(269 days)
Not Found
No
The summary describes standard EEG/EP acquisition and display methods and does not mention any AI or ML components for analysis or interpretation.
No.
The device is used for acquisition, display, analysis, storage, reporting, and management of EEG and AEP information, which are diagnostic functions, not therapeutic.
Yes
The "Intended Use / Indications for Use" section states that the system is for the "acquisition, display, analysis, storage, reporting and management of electroencephalograph (EEG) and auditory evoked potentials (AEP) information," which are common diagnostic tools used to assess brain function and detect neurological conditions. The "Device Description" further elaborates on its ability to record and display EEG and EP test data, which are inherently used for diagnostic purposes.
No
The device description explicitly details hardware components including electrode pods, electronic circuits, a handheld control unit, a lithium-ion battery, and a cable connecting the headset to the control unit. While software is mentioned for setup and data evaluation, it is part of a larger system that includes significant hardware.
Based on the provided information, the COGNISION System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the system is for the "acquisition, display, analysis, storage, reporting and management of electroencephalograph (EEG) and auditory evoked potentials (AEP) information." This involves measuring electrical activity from the patient's scalp and responses to auditory stimuli.
- Device Description: The description details a system that interacts directly with the patient's body (scalp) to acquire physiological signals (EEG and AEP). It uses electrodes, a headset, and a control unit.
- Lack of In Vitro Activity: An IVD device is designed to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic purposes. The COGNISION System does not analyze such specimens. It directly measures physiological signals in vivo (within the body).
Therefore, the COGNISION System falls under the category of a medical device that measures physiological signals from the patient, not an IVD device.
N/A
Intended Use / Indications for Use
The COGNISION System is for use by qualified clinical professionals in private practice offices or small clinical settings for the acquisition, display, analysis, storage, reporting and management of electroencephalograph (EEG) and auditory evoked potentials (AEP) information.
Product codes (comma separated list FDA assigned to the subject device)
OLT, GWJ, OMC
Device Description
The COGNISION™ EEG/EP System is a combination device for reduced montage recording and display of electroencephalographic (EEG) and evoked potentials (EP) test data.
The system uses elastic bands to accurately position 10 electrode pods around the head (7 recording channels, 2 linked mastoids, and 1 common).
EEG signal amplification, conditioning, and A/D conversion is performed by electronic circuits closely coupled to the electrode pods through short flexible printed wires.
The headset is connected by a cable to a handheld control unit and data acquisition box (HCU). A lithium-ion battery in the HCU is used to power the system. The HCU communicates via a wireless data link to a Windows PC to stream EEG data.
HydroDot® Biosensors (from HydroDot Inc., and not included as part of this submission) are inserted into each electrode pod to electrically couple the electrode pods to the subjects scalp.
Software on the PC is used to setup the tests and view and evaluate the resultant test data using standard EEG/EP display methods.
Calibrated audiometric earphones (from E-A-R Auditory Systems) can be plugged in to the amplifier A/D converter box to deliver various auditory stimuli to produce evoked potential EEG responses.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient's skin (scalp) (auditory stimulators/earphones)
Indicated Patient Age Range
Adults
Intended User / Care Setting
qualified clinical professionals in private practice offices or small clinical settings
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The COGNISION™ EEG/EP System is tested using an automated test set to perform all necessary electrical and audio tests. The test set includes an electronic fixture, integrated biosignal generator, electronic sensors, and an oscilloscope output to produce all required inputs and measure all necessary electronic performance parameters. The testing protocols are controlled with a LabView application running on a Windowsbased PC. All testing parameters are automatically recorded in a validation report. The validation report lists the parameters tested and results.
The COGNISION™ System was validated in actual use conditions on initial production units or their equivalents. Patients with a neurological condition were observed in an environment consistent with the intended use and the design validation met all acceptance criteria.
Key Results from Non-Clinical Testing:
- Current Draw: -420 to -525mA
- Cal Tones: Low Cal Frequency: 13.50 - 14.50 Hz, Low Cal Power: 31.5 - 33.5 dB μV, High Cal Frequency: 27.00 - 28.00 Hz, High Cal Power: 31.5 - 33.5 dB μV
- Baseline Noise: Noise VRMS: 60 dB @ 10 Hz, 730 mv pk-pk input on driven CH
- CMMR: Min Attenuation :
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 13, 2015
Neuronetrix Solutions % Cheryl Fisher Senior Consultant OA Emergo Group 816 Congress Ave. Suite 1400 Austin TX 78701
Re: K141316 Trade/Device Name: COGNISION™ EEG/EP SYSTEM Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLT, GWJ, OMC Dated: January 12, 2015 Received: January 13, 2015.
Dear Ms. Fisher,
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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) K141316
Device Name COGNISION™ EEG/EP SYSTEM
Indications for Use (Describe)
The COGNISION System is for use by qualified clinical professionals in private practice offices or small clinical settings for the acquisition, display, analysis, storage, reporting and management of electroencephalograph (EEG) and auditory evoked potentials (AEP) information.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
for
COGNISION™ EEG/ERP SYSTEM
1. Submission Sponsor
Neuronetrix Solutions 1044 E. Chestnut Louisville KY, 40204 United States Phone: (502)561-9040 Contact: K.C. Fadem, President
2. Submission Correspondent
Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: (408)410-5920 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Cheryl Fisher, Senior Consultant, QA/RA Email: project.management@emergogroup.com
3. Date Prepared
1/12/2015
4. Device Identification
| Trade/Proprietary Name: | COGNISION™ EEG/ERP SYSTEM |
|---|---|
| Common/Usual Name: | EEG/EP System, EEG Telemetry System |
| Classification Name: | Multiple: Electroencephalograph, Evoked Response Auditory Stimulator |
| Classification Regulation: | Multiple: |
| 882.1400 | |
| 882.1900 | |
| Product Code: | Multiple: |
| OMC, Reduced Montage Electroencephalograph | |
| OLT, Non-Normalizing Quantitative Electroencephalograph Software | |
| GWJ, Stimulator, Auditory, Evoked Response | |
| Device Class: | All product codes utilized are considered Class II |
| Classification Panel: | Neurology |
5. Legally Marketed Predicate Device(s)
| K131383 | Advanced Brain Monitoring X-10/X-24 family |
|---|---|
| K112052 | CareFusion Nicolet EDX 2/ Viking Software |
| K962447 | Physiometrix Equinox Digital EEG System |
6. Device Description
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The COGNISION™ EEG/EP System is a combination device for reduced montage recording and display of electroencephalographic (EEG) and evoked potentials (EP) test data.
The system uses elastic bands to accurately position 10 electrode pods around the head (7 recording channels, 2 linked mastoids, and 1 common).
EEG signal amplification, conditioning, and A/D conversion is performed by electronic circuits closely coupled to the electrode pods through short flexible printed wires.
The headset is connected by a cable to a handheld control unit and data acquisition box (HCU). A lithium-ion battery in the HCU is used to power the system. The HCU communicates via a wireless data link to a Windows PC to stream EEG data.
HydroDot® Biosensors (from HydroDot Inc., and not included as part of this submission) are inserted into each electrode pod to electrically couple the electrode pods to the subjects scalp.
Software on the PC is used to setup the tests and view and evaluate the resultant test data using standard EEG/EP display methods.
Calibrated audiometric earphones (from E-A-R Auditory Systems) can be plugged in to the amplifier A/D converter box to deliver various auditory stimuli to produce evoked potential EEG responses.
7. Indication for Use Statement
The COGNISION System is for use by qualified clinical professionals in private practice offices or small clinical settings for the acquisition, display, analysis, storage, reporting and management of electroencephalograph (EEG) and auditory evoked potentials (AEP) information.
8. Substantial Equivalence Discussion
The following table compares the COGNISION™ EEG/EP System to the predicate device(s) with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.
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| anufactur | euronetrix Solution | Advanced Brain Monitoring | areFusio | Physiometrix In | SIGNIFICANT DIFFERENC |
|---|---|---|---|---|---|
| rade Nam | OGNISION™ EEG/ER | ||||
| SYSTEM | icolet EDX 2/Viki | quinox™ Digital | |||
| 0(k) Numbe | (141316 | 90dB | |||
| 1 | 105 dB | ||||
| N | >110dB at 50/60 Hz | ||||
| 下 | Unknow |
- | N | he COGNISION™ EG/ERP System has ppropriately has ppropriately links MRR consisted by the has he predicates |
| | | | | | ರ್ 8 | me as the X-10 and colet EDX 2 with king Software syste |
| | Yes - | res
ರ್ 8 | Yes
ಂ | Unknowi
ರ್ ರ | ்ல | |
| ഗ് | > 60 MC | > 100 GΩ
்ல | >1000 ΜΩ
்ல | Unknow - | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
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10. Non-Clinical Performance Data
The COGNISION™ EEG/EP System is tested using an automated test set to perform all necessary electrical and audio tests.
The test set includes an electronic fixture, integrated biosignal generator, electronic sensors, and an oscilloscope output to produce all required inputs and measure all necessary electronic performance parameters.
The testing protocols are controlled with a LabView application running on a Windowsbased PC.
All testing parameters are automatically recorded in a validation report. The validation report lists the parameters tested and results. The tests which are performed are shown in the Table below. In addition a user can test system functionality by cycling through a self test (parameters for this listed below).
Neuronetrix Solutions utilized the following FDA Guidance documents in the preparation and testing of the COGNISION™ EEG/EP System:
- Electroencephalograph Devices Guidance for 510(k) Content Draft Document Version ● 1.0, November 3, 1997".
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices May 29, 1998
- Guidelines for Reviewing Premarket Notifications that Claim Substantial Equivalence to Evoked Response Stimulators
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| Test | Test Description | Acceptance Criteria |
|---|---|---|
| Current Draw | Measures current draw for nominal values, | |
| tests for shorts and abnormal functionality | -420 to -525mA | |
| Cal Tones | Determines internal continuity and | |
| functioning CAL Tones | Low Cal Frequency: 13.50 - 14.50 Hz | |
| Low Cal Power: 31.5 - 33.5 dB μV | ||
| High Cal Frequency: 27.00 - 28.00 Hz | ||
| High Cal Power: 31.5 - 33.5 dB μV | ||
| Baseline | ||
| Noise | Measures internal "baseline" noise from | |
| Uberyoke and Electrode Strings by shorting | ||
| amplifiers to ground | Noise VRMS: 60 dB | |
| @ 10 Hz, 730 mv pk-pk input on driven | ||
| CH | ||
| CMMR | Inject a known signal into all electrodes then | |
| evaluate the EEG signal to establish the | ||
| CMRR | Min Attenuation : |