(232 days)
No
The summary describes a standard digital EEG system for measuring and recording brain electrical activity. There is no mention of AI, ML, or any advanced analytical capabilities beyond basic signal acquisition and processing. The performance studies focus on electrical safety and software verification/validation, not on the performance of an AI/ML algorithm.
No.
The device is intended to measure and record electrical activity of the brain, a diagnostic function, not a therapeutic one.
Yes
The device is intended to "measure and record the electrical activity of the patient's brain," which is a diagnostic function.
No
The device description explicitly lists hardware components such as an amplifier, central processing unit, electrodes, and components of a standard personal computer, in addition to the software.
Based on the provided information, the Geodesic EEG System 400 Series™ (GES 400) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "measure and record the electrical activity of the patient's brain." This is a measurement of physiological activity within the body, not an analysis of samples taken from the body (like blood, urine, tissue, etc.).
- Device Description: The description details a system for acquiring electrical signals from electrodes placed on the patient's head. This aligns with in vivo measurement, not in vitro analysis.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with IVD devices.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. The GES 400 measures electrical signals directly from the patient's brain, which is an in vivo measurement.
N/A
Intended Use / Indications for Use
The Geodesic EEG System 400 Series™ (GES 400) is intended to measure and record the electrical activity of the patient's brain. It can be used on adults, children, and infants.
Product codes
OLT, GWQ
Device Description
The Geodesic EEG System™ 400 Series (GES 400) is a digital electroencephalograph system (EEG). Each system consists of an amplifier, central processing unit, software, electrodes, and components of a standard personal computer (monitor, keyboard, and mouse).
The GES 400 Series consists of 3 models (GES 400, GES 405, and GES 410), each of which has a slightly different amplifier. The amplifiers are very similar and all are called Net Amps ". They vary in connectors used to attach the electrodes and in the A/D chips, which support different maximum sampling rates. The other parts of the GES 400 Series are identical and consist of an isolation transformer, a power supply, Net Station software, proprietary EEG electrodes, and data acquisition computer. Optional accessories include a cart that holds the components of the system, interface cable, and articulated arm. The GES 400 Series also accepts third party DIN 42802 electrodes and an SpO22 electrode.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's brain
Indicated Patient Age Range
adults, children, and infants
Intended User / Care Setting
Not Found
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
No animal or clinical testing was submitted.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K131882
FEB 12 2014
510(k) Summary
Contact Details
| Applicant Name: | Electrical Geodesics, Inc.
1600 Millrace Drive, Suite 200, Eugene, OR 97403
541-687-7962 |
|-----------------|------------------------------------------------------------------------------------------------|
| Contact Name: | Linda J. Bovard
Bovard Consulting LLC
29611 Simmons Road, Eugene, OR 97405 |
| Date Prepared: | February 11, 2014 |
Device Name
Trade Name: Geodesic EEG System™ 400 Series
Common Name: Electroencephalograph
Classification Name: Electroencephalograph, 882.1400, primary code OLT Non-normalizing quantitative electroencephalograph, secondary code GWQ electroencephalograph
Legally Marketed Predicate Device(s)
Geodesic EEG System™ 300 (GES 300) by Electrical Geodesics, Inc. K063797
Device Description
The Geodesic EEG System™ 400 Series (GES 400) is a digital electroencephalograph system (EEG). Each system consists of an amplifier, central processing unit, software, electrodes, and components of a standard personal computer (monitor, keyboard, and mouse).
The GES 400 Series consists of 3 models (GES 400, GES 405, and GES 410), each of which has a slightly different amplifier. The amplifiers are very similar and all are called Net Amps ". They vary in connectors used to attach the electrodes and in the A/D chips, which support different maximum sampling rates. The other parts of the GES 400 Series are identical and consist of an isolation transformer, a power supply, Net Station software, proprietary EEG electrodes, and data acquisition computer. Optional accessories include a cart that holds the components of the system, interface cable, and articulated arm. The GES 400 Series also accepts third party DIN 42802 electrodes and an SpO22 electrode.
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Intended Use/Indications for use
The Geodesic EEG System 400 Series™ (GES 400) is intended to measure and record the electrical activity of the patient's brain. It can be used on adults, children, and infants.
Substantial Equivalence Comparison
The GES 400 Series is a modification to the Geodesic EEG System™ 300. In the charts below, the column labeled GES 400 gives a full description for comparison with the predicate device, GES 300. "Same" in the GES 405 and GES 410 columns means that this item is identical to the GES 400.
| Comparison | GES 400 Series | GES 300 | ||
|---|---|---|---|---|
| GES 400 | GES 405 | GES 410 | K063797 | |
| System components: | ||||
| amplifier | Net Amps™ | |||
| 400 | Net Amps™ | |||
| 405 | Net Amps™ | |||
| 410 | Net Amps™ 300 | |||
| CPU | Intel based | Same | Same | Intel based |
| preferred electrodes | HCGSN | Same | Same | HCGSN |
| electrode connector | Hypertronics | GEM | Hypertronics | Hypertronics |
| other supported EEG | ||||
| electrodes | None | Same | Same | None |
| other supported | ||||
| electrodes | Yes – DIN | |||
| 42802 | Same | Same | Yes - DIN 42802 | |
| acquisition software | Yes - Net | |||
| Station® 4.5 | Same | Same | Yes - Net Station® | |
| 4.2 | ||||
| diagnostic software | No | Same | Same | No |
Table 1: Overall Comparison
The overall features of the GES 400 Series and the GES 300 are very similar. They have the same basic components and accept the same electrode types. The software has been upgraded from Net Station 4.2 to Net Station 4.5. There are three models of amplifier, which lead to the three models in the GES 400 Series. These amplifiers are described more fully in Table 2. As noted in Table 1, the Net Amps 400 and Net Amps 410 accept HCGSN electrodes with a Hypertronics connector, just like the GES 300. The Net Amps 405 accepts HCGSN electrodes with a GEM connector, which was cleared with the Geodesic EEG System Mobile (GEM) under K 112353. The electrodes used with all models are identical.
In overall features the GES 400, GES 405 and GES 410 are substantially equivalent to the GES 300.
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| Comparison | GES 400 Series | GES 300 | ||
|---|---|---|---|---|
| GES 400 | GES 405 | GES 410 | K063797 | |
| Amplifier designation | Net Amps 400 | Net Amps 405 | Net Amps 410 | Net Amps 300 |
| Number of channels | Up to 256 | Up to 32 | Up to 256 | Up to 256 |
| A/D conversion | 24 bit | Same | Same | 24 bit |
| Sampling rate | 8,000 Hz | 8,000 Hz | 20,000 Hz | Up to 20,000 Hz |
| Sample and hold | Yes | Same | Same | Yes |
| Sensitivity | ||||
| - digitization precision | 0.024 µV/bit | Same | Same | 0.024 µV/bit |
| - display sensitivity | selectable | Same | Same | selectable |
| High and low pass filters | Fully selectable in software. | Same | Same | Fully selectable in software. |
| Notch filter | 50 Hz and 60 Hz in software | Same | Same | 50 Hz and 60 Hz in software |
| Input impedance | >1.0 GΩ | Same | Same | >200 ΜΩ |
| CMRR | >90dB 50/60 Hz | Same | Same | 90dB 50/60 Hz |
| Noise level | 0.7 µV RMS (1.4 µV peak-to-peak) | Same | Same | 0.7 µV RMS (1.4 µV peak-to-peak) |
| Digital interface | Ethernet | Same | Same | FireWire |
| Processor | Embedded Atom processor | Same | Same | Embedded Mindready processor |
| Fully software controlled | Yes | Same | Same | Yes |
| Power supply | 100-240 VAC, 50/60 Hz, 1.0 A | Same | Same | 100-240 VAC, 50/60 Hz, 1.0 A |
Table ?. Amplifier Comparison
Both the Net Amps 400 Series and the Net Amps 300 are very similar. The Net Amps 400 and 410 accept the same number of channels as the Net Amps 300. Because the Net Amps 405 accepts only the GEM connector the maximum number of channels is 32. The sampling rate varies in the Net Amps 400 series, though the sampling rate in the Net Amps 410 is identical to the Net Amps 300. The input impedance of all the Net Amps 400 models has been improved with respect to the Net Amps 300. The digital interface and the embedded processor have changed from the Net Amps 300. Both of these hardware changes are upgrades to widely used current technologies. All other amplifier features are the same. None of the differences between the Net Amps 400 Series amplifiers and the Net Amps 300 raise new issues of safety and effectiveness.
3
Testing
Electrical safety and electromagnetic interference testing have been conducted to UL 60601-1, IEC 60601-1-2, IEC 60601-2-26, CAN/CSA 601.1-M90, and CAN/CSA 60601-2-26. Additional standards used in the development of the product were EN 62304 and EN 62366. Verification and validation testing of the software has also been conducted.
No animal or clinical testing was submitted.
Conclusion
The Geodesic EEG System™ 400 Series (GES 400) is substantially equivalent to the Geodesic EEG System™ 300 (GES 300) based on intended use and device features.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2014
Electrical Geodesics, Inc. c/o Ms. Linda J. Bovard, RAC Bovard Consulting LLC 29611 Simmons Road Eugene, OR 97405
Re: K131882
Trade/Device Name: Geodesic EEG System 400 Series (GES 400) Regulation Number: 21 CFR 882.1400 Regulation Name: Non-normalizing quantitative electroencephalograph software Regulatory Class: Class II Product Code: OLT Additional Product Codes: GWQ Dated: December 23, 2013 Received: December 27, 2013
Dear Ms. Linda J. Bovard:
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
5
Page 2 - Ms. Linda J. Bovard
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); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 vours.
Carlos L. Riena S
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K131882
Device Name
Geodesic EEG System 400 Series (GES 400)
Indications for Use (Describe)
The Geodesic EEG System 400 Series (GES 400) is intended to measure and record the electrical activity of the patient's brain. It can be used on adults, children, and infants.
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)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FO Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Carlos ਟੂena -S
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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