(462 days)
Not Found
No
The device description explicitly states it uses linear inverse methods (LORETA, LAURA, sLORETA) and standard head models (sphere, Finite Difference), which are traditional signal processing techniques, not AI/ML. There is no mention of AI, DNN, or ML in the provided text.
No
The device is described as an "add-on software module" that "approximates source localization of EEG signals and visualizes those estimated locations." Its "intended use" is for "visualization of human brain function" by fusing EEG information with images. There is no mention of treating or diagnosing a disease or condition, which would make it a therapeutic device.
Yes
The device is intended for use by a trained/qualified EEG technologist or physician for the visualization of human brain function by fusing EEG information with rendered images, and for approximating source localization of EEG signals and visualizing estimated locations. This information assists in understanding brain function and locating neurological activity, which are diagnostic purposes. The performance study also involves evaluating source localization results in relation to resected brain regions in epilepsy subjects, further supporting its diagnostic application.
Yes
The device description explicitly states that GeoSource is an "add-on software module" and "runs on a personal computer," indicating it is a software-only component that processes data from separate hardware (EGI's Net Station and EEG hardware).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- GeoSource's Function: GeoSource processes EEG data, which is a measurement of electrical activity in the brain. It does not analyze biological samples taken from the body.
- Intended Use: The intended use describes visualization of brain function by fusing EEG information with head models and MRI images. This is a diagnostic tool for analyzing brain activity, not for testing biological samples.
Therefore, GeoSource falls under the category of a medical device used for diagnostic purposes, but specifically for analyzing physiological signals (EEG) rather than biological samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OLX
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
EEG
Anatomical Site
human brain
Indicated Patient Age Range
adult and pediatric subjects at least 3 years of age
Intended User / Care Setting
trained/qualified EEG technologist or physician
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
A retrospective data analysis of 20 epilepsy subjects aged 3 to 55 who had previously undergone resection surgery was provided. 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).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical testing: A retrospective clinical study was done to compare the source localization accuracy of the GeoSource as compared to that of the predicate device. 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). 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.
Non-clinical testing: Software verification and validation testing has been conducted. This includes verification of the algorithms and checks of accuracy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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
GeoSource 510(k) Notification
510(k) SUMMARY
DEC 2 1 2010
| Submitter's name: | Electrical Geodesics, Inc.
1600 Millrace Drive, Suite 307, Eugene, OR 97403 | | |
|---------------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact name and address: | | Paul Holman
Electrical Geodesics, Inc.
1600 Millrace Dr., Suite 307, Eugene, OR 97403
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
84 OLX, Source Localization Software for
Electroencephalograph or Magnetoencephalograph | |
Legally marketed devices for substantial equivalence comparison:
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| K002631 | GWQ | ||
| 882.1400 | Electroencephalograph Software | ||
| eemagine EEG | eemagine Medical | ||
| Imaging Solutions GmbH | |||
| K001781 | GWQ | ||
| 882.1400 | CURRY Multimodal Neuroimaging | ||
| 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.
1
GeoSource 510(k) Notification
Technological characteristics:
| Characteristic | GeoSource
K092844 | Electroencephalograph
Software eemagine EEG
K002631 | CURRY Multimodal
Neuroimaging Software
K001781 |
|--------------------------|------------------------------------------|-----------------------------------------------------------|----------------------------------------------------------------------|
| Software only product? | Yes | Yes | Yes |
| EEG system | Geodesic EEG System using Net
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)
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
Boundary Element Model (BEM)
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.
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,
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