OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275

K030737 · Ctf Systems (2001), Inc. · OLX · Oct 10, 2003 · Neurology

Device Facts

• Record ID: K030737
• Device Name: OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275
• Applicant: Ctf Systems (2001), Inc.
• Product Code: OLX · Neurology
• Decision Date: Oct 10, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

The Omega Whole-Cortex MEG System 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 physician, the data enhances the diagnostic capability by providing useful information about the location relative to brain anatomy of active tissue responsible for critical brain functions.

Device Story

Omega Whole-Cortex MEG System measures magnetic signals from intercellular dendritic currents using up to 307 dc-SQUID axial gradiometers in a helmet-shaped array. System integrates sensors with workstation computers and data acquisition software to record brain electrical activity simultaneously. Operated by trained clinicians in a clinical setting; output displayed for physician interpretation to localize active brain regions and correlate with anatomical data. Modification includes increased auxiliary channels, updated electronics, and new operating system software. Provides diagnostic information for neurosurgical planning and epilepsy localization; benefits patients by enabling non-invasive functional brain mapping.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technical and functional comparisons of the modified system to the predicate device.

Technological Characteristics

System utilizes up to 307 dc-SQUID (Superconducting Quantum Interference Device) axial gradiometers. Helmet-shaped sensor array. Includes workstation computers, data acquisition electronics, and software/firmware. Connectivity via integrated data acquisition system. Non-invasive measurement of biomagnetic signals.

Indications for Use

Indicated for non-invasive measurement of magnetoencephalographic (MEG) and optional electroencephalographic (EEG) signals from electrically active brain tissue. Used to localize active brain areas, identify visual, auditory, somatosensory, and motor cortex locations (with evoked response averaging), and locate regions of epileptic activity. Used in neurosurgical planning in conjunction with other diagnostic data.

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

• CTF Systems Inc. Whole-Cortex MEG System (K971329)

Submission Summary (Full Text)

{0}------------------------------------------------

Special 510(k) Device Modification

## 2.3. 510(K) Summary of Safety and Effectiveness

### Submitter

CTF Systems Inc. #15, 1750 McLean Avenue Port Coquitlam, BC V3C 1M9 CANADA

### Company Contact

Daryl Wisdahl Director of Regulatory Affairs and Clinical Research Phone: [phone] Fax: [phone]

# Regulatory Identification

Device Name: CTF Whole-Cortex MEG System

Model Names: Omega 151, Omega 275 Device Classification Name: Electroencephalograph Device Class: II Regulation Number: CFR 882.1400 Panel: Neurology (84) Product Code: OLX, OLY Classification Advisory Committee: Neurology Establishment Registration Number (Owner/Operator): 9034609

### Predicate Device Information

CTF Systems Inc. Whole-Cortex MEG System as cleared by K971329

#### Device Description

The Omega Whole-Cortex MEG Systems integrate up to 307 dc-SQUID axial gradiometers with workstation computers and data acquisition software in order to measure the magnetic signals generated by intercellular dendritic currents. These detectors positioned in a helmet shaped array gives the user the ability to record electrical activity of the entire surface of the brain simultaneously without having to move the position of the probe.

{1}------------------------------------------------

#### CTF Systems Inc.

# Description of Modification

The Omega Whole-Cortex MEG System was modified to increase the number of auxiliary channels, include changes to the electronics of the device, including the software/firmware that control the operation of the electronics, and the addition of a new software operating system for the MEG System.

### Indications for Use

MEG System non-invasively Omega Whole-Cortex measures the 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.

### Intended Use

Whole-Cortex MEG System is intended for use The Omega 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 physician, the data enhances the diagnostic capability by providing useful information about the location relative to brain anatomy of active tissue responsible for critical brain functions.

Image /page/1/Picture/8 description: The image shows a black arrow pointing to the left. The arrow has a thick shaft and a pointed head. The background of the image is white and filled with small black dots. The arrow is the most prominent feature in the image.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like figure with three heads, representing the department's focus on health, human services, and the well-being of the population. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird-like figure.

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

CTF Systems, Inc. c/o Mr. Daryl Wisdahl Director of Regulatory affairs and Clinical Research 15-1750 McLean Avenue Port Coquitlam BC V3C 1M9_Canada

Re: K030737

Trade/Device Name: Omega Whole-Cortex MEG System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLX, OLY Dated (Date on orig SE ltr): September 10, 2003 Received (Date on orig SE ltr): September 10, 2003

APR - 9 2012

Dear Mr. Wisdahl:

This letter corrects our substantially equivalent letter of October 10, 2003.

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.

{3}------------------------------------------------

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.

Q' = 1

Sincerely yours,
Kesia Alexander

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

fa

Enclosure

{4}------------------------------------------------

2.2. Indications for Use Statement

510(k) Number:

Device Name:

Omega Whole-Cortex MEG System

### Indications For Use:

the System non-invasively measures Whole-Cortex MEG Omega 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.

### Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

# Over-The-Counter USE (Optional Format 1-2-96)

(Per 21 CFR 801.109)

iriam C. Provost

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

510(k) Number K030737

page 13 of 30

**Rev 1**

March 7, 2003

C:CC: