GEOSOURCE

K092844 · Electrical Geodesics, Inc. · OLX · Dec 21, 2010 · Neurology

Device Facts

• Record ID: K092844
• Device Name: GEOSOURCE
• Applicant: Electrical Geodesics, Inc.
• Product Code: OLX · Neurology
• Decision Date: Dec 21, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

GeoSource is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least 3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an idealized head model and an idealized MRI image.

Device Story

GeoSource is an add-on software module for EGI's Net Station EEG system; operates on personal computers (Mac OS). Inputs: EEG signals from EGI hardware. Processing: uses linear inverse methods (LORETA, LAURA, sLORETA) and forward head models (sphere, Finite Difference Model) to approximate and visualize brain source localization. Output: visual representation of estimated brain function locations. Used by trained EEG technologists or physicians in clinical settings. Healthcare providers use output to assist in clinical decision-making regarding brain function visualization. Benefits: provides non-invasive source localization estimates to aid in interpreting EEG data.

Clinical Evidence

Retrospective study of 20 epilepsy subjects (ages 3-55) who underwent resection surgery. Compared GeoSource algorithms (LORETA, sLORETA, LAURA with FDM) against predicate (LORETA with spherical model). Three epileptologists evaluated source localization accuracy relative to resected brain regions. Results demonstrated substantial equivalence between GeoSource algorithms and the predicate device algorithm.

Technological Characteristics

Software-only product; runs on Mac OS. Uses linear inverse methods (LORETA, LAURA, sLORETA) and forward head models (sphere, Finite Difference Model). Displays results using idealized MRI. Designed for use with Geodesic EEG System/Net Station. No hardware components.

Indications for Use

Indicated for adult and pediatric subjects aged 3 years and older for visualization of human brain function using EEG data fused with idealized head models and MRI images.

Regulatory Classification

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.

Predicate Devices

• Electroencephalograph Software eemagine EEG (K002631)
• CURRY Multimodal Neuroimaging Software (K001781)

Submission Summary (Full Text)

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K092844

GeoSource 510(k) Notification

## 510(k) SUMMARY

DEC 2 1 2010

| Submitter's name: | Electrical Geodesics, Inc.<br>1600 Millrace Drive, Suite 307, Eugene, OR 97403 | | |
|---------------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact name and address: | | Paul Holman<br>Electrical Geodesics, Inc.<br>1600 Millrace Dr., Suite 307, Eugene, OR 97403<br>541-687-7962 | |
| Date summary prepared: | | 12/21/10 | |
| Device name: | | . | |
| Proprietary name: | | GeoSource | |
| Common or usual name: | | Electroencephalograph software | |
| Classification name: | | Electroencephalograph, Class II, 882.1400<br>84 OLX, Source Localization Software for<br>Electroencephalograph or Magnetoencephalograph | |

Legally marketed devices for substantial equivalence comparison:

| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---------------|-----------------|------------------------------------------------|--------------------------------------------|
| K002631 | GWQ<br>882.1400 | Electroencephalograph Software<br>eemagine EEG | eemagine Medical<br>Imaging Solutions GmbH |
| K001781 | GWQ<br>882.1400 | CURRY Multimodal Neuroimaging<br>Software | Neurosoft, Inc. |

Description of the device:

GeoSource is an add-on software module to EGI's Net Station software and can only be used on EEG data generated by EGI hardware. It runs on a personal computer. It is used to approximate source localization of EEG signals and visualize those estimated locations. It uses the linear inverse methods LORETA, LAURA, and sLORETA and the sphere and Finite Difference forward head models.

Intended use of device:

GeoSource is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least 3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an idealized head model and an idealized MRI image.

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GeoSource 510(k) Notification

Technological characteristics:

| Characteristic | GeoSource<br>K092844 | Electroencephalograph<br>Software eemagine EEG<br>K002631 | CURRY Multimodal<br>Neuroimaging Software<br>K001781 |
|--------------------------|------------------------------------------|-----------------------------------------------------------|----------------------------------------------------------------------|
| Software only product? | Yes | Yes | Yes |
| EEG system | Geodesic EEG System using Net<br>Station | Variety of systems | Variety of systems |
| Computer OS | Mac OS | MS-Windows based | MS-Windows XP based |
| Method of calculation | Idealized head model (average) | Idealized head model (average) | Idealized head model (average)<br>Individualized head model |
| Method of display | Idealized MRI (average) | Idealized MRI (average) | Idealized MRI (average) |
| Source estimate methods: | | | |
| Dipole fit | No | Yes | Yes |
| Linear inverse methods | LORETA, LAURA, sLORETA | No | LORETA |
| Forward head models | Sphere | Boundary Element Model (BEM) | Sphere<br>Boundary Element Model (BEM)<br>Finite Element Model (FEM) |
| | Finite Difference Model (FDM) | | |

Both GeoSource and CURRY use the LORETA linear inverse method and sphere head models. These were demonstrated to be substantially equivalent. Then a retrospective clinical study was done that the other linear inverse methods and head models gave similar results. Therefore, the linear inverse methods and forward head models have been shown to be substantially equivalent.

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Non-clinical testing conducted:

Software verification and validation testing has been conducted. This includes verification of the algorithms and checks of accuracy.

## Clinical testing:

In order to compare the source localization accuracy of the GeoSource as compared to that of the predicate device, a retrospective data analysis of 20 epilepsy subjects aged 3 to 55 who had previously undergone resection surgery was provided. The analysis compared the source localization accuracy of the GeoSource software algorithms (i.e., LORETA, sLORETA, and LAURA with the GeoSource finite difference model [FDM]) to that of the predicate algorithm (i.e., LORETA using a spherical head model). All subjects had previously undergone high density (> 128 electrodes) EEG analysis prior to resection surgery, had operative data available that described the resected zone, and were determined to be Engel 1 or 2 postoperatively. The study included subjects with temporal and extratemporal resected zones.

Each subject's EEG data was reviewed by a clinical neurophysiologist who identified spikes within the EEG. Spikes were then grouped according to topographic distribution and then averaged relative to the peak of the spike to increase the signal-to-noise ratio. The average of this dominant group was used in the source estimate. The time point used in the source estimate was the rising slope of the spike. The data were then run through the GeoSource software algorithms (i.e., LORETA, sLORETA, and LAURA with the GeoSource finite difference model [FDM]) and the predicate algorithm (i.e., LORETA using a spherical head model).

Three experienced epileptologists from the University of Washington's Regional Epilepsy Center were provided the source localization results along with summaries of the postoperative reports and asked to rate whether each of the four algorithm solutions (i.e., LORETA, sLORETA, and LAURA with the GeoSource finite difference model [FDM] and the LORETA using a spherical head model) were located within the resected brain regions. The results demonstrated that the proposed GeoSource algorithms were substantially equivalent to the predicate device algorithm.

## Conclusions:

The conclusions drawn from the non-clinical and clinical tests demonstrate that GeoSource is as safe and effective as the predicate devices, Electroencephalograph Software eemagine EEG and CURRY Multimodal Neuroimaging Software.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Electrical Geodesics, Inc. c/o Mr. Paul Holman 600 Millrace Dr. Suite #307 Eugene, OR 97403

DEC 21 20100

Re: K092844

> Trade/Device Name: GeoSource Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph (EEG) Regulatory Class: Class II Product Code: OLX Dated: November 16, 2010 Received: November 19, 2010

Dear Mr. Holman:

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.

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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 (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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

E. Arthur Brown Jr.

Malvina B. Eydelman, M 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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## Indications for Use

510(k) Number (if known):

Device Name: GeoSource

Indications for Use:

GeoSource is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least 3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an idealized head model and an idealized MRI image.

Prescription Use
(Part 21 CFR 80T Subpart D)

AND/OR

Over-The-Counter Use 21 CFR 801 Subpart

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K092844