(34 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description focuses on standard EEG components and software upgrades.
No
The device is intended to measure and record electrical activity, which is diagnostic, not therapeutic.
Yes
The device is intended to "measure and record the electrical activity of the patient's brain," which is a diagnostic function used to assess brain health or conditions.
No
The device description explicitly lists hardware components such as an amplifier, computer, electrodes, and cables, in addition to software.
Based on the provided information, the Geodesic EEG System™ 300 (GES 300) is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "measure and record the electrical activity of the patient's brain." This describes a device that interacts directly with the patient's body (in vivo) to collect physiological data.
- Device Description: The description details components like an amplifier, electrodes, and software used to capture and process electrical signals from the brain. This aligns with an in vivo diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing samples taken from the body (like blood, urine, tissue, etc.) or performing tests in vitro (in a lab setting).
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease. The GES 300 operates by directly measuring electrical activity within the body.
N/A
Intended Use / Indications for Use
The Geodesic EEG System™ 300 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 (comma separated list FDA assigned to the subject device)
OLT, GWQ
Device Description
The Geodesic EEG System™ 300 (GES 300) is a digital electroencephalograph system (EEG) with dedicated electrodes. It consists of an amplifier, computer, software . Geodesic Sensor Net® (electrodes), and additional components such as cables. Modifications which constitute the GES 300 include a compact amplifier, software upgrade, additional display modes and tools, and options for computer configuration.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative performance testing and clinical evaluations were not submitted as part of this 510(k).
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).
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GES 300 System Special 510(k) Notification Page 28
510(k) SUMMARY
| Submitter's name: | Electrical Geodesics, Inc.
1600 Millrace Drive, Suite 307
Eugene, OR 97403 | |
|---------------------------|------------------------------------------------------------------------------------------------|-------------|
| Contact name and address: | Linda J. Bovard, Bovard Consulting LLC
29611 Simmons Road, Eugene, OR 97405
541-345-5431 | JAN 26 2007 |
| Date summary prepared: | December 19, 2006 | |
Device name:
| Proprietary name: | Geodesic EEG System™ 300 (GES 300) |
|---|---|
| Common or usual name: | EEG system |
| Classification name: | Electroencephalograph, 84 GWQ |
| Class II, 882.1400 |
Legally marketed device for substantial equivalence comparison: Geodesic EEG System™ submitted by Electrical Geodesics, Inc. K012079
Description of the device:
The Geodesic EEG System™ 300 (GES 300) is a digital electroencephalograph system (EEG) with dedicated electrodes. It consists of an amplifier, computer, software . Geodesic Sensor Net® (electrodes), and additional components such as cables. Modifications which constitute the GES 300 include a compact amplifier, software upgrade, additional display modes and tools, and options for computer configuration.
Intended use of device:
The Geodesic EEG System™ 300 is intended to measure and record the electrical activity of the patient's brain. It can be used on adults, children, and infants.
Technological characteristics:
The modifications which constitute the GES 300 do not alter the technological characteristics of the device. These modifications have been controlled by the EGI Design Control procedures.
Testing conducted:
Verification and validation testing has been conducted and the GES 300 passed all structured testing.
Performance testing:
Comparative performance testing and clinical evaluations were not submitted as part of this 510(k).
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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with outstretched wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The eagle is composed of three thick, curved lines that form the wings and body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Electrical Geodesics Incorporated c/o Bovard Consulting LLC Ms. Linda J. Bovard, RAC 29611 Simmons Road Eugene, Oregon 97405
APR - 9 2012
Re: K063797
Trade/Device Name: Geodesic EEG System 300 (GES 300) Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLT, GWQ Dated (Date on orig SE ltr): December 19, 2006 Received (Date on orig SE ltr): December 29, 2006
Dear Ms. Bovard:
This letter corrects our substantially equivalent letter of January 25, 2007.
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 (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.
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.
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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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 yours.
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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GES 300 System Special 510(k) Notification Page 26
Indications for Use
510(k) Number (if known): _ K06 3 297
Deviee Name: Geodesic EEG System™ 300 (GES 300)
Indications for Use:
The Geodesic EEG System™ 300 (GES 300) is intended to measure and record the electrical activity of the patient's brain. It can be used on adults, children, and infants.
| Prescription Use | X | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | 11063797 |
|---|---|
| --------------- | ---------- |
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