cortiQ PRO

K191432 · G.Tec Medical Engineering GmbH · OLU · Jan 24, 2020 · Neurology

Device Facts

• Record ID: K191432
• Device Name: cortiQ PRO
• Applicant: G.Tec Medical Engineering GmbH
• Product Code: OLU · Neurology
• Decision Date: Jan 24, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

The system is intended to statistically evaluate brain activity reflected in a broad band of high-gamma frequencies in the human electroencephalogram (EEG). These measures should always be interpreted in conjunction with review of the original EEG waveform. cortiQ PRO is intended for the evaluation of intracranial EEG recorded with the g.Hlamp.

Device Story

System maps high-gamma broad band brain activity during experimental paradigms; inputs intracranial EEG signals from g.Hlamp amplifier (up to 256 channels) via USB. Software performs real-time signal analysis, comparing high-gamma activity between task intervals using statistical tests; identifies and visualizes significant electrode positions as bubbles on a grid. Used in clinical settings by neurologists/neurosurgeons; requires training. Output includes mapping reports (PDF) and real-time visualization. Assists clinicians in identifying important cortical regions for surgical planning; provides objective statistical evaluation of brain activity to supplement visual EEG review.

Clinical Evidence

Bench testing only. System validated using real ECoG data and artificial noisy sinusoidal waveforms to confirm correct mapping of gamma activity differences to electrode channels. Usability validation performed with N=15 participants (neuroscientists, neurosurgeons, neurologists) using simulated use testing; results confirmed system meets usability requirements at an acceptable risk level.

Technological Characteristics

System includes g.Hlamp amplifier (24-bit SAR A/D, >100 MOhm input impedance, CF-type applied part), PC, and cortiQ PRO software. Connectivity via USB. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26, ISO 14971, IEC 62304, IEC 62366. Signal processing uses Auto Regressive (AR) model for power spectrum estimation. Software requires hardlock USB dongle.

Indications for Use

Indicated for the evaluation of intracranial EEG in patients eligible for brain surgery (e.g., epilepsy, tumor). Intended for use by medical experts (neurologists, neurosurgeons) or neuroscience specialists. Contraindicated for use on the heart, determination of brain death, during defibrillation, in patients with pacemakers/electrical stimulators, or for EMG/EOG/ECG. Not for use in patients non-compliant with procedures due to age or cognitive function.

Regulatory Classification

Identification

An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

Predicate Devices

• NeuroGuide Analysis System (K041263)
• g.Hlamp (K123255)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

g.tec medical engineering GmbH Christoph Guger CEO Sierningerstrasse 14 4521 Schiedlberg, Austria

# Re: K191432

Trade/Device Name: cortiQ PRO Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLU, GWL, OLT Dated: December 18, 2019 Received: December 23, 2019

Dear Christoph Guger:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 (reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K191432

Device Name cortiQ PRO

Indications for Use (Describe)

The system is intended to statistically evaluate brain activity reflected in a broad band of high-gamma frequencies in the human electroencephalogram (EEG). These measures should always be interpreted in conjunction with review of the original EEG waveform.

cortiQ PRO is intended for the evaluation of intracranial EEG recorded with the g.Hlamp.

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

| <span style="font-family: Arial;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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# 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<br>GmbH Sierningstrasse 14<br>4521 Schiedlberg<br>Austria | | |
| Phone:<br>Fax:<br>Contact Person:<br>Date: | ++43 (7251) 22240-12<br>++43 (7251) 22240-39<br>Christoph Guger<br>May 24, 2019 | |
| 807.92(a)(2) | | |
| Trade Name: | cortiQ PRO | |
| Common Name: | Normalizing quantitative electroencephalograph software<br>Amplifier, physiological signal | |
| Classification name: | Electroencephalograph<br>21 CFR section 882.1400 | |
| Product Code: | OLU, OLT, GWL | |
| 807.92(a)(3) | Predicate Device(s) | |
| K#<br>Trade/Device Name<br>Regulation Number<br>Regulation Name<br>Regulatory Class<br>Product Code<br>Date<br>Received<br>Aspect | K041263 (primary predicate)<br>NeuroGuide Analysis System<br>21 CFR 882.1400<br>Electroencephalograph<br>Class II<br>OLU<br>July 20,2004<br>July 22,2004<br>Signal analysis and statistical processing<br>of data | K123255 (secondary predicate)<br>g.Hlamp<br>21 CFR 882.1835<br>Physiological signal amplifier<br>Class II<br>GWL<br>October 10, 2012<br>October 18, 2012<br>Recording of EEG data and providing it to<br>the signal processing via an application |

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807.92(a)(4)

#### Device Description

cortiQ PRO is a system that uses g.Hlamp to map high-gamma broad band brain activity while running an experimental paradigm. The software helps to identify electrode positions coding differences in brain activity by means of experimental paradigm. cortiQ PRO performs the signal analysis in real-time and compares the highgamma broad band activity during specific tasks. Then it performs a statistical analysis and visualizes electrodes coding the information that are statistically significant. It is abstracted from technical details of data acquisition, channel order and signal processing assuring robust and efficient measurements.

cortiQ PRO reads in the digital data from the g.Hlamp amplification system (1200 Hz sampling frequency, up to 256 channels) via USB into the processing computer. The data is acquired without bandpass and notch filtering and without bipolar derivation. The software allows one to select the channels that should be acquired and stores the raw data together with header information for later off-line analysis.

Raw data is visualized on a raw data scope to inspect the data quality. The scope allows scaling of the data in amplitude and time. Furthermore the software allows scaling of all the channels to the same amplitude to make the interpretation easier. In the scope, it is possible to select a new ground and reference channel and to exclude a channel from the processing (if the data quality is bad). The raw data scope filters the data with a high-pass filter to remove DC-offsets for optimal visualization.

cortiQ PRO allows the operator to select an experimental paradigm that instructs the patient to perform certain tasks. The instructions are presented on a patient computer screen or are given via a speaker. The user can select, start and terminate the experimental paradigm. Additionally, the number of repetitions can be selected. A dedicated paradigm editor creates new paradigm files or modifies existing paradigms.

The rapid cortical mapping functions perform a common average reference (CAR) of all the active channels to remove common mode signals such as power line interference. Then the module calculates the high-gamma activity in certain frequency ranges for the different tasks and compares the high-gamma activity to those of another task according to the selected paradigm. Then a statistical analysis is performed and significant activation is plotted as bubble on the defined electrode position in order to identify important regions. When the mapping has ended, cortiQ PRO automatically generates a mapping report containing the montage definition, the paradigm definition, and the mapping results. This report is stored as pdf and can be printed. The mapping result is also stored for later analysis.

cortiQ PRO allows the operator to define montage definition files in the montage creator by loading predefined electrode grids from different manufacturers. Each grid has a certain number of channels. The montage creator allows the operator to assign a patient's name and date of birth, and a montage name to each file. Furthermore, it allows the operator to assign a grid name to each electrode grid. The grids can be placed on different background images to make the location interpretation easier. Electrodes from a grid can be disabled, used as reference or as ground electrodes. The grids can be resized or rotated. The montage creator assigns also the electrode grids automatically to the amplifier inputs channels and creates a report with the channel definition. The results can be stored to be modified later. The report is stored as pdf and can be printed.

cortiQ PRO comes with an installs the software under Windows. A hardlock is required to start the mapping software.

The mapping system comes with Instructions for use and a training program.

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807.92(1)(5)

#### Intended Use(s)

The system is intended to statistically evaluate brain activity reflected in a broad band of high-gamma frequencies in the human electroencephalogram (EEG). These measures should always be interpreted in conjunction with review of the original EEG waveform.

cortiQ PRO is intended for the evaluation of intracranial EEG recorded with the g.HIamp.

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#### g.tec medical engineering GmbH

## 807.92(a)(6)

# Technological Characteristics

System relevant comparison characteristics between cortiQ PRO system and the two predicates g.Hlamp and NeuroGuide Analysis System: Table I

| Table 1 | Item | cortiQ PRO | g.Hlamp<br>K123255 | NeuroGuide Analysis System<br>(NeuroGuide Base, NeuroStat,<br>Neurofeedback) K041263 | Comment |
|---------|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Intended Use | The system is intended to statistically evaluate brain<br>activity reflected in a broad band of high-gamma<br>frequencies in the human electroencephalogram (EEG).<br>These measures should always be interpreted in<br>conjunction with review of the original EEG<br>waveform.<br>cortiQ PRO is intended for the evaluation of<br>intracranial EEG recorded with the g.Hlamp. | The g.Hlamp amplifier is intended to be used to<br>acquire biopotentials and transmit them to a computer<br>via the USB port connection. These biopotentials<br>include for example electroencephalogram (EEG),<br>electromyogram (EMG), electrooculogram (EOG),<br>and electrocardiogram (ECG). | For clinical use the NeuroGuide Analysis<br>system is to be used by qualified medical or<br>clinical professionals for the statistical<br>evaluation of the human<br>electroencephalogram (EEG) | cortiQ PRO combines<br>both intended uses and<br>limits it to the statistical<br>evaluation of brain<br>activity and is therefore<br>equivalent in safety and<br>effectiveness. |
| 2. | Contraindication /<br>Limitations | • The device must not be used directly on the heart.<br>• The device must not be used for the determination of<br>brain death. Additional examinations are needed for<br>diagnosis and no diagnosis may be done only based<br>on using this device.<br>• The device must not be used during defibrillation.<br>Remove all electrodes and probes from the patient<br>before defibrillation, otherwise the operator may<br>receive an electrical shock or the connected<br>instrument may be damaged.<br>• The device must not be used in humans with pace-<br>makers or electrical stimulators<br>• Must not be used for electromyography (EMG),<br>electrooculography<br>(EOG), electrocardiography<br>(ECG)<br>• The device must be used either by a medical expert,<br>such as a medical doctor with expertise in the field of<br>neurology or neurosurgery, or by a medical technical<br>expert such as neuroscience specialists. A user is<br>only eligible to operate the device after completed<br>device training.<br>• The device must not be used when a patient is non-<br>compliant to planned procedures due to age,<br>cognitive function, or cognitive development stage.<br>Such procedures might depend on the active<br>cooperation of the patient and/or a sufficiently<br>developed brain, and/or other aspects. Generally | • The device must not be used directly on the heart.<br>• The device must not be used for the determination<br>of brain death. Additional examinations are needed<br>for diagnosis and no diagnosis may be done only<br>based on using this device.<br>• The device is not protected against the effect of<br>cardiac defibrillator discharge<br>• The device must not be used in humans with pace-<br>makers or electrical stimulators | Only for qualified medical clinical<br>professionals. | cortiQ PRO shows<br>additional limitations<br>and contraindications<br>but is equivalent in<br>safety and<br>effectiveness. |
| | | | | | |
| | | patients that are eligible for brain surgery in general<br>and the individual type of surgery (e.g. epilepsy,<br>tumor, or similar) in particular are also eligible for<br>the usage of this device. In the individual case the<br>responsible surgeon has to decide upon the<br>procedures and the usage of the device.<br>• The device must not be used for diagnosis without<br>validation by another modality.<br>The device must not be used for patient monitoring. | | | |
| 3. | System components | • g.Hlamp including:<br>- amplifier<br>- AC/DC adapter<br>- USB cable<br>- 1-4 electrode connector boxes.<br>- driver software<br>• personal computer inclusive speakers and monitor<br>• additional monitor including USB cable<br>• cortiQ PRO software<br>• hardlock USB dongle | • g.Hlamp including:<br>- amplifier<br>- AC/DC adapter<br>- USB cable<br>- 1-4 electrode connector boxes.<br>- driver software | • software<br>• personal computer<br>• amplifier<br>• additional monitor | cortiQ PRO includes<br>also a processing<br>computer and screen<br>for paradigm<br>presentation, but is<br>equivalent in safety and<br>effectiveness. |
| 4. | Safety standards | IEC60601-1<br>IEC60601-1-2<br>IEC60601-2-26<br>ISO 14971<br>IEC 62304<br>IEC 62366 | IEC60601-1<br>IEC60601-1-2<br>IEC60601-2-26<br>IEC60601-2-40<br>MDD 93/42/EEC<br>IEC60601-1-4<br>ISO 14971<br>IEC 62304 | No remark in 510k summary or instruction for<br>use | cortiQ PRO covers the<br>required standards to<br>ensure equivalence in<br>safety and<br>effectiveness. |
| 5 | Dimensions | • standard personal computer<br>• g.Hlamp:197 (L) x 197 (W) x 90 (H) mm<br>• additional monitor | 197 (L) x 197 (W) x 90 (H) mm | • personal computer<br>• amplifier<br>• additional monitor | cortiQ PRO is<br>equivalent in safety and<br>effectiveness. |
| 6. | Weight | • g.Hlamp 1.875kg<br>• personal computer<br>• additional monitor | 1.875kg | • personal computer<br>• amplifier<br>• additional monitor | cortiQ PRO is<br>equivalent in safety and<br>effectiveness. |
| 7. | Software/ Firmware | Firmware resident on g.Hlamp, g.Hlamp API on<br>personal computer, cortiQ software on personal<br>computer. | Firmware resident on g.Hlamp, g.Hlamp API on<br>personal computer, | Only software on personal computer | cortiQ PRO uses both<br>resident firmware and<br>software components<br>but is equivalent in<br>safety and<br>effectiveness. |
| 8 | User interface | GUI | g.Hlamp API | GUI | cortiQ PRO uses a<br>graphical user interface<br>(GUI) and is therefore<br>equivalent in safety and<br>effectiveness. |

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#### cortiQ PRO 510(k) Premarket Notification

## g.tec medical engineering GmbH

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Comparison between cortiQ PRO and g.HIamp characteristics for data acquisition:

| Table II | |
|----------|--|
|----------|--|

| | Item | cortiQ PRO | g.Hlamp<br>K123255 | Comment |
|-----|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| 9. | EEG/Polygraphic<br>channels | 80-256 monopolar | 80-256 monopolar | Same as predicate. |
| 10. | DC channel | 80-256 | 80-256 | Same as predicate. |
| 11. | Full scale input<br>range | ± 250 mV | ± 250 mV | Same as predicate. |
| 12. | A/D conversion | 24 Bit SAR | 24 Bit SAR | Same as predicate. |
| 13. | Sampling rate | User selectable (256, ... up to 38400<br>Hz/channel) predefined in setting<br>1200 Hz | User selectable (256, ... up to 38400<br>Hz/channel) | Preselected for cortiQ<br>PRO system but<br>equivalent in safety and<br>effectiveness. |
| 14. | Noise | <0.5 µV RMS, <2 µV peak-to-peak | <0.5 µV RMS, <2 µV peak-to-peak | Same as predicate. |
| 15. | Power Supply | External IEC 601-1 mains adapter, 5V<br>DC | External IEC 601-1 mains adapter, 5V<br>DC | Same as predicate. |
| 16. | Internal Storage | N/A<br>Optional on PC HDD | N/A | cortiQ PRO allows<br>signal data storage on<br>the controlling computer<br>but is equivalent in<br>safety and effectiveness. |
| 17. | Amplifier-PC<br>Interface | USB | USB | Same as predicate. |
| 18. | Other Interfaces | Power on LED | Power on LED | Same as predicate. |
| 19. | Use standard sensors<br>and electrodes | Yes (electrodes and sensors are not<br>included with the amplifier) | Yes (electrodes and sensors are not<br>included with the amplifier) | Same as predicate. |
| 20. | Isolation | Opto coupler, patient isolation CF<br>type | Opto coupler, patient isolation CF<br>type | Same as predicate. |
| 21. | Digital<br>inputs/outputs | 16 inputs, all patient separated, no<br>outputs | 16 inputs, all patient separated, no<br>outputs | Same as predicate. |
| 22. | Patient connection<br>and device inputs | 80-256 monopolar inputs - 80-256<br>plugs<br>4 ground inputs - 4 plugs<br>USB - 1 connector<br>DIGITAL IN - 2 connectors<br>HOLD - 1 connector<br>1 x USB - screen<br>1 x USB - hardlock | 80-256 monopolar inputs - 80-256<br>plugs<br>4 ground inputs - 4 plugs<br>USB - 1 connector<br>DIGITAL IN - 2 connectors<br>HOLD - 1 connector | Additional connectors of<br>personal computer in the<br>cortiQ PRO system but<br>equivalent in safety and<br>effectiveness. |
| 23. | Type of applied part | CF | CF | Same as predicate. |
| 24. | Impedance<br>measurement | Possible on hardware but disable in<br>software. | Performed with 10 Hz | No impedance<br>measurement in cortiQ<br>PRO but equivalent in<br>safety and effectiveness. |
| 25. | Input impedance | >100 MOhm | >100 MOhm | Same as predicate. |
| 26. | Filters in the<br>amplifier | DC up to 2000 Hz (depending on<br>sampling frequency). DC used in<br>preset. | DC up to 2000 Hz (depending on<br>sampling frequency) | cortiQ PRO records data<br>without applied<br>hardware filter but is<br>equivalent in safety and<br>effectiveness. |
| 27. | Frequency response | Linear between 0.1 and 170 Hz | Linear between 0.1 and 100 Hz | Same as predicate. |

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Comparison between cortiQ PRO and NeuroStat characteristics for statistical analysis: Table III

| | Item | cortiQ PRO | NeuroGuide Analysis System<br>(NeuroStat)<br>K 041263 | Comment |
|-----|----------------------------------------|------------------------------------------------------|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| 28. | Signal processing | Real-time | Post-hoc | cortiQ PRO performs the<br>analysis in real-time but is<br>equivalent in safety and<br>effectiveness. |
| 29. | Signal source | g.Hlamp API | Imported from a data-file | The cortiQ PRO directly gets<br>data from the g.Hlamp API so<br>it increases the effectiveness<br>but is equivalent in safety. |
| 30. | Band power<br>estimation | Auto regressive model for power<br>spectrum (AR) | Fast Fourier transformation (FFT)<br>for power spectrum | cortiQ PRO uses an AR model<br>for optimized data processing<br>but is equivalent in safety and<br>effectiveness. |
| 31. | Statistical analysis | Parametric statistical test with R2<br>output metric | ANOVA (Analysis of variances) | cortiQ PRO uses R2 values for<br>statistical analysis and<br>NeuroStat ANOVA but is<br>equivalent in safety and<br>effectiveness. |
| 32. | Analysis output | R2 value for each channel | p-value for each channel | cortiQ PRO uses R2 values as<br>output of analysis and<br>NeuroStat p-values but is<br>equivalent in safety and<br>effectiveness. |
| 33. | Visualization | Topographical mapping | Topographical mapping | Same as predicate |
| 34. | Comparison of data<br>segments | Comparison of baseline with task<br>related data | Pre- and post-treatment data | cortiQ PRO performs the<br>comparison within the same<br>measurement but is safer and<br>equivalent<br>in effectiveness. |
| 35. | Type of comparison | In-person comparison | In-person comparison, or group<br>comparison | cortiQ PRO only provides in-<br>person comparison but is<br>equivalent in safety and<br>effectiveness. |
| 36. | Acceptance or reject<br>of the results | Dependent upon the judgement<br>of the clinician | Dependent upon the judgement of<br>the clinician | Same as predicate. |

# Comparison between cortiQ PRO and Neurofeedback add-on characteristics for patient interaction: Table IV

| | Item | cortiQ PRO | NeuroGuide Analysis System<br>(Neurofeedback)<br>K 041263 | Comment |
|-----|-----------------------------------------------------|--------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| 37. | Visual feedback or<br>interaction with<br>patient | via additional monitor and<br>paradigm presenter | via additional monitor and paradigm<br>presenter | Same as predicate |
| 38. | Auditory feedback or<br>interaction with<br>patient | via personal computer speakers<br>and player | via personal computer speakers and<br>player | Same as predicate |
| 39. | Session setup | Paradigm editor for session<br>setup. | Editor for session setup. | Same as predicate |
| 40. | Number of runs | Freely adjustable | Freely adjustable | Same as predicate |
| 41. | Run duration | Freely adjustable with limitation<br>warning. | Freely adjustable | cortiQ PRO informs user when<br>limits are underwent but is<br>equivalent in safety and<br>effectiveness. |

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807.92(b)(1)

cortiQ PRO was subject to safety and performance testing procedures. cortiQ PRO was tested with several real electrocorticographic (ECoG) and artificial test signals. While ECoG data contain task-related differences in the high-gamma frequency band, the artificial test data consists of dedicated noisy sinusoidal waveforms in the gamma range with lower amplitude in the task baseline interval (represents subject at pause) and higher amplitude in the action interval (represents subject doing a task) on all channels. The testing showed that the difference in gamma activity can be correctly mapped to correct electrode channels.

The testing showed that the system cortiQ PRO works like the predicate devices. In cortiQ PRO the medical safety is realized by using the g.Hlamp which is powered by a medical grade power supply unit and provides isolated input and outputs for communication as well as appropriate isolated applied parts for the treatment.

Usability validation testing was performed in N=15 participants from the intended user group (neuroscientists, neurosurgeons, and neurologists). Participants in the usability validation testing performed simulated use testing following the specified device training program. The results of the usability testing demonstrate that the cortiO PRO system (including the control software) meets all specified usability requirements at an acceptable risk level.

Testing of the cortiQ PRO was performed in compliance with the g.tec design control process.

807.92(b)(2)

Not applicable

807.92(b)(3)

Based on the comparison in the technical comparison chart above and confirmed by verification/validation testing in compliance with design control requirements, cortiQ PRO was shown to be equivalent in safety and effectiveness to the predicate devices.