GEODESICEEG SYSTEM 400 SERIES (GES 400)

{0}------------------------------------------------ K131882 FEB 12 2014 # 510(k) Summary ## Contact Details | Applicant Name: | Electrical Geodesics, Inc.<br>1600 Millrace Drive, Suite 200, Eugene, OR 97403<br>541-687-7962 | |-----------------|------------------------------------------------------------------------------------------------| | Contact Name: | Linda J. Bovard<br>Bovard Consulting LLC<br>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. {1}------------------------------------------------ ## 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™<br>400 | Net Amps™<br>405 | Net Amps™<br>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<br>electrodes | None | Same | Same | None | | other supported<br>electrodes | Yes – DIN<br>42802 | Same | Same | Yes - DIN 42802 | | acquisition software | Yes - Net<br>Station® 4.5 | Same | Same | Yes - Net Station®<br>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. {2}------------------------------------------------ | 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. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle. 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 {6}------------------------------------------------ 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. {7}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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