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.

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.

AI/ML Overview

Based on the provided text for the g.Estim PRO, here's a description of the acceptance criteria and the study proving the device meets them:

Disclaimer: This device, "g.Estim PRO," is a cortical stimulator, not an AI-powered diagnostic device. Therefore, many of the typical acceptance criteria and study aspects related to AI (e.g., ground truth establishment for AI, MRMC studies, training/test sets for AI, effect size of human reader improvement with AI) are not applicable to this submission. The provided text describes a traditional medical device submission focused on demonstrating substantial equivalence to a predicate device primarily through technical specifications, safety, and functionality.

Acceptance Criteria and Device Performance for g.Estim PRO

This submission demonstrates substantial equivalence to a predicate device (Chatten Associates S12X, K082629). The "acceptance criteria" for this type of submission are implicitly tied to demonstrating that the new device is as safe and effective as the predicate, despite minor differences. The performance is assessed by comparing technical specifications and functionalities.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) Summary includes a comparative table (Section 807.92(a)(6)) that serves as the basis for demonstrating substantial equivalence. The "acceptance criteria" are the features and performance parameters of the predicate device, and the "reported device performance" are the corresponding features and parameters of the g.Estim PRO.

Item	Implied Acceptance Criteria (Predicate: Chatten Associates S12X)	Reported Device Performance (g.tec medical engineering GmbH: g.Estim PRO)	Comments (Rationale for Equivalence)
1. Intended Use	For intraoperative cortical stimulation mapping to aid in cortical resections in the vicinity of essential cortex.	For functional brain mapping via electrical stimulation prior to cortical resections in the vicinity of essential cortex.	Reduced intended use (no switching unit) but equivalent in safety and effectiveness.
2. User	Medically trained and qualified personnel in medical environment.	Medically trained and qualified personnel in medical environment.	Same as predicate.
3. Current Type	Constant current bi-phasic, rectangular.	Constant current, bi-phasic, rectangular.	Same as predicate.
4. Maximum Stimulation Charge	20 μC	15 μC	Lower limit for additional safety, but equivalent in effectiveness.
5. Pulse Polarity	Selectable (positive, negative, alternating).	Selectable (positive, negative, alternating).	Same as predicate.
6. Train Duration	0.2 to 20 sec in 7 steps.	0.1 to 20 sec.	Shorter minimum train duration but equivalent in safety and effectiveness.
7. Pulse Amplitude	0.2 - 15 mA (peak), constant current, 17 steps.	0.05 - 15 mA (peak), constant current, 0.01 mA increments.	Allows lower start value, lower increments, but equivalent in safety and effectiveness.
8. Stimulation Frequency	2 - 100 Hz in 7 steps.	2-100 Hz, 0.1 Hz steps.	Same frequency range and smaller increments for more flexibility, but equivalent in safety and effectiveness.
9. Stimulation Pulse Duration	0.1 - 1.0 ms per phase (15 mA max); up to 2 ms per phase (10 mA max).	0.1 ms - 1 ms per phase.	1 ms is long enough to achieve necessary stimulation, but equivalent in safety and effectiveness.
10. Max. Transient Voltage	34V, Zener Diode for hardware safety.	80V, lead off via software for safety.	Higher voltage for smaller electrode sizes but equivalent in safety and effectiveness.
11. Power Supply	12V DC, External medical power supply.	Battery, 2 x 9 V.	Battery supply to reduce risk and noise.
12. Electrode Size	Warning that electrodes with less than 4 sq mm can cause tissue damage.	Electrode size defines the safety threshold for stimulation parameters; device calculates max. stimulation current depending on electrode size.	Safe also with smaller electrode size due to calculation, equivalent in safety and effectiveness.
13. Supported Electrodes	Strip, grids, handheld probe.	Strip, grids, handheld probe.	Same as predicate.
14. Stimulus Switching Unit	Yes.	No.	Just a cortical stimulator for 1 bipolar channel, but equivalent in safety and effectiveness.
15. Use Standard Sensors and Electrodes	Electrodes are not included.	Electrodes are not included.	Same as predicate.
16. User Input	Stylus (touch), standard mouse.	Standard computer.	Standard computer, but equivalent in safety and effectiveness.
17. Graphical User Interface	LCD.	LCD display of computer.	Same as predicate.
18. Simulator Parameters Setting	Through displayed controls.	Through displayed controls.	Same as predicate.
19. Active Stimulation LED	Yes.	Yes.	Same as predicate.
20. Actual Current Delivered Displayed	Yes.	Yes.	Same as predicate.
21. Dimension	337 x 165 x 178 mm.	240 x 137 x 80 mm.	Smaller and easier to handle, but equivalent in safety and effectiveness.
22. Weight	2.25 kg.	0.85 kg.	Lighter and easier to carry, but equivalent in safety and effectiveness.
23. Trigger out for external 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, IEC60601-1-2.	IEC60601-1, IEC60601-1-2, IEC60601-2-40, ISO14971, IEC62304, IEC62366.	More standards applied.
27. System Components	Stimulator, Switching array, Hand controller, Touchscreen Stylus, Power Supply, Portable carry case, Cables.	Stimulator with USB cable, Hand switch and foot switch, Portable carry case, Trigger in/out cables.	g.Estim PRO does not provide a switching array, Touchscreen Stylus and power supply, but adds foot switch and trigger cables. Equivalent in safety and effectiveness.
28. Firmware / Software	Resident firmware.	Resident firmware inside g.Estim PRO, API/GUI on computer.	Additional Front-end driver to operate but equivalent in safety and effectiveness.
29. Log file	YES on device transferred with USB flash stick.	YES on computer.	Not saved on device, but equivalent in safety and effectiveness.
30. Digital inputs/outputs	1 external trigger input (disabled), 1 train duration out, 1 trigger out (pulse).	1 trigger input (disabled), 1 pulse output, 1 pulse output to trigger external devices.	Programmable outputs but equivalent in safety and effectiveness.
31. Connectors, switches	Various (handheld controller/probe, output to switching unit, USB, Ethernet, HW switches).	Hand/foot switch connector, safety sockets, USB, DIO in/out, battery housings, on/off switch.	Different connectivity (e.g., no switching unit output, no Ethernet, no HW-switches), but equivalent in safety and effectiveness.
32. Impedance Measurement	Yes.	Yes.	Same as predicate.
33. Isolated Power Out	Yes.	No.	No isolated power out but equal in safety and effectiveness.
34. Embedded Controller	1.	2.	One additional to ensure equal safety and effectiveness.

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

For this traditional medical device submission, there isn't an "AI test set" in the sense of a dataset of patient images or physiological signals. The "test set" consists of the physical device and its components, which were subjected to various engineering tests to verify their functionality and safety according to defined specifications and standards.

Sample Size: The sample size for testing would typically be a specific number of manufactured units of the g.Estim PRO device. The text does not specify the exact number of units tested, but it is implied that a sufficient number were tested to demonstrate reliable performance.
Data Provenance: The tests are performed in a laboratory/engineering environment. The "data" provenance refers to the results of these technical and safety tests. The device manufacturer, g.tec medical engineering GmbH, is based in Austria (Europe). The tests would have been conducted by the manufacturer or accredited testing facilities. The data is prospective, generated specifically for this submission.

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

This is not applicable as the submission is for a medical device (cortical stimulator), not an AI diagnostic tool requiring ground truth established by medical experts on patient data. The "ground truth" for this type of device is its adherence to engineering specifications, safety standards, and functional requirements, which are verified through technical measurements and testing. This is typically done by qualified engineers and technicians.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for a non-AI medical device testing, as there are no interpretations of medical images/data that require adjudication. Functional and safety tests have pass/fail criteria.

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. This is not an AI-powered device, and it does not involve human readers interpreting medical cases.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device, not an algorithm. Its performance is inherent to its physical and software functionality. The text states:

"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."

These describe standalone functional tests of the device's hardware and integrated software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device is primarily the predefined engineering specifications, functional requirements, and relevant safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-40, ISO 14971, IEC 62304, IEC 62366). The device's performance is verified against these objective, measurable criteria.

8. The sample size for the training set

Not applicable. This is not an AI device trained on a dataset.

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

Not applicable. There is no AI training set for this device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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 GmbHSierningstrasse 144521 SchiedlbergAustria
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(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 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.: +43 7251 22240, Fax: +43 7251 22240-39, office@gtec.at, www.gtec.at

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g.tec medical engineering GmbH

807.92(a)(6)

	Item	Chatten AssociatesS12XK082629	g.tec medicalengineering GmbHg.Estim PROThis Submission	Comments
1.	Intended use	The S12X Corticalstimulator is intended forIntraoperative corticalstimulation mapping to aidin cortical resections in thevicinity of essentialcortex.The ESAx option isintended for use with theS1 2X for facilitating theswitching of the patientelectrodes.	The g.Estim PRO is intendedfor functional brain mappingvia electrical stimulation priorto cortical resections in thevicinity of essential cortex.	Reduced intendedused, no switchingunit option realized,but equivalent insafety andeffectiveness
2.	User	The device is intended foruse only by medicallytrained and qualifiedpersonnel, with a hospitalor medical environment.	The device must be used bymedically trained and qualifiedpersonnel within a medicalenvironment.	Same as predicate
3.	Constant type	Constant current bi-phasic, rectangular	Constant current, bi-phasic,rectangular	Same as predicate
4.	Maximum stimulation charge	20 μC	15 μC	Lower limit foradditional safety butequivalent ineffectiveness.
5.	Pulse polarity	Selectable, positive,negative or alternatingstimulus polarity onsuccessive pulses	Selectable, positive, negativeor alternating stimulus polarityon successive pulses	Same as predicate
6.	Train duration	0.2 to 20 sec in 7 steps	0.1 to 20 sec.	Shorter minimumtrain duration butequivalent in safetyand effectiveness.
7.	Pulse amplitude	0.2 - 15 mA (peak),constant current, 17 steps	0.05 - 15 mA (peak), constantcurrent, 0.01 mA increments	Allows lower startvalue, lowerincrements, butequivalent in safetyand effectiveness.
8.	Stimulation frequency	2 - 100 Hz in 7 steps	2-100 Hz, 0,1 Hz steps	Same frequencyrange and smallerincrements for moreflexibility, butequivalent in safetyand effectiveness.
9.	Stimulation pulse duration	0.1 - 1.0 ms per phase (15mA max); up to 2 ms perphase (10 mA max)	0.1 ms - 1 ms per phase	1 ms is long enoughto achieve thenecessarystimulation, butequivalent in safetyand effectiveness.
10.	Max. transient voltage	34V, Zener Diode forhardware safety	80V, lead off via software forsafety	Higher voltage forsmaller electrodesizes but equivalent
				in safety andeffectiveness.
11.	Power supply	12V DC, External medicalpower supply	Battery, 2 x 9 V	Battery supply toreduce risk andnoise.
12.	Electrode size	Warning that electrodeswith less than 4 sq mmcan cause tissue damage.	Electrode size defines thesafety threshold for stimulationparameters.	The g.Estim PRO issafe also withsmaller electrodesize, because thestimulator calculatesthe maximumstimulation currentdepending onelectrode size. Soequivalent in safetyand effectiveness.
13.	Supported electrodes	Strip, grids, handheldprobe	Strip, grids, handheld probe	Same as predicate
14.	Stimulus switching unit	Yes	No	Just a corticalstimulator for 1bipolar channel, butequivalent in safetyand effectiveness.
15.	Use standard sensors andelectrodes	Electrodes are notincluded	Electrodes are not included	Same as predicate
16.	User input	Stylus (touch), standardmouse	Standard computer	Standard computer,but equivalent insafety andeffectiveness.
17.	Graphical user interface	LCD	LCD display of computer	Same as predicate
18.	Simulator parameters setting	Through displayedcontrols	Through displayed controls	Same as predicate
19.	Active stimulation LED	Yes	Yes	Same as predicate
20.	Actual current delivereddisplayed	Yes	Yes	Same as predicate
21.	Dimension	337 x 165 x 178 mm	240 x 137 x 80 mm	Smaller andtherefore easier tohandle, butequivalent in safetyand effectiveness.
22.	Weight	2.25 kg	0.85 kg	Lighter and thereforeeasier to carry, butequivalent in safetyand effectiveness.
23.	Trigger out for externaldevices	Yes	Yes	Same as predicate
24.	Digital input	Isolated	Isolated	Same as predicate
25.	Patient isolation	BF	BF	Same as predicate
26.	Safety standards	IEC60601-1IEC60601-1-2	IEC60601-1IEC60601-1-2IEC60601-2-40ISO14971IEC62304IEC62366	More standardsapplied.

27.	System components	StimulatorSwitching arrayHand controllerTouchscreen StylusPower SupplyPortable carry caseCable to switching arrayCable to manual probe	Stimulator with USB cableHand switch and foot switchPortable carry case1 x Trigger in cable2 x Trigger out cable	g.Estim PRO doesnot provide aswitching array,Touchscreen Stylusand power supply,additionally withfoot switch andtrigger cables.Equivalent in safetyand effectiveness.
28.	Firmware / software	Resident firmware	Resident firmware insideg.Estim PROAPI/GUI on computer	Additional Front-enddriver to operate butequivalent in safetyand effectiveness.
29.	Log file	YES on device transferredwith USB flash stick	YES on computer	Not saved, ondevice, butequivalent in safetyand effectiveness.
30.	Digital inputs/outputs	1 external trigger input(disabled)1 train duration out1 trigger out (pulse)	1 trigger input (disabled)1 pulse output1 pulse output to triggerexternal devices	Programmableoutputs butequivalent in safetyand effectiveness.
31.	Connectors, switches	1 handheld controllerconnector1 handheld probeconnector1 output connector toswitching unit2 USB1 external trigger input1 train duration output1 trigger out(pulse)1 DC power in1 Ethernet connector1 on/off switch1 HW all stop switch1 HW stimulation switch	1 hand/foot switch connector2 safety sockets to connectelectrodes1 USB connectorDIO - 1 input connectorDIO - 1 output connector 1DIO - 1 output connector 22 battery housings1 on/off switch	Different in outputfor the switchingunit, reducedconnectivity withone USB and noEthernet connectorand no HW-switches, but equivalent insafety andeffectiveness.
32.	Impedance measurement	Yes	Yes	Same as predicate
33.	Isolated power out	Yes	No	No isolated powerout but equal insafety andeffectiveness.
34.	Embedded controller	1	2	One additional toensure the equalsafety andeffectiveness.

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.

Regulation Number and Section

§ 882.1310 Cortical electrode.

(a)
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.(b)
Classification. Class II (performance standards).