(533 days)
No
The document describes signal processing and interference elimination techniques (Spatiotemporal interference elimination, Maxwell Filter, internal active shielding) which are not inherently AI/ML. There is no mention of AI, ML, or related terms like deep learning or neural networks. The focus is on signal acquisition, filtering, and localization based on established biophysical principles.
No
The device is used to non-invasively detect and display biomagnetic signals to enhance diagnostic capability and localize active nerve tissue, not to provide therapy.
Yes
The device is intended to "non-invasively detects and displays biomagnetic signals produced by electrically active nerve tissue in the brain" and "when interpreted by a trained clinician, the data enhances the diagnostic capability by providing useful information about the location relative to brain anatomy of active nerve tissue responsible for critical brain functions." It is also stated that "MEG is routinely used to identify the locations of visual, auditory, somatosensory, and motor cortex in the brain" and "non-invasively locate regions of epileptic activity within the brain." This information is clearly for diagnostic purposes.
No
The device description explicitly states it is a modification to a "current product" and mentions compatibility with "internal active shielding," which are hardware components of a MEG system. The software (MaxFilter) is intended to be used with Elekta Neuromag® MEG products, which are hardware devices.
Based on the provided information, the Elekta Neuromag® with MaxFilter 2.1 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use and device description clearly state that the Elekta Neuromag® with MaxFilter 2.1 non-invasively detects and displays biomagnetic signals produced by electrically active nerve tissue in the brain. This is a direct measurement of physiological activity within the body, not an analysis of a specimen taken from the body.
- The device measures MEG and optionally EEG signals. These are electrophysiological signals measured directly from the patient, not from a sample like blood, urine, or tissue.
The device is a diagnostic tool, but it falls under the category of in vivo diagnostic devices as it measures physiological signals directly from the living body.
N/A
Intended Use / Indications for Use
The Elekta Neuromag® with MaxFilter 2.1 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 clinician, the data enhances the diagnostic capability by providing useful information about the location relative to brain anatomy of active nerve tissue responsible for critical brain functions.
Elekta Neuromag® with MaxFilter™ 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.
Product codes (comma separated list FDA assigned to the subject device)
OLX, OLY
Device Description
This premarket notification represents modifications made to our current product. The present device differs from the predicate device, K050035, Elekta Neuromag® with Maxwell Filter only in the following areas of functionality: Spatiotemporal interference elimination, Graphical user interface; and Offline averager. The modification also adds compatibility with internal active shielding, an interference removal method described in K081430.
MaxFilter™ is intended to be used with Elekta Neuromag® MEG products in reducing measurement artifacts.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetoencephalography (MEG), Electroencephalography (EEG)
Anatomical Site
Brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained clinician, Trained 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)
Performance testing consisted of software validation, phantom testing and clinical testing. As compared to predicate, the Elekta Neuromag® with MaxFilter™ 2.1 modifications is within 2 mm accuracy of the source in a phantom and provided substantially equivalent measurement accuracy in a clinical study with non-moving heads.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
2 mm accuracy of the source in a phantom.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K041264, Elekta Neuromag®, K050035, Elekta Neuromag® with Maxwell Filter
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
510(K) Summary K091393. Elekta Oy Siltasaarenkatu 18-20 A FI-00530 Helsinki, Finland (P.O. Box 34, FI-00531 Helsinki, Finland) Tel: +358 9 756 240 0 Fax: +358 9 756 240 11 Contact: Mrs Anne Karvinen Date prepared: October 23, 2010
OCT 2 6 2010
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Trade Name: Elekta Neuromag® with MaxFilter 2.1 1.
री -
Common Name: Electroencephalograph (Magnetoencephalograph) 2.
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Classification Name: Electroencephalograph, product codes OLX and OLY, 3. Regulation: 882.1400 Class of device: Class II.
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The legally marketed device to which we are claiming equivalence [807.92(a)(3)] : 4. K041264, Elekta Neuromag®, K050035, Elekta Neuromag® with Maxwell Filter
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Description of device: This premarket notification represents modifications made to our 5. current product. The present device differs from the predicate device, K050035, Elekta Neuromag® with Maxwell Filter only in the following areas of functionality: Spatiotemporal interference elimination, Graphical user interface; and Offline averager. The modification also adds compatibility with internal active shielding, an interference removal method described in K081430.
-
Intended use: The Elekta Neuromag® with MaxFilter 2.1 is intended for use as a 6. 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 clinician, the data enhances the diagnostic capability by providing useful information about the location relative to brain anatomy of active nerve tissue responsible for critical brain functions.
-
Indications for use: Elekta Neuromag® with MaxFilter 2.1 non-invasively measures the 7. 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,
-
Technological characteristics: MaxFilter™ is intended to be used with Elekta 8. Neuromag® MEG products in reducing measurement artifacts.
1
- Performance: Performance testing consisted of software validation, phantom testing and 9. clinical testing. As compared to predicate, the Elekta Neuromag® with MaxFilter™ 2.1 modifications is within 2 mm accuracy of the source in a phantom and provided substantially equivalent measurement accuracy in a clinical study with non-moving heads.
な
| Feature | Predicate
devices
K050035 | Modified Device
MaxFilter™ 2.1 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|-----------------------------------|
| Automated detection of bad channels | Yes | Yes |
| Support for Internal Active Shielding (K081430) | No | Yes |
| Interference elimination | | |
| Software shielding, interference elimination
with spatial signal space separation (SSS) | Yes | Yes |
| Interference elimination with spatiotemporal
signal space separation (tSSS) | No | Yes |
| Offline averager function to process raw data files
To improve user friendliness, online averager
that exists already in data acquisition software,
is also available in MaxFilter as offline version.
No clinical utility. | No | Yes |
| Graphical user interface | | |
| To improve user friendliness, parallel to
command line user interface, also a graphical
user interface is available in MaxFilter™ 2.1.
Both user interfaces perform same software
modules (code) of the SSS technologies. No
clinical utility. | No | Yes |
Comparison Table
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States. The logo features a stylized depiction of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Elekta Neuromag Oy c/o Mr. Daniel Kamm, P.E. Kamm & Associates 8726 Ferrara Ct. Naples, FL 34114
QCT 2 6 2010
Re: K091393
Trade/Device Name: Elekta Neuromag with Maxfilter Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLX, OLY Dated: July 7, 2010 Received: July 12, 2010
Dear Mr. Kamm:
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. Ilisting 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
Page 2 - Mr. Daniel Kamm, P.E.
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.
http://www.fda.gov/MedicalDevices/ResourcestoYourIndustry/default.htm.
Sincerely vours.
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
4
Indications for Use
510(k) Number (if known): K09 | 393
OCT 2 6 2010
TM Device Name: Elekta Neuromag® with MaxFilter
Indications For Use:
Elekta Neuromag® with MaxFilter™ 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kristen Bowsher
(Division Sign-on)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
$10(k) Number_K091393
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