CTF SYSTEMS INC, WHOLE-CORTEX MEG SYSTEM (WITH OPTIONAL EEG SUBSYSTEM)

K971329 · Ctf Systems, Inc. · GWQ · Nov 20, 1997 · Neurology

Device Facts

• Record ID: K971329
• Device Name: CTF SYSTEMS INC, WHOLE-CORTEX MEG SYSTEM (WITH OPTIONAL EEG SUBSYSTEM)
• Applicant: Ctf Systems, Inc.
• Product Code: GWQ · Neurology
• Decision Date: Nov 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

The CTF Systems Inc. "Whole-Cortex MEG System" non-invasively measures the magnetoencephalographic (MEG) signals (and optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. The signals are recorded by the data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. MEG locations may then be correlated with anatomical information of the brain. 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.

Device Story

The Whole-Cortex MEG System measures biomagnetic signals generated by dendritic currents in the brain using 64 to 200 dc-SQUID axial gradiometers. The system integrates these sensors into a helmet-shaped dewar, allowing simultaneous whole-head recording without repositioning the probe. It utilizes a digital flux-locked loop for signal processing. The device is operated by trained clinicians in a clinical setting. Output consists of displayed biomagnetic signals and localization data, which clinicians interpret to identify active nerve tissue and epileptic regions. This information is correlated with brain anatomy to assist in neurosurgical planning and diagnostic decision-making, providing a non-invasive alternative to invasive localization methods.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and technical comparison of system parameters, including sensor count, gradiometer configuration, and signal acquisition capabilities against predicate devices.

Technological Characteristics

System utilizes 64-200 dc-SQUID axial first-order gradiometers cooled by liquid helium. Features a digital flux-locked loop, 88 auxiliary channels, and a floor-mounted gantry (fixed or 90° tilt). Connectivity via Ethernet to workstations. Operates on HP workstations in a UNIX environment. Includes head position indicator and magnetic shielded room accessories (lights, video, intercom).

Indications for Use

Indicated for patients requiring non-invasive localization of electrically active brain tissue, including visual, auditory, somatosensory, and motor cortex, and regions of epileptic activity, to assist 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

• Neuromag-122 (K962764)
• Biomagnetic Technologies Magnes Single (K901215A)

Submission Summary (Full Text)

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NON 20 1997

# 1971329

## 510(K) SUMMARY 10.

# Summary Of Safety And Effectiveness

#### General Information 10.1.

Classification: Class II Magnetoencephalograph

Magnetoencephalographic (MEG) Device Common/Usual Name:

Proprietary Name:

Establishment Registration:

Manufacturer:

CTF Systems Inc. 15 - 1750 McLean Ave. Port Coquitlam, BC Canada V3C 1M9 Phone: [phone] [phone] Fax:

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

## 10.2. Intended Uses

The CTF "Whole-Cortex MEG System" system is intended for use as a The CTF Whole-Collex MLC Of Stein - Jystem - Jysical results 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 interpreted by a tranced cinnerali, the cata cindicos and chaplession of active nerve tissue responsible for critical brain functions.

#### Device Description 10.3.

The CTF "Whole-Cortex MEG System" integrates up to 200 dc-SQUID axial I he CTF While-Collex MES of station computers and data acquisition software in order to measure the magnetic signals generated by the interestly and dendritic currents. These measure the magnetic signals generation of an which gives the user the ability to record delectors positioned in a nemice surface of the brain simultaneously without having to move the position of the probe.

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### Safety and Effectiveness 10.4.

The CTF "Whole-Corex MEG System" is substantially equivalent to both the The CTF "Whole-Corder" and the Biomagnetic Technologies Magness Single Neuromag-122 (K902764) and effectiveness. The following chart has been compiled to
(K901215A) in safety and effectiveness. The following chart has been compiled to (K901215A) in safety and effectiveness. " Hic following that the Scontral equivalence to these devices.

| Parameter | CTF "Whole-Cortex<br>MEG System" | Neuromag-122<br>(K962764) | Biomagnetic<br>Technologies<br>Magnes Single<br>(K901215A) |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| No. of SQUID<br>detectors/channels<br>for MEG data: | 64 to 200 | 122 | 37 |
| Operating Principle | superconducting flux<br>transformer coupled with<br>dc-SQUID controlled by<br>digital flux-locked loop | superconducting flux<br>transformer coupled with<br>dc-SQUID controlled by<br>analog flux-locked loop | superconducting flux<br>transformer coupled with<br>dc-SQUID controlled by<br>analog flux-locked loop |
| No. of auxiliary<br>channels for other<br>types of data: | 88 | 166 | 51 |
| Gradiometer: | 1 axial first order<br>gradiometer per location | 2 orthogonal planar first<br>order gradiometers per<br>location | 1 axial first order<br>gradiometer per location |
| Intersensor spacing: | 32 mm (150 sensor<br>configuration) | 43-44 mm | 20 mm |
| Gradiometer<br>placement: | 64 to 200 locations<br>distributed across the<br>helmet shaped lower tip<br>of a dewar (Optional<br>Caucasian or Oriental<br>head shape). | 61 locations distributed<br>across the helmet shaped<br>lower tip of a dewar. | 37 locations positioned<br>in a circular array over a<br>concave spherical surface. |
| Cryogen used: | Liquid Helium | Liquid Helium | Liquid Helium |
| Coverage: | One acquisition to cover<br>entire head. | One acquisition to cover<br>entire head. | Six to ten acquisitions to<br>cover entire head. |
| Gantry: | Floor mounted, standard<br>gantry is fixed. Optional<br>gantry tilts to 90°. | Floor mounted, standard<br>gantry tilts up to 30°.<br>Optional gantry tilts to<br>45°. | Suspended from ceiling,<br>gantry can tilt up to 45°. |
| Patient Position: | Seated, or lying on back<br>with optional bed. | Seated or supine.<br>Optional chair insert for<br>children | Seated, or lying on back<br>or side. |
| Head position<br>indicator: | Included | Available | Available |
| Computer: | HP workstation with<br>UNIX environment | HP workstation with<br>UNIX environment | SUN workstation with<br>UNIX environment |
| Networking<br>capabilities: | Ethernet connections to<br>other workstations | Ethernet connections to<br>other workstations | Ethernet connections to<br>other workstations<br>available |

| | Substantial Equivalence Chart. | |
|--|--------------------------------|--|
|--|--------------------------------|--|

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| Magnetic shielded<br>room accessories: | Interior DC lights, video<br>camera and monitor and<br>two-way intercom for<br>monitoring patients | Video monitor and two-<br>way intercom for<br>monitoring patients | Interior DC lights, video<br>cameras and two-way<br>intercom for monitoring<br>patients |
|----------------------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
|----------------------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|-----------------------------------------------------------------------------------------|

## Intended use comparison:

The CTF "Whole-Cortex MEG System" non-invasively measures the The CTF "Whole-Correx WEG System" non-arves by the active tissue of the brain.
magnetoencephalographic (MEG) signals produces by the brain.
magnetoencephalographic (MEG) sign magnetoencephalographic (MLC) signals produced by trained physicians to help
These signals are displayed and may be interpreted by manneligel inform These signals are displayed and may be interpreted by author physions of the mation of the brain.

Based on the product literature: The Neuromag-122 system is intended for use as a
nd display of the count in the CCD device which non invasive detects and displays Based on the product iterature: " The New Yorks ive detects and displays
magnetoencephalographic (MEG) device which notive newe institution while biomagnetic signals produced by electrically active nerve tissues in the brain. When
biomagnetic signals produced by electrically active nerve tissues in the brain. When biomagnetic signals produced by the data enhances the diagnostic capability by interpreted by a trained cimation about the location relative to brain analomy of active nerve providing asolule for critical brain functions.

Based on the product literature: The Magnes Single non-invasively detects small Based on the product fiferature: "The Nagies information about the location of
biomagnetic signals produced by brain and provides information about the data is biomagnetic signals produced by brong ing these signals. The data is
electrically active nerve tissue responsible for producing these signals. The data is electrically active nerve displine to from which they may draw information
presented to the physicians in an MEG image, from which they may draw information
s and the physici presented to the physicians in an MEG milligentive to brain anatomy.

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Image /page/3/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 symbol that resembles a stylized human figure.

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

Stephen E. Robinson, Ph.D. Senior Scientist CTF Systems, Inc. 15 - 1750 McLean Avenue Port Coquitlam, British Columbia CANADA V3C 1M9

APR - 9 2012

Re: K971329

Trade/Device Name: Whole-Cortex MEG System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLY, GWQ Dated (Date on orig SE ltr): September 5, 1997 Received (Date on orig SE ltr): September 8, 1997

Dear Mr. Robinson:

This letter corrects our substantially equivalent letter of November 20, 1997.

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 - Mr. Stephen E. Robinson

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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely vour

for

Mal
Dire
Divi

a

Offi
Cen

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___

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Whole-cortex MEG System (with_optional EEG)

Indications For Use:

The CTF Systems Inc. "Whole-Cortex MEG System" non-invasively measures the The CTP Systems Inc. "Whole-Cortex now optionally, electroencephalographic These signals magnetoencephalographic (nEo) signals (and) of the brain.
EEG signals) produced by electrically active tissue of the brain.
The signals in the starterised des acquisition sys EEG signals> produced by alectrically active clase or the olayed, and may then are recorded by crained physicians to help localize these active areas.
be interpreted by trained physicians to help localize these active areas. be interpreted by trained with anatomical information of the brain.
locations may then be correlated with anatomical information of the brain MEG locations may the be correlated with and insult , auditory, somatoreansory, and motor cortex in the brain.* MGG is also used to non-invasively locate and motor cortex in the brain. * he brain the break of the localization information
regions of external and de conjunction with other diagnostic data, in regions of epileptic activity within the brain. "Inc 10002200
provided by MEG may be used, in conjunction with other diagnostic data, in neurosurgical planning.

*when routinely used in conjunction with evoked response averaging devices

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
K971329

Prescription Use (Per 21 CFR 801.109)

510(k) Number

OR

Over-The-Counter Use_

(Optional Format 1-2-96)