NEUROMAG VECTORVIEW

K984401 · Philips Medical Systems (Cleveland), Inc. · OLX · Dec 30, 1998 · Neurology

Device Facts

• Record ID: K984401
• Device Name: NEUROMAG VECTORVIEW
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: OLX · Neurology
• Decision Date: Dec 30, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

The Neuromag Vectorview system 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

Vectorview is a magnetoencephalography (MEG) system; utilizes 306 sensor elements (planar gradiometers and magnetometers) in a helmet-shaped array to measure magnetic signals from intracellular dendritic currents in the brain. Operates via liquid helium-cooled SQUID sensors; records electrical activity of the entire brain surface simultaneously without probe repositioning. Used in clinical settings by trained clinicians; data processed by medical super-computers and acquisition software. Output consists of displayed biomagnetic signals and anatomical localization of active nerve tissue. Clinicians interpret output to enhance diagnostic capabilities regarding critical brain function localization. Benefits include non-invasive mapping of brain activity to support clinical decision-making.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological comparison and bench-level specifications.

Technological Characteristics

System utilizes 306-channel MEG with 102 SQUID sensor locations. Sensors include planar first-order gradiometers and magnetometers. Helmet-shaped array follows EN960:1994 standards. Cooling via liquid helium. Connectivity includes Ethernet for workstation networking. Software includes data acquisition, display plotting, and signal processing. Gantry supports seated or supine patient positioning.

Indications for Use

Indicated for non-invasive detection and display of biomagnetic signals from electrically active brain tissue to assist clinicians in localizing nerve tissue responsible for critical brain functions.

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

• Neuromag-122 (K962764)

Submission Summary (Full Text)

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DEC 30 1998

K984401

## SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)

#### 1. General Information

| Classification: | Class II<br>Magnetoencephalograph |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Magnetoencephalographic (MEG) Device |
| Proprietary Name: | Vectorview |
| Establishment Registration: | Manufacturer:<br>Neuromag Ltd.<br>P.O. Box 357<br>00511 Helsinki, Finland<br>Phone: [phone]<br>Fax: [phone]<br>FDA Facility Registration: #9680891<br>United States Representative:<br>Picker International, Inc.<br>World Headquarters<br>595 Miner Road<br>Highland Heights, Ohio 44143<br>FDA Owner Number: #1580240<br>FDA Registration Number: #1525965 |

No applicable performance standards have been Performance Standards: issued under section 514 of the Food, Drug and Cosmetic Act.

#### 2. Intended Uses

The Neuromag Vectorview system does not change the existing intended use and indications for use for the Neuromag-122 as defined below.

The Neuromag Vectorview system 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.

【- | PICKER INTERNATIONAL, INC. (VECTOR) 12/01/98

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### Device Description 3.

This device integrates 306 sensor elements, including planar gradiometers and magnetometers, with medical super-computers and data acquisition 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 probe.

### Safety and Effectiveness 4.

The Neuromag Vectorview is substantially equivalent to the Neuromag-122 in safety and effectiveness. The following chart has been compiled to demonstrate this equivalence.

| Parameter | Neuromag Vectorview | Predicate Device<br>Neuromag-122 (K962764) |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| No. of SQUID sensor<br>elements | 102 | 61 |
| No. of channels for MEG<br>data | 306 | 122 |
| No. of auxiliary channels<br>for other types of data (e.g<br>EEG) | 144<br>(typically 64 for EEG) | 134<br>(typically use 32 for EEG) |
| Coil Configuration | Two orthogonal planar-first-<br>order gradiometers and one<br>magnetometer per location | Two orthogonal planar-first-order<br>gradiometers per location |
| Intersensor spacing | 34-35 mm | 43-44 mm |
| Sensor element placement | 102 locations distributed<br>across helmet-shaped lower tip<br>of dewar, shape based on<br>anatomy (standard<br>EN960:1994). Inside<br>dimensions 222 mm (length) x<br>181 mm (width) x 209 mm<br>(depth). | Sixty-one locations distributed across<br>helmet-shaped lower tip of dewar.<br>Radius of curvature of helmet is 83<br>mm (front-portion) and 91 mm (back-<br>portion). |
| Cryogen Used | Same. | Liquid Helium |
| Coverage | Same. | One acquisition to cover entire head |
| Gantry | Floor mounted. Dewar helmet<br>is either tilted 30° for seated<br>position or horizontal (180°)<br>for supine position. | Floor mounted, standard gantry tilts<br>up to 30°. Optional gantry tilts to 45°. |

## Substantial Equivalence Chart

PICKER INTERNATIONAL, INC. (VECTOR) 12/01/98

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| Parameter | Neuromag Vectorview | Predicate Device<br>Neuromag-122 (K962764) |
|---------------------------------------|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient Position | Same. | Seated or Supine. Optional chair<br>insert for children. |
| Head Position Indicator | Same. | Available |
| Computer | Same. | Hewlett Packard workstation with<br>UNIX environment. |
| Networking Capabilities | Same. | Ethernet connections to other<br>workstations available |
| Software | Same. | Data Acquisition, Display plotting and<br>Signal processor for continuous data. |
| Magnetic Shielded Room<br>Accessories | Same. | Video monitor and two-way intercom<br>for monitoring patients. |
| Intended Use & Indications<br>for Use | Same. | The Neuromag-122 system is intended<br>for use as a magneto encephalographic<br>(MEG) device which non-invasively<br>detects and displays biomagnetic<br>signals produced by electrically active<br>nerve tissue in the brain. When<br>interpreted by a trained clinician, the<br>data enhances the diagnostic capability<br>by providing useful information about<br>the location relative to brain anatomy<br>of active nerve tissue responsible for<br>critical brain functions. |

12/01/98

(VECTOR)

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written 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. Elaine K. Keeler, Ph.D. Manager, MR Clinical Science Picker International, Inc. 595 Miner Road Highland Heights, Ohio 44143

APR - 9 2012

Re: K984401

Trade/Device Name: Neuromag Vectorview Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLX, OLY, GWQ Dated (Date on orig SE Itr): December 7, 1998 Received (Date on orig SE ltr): December 9, 1998

Dear Ms. Keeler:

This letter corrects our substantially equivalent letter of December 30, 1998.

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, listing 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 - Ms. Elaine K. Keeler

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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/4/Picture/6 description: The image shows a stylized, handwritten letter 'J' in black ink on a white background. The 'J' has a flowing, cursive style with a prominent loop at the bottom and a curved stroke extending from the top. The stroke at the top of the 'J' appears to form a small, connected 'or' or 'ar' shape, adding a unique flourish to the letter.

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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Page 1 of 1

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510(k) Number (if known): K984401

Device Name: Vectorview

# Indications for Use:

4-1 - 1

The Vectorview is intended for use as a magneto encephalographic (MEG) device which noninvasively 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 the viding useful information about the location relative to brain anatomy of active nerve tissue responsible for critical brain functions.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark McMullen

for
Cyma (Division Sign-Off)
cre Division of General Restorative Devices
510(k) Number. K984401

× Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)