(224 days)
K902764, K901215A
K902764, K901215A
No
The summary describes a system for measuring and displaying MEG/EEG signals for interpretation by trained physicians. There is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML information.
No.
The device is used for non-invasive measurement and localization of brain activity to aid in diagnosis and neurosurgical planning, not for direct treatment or therapy.
Yes
The device measures physiological signals (MEG and EEG) to help physicians localize active areas and epileptic activity within the brain, and the localization information can be used with other diagnostic data for neurosurgical planning, all of which are functions characteristic of a diagnostic device.
No
The device description explicitly states it integrates hardware components such as dc-SQUID axial gradiometer detectors, a patient bed, a magnetic shielded room, and workstation computers, in addition to data acquisition software. This indicates it is a system with both hardware and software, not a software-only device.
Based on the provided information, the CTF Systems Inc. "Whole-Cortex MEG System" is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states that the device is used to "help localize these active areas" and that "MEG locations may then be correlated with anatomical information of the brain." It also mentions using the localization information "in conjunction with other diagnostic data, in neurosurgical planning." This indicates the device is used to provide diagnostic information about the brain.
- Localization of Epileptic Activity: The statement "MEG is also used to non-invasively locate regions of epileptic activity within the brain" is a clear indication of a diagnostic purpose.
- Use in Conjunction with Other Diagnostic Data: The mention of using the information "in conjunction with other diagnostic data" further supports its role in the diagnostic process.
- Interpretation by Trained Physicians: The signals are "interpreted by trained physicians," which is typical for diagnostic devices.
While the device measures signals from the body (in vivo), the interpretation and use of these signals for diagnostic purposes is what classifies it as an IVD. The device provides data that is then used by a trained professional to make a diagnosis or inform treatment decisions.
Therefore, the CTF Systems Inc. "Whole-Cortex MEG System" fits the definition of an In Vitro Diagnostic device because it is used to provide information for diagnostic purposes, even though the initial signal acquisition is from within the body.
N/A
Intended Use / Indications for Use
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.
The CTF Systems Inc. "Whole-Cortex MEG System" non-invasively measures the The CTP Systems Inc. "Whole-Cortex now optionally, electroencephalographic 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 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
Product codes
OLY, GWQ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained clinician / physicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Neuromag-122 (K902764), Biomagnetic Technologies Magnes Single (K901215A)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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).
0
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.
1
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
MEG System" | Neuromag-122
(K962764) | Biomagnetic
Technologies
Magnes Single
(K901215A) |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| No. of SQUID
detectors/channels
for MEG data: | 64 to 200 | 122 | 37 |
| Operating Principle | superconducting flux
transformer coupled with
dc-SQUID controlled by
digital flux-locked loop | superconducting flux
transformer coupled with
dc-SQUID controlled by
analog flux-locked loop | superconducting flux
transformer coupled with
dc-SQUID controlled by
analog flux-locked loop |
| No. of auxiliary
channels for other
types of data: | 88 | 166 | 51 |
| Gradiometer: | 1 axial first order
gradiometer per location | 2 orthogonal planar first
order gradiometers per
location | 1 axial first order
gradiometer per location |
| Intersensor spacing: | 32 mm (150 sensor
configuration) | 43-44 mm | 20 mm |
| Gradiometer
placement: | 64 to 200 locations
distributed across the
helmet shaped lower tip
of a dewar (Optional
Caucasian or Oriental
head shape). | 61 locations distributed
across the helmet shaped
lower tip of a dewar. | 37 locations positioned
in a circular array over a
concave spherical surface. |
| Cryogen used: | Liquid Helium | Liquid Helium | Liquid Helium |
| Coverage: | One acquisition to cover
entire head. | One acquisition to cover
entire head. | Six to ten acquisitions to
cover entire head. |
| Gantry: | Floor mounted, standard
gantry is fixed. Optional
gantry tilts to 90°. | Floor mounted, standard
gantry tilts up to 30°.
Optional gantry tilts to
45°. | Suspended from ceiling,
gantry can tilt up to 45°. |
| Patient Position: | Seated, or lying on back
with optional bed. | Seated or supine.
Optional chair insert for
children | Seated, or lying on back
or side. |
| Head position
indicator: | Included | Available | Available |
| Computer: | HP workstation with
UNIX environment | HP workstation with
UNIX environment | SUN workstation with
UNIX environment |
| Networking
capabilities: | Ethernet connections to
other workstations | Ethernet connections to
other workstations | Ethernet connections to
other workstations
available |
| Substantial Equivalence Chart. | ||
|---|---|---|
| -- | -------------------------------- | -- |
2
| Magnetic shielded
room accessories: | Interior DC lights, video
camera and monitor and
two-way intercom for
monitoring patients | Video monitor and two-
way intercom for
monitoring patients | Interior DC lights, video
cameras and two-way
intercom for monitoring
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.
3
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.
4
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
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
5
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)