| Patient connection and inputs | 256 monopolar inputs - 256 plugs, 4 ground inputs - 4 plugs, etc. | Receiver: USB – 1 connector, DIGITAL IN - 1 connector | No connectors at the applied part and therefore better in safety and effectiveness. |
| Type of applied part | CF | BF | Only BF applied part but equivalent in safety and effectiveness considering the 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 sampling frequency) | DC up to 200 Hz (depending on sampling frequency) | Less digital filters but equivalent 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. |
2. Sample size used for the test set and the data provenance
The document describes bench testing rather than a clinical study with a "test set" in the sense of patient data.
- Test Sample: The amplifier itself was tested. The "sample size" is effectively n=1 (the g.Nautilus PRO device).
- Data Provenance: Not applicable as it's not patient data. The testing was performed by applying "sinusoidal signals with different frequencies and amplitudes to the inputs of the amplifier" using an "external signal generator." This suggests laboratory-based, controlled input signals.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was a 510(k) focused on technical equivalence and safety standards, not an AI or diagnostic device requiring expert review of output. The "ground truth" for the performance tests was the known characteristics of the input signals from the external signal generator.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No human adjudication was involved as the test was based on comparing measured electrical signals against known input signals and technical specifications.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device is a physiological signal amplifier, not an AI-assisted diagnostic tool for interpretation of medical images or signals by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "standalone" performance here refers to the device's ability to accurately acquire and transmit EEG signals. The document states:
- "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."
This constitutes a form of "standalone" functional and performance testing of the hardware.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the technical performance tests, the ground truth was the known, precisely controlled electrical signals generated by an external signal generator and the expected device outputs based on its design specifications.
8. The sample size for the training set
Not applicable. This is a hardware device (physiological signal amplifier) and does not involve machine learning or a "training set" in the context of AI.
9. How the ground truth for the training set was established
Not applicable (as above).
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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
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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 GmbHSierningstrasse 144521 SchiedlbergAustria |
|---|
| ------------------------------------------------------------------------------------- |
| 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 GmbHElectro-cap International Inc. | g.Hlamp K123255Electro-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 engineeringGmbH g.HIampK123255 | g.tec medical engineering GmbHg.Nautilus PROThis Submission | SubstantialEquivalenceComments |
| Intended Use | The g.Hlamp amplifier is intendedto be used to acquire biopotentialsand transmit them to a computer viathe USB port connection. Thesebiopotentials include for examplethe electroencephalogram (EEG),electromyogram (EMG),electrooculogram (EOG), andelectrocardiogram (ECG). | The g.Nautilus PRO is intendedto be used to acquire theelectroencephalogram (EEG)and transmit it wirelessly to acomputer. | Similar to predicatein measuring EEGbut equivalent insafety andeffectiveness |
| EEG/Polygraphic channels | Up to 256 monopolar | Up to 32 monopolar channels.Different electrode gridsavailable providing 8, 16 or 32channels and 32 or 16 channelCSP layout on predefinedpositions | Less maximumamount of channelsbut equivalent insafety andeffectiveness |
| DC channel | All | All | Same as predicate |
| Full scale input range | $\pm$ 250 mV | $\pm$ 187.5 mV to $\pm$ 2.25 V | Configurable fullscale input rangebut equivalent insafety andeffectiveness |
| A/D conversion | 24 Bit SAR | 24 Bit Delta-Sigma | Other A/Dtechnique butequivalent in safetyand effectiveness |
| Sampling rate | User selectable (256, ... up to38400 Hz/channel) | User selectable (250, 500Hz/channel) | Less maximumsampling rate butequivalent in safetyand 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 noisebut equivalent insafety andeffectiveness |
| Power Supply | External IEC 601-1 mains adapter,5V DC | Battery, 3.7 V DC | Other power supplybut equivalent insafety andeffectiveness |
| Rated power consumption | 20 VA | 0.5 VA | Less powerconsumption butequivalent in safetyand effectiveness |
| Internal Storage | N/A | N/A | Same as predicate |
| Amplifier-PC Interface | USB | Wireless to receiver, USB tocomputer | Other technique ofdata transfer butequivalent in safetyand effectiveness |
| Other Interfaces | Power on LED | Power on LED | Same as predicate |
| Use standard sensors andelectrodes | Electrodes and sensors are notincluded with the amplifier | Electrodes and cap are included(Ag/AgCl or golden dryelectrodes, elastic cap withcertain electrode positions) | Electrodes arededicated to deviceand therefore betterin safety andeffectiveness |
| Dimension | 197 (L) x 197 (W) x 90 (H) mm | 80 (L) x 60 (W) x 27 (H) mm | Smaller dimensionsbut equivalent insafety andeffectiveness |
| but equivalent insafety andeffectiveness | |||
| Weight | 1,875 kg | <200 g | Lighter weight butequivalent in safetyand effectiveness |
| Isolation | Opto coupler, patient isolation CFtype | wireless, patient isolation BFtype | Only BF appliedpart but equivalentin safety andeffectivenessconsidering theintended use |
| Safety standards | IEC60601-1IEC60601-1-2IEC60601-2-25IEC60601-2-26IEC60601-2-40IEC60601-1-4ISO 14971IEC 62304 | IEC 60601-1 / AAMI ANSIES60601-1IEC 60601-1-2IEC 60601-2-26IEC 60601-2-40ISO 14971IEC 62304 / AAMI ANSI IEC62304AAMI ANSI ISO 10993-1AAMI ANSI IEC 62366IEEE 2010-2012 | Similar to predicatebut equivalent insafety andeffectivenessconsidering theintended use |
| System Components | Amplifier/DigitizationAC/DC AdapterUSB cableElectrode connector box andconnector cable | Amplifier/Digitization/Electrodes/CapCharging Device + USB cableReceiver + USB cable | Different systemcomponents butequivalent in safetyand effectiveness |
| Firmware / driver software | Resident / CD | Resident / CD | Same as predicate |
| Digital inputs/outputs | 16 inputs, all patient separated, nooutputs | 8 inputs, all patient separated,no outputs | Less digital inputsbut equivalent insafety andeffectiveness |
| Stimulation unitinput/output | Not available | Not available | Same as predicate |
| Patient connection andinputs | 256 monopolar inputs - 256 plugs4 ground inputs - 4 plugsUSB – 1 connectorDIGITAL IN – 2 connectorsHOLD - 1 connector | Receiver:USB – 1 connectorDIGITAL IN - 1 connector | No connectors atthe applied part andtherefore better insafety andeffectiveness |
| Type of applied part | CF | BF | Only BF appliedpart but equivalentin safety andeffectivenessconsidering theintended 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 onsampling frequency) | DC up to 200 Hz (depending onsampling frequency) | Less digital filtersbut equivalent insafety andeffectiveness |
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| Item | Electro-capInternational Inc.Electro-cap SystemK112319 | g.tec medicalengineering GmbHg.Nautilus PROThis Submission | SubstantialEquivalenceComments |
|---|---|---|---|
| Intended Use | The Electro-cap is intended for | The g.Nautilus PRO is intended to | Not intended for |
| use in routine clinical settingswhere rapid placement of anumber of EEG electrodes isdesired | be used to acquire theelectroencephalogram (EEG) andtransmit it wirelessly to acomputer. | clinicla settings butequivalent in safetyand effectiveness | |
| Environment of Use | Electrophysiological | Electrophysiological | Same as predicate |
| Where Used | On the head | On the head | Same as predicate |
| Number of possibleelectrodes | 2-256 | Different electrode grids availableproviding 8, 16 or 32 channelsand 32 or 16 channel CSP layouton predefined positions | Less number ofpossible electrodesbut equivalent insafety andeffectiveness |
| 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), headcircumference: 32-62 cm | Similar sizes butequivalent in safetyand effectiveness |
| Style of caps | Full head cap | Full head cap | Same as predicate |
| Ear slits | Yes | Yes | Same as predicate |
| Performancerequirements | Needs to transmitelectrophysiological signals froman individual to data collectiondevice | Needs to transmitelectrophysiological signals froman individual to data collectiondevice | Same as predicate |
| Manufacturing methodcap | 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 butequivalent in safetyand effectiveness |
| Electrode mounts | Polyethylene | POM-C | Other material butequivalent in safetyand effectiveness |
| Location of wiring | Inside cap | Outside cap | Other location ofwiring but equivalentin safety andeffectiveness |
| Cable length | 3-5 feet | Up to 25 cm | Shorter cable lengthbut equivalent insafety andeffectiveness |
| Type of cables | Standard ribbon cable and leadwires | Flex-print, material polyimide | Other type of cablesbut equivalent insafety andeffectiveness |
| Type of electrodeconnector | D-Sub connector | No connector. Cables go directlyinto amplifier | No connector andtherefore better insafety andeffectiveness |
| Biocompatibility testing | None was conducted | Evaluation done | Better in safety andeffectiveness |
| Type of electrodes | Passive, wet | Active, wet and dry | Better in safety andeffectiveness |
| Reprocessing | Low level disinfection withIVORY® or PALMOLIVE®.Sterilization possible via coldsterilizing solution or cold gassterilization process | Cleaning with multistageenzymatic cleaner of cap and wetelectrodes. Disinfection of capand wet electrodes with low leveldisinfectant based onGlucoprotamin. Cleaning of dryelectrodes with cleaning wipe.Disinfection of dry electrodes | Similar reprocessingbut better in safetyand 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.
§ 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).