(185 days)
Not Found
No
The summary describes a standard digital EEG system for recording brain electrical activity. There is no mention of AI, ML, or any advanced analytical capabilities beyond basic data acquisition and archiving. The performance studies focus on electrical safety and software validation, not on algorithmic performance metrics typically associated with AI/ML.
No.
The device is intended to measure and record electrical activity of the brain, rather than treat a condition or restore function.
Yes
Explanation: The "Intended Use / Indications for Use" states that the device is "intended to measure and record the electrical activity of the patient's brain," which is a fundamental aspect of diagnosis in neurology (e.g., diagnosing epilepsy, sleep disorders, etc.).
No
The device description explicitly lists multiple hardware components including an amplifier, adapters, central processing unit, electrodes, isolation transformer, and standard personal computer components, in addition to the software.
Based on the provided information, the Geodesic EEG Mobile 100 (GEM 100) 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 direct measurement of physiological activity within the body (in vivo), not an examination of samples taken from the body (in vitro).
- Device Description: The description details a system for acquiring and processing electrical signals from electrodes placed on the patient's head. This aligns with in vivo measurement.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on such samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. The GEM 100 operates by directly interacting with the patient's body to record electrical signals.
N/A
Intended Use / Indications for Use
The Geodesic EEG Mobile (GEM 100) 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
GWQ
Device Description
The Geodesic EEG Mobile 100 (GEM 100) is a digital electroencephalograph system (EEG). It consists of an amplifier, two adapters, central processing unit, software, electrodes, isolation transformer, and components of a standard personal computer (monitor, keyboard, and mouse). Integral components allow wireless communication.
The GEM 100 has 4 configurations. These are based on the type of EEG electrodes that will be used and the environment for use. The Neurotravel software is used to acquire, record, and archive the data from all 4 configurations. These configurations are:
- Ambulatory EEG only .
- Ambulatory EEG with conventional electrodes and physiological sensors ●
- Stationary (in-clinic) EEG only .
- Stationary (in-clinic) EEG with conventional electrodes and physiological sensors .
The GEM 100 EEG Amplifier is used with all configurations, but the other components vary depending on the requirements of the patient and physician. Accessories that can be used with the GEM 100 include: Sensor Kit for SpO2, LTM Net Support Kit, Video EEG, photic stimulator, TTL patient event switch, laser or inkjet printer, mobile cart, and ambulatory pouch.
The GEM 100 operates like other digital electroencephalographs. It can run on mains power or on battery power. Data can be recorded to a CompactFlash card or to the system computer. Data can be transmitted by USB connection or by Bluetooth or can be transferred from the Compact Flash card to the system computer.
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
Intended user: EEG technician or physician
Intended environment: Healthcare facilities and ambulatory 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
Non-clinical Testing: Extensive testing was conducted. The product passed general testing to IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-2-26. Additional testing was conducted to verify long term monitoring capabilities and use of an SpO2 sensor. Software verification and validation activities were also successfully completed.
Clinical Testing: No clinical testing was submitted.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
K112353
FEB 17 2012
510(k) Summary
Contact Details
| Applicant Name: | Electrical Geodesics, Inc. |
|---|---|
| Address: | 1600 Millrace Drive, Suite 307, Eugene, OR 9740 |
| Phone: | 541-687-7962 |
| Fax: | 541-687-7963 |
| Contact: | Linda Bovard |
| Bovard Consulting LLC | |
| 29611 Simmons Road, Eugene, OR 97405 | |
| 541-345-5431 | |
| Date Prepared: | November 17, 2011 |
Device Name
Trade Name: Geodesic EEG Mobile 100 (GEM 100)
Common Name: EEG
Classification Name: Electroencephalograph, 882.1400, GWQ
Legally Marketed Predicate Device(s)
K033399, GWQ, Geodesic EEG System 100, Model 120, Electrical Geodesics, Inc.
Device Description
The Geodesic EEG Mobile 100 (GEM 100) is a digital electroencephalograph system (EEG). It consists of an amplifier, two adapters, central processing unit, software, electrodes, isolation transformer, and components of a standard personal computer (monitor, keyboard, and mouse). Integral components allow wireless communication.
The GEM 100 has 4 configurations. These are based on the type of EEG electrodes that will be used and the environment for use. The Neurotravel software is used to acquire, record, and archive the data from all 4 configurations. These configurations are:
- Ambulatory EEG only .
- Ambulatory EEG with conventional electrodes and physiological sensors ●
- Stationary (in-clinic) EEG only .
- Stationary (in-clinic) EEG with conventional electrodes and physiological sensors .
1
The GEM 100 EEG Amplifier is used with all configurations, but the other components vary depending on the requirements of the patient and physician. Accessories that can be used with the GEM 100 include: Sensor Kit for SpO2, LTM Net Support Kit, Video EEG, photic stimulator, TTL patient event switch, laser or inkjet printer, mobile cart, and ambulatory pouch.
The GEM 100 operates like other digital electroencephalographs. It can run on mains power or on battery power. Data can be recorded to a CompactFlash card or to the system computer. Data can be transmitted by USB connection or by Bluetooth or can be transferred from the Compact Flash card to the system computer.
Intended Use/Indications for use
The Geodesic EEG Mobile (GEM 100) 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 Geodesic EEG Mobile 100 (GEM 100) is a modification to the Geodesic EEG System 100, Model 120, which was submitted by Electrical Geodesics, Inc. and cleared for marketing under K033399 on August 4, 2004. There are no changes that affect intended use or fundamental scientific technologies. Parameters shown for Model 120 are those originally cleared.
| Category | GEM 100 | Model 120
K033399 |
|-----------------------------------|------------------------------|----------------------------------------------------|
| System components: | | |
| amplifier | Yes – Neurotravel SMART | Yes – Neurotravel WIDE |
| CPU | Yes – PC based | Yes – PC based |
| headbox | Yes – for some uses | Yes |
| adaptor | Yes – for some uses | No |
| data recording media | Yes | Yes |
| preferred electrodes | HCGSN GEM | Geodesic Sensor Net® 200 or
300 or HCGSN |
| electrolyte | KCl solution or Elefix | KCl solution |
| acquisition software | Yes – Neurotravel Win for PC | Yes – Neurotravel Win for PC |
| diagnostic software | No | No |
| Other supported EEG
electrodes | Standard EEG electrodes | Standard EEG electrodes and
cap-type electrodes |
2
| Category | GEM 100 | Model 120
K033399 |
|--------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------|
| Other supported
sensors | Standard 1.5mm safety plug
passive sensors
Nonin 8000AA SpO2 sensor | Standard 1.5mm safety plug
passive sensors
Nonin SpO2 sensors |
| Intended environment | Healthcare facilities and
ambulatory settings | Healthcare facilities |
| Intended user | EEG technician or physician | EEG technician or physician |
| Mode of operation | Microprocessor based unit
which records patient data | Microprocessor based unit
which records patient data |
| Energy source | Mains power or battery power | Mains power |
| Standard number of
channels | 32 channels | 32 channels |
Non-clinical Testing
Extensive testing was conducted. The product passed general testing to IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-2-26. Additional testing was conducted to verify long term monitoring capabilities and use of an SpO2 sensor. Software verification and validation activities were also successfully completed.
Clinical Testing
No clinical testing was submitted.
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 emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized depiction of an eagle, with its wings forming three distinct, curved lines. The eagle is facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 1 7 2012
Electrical Geodesics, Inc. c/o Bovard Consulting LLC Ms. Linda J. Bovard, RAC President 29611 Simmons Road Eugene, OR 97405
Re: K112353
Trade/Device Name: Geodesic EEG Mobile 100 (GEM 100) Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ Dated: November 17, 2011 Received: November 18, 2011
Dear Ms. 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 r ou mayy are systems 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.
4
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 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 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,
Debra Falls
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
5
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Geodesic EEG Mobile 100 (GEM 100)
Indications for Use:
The Geodesic EEG Mobile 100 (GEM 100) 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 (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Kinf
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
KII2353 510(k) Number.