ELEKTA OY

K041264 · Elekta Neuromag OY · OLX · Aug 10, 2004 · Neurology

Device Facts

• Record ID: K041264
• Device Name: ELEKTA OY
• Applicant: Elekta Neuromag OY
• Product Code: OLX · Neurology
• Decision Date: Aug 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

The Elekta Neuromag™ is intended for use as a magneto encephalographic (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™ is an upgraded MEG system measuring magnetic signals from intracellular dendritic currents in the brain. Device utilizes a helmet-shaped array containing 306 sensor elements (planar gradiometers and magnetometers) to record electrical activity across the entire brain surface simultaneously. System integrates sensors with computers and data acquisition/analysis software. Operated by trained clinicians in a clinical setting; output consists of displayed biomagnetic signals and localized active brain areas. Clinicians interpret these outputs to identify functional cortex (visual, auditory, somatosensory, motor) and epileptic regions. Localization data is correlated with anatomical brain information to assist in neurosurgical planning. Benefits include non-invasive mapping of brain function and pathology, aiding surgical decision-making.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technical characteristics and comparison to the predicate device.

Technological Characteristics

System features 306 sensor elements, including planar gradiometers and magnetometers, arranged in a helmet-shaped array. Integrates computerized data acquisition and analysis software. Supports optional EEG signal recording. Operates as a magnetoencephalograph (MEG) for non-invasive brain signal detection.

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 brain 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

• Omega Whole-Cortex MEG System (K030737)

Reference Devices

• Neuromag Vectorview (K984401)

Submission Summary (Full Text)

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K 041264

# ELEKTA NEUROMAG OY

Dokumentnamn/Name of do Traditional 510fk)

| Ulfärdare/Issuer | Louise Lindblad |
|-----------------------------|------------------|
| Avser/Regarding | Elekta Neuromag™ |
| Rel nr/Dak ns/Rof no/Doc no | |
| Utgåva /Edition | Directory |
| Sida/Page | |

AUG 1 0 2004

### Section 5- 510(k) Summary As Required by 21 CFR 807.87(k)510 (k) Summary

### 1. Subscribers Name & Address

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: Birgitta Fagerström Official Correspondent: Birgitta Fagerström

#### Trade Name 2.

Elekta Neuromag™

#### 3. Device Classification

| Common Name | Product Code | Class | Regulation Number |
|-----------------------|--------------|-------|-------------------|
| Electroencephalograph | GWQ | II | 882.1400 |

#### 4. Predicate Device Identification

| Legally marketed devices to which equivalence is being claimed | 510(k) # |
|----------------------------------------------------------------|----------|
| Omega Whole-Cortex MEG System | K030737 |

#### ડ. Other relevant submissions

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| ELEKTA NEUROMAG OY | | Dokumentnamn/Name of document<br>Traditional 510(k) | |
|-------------------------------------|-----------------------------|-----------------------------------------------------|-----------|
| Utfärdara/Issuer<br>Louise Lindblad | Ref nr/Dok nr/Ref no/Doc no | Utgåva / Edition | Sido/Page |
| Avser/Regarding<br>Elekta Neuromag™ | | Directory | |

Device Description (for detailed description see Section "Device Description") હ.

The Elekta Neuromag™ is an upgraded version of the currently available Neuromag Vectorview (K984401). The Elekta Neuromag™ does not change the intended use or the fundamental scientific technology of the Neuromag Vectorview.

The Elekta Neuromag™ integrates 306 sensor elements, including planar gradiometers and and magnetometers, with computers and data acquisition and data analysis software in order to measure the differences in the magnetic signals generated by the intracellular dendritic currents. These detectors are positioned in a helmet shaped array that gives the user the ability to record the electrical activity of the entire surface of the brain simultaneously without having to move the position of the measuring device.

#### 7. Indications for use:

The Elekta Neuromag™ non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electrocncephalographic (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 Elekta Neuromag™ is intended for use as a magneto encephalographic (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.

#### 9. Substantial Equivalence:

The Elekta Neuromag™ is substantially equivalent to its predicate device the Omega Whole-Cortex MEG System (K030737) 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 510 k submission.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

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

Ms. Birgitta Fagerström Manager, Quality and Regulatory Affairs Elekta Neuromag Ov Elimäenkatu 22 B, P.O. Box 68 FIN-00511 Helsinki, Finland

Re: K041264 Trade/Device Name: Elekta Neuromag® Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLX, OLY, GWQ Dated (Date on orig SE ltr): May 12, 2004

Received (Date on orig SE ltr): May 12, 2004

APR

Dear Ms. Fagerström:

This letter corrects our substantially equivalent letter of August 10, 2004.

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. Iisting 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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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 vours.

Kesia Alexander

Malvina B. Evdelman, 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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## ELEKTA NEUROMAG OY

Dokumentnomn/Nome of document

Traditional 510(k)

| Utfärdare/Issuer | Louise Lindblad |
|-----------------------------|-------------------------------|
| Avser/Regarding | Elekta Neuromag ^TM |
| Ref nr/Dok nr/Ref no/Doc no | |
| Utgåva /Edition | Directory |
| Sida/Page | |

### Section 8 - Indications for Use Statement

| 510(k) Number | To be defined | K 041264 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Device Name | Elekta Neuromag™ | |
| Indications for Use | The Elekta Neuromag non-invasively measures the<br>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. | |

Prescription Use__ X (Per 21 CFR 801 Subpart D)

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OR

Over-The-Counter Use_

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Meriam C. Provost

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

8041264 Elck STA() nd_Icl_LcL_L_358 9 756 2400 Fax [phone]