(56 days)
Not Found
Not Found
No
The description focuses on photogrammetry and image processing for electrode localization, with no mention of AI or ML terms or concepts.
No
The device is described as a system for recording electrode locations, and its intended use does not include treating or diagnosing a disease or condition. It is an accessory for EEG systems.
No
The device is used for recording precise locations of EEG electrodes and is an accessory to an EEG system. It does not provide any diagnostic information itself.
No
The device description explicitly lists hardware components including a geodesic dome structure, cameras, a steel supporting structure, and a dedicated computer, in addition to the software.
Based on the provided information, the Geodesic Photogrammetry System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to record the precise locations of EEG electrodes on a patient's head. This is a measurement of a physical characteristic (electrode position) on the patient's body.
- Device Description: The device description confirms it's a system for capturing images of the head with the sensor net. It explicitly states "No part of the Geodesic Photogrammetry System touches the patient."
- Lack of Biological Sample Analysis: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. This device does not analyze any biological samples.
The device is used in conjunction with an EEG system, which is a medical device, but the Geodesic Photogrammetry System itself is an accessory for positioning and recording the location of the EEG electrodes on the patient's head. This falls under the category of a medical device accessory, but not an IVD.
N/A
Intended Use / Indications for Use
The Geodesic Photogrammetry System is intended for use in recording precise locations of EEG electrodes in the Geodesic Sensor Net on a patient's head.
Product codes (comma separated list FDA assigned to the subject device)
GWQ, KQM
Device Description
The GPS consists of a geodesic dome structure containing 11 mounted cameras, a steel supporting structure, a dedicated computer, and accompanying software. It is used with a Geodesic Sensor Net and any EGI Geodesic EEG system. It allows the user to record the locations of the dense array EEG electrodes on a patient's head. No part of the Geodesic Photogrammetry System touches the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's head
Indicated Patient Age Range
Not Found
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)
Testing was conducted to international standards related to electrical safety and electromagnetic compatibility. The GPS passed all essential performance tests. 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.
Not Found
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).
0
04 3309
JAN 2 6 2005
Page ① of :
510(k) SUMMARY
| Submitter's name: | Electrical Geodesics, Inc.
1600 Millrace Drive, Suite 307, Eugene, OR 97403
541-687-7962 |
| ------------------- | ------------------------------------------------------------------------------------------------ |
|---|
Linda J. Bovard, Bovard Consulting LLC Contact name: 29611 Simmons Road, Eugene, OR 97405 541-345-2431
November 19, 2004 Date summary prepared:
Device name:
Geodesic Photogrammetry System (GPS) Proprietary name: EEG accessory Common or usual name: Classification name: Electroencephalograph, 84 GWQ Class II, 21 CFR 882.1400.
Legally marketed device for substantial equivalence comparison:
There is no predicate accessory for EEG. The Geodesic Photogrammetry System (GPS) is substantially equivalent to surgical cameras used as recording accessories to surgical procedures (21 CFR 878.4160, 79 KQM). In the same way, this accessory does not alter the intended use, the environment for use, or the target population of the previously cleared Electrical Geodesics, Inc. Geodesic EEG System (EGI GES) products with which it can be used. It simply records the use of the main product.
Description of the device:
The GPS consists of a geodesic dome structure containing 11 mounted cameras, a steel supporting structure, a dedicated computer, and accompanying software. It is used with a Geodesic Sensor Net and any EGI Geodesic EEG system. It allows the user to record the locations of the dense array EEG electrodes on a patient's head. No part of the Geodesic Photogrammetry System touches the patient.
Intended use of device:
The Geodesic Photogrammetry System is intended for use in recording precise locations of EEG electrodes in the Geodesic Sensor Net on a patient's head.
Technological characteristics:
The Geodesic Photogrammetry System is an accessory to EGI's GES products. It contains digital cameras arranged to record EEG clectrode placement. The cameras are controlled by software. The GPS does not change the main GES products in any way.
Testing conducted:
Testing was conducted to international standards related to clectrical safety and electromagnetic compatibility. The GPS passed all essential performance tests.
Performance testing:
Comparative performance testing and clinical evaluations were not submitted as part of this 510(k).
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Electrical Geodesics Incorporated c/o Ms. Linda J. Bovard, RAC Bovard Consulting LLC 29611 Simmons Road Eugene, Oregon 97405
Re: K043309
Trade/Device Name: Geodesic Photogrammetry System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWO, KOM Dated (Date on orig SE ltr): November 22, 2004 Received (Date on orig SE Itr): December 1, 2004
APR - 9 2012
Dear Ms. Bovard:
This letter corrects our substantially equivalent letter of January 26, 2005.
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.
2
Page 2 - Ms. Linda J. Bovard, RAC
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/ReportalProblem/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. Evdelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Appendix 1
Indications for Use
510(k) Number (if known): K043309
Device Name: Geodesic Photogrammetry System
Indications for Use: The Geodesic Photogrammetry System is intended for use in recording precise locations of EEG electrodes in the Geodesic Sensor Net on a patient's head.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
. . . . . . . . . .
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
Page 4 of 10