(240 days)
Not Found
No
The description focuses on statistical analysis and signal processing techniques (common average reference, high-gamma calculation, statistical analysis) rather than AI/ML algorithms. There is no mention of training data, models, or learning processes.
No.
The device is intended to statistically evaluate brain activity and identify electrode positions related to brain activity, not to treat a condition or disease.
Yes
The device is intended for the "evaluation of intracranial EEG" to "statistically evaluate brain activity" and "identify electrode positions coding differences in brain activity." This indicates its use in assessing and understanding physiological conditions, which falls under the definition of a diagnostic device. While it maps and visualizes data, the ultimate purpose is to provide information for evaluation, which is a diagnostic function.
No
The device description explicitly states that cortiQ PRO is a system that uses g.Hlamp to map brain activity. It also mentions that cortiQ PRO reads digital data from the g.Hlamp amplification system via USB. This indicates that the device is not solely software, but relies on and integrates with a specific hardware component (g.Hlamp) for data acquisition. The predicate devices also include a hardware component (g.Hlamp).
Based on the provided information, it is highly likely that this device is an IVD (In Vitro Diagnostic). Here's why:
- 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)." While EEG is typically considered an in vivo measurement, the evaluation and statistical analysis of this data to identify differences in brain activity based on experimental paradigms strongly suggests it's being used to provide information about a physiological state or condition.
- Device Description: The device performs "signal analysis in real-time," "compares the high-gamma broad band activity during specific tasks," and performs "a statistical analysis" to identify "statistically significant" differences. This processing and analysis of biological signals (EEG) to provide information for medical purposes aligns with the definition of an IVD.
- Testing: The testing involved analyzing "real electrocorticographic (ECoG) and artificial test signals" to determine if "the difference in gamma activity can be correctly mapped to correct electrode channels." This testing focuses on the analytical performance of the device in processing and interpreting biological signals.
- Predicate Devices: One of the predicate devices listed is "K041263 NeuroGuide Analysis System." While I don't have the details of this specific predicate, the name "Analysis System" further supports the idea that this type of device, which analyzes neurophysiological data, is often classified as an IVD.
However, there's a nuance:
The definition of an IVD typically involves testing specimens derived from the human body. EEG is a measurement of electrical activity from the body, not a specimen derived from the body in the same way as blood, urine, or tissue.
Despite this nuance, the overall function and intended use of the cortiQ PRO system, which is to analyze and statistically evaluate biological signals (EEG) to provide information about brain activity for medical interpretation, strongly points towards it being classified as an IVD. Regulatory bodies often interpret the scope of IVDs to include devices that analyze biological signals to provide diagnostic or prognostic information.
In conclusion, while the input is an in vivo measurement (EEG), the device's function of analyzing and statistically evaluating this biological data to provide information for medical interpretation makes it highly likely to be considered an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
OLU, GWL, OLT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Electroencephalogram (EEG)
Anatomical Site
Brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical expert, such as a medical doctor with expertise in the field of neurology or neurosurgery, or by a medical technical expert such as neuroscience specialists.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing: cortiQ PRO was tested with several real electrocorticographic (ECoG) and artificial test signals. 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.
Usability Validation Testing: Performed in N=15 participants from the intended user group (neuroscientists, neurosurgeons, and neurologists). Participants performed simulated use testing following the specified device training program. The results demonstrate that the cortiO PRO system meets all specified usability requirements at an acceptable risk level.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.1400 Electroencephalograph.
(a)
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.(b)
Classification. Class II (performance standards).
0
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------- |
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3
510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).
807.92(a)(1)
| Submitter Information | ||
|---|---|---|
| g.tec medical engineering | ||
| GmbH Sierningstrasse 14 | ||
| 4521 Schiedlberg | ||
| Austria | ||
| Phone: | ||
| Fax: | ||
| Contact Person: | ||
| Date: | ++43 (7251) 22240-12 | |
| ++43 (7251) 22240-39 | ||
| Christoph Guger | ||
| May 24, 2019 | ||
| 807.92(a)(2) | ||
| Trade Name: | cortiQ PRO | |
| Common Name: | Normalizing quantitative electroencephalograph software | |
| Amplifier, physiological signal | ||
| Classification name: | Electroencephalograph | |
| 21 CFR section 882.1400 | ||
| Product Code: | OLU, OLT, GWL | |
| 807.92(a)(3) | Predicate Device(s) | |
| K# | ||
| Trade/Device Name | ||
| Regulation Number | ||
| Regulation Name | ||
| Regulatory Class | ||
| Product Code | ||
| Date | ||
| Received | ||
| Aspect | K041263 (primary predicate) | |
| NeuroGuide Analysis System | ||
| 21 CFR 882.1400 | ||
| Electroencephalograph | ||
| Class II | ||
| OLU | ||
| July 20,2004 | ||
| July 22,2004 | ||
| Signal analysis and statistical processing | ||
| of data | K123255 (secondary predicate) | |
| g.Hlamp | ||
| 21 CFR 882.1835 | ||
| Physiological signal amplifier | ||
| Class II | ||
| GWL | ||
| October 10, 2012 | ||
| October 18, 2012 | ||
| Recording of EEG data and providing it to | ||
| the signal processing via an application |
4
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.
5
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.
6
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
K123255 | NeuroGuide Analysis System
(NeuroGuide Base, NeuroStat,
Neurofeedback) K041263 | Comment |
|---------|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | 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. | 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 electroencephalogram (EEG),
electromyogram (EMG), electrooculogram (EOG),
and electrocardiogram (ECG). | For clinical use the NeuroGuide Analysis
system is to be used by qualified medical or
clinical professionals for the statistical
evaluation of the human
electroencephalogram (EEG) | cortiQ PRO combines
both intended uses and
limits it to the statistical
evaluation of brain
activity and is therefore
equivalent in safety and
effectiveness. |
| 2. | Contraindication /
Limitations | • The device must not be used directly on the heart.
• The device must not be used for the determination of
brain death. Additional examinations are needed for
diagnosis and no diagnosis may be done only based
on using this device.
• The device must not be used during defibrillation.
Remove all electrodes and probes from the patient
before defibrillation, otherwise the operator may
receive an electrical shock or the connected
instrument may be damaged.
• The device must not be used in humans with pace-
makers or electrical stimulators
• Must not be used for electromyography (EMG),
electrooculography
(EOG), electrocardiography
(ECG)
• The device must be used either by a medical expert,
such as a medical doctor with expertise in the field of
neurology or neurosurgery, or by a medical technical
expert such as neuroscience specialists. A user is
only eligible to operate the device after completed
device training.
• The device must not be used when a patient is non-
compliant to planned procedures due to age,
cognitive function, or cognitive development stage.
Such procedures might depend on the active
cooperation of the patient and/or a sufficiently
developed brain, and/or other aspects. Generally | • The device must not be used directly on the heart.
• The device must not be used for the determination
of brain death. Additional examinations are needed
for diagnosis and no diagnosis may be done only
based on using this device.
• The device is not protected against the effect of
cardiac defibrillator discharge
• The device must not be used in humans with pace-
makers or electrical stimulators | Only for qualified medical clinical
professionals. | cortiQ PRO shows
additional limitations
and contraindications
but is equivalent in
safety and
effectiveness. |
| | | | | | |
| | | patients that are eligible for brain surgery in general
and the individual type of surgery (e.g. epilepsy,
tumor, or similar) in particular are also eligible for
the usage of this device. In the individual case the
responsible surgeon has to decide upon the
procedures and the usage of the device.
• The device must not be used for diagnosis without
validation by another modality.
The device must not be used for patient monitoring. | | | |
| 3. | System components | • g.Hlamp including:
- amplifier
- AC/DC adapter
- USB cable
- 1-4 electrode connector boxes.
- driver software
• personal computer inclusive speakers and monitor
• additional monitor including USB cable
• cortiQ PRO software
• hardlock USB dongle | • g.Hlamp including: - amplifier
- AC/DC adapter
- USB cable
- 1-4 electrode connector boxes.
- driver software | • software
• personal computer
• amplifier
• additional monitor | cortiQ PRO includes
also a processing
computer and screen
for paradigm
presentation, but is
equivalent in safety and
effectiveness. |
| 4. | Safety standards | IEC60601-1
IEC60601-1-2
IEC60601-2-26
ISO 14971
IEC 62304
IEC 62366 | IEC60601-1
IEC60601-1-2
IEC60601-2-26
IEC60601-2-40
MDD 93/42/EEC
IEC60601-1-4
ISO 14971
IEC 62304 | No remark in 510k summary or instruction for
use | cortiQ PRO covers the
required standards to
ensure equivalence in
safety and
effectiveness. |
| 5 | Dimensions | • standard personal computer
• g.Hlamp:197 (L) x 197 (W) x 90 (H) mm
• additional monitor | 197 (L) x 197 (W) x 90 (H) mm | • personal computer
• amplifier
• additional monitor | cortiQ PRO is
equivalent in safety and
effectiveness. |
| 6. | Weight | • g.Hlamp 1.875kg
• personal computer
• additional monitor | 1.875kg | • personal computer
• amplifier
• additional monitor | cortiQ PRO is
equivalent in safety and
effectiveness. |
| 7. | Software/ Firmware | Firmware resident on g.Hlamp, g.Hlamp API on
personal computer, cortiQ software on personal
computer. | Firmware resident on g.Hlamp, g.Hlamp API on
personal computer, | Only software on personal computer | cortiQ PRO uses both
resident firmware and
software components
but is equivalent in
safety and
effectiveness. |
| 8 | User interface | GUI | g.Hlamp API | GUI | cortiQ PRO uses a
graphical user interface
(GUI) and is therefore
equivalent in safety and
effectiveness. |
7
cortiQ PRO 510(k) Premarket Notification
g.tec medical engineering GmbH
8
Comparison between cortiQ PRO and g.HIamp characteristics for data acquisition:
| Table II | |
|---|---|
| ---------- | -- |
| | Item | cortiQ PRO | g.Hlamp
K123255 | Comment |
|-----|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| 9. | EEG/Polygraphic
channels | 80-256 monopolar | 80-256 monopolar | Same as predicate. |
| 10. | DC channel | 80-256 | 80-256 | Same as predicate. |
| 11. | Full scale input
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
Hz/channel) predefined in setting
1200 Hz | User selectable (256, ... up to 38400
Hz/channel) | Preselected for cortiQ
PRO system but
equivalent in safety and
effectiveness. |
| 14. | Noise | 100 MOhm | >100 MOhm | Same as predicate. |
| 26. | Filters in the
amplifier | DC up to 2000 Hz (depending on
sampling frequency). DC used in
preset. | DC up to 2000 Hz (depending on
sampling frequency) | cortiQ PRO records data
without applied
hardware filter but is
equivalent in safety and
effectiveness. |
| 27. | Frequency response | Linear between 0.1 and 170 Hz | Linear between 0.1 and 100 Hz | Same as predicate. |
9
Comparison between cortiQ PRO and NeuroStat characteristics for statistical analysis: Table III
| | Item | cortiQ PRO | NeuroGuide Analysis System
(NeuroStat)
K 041263 | Comment |
|-----|----------------------------------------|------------------------------------------------------|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| 28. | Signal processing | Real-time | Post-hoc | cortiQ PRO performs the
analysis in real-time but is
equivalent in safety and
effectiveness. |
| 29. | Signal source | g.Hlamp API | Imported from a data-file | The cortiQ PRO directly gets
data from the g.Hlamp API so
it increases the effectiveness
but is equivalent in safety. |
| 30. | Band power
estimation | Auto regressive model for power
spectrum (AR) | Fast Fourier transformation (FFT)
for power spectrum | cortiQ PRO uses an AR model
for optimized data processing
but is equivalent in safety and
effectiveness. |
| 31. | Statistical analysis | Parametric statistical test with R2
output metric | ANOVA (Analysis of variances) | cortiQ PRO uses R2 values for
statistical analysis and
NeuroStat ANOVA but is
equivalent in safety and
effectiveness. |
| 32. | Analysis output | R2 value for each channel | p-value for each channel | cortiQ PRO uses R2 values as
output of analysis and
NeuroStat p-values but is
equivalent in safety and
effectiveness. |
| 33. | Visualization | Topographical mapping | Topographical mapping | Same as predicate |
| 34. | Comparison of data
segments | Comparison of baseline with task
related data | Pre- and post-treatment data | cortiQ PRO performs the
comparison within the same
measurement but is safer and
equivalent
in effectiveness. |
| 35. | Type of comparison | In-person comparison | In-person comparison, or group
comparison | cortiQ PRO only provides in-
person comparison but is
equivalent in safety and
effectiveness. |
| 36. | Acceptance or reject
of the results | Dependent upon the judgement
of the clinician | Dependent upon the judgement of
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
(Neurofeedback)
K 041263 | Comment |
|-----|-----------------------------------------------------|--------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| 37. | Visual feedback or
interaction with
patient | via additional monitor and
paradigm presenter | via additional monitor and paradigm
presenter | Same as predicate |
| 38. | Auditory feedback or
interaction with
patient | via personal computer speakers
and player | via personal computer speakers and
player | Same as predicate |
| 39. | Session setup | Paradigm editor for session
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
warning. | Freely adjustable | cortiQ PRO informs user when
limits are underwent but is
equivalent in safety and
effectiveness. |
10
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.