(173 days)
Not Found
No
The description focuses on visualization and data display, with all functions controlled and interpreted by the user. There is no mention of automated analysis, learning, or adaptive algorithms.
No
The software is for visualizing human brain function and provides tools for analysis and reporting; it does not directly treat or diagnose conditions.
No
Explanation: The device is intended for visualization of brain function by fusing MEG and EEG information with rendered images. It displays brain activity and allows user interpretation, but it does not perform a diagnosis itself. It is a tool for a trained professional to use in evaluating brain function.
Yes
The device description explicitly states "The MaxInsight ™ software is a software-only product. It runs on a personal computer and requires no specialized 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the software is used for the "visualization of human brain function" by processing and displaying MEG and EEG data, along with anatomical information from MR images. It's a tool for analyzing and visualizing signals and images related to brain activity.
- No Sample Analysis: There is no mention of the software analyzing biological samples taken from the patient. The inputs are digital signals (MEG/EEG) and image data (MR).
- Intended Use: The intended use is for visualization and interpretation of brain function, not for performing diagnostic tests on biological samples.
Therefore, the MaxInsight™ software, as described, falls under the category of medical device software used for analysis and visualization of physiological and anatomical data, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The software is intended for use by a trained/qualified MEG technologist or physician on both adult and pediatric subjects for the visualization of human brain function by fusing a variety of magnetocncephalographic (MEG) and electroencephalographic (EEG) information with rendered images of either an idealized head model and an idealized magnetic resonance (MR) image or a subject's MR image based head model and the subject's MR images.
Product codes
OLK
Device Description
The MaxInsight software is a software-only product. It runs on a personal computer and requires no specialized hardware. It displays digitized MEG signals, topographic maps, etc. It displays electrical brain activity correlated to anatomical brain information, which is provided by means of either an idealized head model and an idealized MRI image or a subject's MRI image based head model and the subject's MRI images. These functions are all controlled and interpreted by the user. The MaxInsight software imports digital MEG and co-registered EEG data (in the Neuromag Functional Image File Format) and permits its visualization. The digitized MEG/EEG input is read from a file on the personal computer (or available across the network). The software also provides a report generator to transfer relevant information, such as patient and recording information, event information, topographic images and images of brain activity, to a printable document.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
magnetoencephalographic (MEG) and electroencephalographic (EEG) information with rendered images of either an idealized head model and an idealized magnetic resonance (MR) image or a subject's MR image based head model and the subject's MR images
Anatomical Site
human brain
Indicated Patient Age Range
adult and pediatric subjects
Intended User / Care Setting
trained/qualified MEG technologist or 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)
Predetermined software development processes were employed in the design and testing of this software product, and validation testing was performed to ensure compliance with the product specifications. The tests demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device. After analyzing both bench and clinical testing data, it is the precedes as not relies and Jang Solutions GmbH that the MaxInsight™ software is as safe and effective as the predicate devices, has few technological differences, and has no new indication for use, thus rendering it substantially equivalent to the data analysis package of the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K041264, Elekta Neuromag, manufactured by Elekta Neuromag Oy
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
JUL 3 0 2007
510(K) Summary Page 1 of 2 eemagine Medical Imaging Solutions GmbH Gubener Str. 47 D-10243 Berlin Germany Phone +49 (0)30 29048404 +49 (0)30 29048405 Fax e-mail info@eemagine.com Contact: Frank Zanow, President Date prepared: June 23, 2007
- Trade Name: MaxInsight™ 1. Common Name: Electroencephalograph Software Classification Name: Electroencephalograph, product code OLK Regulation: 882.1400 Class of device: Class II.
- The legally marketed device to which we are claiming equivalence [807.92(a)(3)] : 2. K041264, Elekta Neuromag, manufactured by Elekta Neuromag Oy
- Description of device: The MaxInsight ™ software is a software-only product. It runs 3. on a personal computer and requires no specialized hardware. It displays digitized MEG signals, topographic maps, etc. It displays electrical brain activity correlated to anatomical brain information, which is provided by means of either an idealized head model and an idealized MRI image or a subject's MRI image based head model and the subject's MRI images. These functions are all controlled and interpreted by the user. The MaxInsight software imports digital MEG and co-registered EEG data (in the Neuromag Functional Image File Format) and permits its visualization. The digitized MEG/EEG input is read from a file on the personal computer (or available across the network). The software also provides a report generator to transfer relevant information, such as patient and recording information, event information, topographic images and images of brain activity, to a printable document.
- Intended use: The software is intended for use by a trained/qualified MEG 4. technologist or physician on both adult and pediatric subjects for the visualization of human brain function by fusing a variety of magnetoencephalographic (MEG) and electroencephalographic (EEG) information with rendered images of either an idealized head model and an idealized magnetic resonance (MR) image or a subject's MR image based head model and the subject's MR images
- Technological characteristics: Both MaxInsight™ and the data analysis software of ર. Elekta Neuromag support the following digital MEG/EEG review, topographic magnetic fields, topographic voltage. Both require that the signal be digitized by a separate MEG/EEG acquisition system. MaxInsight is a software only product, whereas the analysis software package of Elekta Neuromag is part of a system to measure and analyze MEG and optionally EEG signals ..
1
510(K) Summary Page 2 of 2 eemagine Medical Imaging Solutions GmbH
- Predetermined software development processes were employed in the હ. Performance: design and testing of this software product, and validation testing was performed to ensure compliance with the product specifications. The tests demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device. After analyzing both bench and clinical testing data, it is the precedes as not relies and Jang Solutions GmbH that the MaxInsight™ software is as safe and effective as the predicate devices, has few technological differences, and has no new indication for use, thus rendering it substantially equivalent to the data analysis package of the predicate devices.
2
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 eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The logo is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Eemagine Medical Imaging Solutions GMBH c/o Mr. Daniel Kamm Kamm & Associates P.O. Box 7007 Deerfield, IL 60015
APR - 9 2012
Re: K070358 Trade/Device Name: Maxinsight™ Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLX Dated (Date on orig SE ltr): June 23, 2007 Received (Date on orig SE ltr): June 25, 2007
Dear Mr. Kamm:
This letter corrects our substantially equivalent letter of July 30, 2007.
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 (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 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.
3
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,
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
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The software is intended for use by a trained/qualified MEG technologist or physician on both adult and pediatric subjects for the visualization of human brain function by fusing a variety of magnetocncephalographic (MEG) and electroencephalographic (EEG) information with rendered images of either an idealized head model and an idealized magnetic resonance (MR) image or a subject's MR image based head model and the subject's MR images
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Erallustion (ODE)
(Division S
Division of Gene storative. and Normingical
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