(7 days)
No
The summary describes image processing and display of fMRI data but does not mention AI, ML, or related terms. The focus is on standard BOLD signal processing and visualization.
No
The device is described as aiding in the "determination of a course of treatment" by providing diagnostic information (brain mapping results), not by directly treating a condition.
Yes
The "Intended Use / Indications for Use" section states that "When interpreted by a trained physician these results may be useful in the determination of a course of treatment," which indicates it provides information for medical decision-making related to patient care.
No
The device description explicitly states it is a "software and hardware package" and mentions its use with MRI systems, which are 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.
- Device function: The GE Functional Brain Mapping Option and BrainWave Option are used to acquire, process, and display the results of in vivo (within the living body) MRI scans of the brain. They analyze the BOLD signal, which is a physiological response within the brain itself.
- No sample analysis: The device does not analyze samples taken from the body. It directly interacts with and measures activity within the body.
Therefore, this device falls under the category of in vivo diagnostic imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The GE Functional Brain Mapping Option is a software and hardware package that can be used to acquire, process and display the results of BOLD (blood oxygen level dependent) MRI scan studies taken in the presence of synchronized stimuli presented to a person being scanned. When interpreted by a trained physician these results may be useful in the determination of a course of treatment.
Product codes
90 LNH
Device Description
The GE BrainWave Option(s) for MRI systems is a modification to the GE Functional Brain Mapping Imaging Option for MRI systems. The GE BrainWave Option(s) produces difference images highlighting changes in blood oxygen level dependent (BOLD) images over time. These differences corresponding to changing stimuli presented to patients that are synchronized with scanning. The resulting parametric or activation images are superimposed on structural images from the same patient. The device can be used to acquire, process and display the results of BOLD (blood oxygen level dependent) MRI studies with or without external stimulation hardware.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
Brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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)
The GE BrainWave Option(s) for MRI systems was evaluated to the appropriate NEMA performance standards as well as the IEC 60601-1 International Medical Equipment Safety standard and IEC 60601-2-33 Particular Requirements for Safety of Magnetic Resonance Equipment for Medical Diagnosis. The GE BrainWave Option(s) for MRI systems is comparable to the currently marketed GE Functional Brain Mapping Option for MRI systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular shape. The letters are in a stylized font, and the circle has a swirling pattern around the letters. The logo is black and white.
03 3867
GE Medical Systems
General Electric Company P.O. Box 414, Milwaukee, Wi 53201
510(k) Summarv
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.92(c).
| Submitter: | GE Medical Systems
PO Box 414
Milwaukee, WI 53201 |
|-----------------|---------------------------------------------------------|
| Contact Person: | Larry A. Kroger Ph.D.
Manager, Regulatory Programs |
| Telephone: | 262- 544-3894 |
| Fax: | 262- 548-4768 |
| Date Prepared: | December 9, 2003 |
Device Name:
GE BrainWave Option(s) for MRI systems Magnetic Resonance Diagnostic System, 21 CFR 892.1000, 90-LNH
Marketed Device:
The GE BrainWave Option(s) for MRI systems is substantially equivalent to the currently marketed GE Functional Brain Mapping (K003947) with the main differences being that the product will be configured in several different ways, none of which include external stimulation hardware.
Device Description:
The GE BrainWave Option(s) for MRI systems is a modification to the GE Functional Brain Mapping Imaging Option for MRI systems. The GE BrainWave Option(s) produces difference images highlighting changes in blood oxygen level dependent (BOLD) images over time. These differences corresponding to changing stimuli presented to patients that are synchronized with scanning. The resulting parametric or activation images are superimposed on structural images from the same patient. The device can be used to acquire, process and display the results of BOLD (blood oxygen level dependent) MRI studies with or without external stimulation hardware.
Indications for Use:
The GE Functional Brain Mapping Option is a software and hardware package that can be used to acquire, process and display the results of BOLD (blood oxygen level dependent) MRI scan studies taken in the presence of synchronized stimuli presented to a person being scanned. When interpreted by a trained physician these results may be useful in the determination of a course of treatment.
1
Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a stylized script, enclosed within a circular frame. The logo is black and white.
General Electric Company P.O. Box 414, Milwaukee, WI 53201
Comparison with Predicate Device:
Oompanoon www.vousings.com is a modification of the GE Functional Brain
The GE BrainWave Option(s) for MRI systems difference boing the various configurations The GE BrainWave Option(s) for MH systems is a modiference being the various configurations
Mapping Option for MRI systems, with the main difference being the various config that the product is marketed in.
Summary of Studies:
Gummerly .
The GE BrainWave Option(s) for MRI systems was evaluated to the appropriate NEMA
The GE BrainWave Option(s) for MRI systems of International Modical Fruinment Sale The GE BrainWave Option(s) for Mini Systems was Systems Modical Equipment Safety
performance standards as well as the IEC 60601-1 International Medical Resonance performance standards as well as the Incometits for Safety of Magnetic Resonance
standard and IEC 60601-2-33 Particular Requirements for Safety of Magnetic Resonance standard and fEC 60601-2-33 Fatilicular Trequirente oprion(s) for MHs) systems is
Equipment for Medical Diagnosis. The GE BrainMave Option(or MB) Equipment for Medical Diagnosis. The GE DrainWave Option (or MR =ystems.
comparable to the currently marketed GE Functional Brain Mapping Option for MRI systems.
Conclusion:
Oonblacion:
It is the opinion of GE that the GE BrainWave Option(s) for MRI systems is substantially It is the opinion of GE that the GE Brainwave Option for MRI wystems. Usage of the GE
equivalent to the GE Functional Brain Mapping Option for now notograph the GE equivalent to the GE Functional Drain Mapping Option NFF
BrainWave Option(s) for MRI systems does not result in any new potential hazards.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle or other bird with three curved lines representing its body and wings. The bird is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 2003
Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager General Electric Co. GE Medical Systems P.O. Box 414 MILWAUKEE WI 53201
Re: K033867 Trade/Device Name: GE BrainWave Option(s) for MRI Systems Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: December 9, 2003 Received: December 12, 2003
Dear Dr. Kroger:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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); 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.
3
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. Ixxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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GE Medical Systems
General Electric Company P.O. Box 414, Milwaukee, WI 53201
STATEMENT OF INTENDED USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: GE BrainWave Option(s) for MRI systems
Indications for Use
The GE Functional Brain Mapping Option is a software and hardware package that can be used to acquire, process and display the results of BOLD (blood oxygen level dependent) MRI scan studies taken in the presence of synchronized stimuli presented to a person being scanned. When interpreted by a trained physician these results may be useful in the determination of a course of treatment.
David A. Seymour
(Division Sign-Off Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number .
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801-109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________