g.Estim PRO

K173684 · G.Tec Medical Engineering GmbH · GYC · May 4, 2018 · Neurology

Device Facts

• Record ID: K173684
• Device Name: g.Estim PRO
• Applicant: G.Tec Medical Engineering GmbH
• Product Code: GYC · Neurology
• Decision Date: May 4, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1310
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The g.Estim PRO is intended for functional brain mapping via electrical stimulation prior to cortical resections in the vicinity of essential cortex. The device must be used by medically trained and qualified personnel within a medical environment.

Device Story

g.Estim PRO is a battery-powered, constant-current, monophasic/biphasic cortical stimulator; used for functional brain mapping prior to cortical resections. Device inputs include user-defined stimulation parameters (amplitude, frequency, pulse width, polarity) via a host computer GUI; external trigger signals (TTL compatible) via hand/foot switches. Device outputs include electrical stimulation pulses to cortical electrodes; trigger signals to external devices (e.g., EEG acquisition systems) for synchronization. Operated by physicians/trained personnel in medical environments. System includes stimulator unit, USB cable, trigger cables, and software. Impedance measurement performed prior to stimulation; stimulation inhibited if impedance is high. Optical isolation between stimulator and computer ensures patient safety. Output allows clinicians to map essential cortex, aiding surgical planning and potentially improving patient outcomes by minimizing post-surgical deficits.

Clinical Evidence

Bench testing only. Testing verified stimulation pulse characteristics (frequency, amplitude, pulse width), impedance measurement accuracy, and trigger signal functionality (TTL compatibility). Safety verified via optical isolation and battery power. No clinical data presented.

Technological Characteristics

Constant-current stimulator; battery-powered (2 x 9V); optical isolation for USB communication. Delivers bi-phasic/monophasic rectangular pulses. Stimulation range: 0.05-15 mA, 2-100 Hz, 0.1-1.0 ms pulse duration. Connectivity: USB to host PC, TTL-compatible trigger I/O. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-40, ISO 14971, IEC 62304, IEC 62366. Patient isolation: Type BF.

Indications for Use

Indicated for functional brain mapping via electrical stimulation prior to cortical resections in the vicinity of essential cortex. For use by trained/qualified personnel in medical environments.

Regulatory Classification

Identification

A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity.

Predicate Devices

• Chatten Associates S12X (K082629)

Submission Summary (Full Text)

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May 4, 2018

g.tec medical engineering GmbH % Olaf Teichert Responsible Third Party Official TUV SUD America Inc. 1775 Old Highway 8 NW New Brighton, Minnesota 55112-1891

Re: K173684

Trade/Device Name: g.Estim PRO Regulation Number: 21 CFR 882.1310 Regulation Name: Cortical electrode Regulatory Class: Class II Product Code: GYC Dated: April 20, 2018 Received: April 25, 2018

Dear Olaf Teichert:

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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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) K173684

Device Name g.Estim PRO

Indications for Use (Describe)

The g.Estim PRO is intended for functional brain mapping via electrical stimulation prior to cortical resections in the vicinity of essential cortex. The device must be used by trained and qualified personnel within a medical environment.

| 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) |

|X Prescription Use (Part 21 CFR 801 Subpart D)

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

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g.tec medical engineering GmbH

# 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: | 14th November 2016 | |
| 807.92(a)(2) | | |
| Trade Name: | g.Estim PRO | |
| Common Name: | Cortical Stimulator | |
| Classification Names(s): | Cortical Electrode<br>(per 21 CFR section 21 CFR 882.1310) | |
| Product Code: | GYC | |
| 807.92(a)(3) | | |
| | Predicate Device(s) | |
| Chatten Associates | S12X | K082629 |

g.tec medical engineering GmbH, Sierningstrasse 14, 4521 Schiedlberg, Austria, Europe,

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807.92(a)(4)

#### Device Description

The g.Estim PRO is a neural, constant current, monophasic stimulator for electrical stimulation of the brain (cortical stimulator). The device is battery supplied and can be controlled via USB from a computer. It can be trigged via software or with external devices and can provide beside the stimulation pulse also trigger signals for other devices.

The system consists of the stimulator, a USB connector cable to connect the device to a host computer, trigger out cables and trigger in cables, the driver and software package (including a graphical user interface and communication interface). Additionally the device can be triggered with a hand switch and/or foot switch.

The stimulator can be programmed and is a constant-current stimulator that can deliver electrical pulses with alternating polarities, lengths, amplitudes or trains of such pulses. The device is connected via USB to a computer and on the computer stimulator settings can be performed. On the computer a graphical user interface allows to perform all settings required for the stimulator. The stimulator is battery powered and has an optical isolation from the computer for safety reasons. A LED shows the stimulus time point.

The stimulator allows to send trigger pulses to external devices to synchronize the stimulus e.g. with EEG data acquisition devices. Such a trigger pulse can be programmed to occur prior to the stimulus so that e.g. a switching unit can switch before the stimulus occurs and can last longer than the electrical pulse to switch back after the pulse. Furthermore the triggers can be perfectly aligned with the stimulus so that an accurate trigger signal can be sent to the external device. The trigger lines are TTL compatible. Two trigger lines are supported.

The stimulus can be triggered via the software running on the computer or via external inputs to the stimulator. Important is that the stimulus is triggered very accurately for perfect synchronization. A foot switch or hand switch can be used to trigger the stimulator. The trigger input is TTL compatible. One trigger line is supported.

The device can perform an impedance measurement to check the electrodes impedance before the stimulation is done and can measure the actual stimulation current when a stimulation is done. The results are shown in the graphical user interface and can be passed also to other applications via an interface. The impedance measurement is done quickly so that the stimulation can rapidly be performed. If a high impedance is detected the stimulator does not stimulate.

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

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g.tec medical engineering GmbH

807.92(1)(5)

#### Intended Use(s)

The g.Estim PRO is intended for functional brain mapping via electrical stimulation prior to cortical resections in the vicinity of essential cortex. The device must be used by medically trained and qualified personnel within a medical environment.

> g.tec medical engineering GmbH, Sierningstrasse 14, 4521 SchiedIberg, Austria, Europe, Tel.: [phone], Fax: [phone], [e-mail], www.gtec.at

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#### g.tec medical engineering GmbH

807.92(a)(6)

| | Item | Chatten Associates<br>S12X<br>K082629 | g.tec medical<br>engineering GmbH<br>g.Estim PRO<br>This Submission | Comments |
|-----|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Intended use | The S12X Cortical<br>stimulator is intended for<br>Intraoperative cortical<br>stimulation mapping to aid<br>in cortical resections in the<br>vicinity of essential<br>cortex.<br>The ESAx option is<br>intended for use with the<br>S1 2X for facilitating the<br>switching of the patient<br>electrodes. | The g.Estim PRO is intended<br>for functional brain mapping<br>via electrical stimulation prior<br>to cortical resections in the<br>vicinity of essential cortex. | Reduced intended<br>used, no switching<br>unit option realized,<br>but equivalent in<br>safety and<br>effectiveness |
| 2. | User | The device is intended for<br>use only by medically<br>trained and qualified<br>personnel, with a hospital<br>or medical environment. | The device must be used by<br>medically trained and qualified<br>personnel within a medical<br>environment. | Same as predicate |
| 3. | Constant type | Constant current bi-<br>phasic, rectangular | Constant current, bi-phasic,<br>rectangular | Same as predicate |
| 4. | Maximum stimulation charge | 20 μC | 15 μC | Lower limit for<br>additional safety but<br>equivalent in<br>effectiveness. |
| 5. | Pulse polarity | Selectable, positive,<br>negative or alternating<br>stimulus polarity on<br>successive pulses | Selectable, positive, negative<br>or alternating stimulus polarity<br>on successive pulses | Same as predicate |
| 6. | Train duration | 0.2 to 20 sec in 7 steps | 0.1 to 20 sec. | Shorter minimum<br>train duration but<br>equivalent in safety<br>and effectiveness. |
| 7. | Pulse amplitude | 0.2 - 15 mA (peak),<br>constant current, 17 steps | 0.05 - 15 mA (peak), constant<br>current, 0.01 mA increments | Allows lower start<br>value, lower<br>increments, but<br>equivalent in safety<br>and effectiveness. |
| 8. | Stimulation frequency | 2 - 100 Hz in 7 steps | 2-100 Hz, 0,1 Hz steps | Same frequency<br>range and smaller<br>increments for more<br>flexibility, but<br>equivalent in safety<br>and effectiveness. |
| 9. | Stimulation pulse duration | 0.1 - 1.0 ms per phase (15<br>mA max); up to 2 ms per<br>phase (10 mA max) | 0.1 ms - 1 ms per phase | 1 ms is long enough<br>to achieve the<br>necessary<br>stimulation, but<br>equivalent in safety<br>and effectiveness. |
| 10. | Max. transient voltage | 34V, Zener Diode for<br>hardware safety | 80V, lead off via software for<br>safety | Higher voltage for<br>smaller electrode<br>sizes but equivalent |
| | | | | in safety and<br>effectiveness. |
| 11. | Power supply | 12V DC, External medical<br>power supply | Battery, 2 x 9 V | Battery supply to<br>reduce risk and<br>noise. |
| 12. | Electrode size | Warning that electrodes<br>with less than 4 sq mm<br>can cause tissue damage. | Electrode size defines the<br>safety threshold for stimulation<br>parameters. | The g.Estim PRO is<br>safe also with<br>smaller electrode<br>size, because the<br>stimulator calculates<br>the maximum<br>stimulation current<br>depending on<br>electrode size. So<br>equivalent in safety<br>and effectiveness. |
| 13. | Supported electrodes | Strip, grids, handheld<br>probe | Strip, grids, handheld probe | Same as predicate |
| 14. | Stimulus switching unit | Yes | No | Just a cortical<br>stimulator for 1<br>bipolar channel, but<br>equivalent in safety<br>and effectiveness. |
| 15. | Use standard sensors and<br>electrodes | Electrodes are not<br>included | Electrodes are not included | Same as predicate |
| 16. | User input | Stylus (touch), standard<br>mouse | Standard computer | Standard computer,<br>but equivalent in<br>safety and<br>effectiveness. |
| 17. | Graphical user interface | LCD | LCD display of computer | Same as predicate |
| 18. | Simulator parameters setting | Through displayed<br>controls | Through displayed controls | Same as predicate |
| 19. | Active stimulation LED | Yes | Yes | Same as predicate |
| 20. | Actual current delivered<br>displayed | Yes | Yes | Same as predicate |
| 21. | Dimension | 337 x 165 x 178 mm | 240 x 137 x 80 mm | Smaller and<br>therefore easier to<br>handle, but<br>equivalent in safety<br>and effectiveness. |
| 22. | Weight | 2.25 kg | 0.85 kg | Lighter and therefore<br>easier to carry, but<br>equivalent in safety<br>and effectiveness. |
| 23. | Trigger out for external<br>devices | Yes | Yes | Same as predicate |
| 24. | Digital input | Isolated | Isolated | Same as predicate |
| 25. | Patient isolation | BF | BF | Same as predicate |
| 26. | Safety standards | IEC60601-1<br>IEC60601-1-2 | IEC60601-1<br>IEC60601-1-2<br>IEC60601-2-40<br>ISO14971<br>IEC62304<br>IEC62366 | More standards<br>applied. |
| | | | | |
| 27. | System components | Stimulator<br>Switching array<br>Hand controller<br>Touchscreen Stylus<br>Power Supply<br>Portable carry case<br>Cable to switching array<br>Cable to manual probe | Stimulator with USB cable<br>Hand switch and foot switch<br>Portable carry case<br>1 x Trigger in cable<br>2 x Trigger out cable | g.Estim PRO doesnot provide a<br>switching array,<br>Touchscreen Stylus<br>and power supply,<br>additionally with<br>foot switch and<br>trigger cables.<br>Equivalent in safety<br>and effectiveness. |
| 28. | Firmware / software | Resident firmware | Resident firmware inside<br>g.Estim PRO<br>API/GUI on computer | Additional Front-end<br>driver to operate but<br>equivalent in safety<br>and effectiveness. |
| 29. | Log file | YES on device transferred<br>with USB flash stick | YES on computer | Not saved, on<br>device, but<br>equivalent in safety<br>and effectiveness. |
| 30. | Digital inputs/outputs | 1 external trigger input<br>(disabled)<br>1 train duration out<br>1 trigger out (pulse) | 1 trigger input (disabled)<br>1 pulse output<br>1 pulse output to trigger<br>external devices | Programmable<br>outputs but<br>equivalent in safety<br>and effectiveness. |
| 31. | Connectors, switches | 1 handheld controller<br>connector<br>1 handheld probe<br>connector<br>1 output connector to<br>switching unit<br>2 USB<br>1 external trigger input<br>1 train duration output<br>1 trigger out(pulse)<br>1 DC power in<br>1 Ethernet connector<br>1 on/off switch<br>1 HW all stop switch<br>1 HW stimulation switch | 1 hand/foot switch connector<br>2 safety sockets to connect<br>electrodes<br>1 USB connector<br>DIO - 1 input connector<br>DIO - 1 output connector 1<br>DIO - 1 output connector 2<br>2 battery housings<br>1 on/off switch | Different in output<br>for the switching<br>unit, reduced<br>connectivity with<br>one USB and no<br>Ethernet connector<br>and no HW-switches<br>, but equivalent in<br>safety and<br>effectiveness. |
| 32. | Impedance measurement | Yes | Yes | Same as predicate |
| 33. | Isolated power out | Yes | No | No isolated power<br>out but equal in<br>safety and<br>effectiveness. |
| 34. | Embedded controller | 1 | 2 | One additional to<br>ensure the equal<br>safety and<br>effectiveness. |

g.tec medical engineering GmbH, Siemingstrasse 14, 4521 Schiediberg, Austria, Europe,

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# g.tec medical engineering GmbH

g.tec medical engineering GmbH, Sierningstrasse 14, 4521 Schiediberg, Austria, Europe,

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# g.tec medical engineering GmbH

g.tec medical engineering GmbH, Sierningstrasse 14, 4521 Schiedlberg, Austria, Europe,

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#### 807.92(b)(1)

The stimulator was tested with a data acquisition device and provides rectangular stimulation pulses with the necessary frequency and amplitude range. Furthermore digital outputs were tested to provide trigger signals and digital inputs were tested to trigger the stimulation. The impedance measurement was tested with test impedances. The tests show that the stimulator works like the predicate device.

In g.Estim PRO medical safety is realized by isolating the applied part optically for data transmission via USB and by battery supply. The current for the impedance measurement is limited with resistors.

807.92(b)(2) Not applicable

#### 807.92(b)(3)

The conclusion is that g.Estim PRO and the predicate device provide electrical stimuli with varying pulse width, frequency and amplitude in the same way and that the stimulator is working substantial equivalent and as effective as the marketed device. g.Estim PRO is using battery supply and optical separated USB transmission and is therefore considered to be safe.