GEODESIC EEG SYSTEM SERIES 100

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters and numbers. The sequence starts with the letter 'K', followed by the number '0', and then the numbers '33399'. The numbers are written in a cursive style, and the overall image has a simple, handwritten appearance. ### 510(k) SUMMARY Submitter's name: Electrical Geodesics. Inc. 1600 Millrace Drive, Suite 307 Eugene, OR 97403 541-687-7962 June 21, 2004 Date summary prepared: Device name: Proprietary name: Common or usual name: Classification name: Geodesic EEG System™ Series 100 EEG machine Electroencephalograph, 84 GWO Class II, 21 CFR 882.1400. Legally marketed device for substantial equivalence comparison: The predicate device for this submission is the Geodesic EEG System™ Model 200 submitted by Electrical Geodesics, Inc. and cleared for marketing under 510(k) *K012079. Description of the device: The Geodesic EEG System™ Series 100 products, also known as the GES Series 100, are digital electroencephalography systems (EEG) that can accommodate up to 256 electrodes. The GES Series 100 is computer controlled and capable of acquiring, storing, and displaying data. It includes electrodes, amplifiers, a central processing unit, and software. The GES Series 100 uses some components from the previously submitted and cleared Geodesic EEG System™ Model 200. It blends these with components from another manufacturer. The combined product is new and has not been previously submitted to FDA. The GES Series 100 products are composed of the following components. The Geodesic Sensor Net® is a dense array of scalp electrodes designed to allow rapid application in an even distribution across the head and is the preferred electrode system. Standard EEG electrodes and cap-type electrodes purchased from other vendors may also be used. The Neurotravel WIDE consists of multiple amplifiers for physiological signals that are fully software controlled. The central processing unit can be either Mac based or PC based. Mac based systems use the proprietary Net Station® software package to control acquisition of data, storage of digital data, and manipulation of data for review. PC based systems use the Neurotravel Win software package to control similar system features. Neither software package performs any diagnosis. Additional components of the system are an articulated arm with extended cable, isolation transformer, rack system, various cables, standard components of personal computer (monitor, keyboard, and mouse), photic stimulator, video EEG, electrolyte solution, and disinfectant. {1}------------------------------------------------ Intended use of device: The Geodesic EEG System Series 100 products are intended to measure and record the :: ectrical activity of the patient's brain. They can be used on adults, children, and infants. Technological characteristics: The technological characteristics of the Geodesic EEG System Series 100 are similar to those of the predicate device. Each product is a digital EEG system that is software controlled, and that can acquire, display, and record EEG data. The preferred electrodes for both systems are the Geodesic Sensor Nets. The amplifiers are different and so some differences in electrical parameters exist. The GES Series 100 can be based on either a Mac or a PC, with matching software, while the predicate device is based on a Mac. None of the software involved with these products analyzes the data independent of the operator or provides diagnosis. #### Testing conducted: Testing was conducted to ensure compliance with international standards related to electroencephalographs. The general safety standard used was: IEC 601.1 including Amendments 1 and 2. The electromagnetic compatibility standard was EN60601-1-2(1993). The electroencephalograph standards were EN 60601-2-26 (1994) and EN 60601-2-40 (1998). The biocompatibility standard was ISO 10993. #### Performance testing: Comparative performance testing and clinical evaluations were not submitted as part of this 510(k). {2}------------------------------------------------ ## Previously Submitted Materials Being Withdrawn The following materials which were submitted in the Original 510(k) or in the Supplement are being withdrawn or revised because of the withdrawal of the EP indication for use. All other parts of the previous submissions still support this application. ### Original 510(k) | Section | Status | |-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Section 4 | Withdraw statements on page 16 describing Win software<br>support of EP/ERP. | | Appendix IX | Neurotravel Win Technical Manual has been revised to<br>delete references to EP. Revised and complete manual<br>can be found in Appendix IV of the current submission. | ### Supplement | Section | Status | |--------------|--------------------------------| | Cover Letter | Withdraw answer to question 1. | | Appendix I | Withdrawn | All other previously submitted material supports the EEG indications for use. {3}------------------------------------------------ Image /page/3/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" arranged around the perimeter. Inside the circle is a stylized symbol featuring three angled lines that resemble a person with outstretched arms. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG - 4 2004 Electrical Geodesics, Inc. c/o Ms. Linda J. Bovard, B.S. RAC R.S. McQuate & Associates 29611 Simmons Road Eugene, Oregon 97405 Re: K033399 KU33399 Trade/Device Name: Geodesic EEG System™ Series 100 (GES Series 100) Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWQ Dated: June 22, 2004 Received: June 25, 2004 Dear Ms. Bovard: We have reviewed your Section 510(k) premarket notification of intent to market the devices indication we have reviewed your Section - Fredry premained is substantially equivalent (for the indications felerenced above and nave decemblicated predicate devices marketed in interstate for use stated in the enorosale) to regars the Medical Device Americal Device American on to commerce proof to May 20, 1976, the excordance with the provisions of the Federal Food, Drug. devices that have been recuire approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require appen of controls provisions of the Act. The r ou may, merelore, market the do rest, so, colorements for annual registration, listing of general controls provisions of the rice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (500 a0010) and Existing major regulations affecting your device can may be subject to such additional controls. Existing major regulations FDA may be subject to such additional controlions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of I cases oncerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I DTT a liseantes or our device complies with other requirements of the Act that I DA has made a acterinations administered by other Federal agencies. You must of any I cuclar statutes and regaranents ancluding, but not limited to: registration and listing (21 Comply with an the Hot 3 requirements, and manufacturing practice requirements as set CFK 1 at 807, ratemig (21 OFR Part 820); government (21 CFR Part 820); and 1f applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. {4}------------------------------------------------ ## Page 2 - Ms. Linda J. Bovard, B.S. RAC This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you'to oegin mailiems of substantial equivalence of your device to a legally prematication. The PDF mainig of casions of your device and thus,-permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice io. Jose 301) 594-4659. Also, please note the regulation entitled, Comact the Office of Compullied in (SS ) (SS Part 807.97). You may obtain Misolaining by reference to premainters some the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, iriam C Provost Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indications for Use 510(k) Number (if known):_K033399 Geodesic EEG System™ Series 100 (GES Series 100) Device Name:__________________________________________________________________________________________________________________________________________________________________ Indications For Use: The Geodesic EEG System™ Series 100 products are intended to measure and record The Clectrical activity of the patient's brain. They can be used on adults, children, and infants. X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use -------(21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Miriam C. Provost (Division Sign-Off) Division of General, Restorative, and Neurological Devices Page 1 of 1 510(k) Number_KO33399