(214 days)
The Omega Whole-Cortex MEG System non-invasively measures 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.
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.
The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the way typically expected for a medical device's performance evaluation (e.g., sensitivity, specificity, accuracy metrics).
The document is a 510(k) summary for a Special 510(k) Device Modification, focusing on changes to an existing device (CTF Whole-Cortex MEG System) and establishing substantial equivalence to a predicate device. It discusses modifications to auxiliary channels, electronics, and software/firmware, along with a new operating system.
The "Indications for Use" and "Intended Use" sections describe what the device does and what it's used for, but these are not quantitative performance metrics or acceptance criteria for a specific clinical outcome or diagnostic accuracy.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not present in the provided text.
Based on the available information:
- A table of acceptance criteria and the reported device performance: Not available. The document describes the device's function and intended use, but not specific performance metrics (e.g., detection rates, localization accuracy) that would be compared against predefined acceptance criteria.
- Sample size used for the test set and the data provenance: Not available. No clinical or performance study data is presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- Adjudication method for the test set: Not available.
- 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: Not applicable. The device described is a Magnetoencephalograph (MEG) system, which measures brain signals. It's not an AI-assisted diagnostic tool for human readers in the way typically evaluated by MRMC studies (e.g., comparing radiologists with and without AI assistance for image interpretation).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the context of an algorithm's diagnostic performance. The device itself acquires and displays signals, which are then interpreted by trained physicians. There's no "standalone algorithm" performance described.
- The type of ground truth used: Not available.
- The sample size for the training set: Not available (as no machine learning algorithm development is described in this context).
- How the ground truth for the training set was established: Not available.
The document mainly focuses on regulatory aspects of a device modification, asserting that the modified device remains substantially equivalent to the predicate device for its stated indications for use. It does not contain a detailed performance study comparing quantitative measures against predefined acceptance criteria.
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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: (604) 941-8561 Fax: (604) 941-8565
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.
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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.
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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.
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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 (800) 638-2041 or (301) 796-7100 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
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Enclosure
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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:
§ 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).