The CTF Systems Inc. "Whole-Cortex MEG System" non-invasively measures the magnetoencephalographic (MEG) signals (and, now optionally, electroencephalographic EEG signals) produced by electrically active tissue of the brain. These 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 the visual, auditory, somatosensory, and motor cortex in 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. *when routinely used in conjunction with evoked response averaging devices

Device Description

The CTF "Whole-Cortex MEG System" integrates up to 200 dc-SQUID axial gradiometer detectors, a patient bed, a magnetic shielded room, workstation computers and data acquisition software in order to measure the magnetic signals generated by the intracellular and dendritic currents. These detectors are positioned in a helmet shaped array which gives the user the ability to record signals from the entire surface of the brain simultaneously without having to move the position of the probe.

AI/ML Overview

The provided text describes the 510(k) summary for the CTF "Whole-Cortex MEG System." It asserts the device's substantial equivalence to two predicate devices (Neuromag-122 and Biomagnetic Technologies Magnes Single) based on a comparison of technical parameters and intended use. However, the text does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it include details about sample sizes, data provenance, expert qualifications, or adjudication methods for any test or training sets.

The document is a regulatory submission focused on demonstrating substantial equivalence, not a performance study. It lists specifications of the new device and compares them to predicate devices, but there is no mention of performance metrics (sensitivity, specificity, accuracy, etc.) or a study designed to evaluate them against predefined acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's a breakdown of what can and cannot be answered based only on the provided text:

Acceptance Criteria and Device Performance Study Details

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not provided in the text.
Reported Device Performance: Not provided in the text. The document focuses on demonstrating substantial equivalence in design and intended use, not on presenting performance metrics like sensitivity, specificity, or accuracy compared to a ground truth. The table presented compares technical specifications of the device to predicate devices.

Parameter	Acceptance Criteria (Not Provided)	Reported Device Performance (Not Provided)
Clinical performance metrics (e.g., sensitivity, specificity, accuracy)	N/A	N/A
Other performance metrics	N/A	N/A

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size (Test Set): Not mentioned.
Data Provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not mentioned.
Qualifications of Experts: Not mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: Not mentioned as having been done.
Effect Size: Not applicable, as no MRMC study or AI assistance is described. The device itself is a MEG system, not an AI-powered diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Standalone Performance: Not described. The device is a measurement system; its performance is related to its technical specifications for capturing biomagnetic signals, not an "algorithm only" performance as might be seen with AI. The document states "When interpreted by a trained clinician, the data enhances the diagnostic capability..." implying human interpretation is integral.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: Not mentioned. The document describes the device's function (measuring MEG signals) and its intended use (data interpreted by a trained clinician to help localize active areas), but not how its accuracy in localization would be verified against a ground truth.

8. The sample size for the training set

Sample Size (Training Set): Not mentioned.

9. How the ground truth for the training set was established

Ground Truth Establishment (Training Set): Not mentioned.

Summary of available information from the text:

The document is a 510(k) summary (K971329) for the CTF "Whole-Cortex MEG System," a Class II Magnetoencephalograph. It demonstrates substantial equivalence to predicate devices (Neuromag-122 and Biomagnetic Technologies Magnes Single) by comparing technical specifications such as:

Number of SQUID detectors/channels (64 to 200)
Operating Principle (superconducting flux transformer coupled with dc-SQUID controlled by digital flux-locked loop)
Number of auxiliary channels (88)
Gradiometer type (1 axial first order gradiometer per location)
Intersensor spacing (32 mm for 150 sensor configuration)
Gradiometer placement (64 to 200 locations across a helmet-shaped dewar)
Cryogen used (Liquid Helium)
Coverage (One acquisition to cover the entire head)
Gantry type (Floor mounted, standard fixed; optional tilts to 90°)
Patient Position (Seated, or lying on back with optional bed)
Head position indicator (Included)
Computer (HP workstation with UNIX environment)
Networking capabilities (Ethernet connections)
Magnetic shielded room accessories (Interior DC lights, video camera and monitor, two-way intercom)

The intended use is to non-invasively measure MEG (and optionally EEG) signals produced by electrically active tissue of the brain. These signals are displayed and interpreted by trained physicians to help localize active areas, which can then be correlated with anatomical information. The system is also used to non-invasively locate motor, sensory, auditory, and somatosensory cortex and regions of epileptic activity, and for neurosurgical planning in conjunction with other diagnostic data.

Crucially, the provided text is a regulatory submission for device clearance based on substantial equivalence, not a scientific study reporting detailed performance metrics against a defined standard or ground truth.

Summary

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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: (604) 941-8561 (604) 941-8565 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-CortexMEG System"	Neuromag-122(K962764)	BiomagneticTechnologiesMagnes Single(K901215A)
No. of SQUIDdetectors/channelsfor MEG data:	64 to 200	122	37
Operating Principle	superconducting fluxtransformer coupled withdc-SQUID controlled bydigital flux-locked loop	superconducting fluxtransformer coupled withdc-SQUID controlled byanalog flux-locked loop	superconducting fluxtransformer coupled withdc-SQUID controlled byanalog flux-locked loop
No. of auxiliarychannels for othertypes of data:	88	166	51
Gradiometer:	1 axial first ordergradiometer per location	2 orthogonal planar firstorder gradiometers perlocation	1 axial first ordergradiometer per location
Intersensor spacing:	32 mm (150 sensorconfiguration)	43-44 mm	20 mm
Gradiometerplacement:	64 to 200 locationsdistributed across thehelmet shaped lower tipof a dewar (OptionalCaucasian or Orientalhead shape).	61 locations distributedacross the helmet shapedlower tip of a dewar.	37 locations positionedin a circular array over aconcave spherical surface.
Cryogen used:	Liquid Helium	Liquid Helium	Liquid Helium
Coverage:	One acquisition to coverentire head.	One acquisition to coverentire head.	Six to ten acquisitions tocover entire head.
Gantry:	Floor mounted, standardgantry is fixed. Optionalgantry tilts to 90°.	Floor mounted, standardgantry tilts up to 30°.Optional gantry tilts to45°.	Suspended from ceiling,gantry can tilt up to 45°.
Patient Position:	Seated, or lying on backwith optional bed.	Seated or supine.Optional chair insert forchildren	Seated, or lying on backor side.
Head positionindicator:	Included	Available	Available
Computer:	HP workstation withUNIX environment	HP workstation withUNIX environment	SUN workstation withUNIX environment
Networkingcapabilities:	Ethernet connections toother workstations	Ethernet connections toother workstations	Ethernet connections toother workstationsavailable

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

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Magnetic shieldedroom accessories:	Interior DC lights, videocamera and monitor andtwo-way intercom formonitoring patients	Video monitor and two-way intercom formonitoring patients	Interior DC lights, videocameras and two-wayintercom for monitoringpatients
----------------------------------------	----------------------------------------------------------------------------------------------------	-------------------------------------------------------------------	-----------------------------------------------------------------------------------------

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vour

for

Mal
Dire
Divi

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

Over-The-Counter Use_

(Optional Format 1-2-96)

Regulation Number and Section

§ 882.1400 Electroencephalograph.

(a)
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.(b)
Classification. Class II (performance standards).