ELEKTA NEUROMAG WITH MAXFILTER

K091393 · Elekta Neuromag OY · OLX · Oct 26, 2010 · Neurology

Device Facts

• Record ID: K091393
• Device Name: ELEKTA NEUROMAG WITH MAXFILTER
• Applicant: Elekta Neuromag OY
• Product Code: OLX · Neurology
• Decision Date: Oct 26, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

The Elekta Neuromag® with MaxFilter 2.1 is intended for use as a magnetoencephalographic (MEG) device which non-invasively detects and displays biomagnetic signals produced by electrically active nerve tissue in the brain. When interpreted by a trained clinician, the data enhances the diagnostic capability by providing useful information about the location relative to brain anatomy of active nerve tissue responsible for critical brain functions.

Device Story

Elekta Neuromag® with MaxFilter 2.1 is a magnetoencephalography (MEG) system; records biomagnetic signals from brain; optionally records EEG. System uses computerized data acquisition; processes signals via MaxFilter software to eliminate interference; employs spatial signal space separation (SSS) and spatiotemporal signal space separation (tSSS). Supports internal active shielding. Used in clinical settings by trained physicians; output displayed for interpretation to localize active nerve tissue; correlates with brain anatomy. Assists in neurosurgical planning and identifying epileptic foci. Modifications include improved graphical user interface and offline averager functionality. Device provides non-invasive diagnostic information to clinicians for surgical decision-making.

Clinical Evidence

Performance testing included software validation, phantom testing, and clinical testing. Phantom testing demonstrated accuracy within 2 mm of the source. Clinical study with non-moving heads confirmed measurement accuracy substantially equivalent to the predicate device.

Technological Characteristics

MEG system utilizing SSS and tSSS algorithms for interference elimination. Supports internal active shielding. Features graphical user interface and offline averager. Software-based signal processing for artifact reduction. Connectivity includes computerized data acquisition system.

Indications for Use

Indicated for non-invasive measurement of MEG and optional EEG signals from brain tissue. Used by trained physicians to localize active brain areas, including visual, auditory, somatosensory, and motor cortex, and to locate regions of epileptic activity. Localization data used in conjunction with other diagnostic data for neurosurgical planning.

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)
• Elekta Neuromag® with Maxwell Filter (K050035)

Reference Devices

• Internal active shielding method (K081430)

Submission Summary (Full Text)

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510(K) Summary K091393. Elekta Oy Siltasaarenkatu 18-20 A FI-00530 Helsinki, Finland (P.O. Box 34, FI-00531 Helsinki, Finland) Tel: [phone] Fax: [phone] Contact: Mrs Anne Karvinen Date prepared: October 23, 2010

OCT 2 6 2010

- Trade Name: Elekta Neuromag® with MaxFilter 2.1 1.
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- Common Name: Electroencephalograph (Magnetoencephalograph) 2.
- Classification Name: Electroencephalograph, product codes OLX and OLY, 3. Regulation: 882.1400 Class of device: Class II.
- The legally marketed device to which we are claiming equivalence [807.92(a)(3)] : 4. K041264, Elekta Neuromag®, K050035, Elekta Neuromag® with Maxwell Filter
- Description of device: This premarket notification represents modifications made to our 5. current product. The present device differs from the predicate device, K050035, Elekta Neuromag® with Maxwell Filter only in the following areas of functionality: Spatiotemporal interference elimination, Graphical user interface; and Offline averager. The modification also adds compatibility with internal active shielding, an interference removal method described in K081430.
- Intended use: The Elekta Neuromag® with MaxFilter 2.1 is intended for use as a 6. magnetoencephalographic (MEG) device which non-invasively detects and displays biomagnetic signals produced by electrically active nerve tissue in the brain. When interpreted by a trained clinician, the data enhances the diagnostic capability by providing useful information about the location relative to brain anatomy of active nerve tissue responsible for critical brain functions.
- Indications for use: Elekta Neuromag® with MaxFilter 2.1 non-invasively measures the 7. magnetoencephalographic (MEG) signals (and, optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, somatosensory, and motor cortex in the brain when used in conjunction with evoked response averaging devices. MEG is also used to non-invasively locate regions of epileptic activity within the brain. The localization information provided by MEG may be used, in conjunction with other diagnostic data, in neurosurgical planning,
- Technological characteristics: MaxFilter™ is intended to be used with Elekta 8. Neuromag® MEG products in reducing measurement artifacts.

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- Performance: Performance testing consisted of software validation, phantom testing and 9. clinical testing. As compared to predicate, the Elekta Neuromag® with MaxFilter™ 2.1 modifications is within 2 mm accuracy of the source in a phantom and provided substantially equivalent measurement accuracy in a clinical study with non-moving heads.
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| Feature | Predicate<br>devices<br>K050035 | Modified Device<br>MaxFilter™ 2.1 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|-----------------------------------|
| Automated detection of bad channels | Yes | Yes |
| Support for Internal Active Shielding (K081430) | No | Yes |
| Interference elimination | | |
| Software shielding, interference elimination<br>with spatial signal space separation (SSS) | Yes | Yes |
| Interference elimination with spatiotemporal<br>signal space separation (tSSS) | No | Yes |
| Offline averager function to process raw data files<br>To improve user friendliness, online averager<br>that exists already in data acquisition software,<br>is also available in MaxFilter as offline version.<br>No clinical utility. | No | Yes |
| Graphical user interface | | |
| To improve user friendliness, parallel to<br>command line user interface, also a graphical<br>user interface is available in MaxFilter™ 2.1.<br>Both user interfaces perform same software<br>modules (code) of the SSS technologies. No<br>clinical utility. | No | Yes |

## Comparison Table

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Elekta Neuromag Oy c/o Mr. Daniel Kamm, P.E. Kamm & Associates 8726 Ferrara Ct. Naples, FL 34114

QCT 2 6 2010

Re: K091393

Trade/Device Name: Elekta Neuromag with Maxfilter Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLX, OLY Dated: July 7, 2010 Received: July 12, 2010

Dear Mr. Kamm:

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. Ilisting 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.

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Page 2 - Mr. Daniel Kamm, P.E.

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.

http://www.fda.gov/MedicalDevices/ResourcestoYourIndustry/default.htm.

Sincerely vours.

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): K09 | 393

OCT 2 6 2010

TM Device Name: Elekta Neuromag® with MaxFilter

Indications For Use:

Elekta Neuromag® with MaxFilter™ non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, somatosensory, and motor cortex in the brain when used in conjunction with evoked response averaging devices. MEG is also used to non-invasively locate regions of epileptic activity within the brain. The localization information provided by MEG may be used, in conjunction with other diagnostic data, in neurosurgical planning.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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 Evaluation (ODE)

Kristen Bowsher
(Division Sign-on)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

\$10(k) Number_K091393

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