MAXINSIGHT

K070358 · Eemagine Medical Imaging Solutions GmbH · OLX · Jul 30, 2007 · Neurology

Device Facts

• Record ID: K070358
• Device Name: MAXINSIGHT
• Applicant: Eemagine Medical Imaging Solutions GmbH
• Product Code: OLX · Neurology
• Decision Date: Jul 30, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended 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 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

Device Story

MaxInsight is a software-only product for personal computers; it imports digitized MEG and co-registered EEG data. The software fuses these signals with anatomical brain information derived from either idealized head models/MRIs or subject-specific MRI-based head models. It generates topographic maps and displays electrical brain activity correlated to anatomical structures. Operated by trained MEG technologists or physicians in clinical settings, the software provides visualization tools and a report generator for clinical documentation. By integrating functional MEG/EEG data with anatomical MR images, the device assists clinicians in interpreting brain activity, supporting clinical decision-making regarding neurological function.

Clinical Evidence

Bench testing only. Validation testing was performed to ensure compliance with product specifications and to demonstrate that the software performs in a substantially equivalent manner to the predicate device.

Technological Characteristics

Software-only product; runs on standard personal computers. Supports digital MEG/EEG review, topographic magnetic field mapping, and topographic voltage mapping. Requires external MEG/EEG acquisition system for signal digitization. No specialized hardware required.

Indications for Use

Indicated for adult and pediatric subjects requiring visualization of human brain function via fusion of MEG/EEG data with idealized or subject-specific MR head models.

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

• Elekta Neuromag (K041264)

Submission Summary (Full Text)

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K070358

JUL 3 0 2007

510(K) Summary Page 1 of 2 eemagine Medical Imaging Solutions GmbH Gubener Str. 47 D-10243 Berlin Germany Phone [phone] [phone] Fax e-mail [e-mail] 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 ..

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## 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.

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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 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.

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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,

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

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## 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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