(90 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as an upgrade to a previous version without changing the fundamental technology.
No
The device is described as measuring and localizing brain signals for diagnostic purposes, such as identifying areas of epileptic activity or localizing brain functions for neurosurgical planning, rather than providing therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device helps "localize ... active areas" and identifies "regions of epileptic activity within the brain," and that "MEG may be used, in conjunction with other diagnostic data in neurosurgical planning." These functions directly support making a diagnosis or contributing to diagnostic information.
No
The device description explicitly states that the Elekta Neuromag™ integrates 306 sensor elements (hardware) with computers and software. It is not solely software.
Based on the provided information, the Elekta Neuromag is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Elekta Neuromag's Function: The Elekta Neuromag directly measures in vivo signals (MEG and EEG) produced by the brain. It does not analyze specimens taken from the body.
- Intended Use: The intended use describes measuring brain signals and localizing active areas to aid in diagnosis and neurosurgical planning. This is a direct measurement of physiological activity, not an analysis of a biological sample.
Therefore, the Elekta Neuromag falls under the category of a medical device that performs a direct physiological measurement, rather than an IVD.
N/A
Intended Use / Indications for Use
The Elekta Neuromag™ is intended for use as a magneto encephalographic (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.
The Elekta Neuromag 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)
GWQ, OLX, OLY
Device Description
The Elekta Neuromag™ is an upgraded version of the currently available Neuromag Vectorview (K984401). The Elekta Neuromag™ does not change the intended use or the fundamental scientific technology of the Neuromag Vectorview.
The Elekta Neuromag™ integrates 306 sensor elements, including planar gradiometers and and magnetometers, with computers and data acquisition and data analysis software in order to measure the differences in the magnetic signals generated by the intracellular dendritic currents. These detectors are positioned in a helmet shaped array that gives the user the ability to record the electrical activity of the entire surface of the brain simultaneously without having to move the position of the measuring device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MEG (magnetoencephalographic), EEG (electroencephalographic)
Anatomical Site
Brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physicians/clinician
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): 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.
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
K 041264
ELEKTA NEUROMAG OY
Dokumentnamn/Name of do Traditional 510fk)
| Ulfärdare/Issuer | Louise Lindblad |
|---|---|
| Avser/Regarding | Elekta Neuromag™ |
| Rel nr/Dak ns/Rof no/Doc no | |
| Utgåva /Edition | Directory |
| Sida/Page |
AUG 1 0 2004
Section 5- 510(k) Summary As Required by 21 CFR 807.87(k)510 (k) Summary
1. Subscribers Name & Address
Elekta Neuromag Oy Elimäenkatu 22 B, P.O. Box 68 FIN-00511 Helsinki, Finland Tel: + 358 9 756 240 0 Fax: + 358 9 756 240 11 Contact Person for this submission: Birgitta Fagerström Official Correspondent: Birgitta Fagerström
Trade Name 2.
Elekta Neuromag™
3. Device Classification
| Common Name | Product Code | Class | Regulation Number |
|---|---|---|---|
| Electroencephalograph | GWQ | II | 882.1400 |
4. Predicate Device Identification
| Legally marketed devices to which equivalence is being claimed | 510(k) # |
|---|---|
| Omega Whole-Cortex MEG System | K030737 |
ડ. Other relevant submissions
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| ELEKTA NEUROMAG OY | | Dokumentnamn/Name of document
Traditional 510(k) | |
|-------------------------------------|-----------------------------|-----------------------------------------------------|-----------|
| Utfärdara/Issuer
Louise Lindblad | Ref nr/Dok nr/Ref no/Doc no | Utgåva / Edition | Sido/Page |
| Avser/Regarding
Elekta Neuromag™ | | Directory | |
Device Description (for detailed description see Section "Device Description") હ.
The Elekta Neuromag™ is an upgraded version of the currently available Neuromag Vectorview (K984401). The Elekta Neuromag™ does not change the intended use or the fundamental scientific technology of the Neuromag Vectorview.
The Elekta Neuromag™ integrates 306 sensor elements, including planar gradiometers and and magnetometers, with computers and data acquisition and data analysis software in order to measure the differences in the magnetic signals generated by the intracellular dendritic currents. These detectors are positioned in a helmet shaped array that gives the user the ability to record the electrical activity of the entire surface of the brain simultaneously without having to move the position of the measuring device.
7. Indications for use:
The Elekta Neuromag™ non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electrocncephalographic (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.
8. Intended Use:
The Elekta Neuromag™ is intended for use as a magneto encephalographic (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.
9. Substantial Equivalence:
The Elekta Neuromag™ is substantially equivalent to its predicate device the Omega Whole-Cortex MEG System (K030737) in safety and effectiveness. The fundamental technical characteristics are similar to those of the predicate device and are listed on the comparison charts provided in this 510 k submission.
2
Image /page/2/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 image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Birgitta Fagerström Manager, Quality and Regulatory Affairs Elekta Neuromag Ov Elimäenkatu 22 B, P.O. Box 68 FIN-00511 Helsinki, Finland
Re: K041264 Trade/Device Name: Elekta Neuromag® Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLX, OLY, GWQ Dated (Date on orig SE ltr): May 12, 2004
Received (Date on orig SE ltr): May 12, 2004
APR
Dear Ms. Fagerström:
This letter corrects our substantially equivalent letter of August 10, 2004.
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. Iisting 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Kesia Alexander
Malvina B. Evdelman, 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
ELEKTA NEUROMAG OY
Dokumentnomn/Nome of document
Traditional 510(k)
| Utfärdare/Issuer | Louise Lindblad |
|---|---|
| Avser/Regarding | Elekta Neuromag TM |
| Ref nr/Dok nr/Ref no/Doc no | |
| Utgåva /Edition | Directory |
| Sida/Page |
Section 8 - Indications for Use Statement
| 510(k) Number | To be defined | K 041264 |
|---|---|---|
| Device Name | Elekta Neuromag™ | |
| Indications for Use | The Elekta Neuromag 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 (Per 21 CFR 801 Subpart D)
OR
Over-The-Counter Use_
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Meriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
8041264 Elck STA() nd_Icl_LcL_L_358 9 756 2400 Fax +358 9 756 24011