ELEKTA NEUROMAG WITH MAXWELL FILTER

K050035 · Elekta Neuromag OY · OLX · Jan 25, 2005 · Neurology

Device Facts

• Record ID: K050035
• Device Name: ELEKTA NEUROMAG WITH MAXWELL FILTER
• Applicant: Elekta Neuromag OY
• Product Code: OLX · Neurology
• Decision Date: Jan 25, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

The Elckta Neuromag® with Maxwell Filter is intended for use as a magnetoencephalographic (MEG) device which non-invasively detects and displays hiomagnetic 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 Maxwell Filter is a magnetoencephalography (MEG) system that measures biomagnetic signals from brain tissue; optionally records EEG signals. The Maxwell Filter component processes raw sensor data to separate brain signals from external magnetic disturbances and reduce measurement artifacts. The system records, displays, and allows trained physicians to interpret signal data to localize active brain regions. Localization results are correlated with anatomical brain information. Used in clinical settings for neurosurgical planning and identifying functional cortex (visual, auditory, somatosensory, motor) and epileptic activity regions. The device enhances diagnostic capability by providing spatial information about active nerve tissue.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technical characteristics and the addition of the Maxwell Filter for signal processing.

Technological Characteristics

Magnetoencephalographic (MEG) system with optional EEG capability. Features Maxwell Filter software for signal processing, disturbance separation, and artifact reduction. Computerized data acquisition system for signal recording and display. Class II device.

Indications for Use

Indicated for non-invasive measurement of MEG and optional EEG signals from electrically active brain tissue. Used by trained physicians to localize active areas, identify visual, auditory, somatosensory, and motor cortex (with evoked response averaging), and locate regions of epileptic activity. Localization data may be used in 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)

Submission Summary (Full Text)

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## ELEKTA NEUROMAG Oy

# JAN 2 5 2005

Special 510lk)

| Utfärdare/Issuer | Ref nr/Dok nr/Ref no/Doc no | Utgåva /Edition | Sida/Page |
|--------------------------------------|-----------------------------|-----------------|-----------|
| Louise Lindblad | | | 12 |
| Avser/Regarding | | Directory | |
| Elekta Neuromag® with Maxwell Filter | | | |

### Section 4 - 510(k) Summary

As Required by 21 CFR 807.87(k) 510(k) Summary

#### Subscribers Name & Address 1.

Elekta Neuromag Oy Elimäenkatu 22 B, P.O. Box 68 FIN-00511 Helsinki, Finland Tel: + 358 9 756 240 0 Fax: + 358 9 756 240 11

- Contact Person for this submission: Ms Louise Lindblad, Elekta Instrument AB, P.O. Box 7593, Stockholm, Sweden S-103 93
Official Correspondent: Mr Peter Löwendahl

#### Trade Name 2.

Elekta Neuromag with Maxwell Filter

#### Device Classification 3.

| Common Name | Classification<br>Number | Class | Regulation Number |
|-----------------------|--------------------------|-------|-------------------|
| Electroencephalograph | GWQ | II | 882.1400 |

#### 4. Regulatory History (Unmodified Predicate Device)

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### ELEKTA NEUROMAG Oy

Dokumentnamn/Name of document

| ELEKTA NEUROMAG Oy | | Special 510(k) | |
|--------------------------------------|-----------------------------|-----------------|-----------|
| Utfärdare/Issuer | Ref nr/Dok nr/Ref no/Doc no | Utgåva /Edition | Sida/Page |
| Louise Lindblad | | | 13 |
| Avser/Regarding | | Directory | |
| Elekta Neuromag® with Maxwell Filter | | | |

#### Device Description (for detailed description see Section "Device Description") 6.

The Elekta Neuromag with Maxwell Filter adds support for separating brain signals from external disturbances and reducing mcasurements artifacts.

#### 7. Indications for use:

The Flekta Neuromag® with Maxwell Filter 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.

#### 8. Intended Use:

The Elckta Neuromag® with Maxwell Filter is intended for use as a magnetoencephalographic (MEG) device which non-invasively detects and displays hiomagnetic 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.

### 9. Substantial Equivalence

The Elekta Neuromag® with Maxwell Filter is substantially equivalent to its predicate device the Elekta Neuromag® (K041264) in safety and effectiveness. The fundamental technical characteristics are similar to those of the predicate device and are listed on the comparison charts provided in this 510k submission.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 with three curved lines representing its wings and body. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 5 2005

Elekta Neuromag Oy c/o Ms. Louise Lindblad Elekta Instrument AB P.O. Box 7593 Stockholm, Sweden SE-103 93

Re: K050035

K050035
Trade/Device Name: Elekta Neuromag® with Maxwell Filter Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWQ Dated: January 4, 2005 Received: January 7, 2005

Dear Ms. Lindblad:

We have reviewed your Section 510(k) premarket notification of intent to market the devices in discri we nave reviewed your bection of the device is substantially equivalent (for the indications felerenced above and nave determined we are are and and one marketed in interstate for use stated in the encrosule) to tegans atment date of the Medical Device Amendments, or to commerce provide to May 20, 1976, the exactions of the Federal Food, Drug, devices that have occh reculasined in access approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r out may, mercrore, manel are as not, and include requirements for annual registration, listing of general controls provisions of use tice, 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 If your device is classified (500 above) ans. Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in ther announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean i lease be advised that i Dr i seem that your device complies with other requirements of the Act that I DA has made a actoriniations administered by other Federal agencies. You must or any I edetal slated and registanents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IC Fart 6077, adoling (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quarty bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Ms. Louise Lindblad

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ough manteeing your antial equivalence of your device to a legally premarket nothleation: "The PDA mining of basification 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 If you desire specific advice for Jour at 11-10-11 5. Also, please note the regulation entitled, Colliact the Office of Compulance an (21 t notification" (21CFR Part 807.97). You may obtain Misolanding by reference to premainterial interest of the Act from the Division of Small other general information on your response Assistance at its toll-free number [phone] or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Miriam C Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### ELEKTA NEUROMAG OY

. • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • •

Dokumentnamn/Name of document

| ELEKTA NEUROMAG Oy | | Special 510(k) | |
|--------------------------------------|-----------------------------|-----------------|-----------|
| Utfärdare/Issuer | Ref nr/Dok nr/Ref no/Doc no | Utgåva /Edition | Sida/Page |
| Louise Lindblad | | | 16 |
| Avser/Regarding | | | |
| Elekta Neuromag® with Maxwell Filter | | Directory | |

### Section 7- Indications for Use Statement

| 510(k) Number | defined K050035 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Elekta Neuromag® with Maxwell Filter |
| Indications for Use | The Elekta Neuromag® with Maxwell Filter non-invasively measures<br>the magnetoencephalographic (MEG) signals (and, optionally,<br>electroencephalographic (EEG) signals) produced by electrically active<br>tissue of the brain. These signals are recorded by a computerized data<br>acquisition system, displayed, and may then be interpreted by trained<br>physicians to help localize these active areas. The locations may then<br>be correlated with anatomical information of the brain. MEG is<br>routinely used to identify the locations of visual, auditory,<br>somatosensory, and motor cortex in the brain when used in<br>conjunction with evoked response averaging devices. MEG is also used<br>to non-invasively locate regions of epileptic activity within the brain.<br>The localization information provided by MEG may be used, in<br>conjunction with other diagnostic data, in neurosurgical planning. |

X Prescription Use_ (Per 21 CFR 801 Subpart D)

— — — — — — — —

AND/OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

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Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

K650035 58 98, 11 1 0 0 2 0 0 0 0 0 0 0 0 0 0 5 5 5 9 756 2400 Fax [phone]
1 1 0 0 0 0 0 0 0 Elekta Neuromag O