(68 days)
Not Found
No
The document describes a hardware modification (active shielding) to improve signal quality and does not mention any software or algorithmic components related to AI or ML for data interpretation or analysis.
No
The device is used to measure and localize brain activity for diagnostic purposes and neurosurgical planning, not for direct therapeutic intervention.
Yes
The device is described as helping to "localize these active areas" (brain activity) which can then be "correlated with anatomical information of the brain." It is also explicitly stated that "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." These all indicate its role in diagnosis.
No
The device description explicitly mentions hardware components like "internal active shielding system," "compensation coils," and "sensor array of the biomagnetometer," indicating it is a hardware-based medical device with software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Device Function: The Elekta Neuromag® with active shielding is a device that measures signals directly from the brain (MEG and optionally EEG). It does not analyze samples taken from the body.
- Intended Use: The intended use describes the device as non-invasively measuring signals produced by the brain to help localize active areas for interpretation by physicians and potential use in neurosurgical planning. This is a diagnostic process performed on the patient, not on a sample from the patient.
Therefore, the device falls under the category of a medical device used for diagnostic purposes, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Elekta Neuromag® with internal active shielding is intended for use as a magnetvencephalographic (MEG) device which non-invasively detects and disolays 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 active shielding 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 eplieptic activity within the brain. The localization information provided by MEG may be used, in conjunction with other diagnostic data, in neurosurgical planning.
Product codes
GWQ, OLX, OLY
Device Description
This premarket notification represents modifications made to our current product. Internal active shielding has been added to enhance the signal to noise ratio.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MEG (magnetvencephalographic), EEG (electroencephalographic)
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)
The results of laboratory, bench testing, clinical testing, and software validation activities show that the internal active shielding modification poses no new issues of safety or effectivencss, and is therefore substantially equivalent to our predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
JUL 2 8 2008
510(K) Summary Elekta Neuromag Oy Siltasaarenkatu 18-20 A FI-00530 Helsinki, Finland (P.O. Box 68, FI-00511 Helsinki, Finland) Tel: +358 9 756 240 0 Fax: +358 9 756 240 11 Contact: Mrs Anne Karvinen Date prepared: April 1, 2008
- Trade Name: Elekta Neuromag® with internal active shielding 1.
- Common Name: Electroencephalograph 2.
-
- Classification Name: Electroencephalograph, product code GWQ, Regulation: 882.1400 Class of device: Class II. OLY, OLY
- The legally marketed device to which we are claiming equivalence (807.92(a)(3)) : 4. K041264, Elekta Neuromag™, manufactured by Elekta Neuromag Oy and K050035, Elekta Neuromag® with Maxwell Filter.
- Description of device: This premarket notification represents modifications made to ડ. our current product. Internal active shielding has been added to enhance the signal to noise ratio.
- Intended use: The Elekta Neuromag® with internal active shielding is intended for 6. use as a magnetvencephalographic (MEG) device which non-invasively detects and disolays 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 active shielding non-invasively measures 7. the magnetoencephalographic (MEG) signals (and, optionally, clectroencephalographic (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 thesc 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. MBG is also used to non-invasively locate regions of eplieptic activity within the brain. The localization information provided by MEG may be used, in conjunction with other diagnostic data, in neurosurgical planning.
- Technological characteristics: The internal active shielding system is a magnetic 8. shielding technique intended to be an integrated, optional part of Elekta Neuromag® magnetoencephalograph.
1
510(K) Summary Elekta Neuromag Oy Page 2 of 2
Technological characteristics, continued
The internal active shielding system increases the dynamic range of the magnetometers. related external magnetic interferences, by internal feedback compensation that uses the sensor array of the biomagnetometer as a zero indicator and compensation coils placed inside the magnetically shielded room to deliver a cancellation field for attenuating the interference
- Performance: 'The results of laboratory, bench testing, clinical testing, and software છે. validation activities show that the internal active shielding modification poses no new issues of safety or effectivencss, and is therefore substantially equivalent to our predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three bodies, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Elekta Neuromag Oy c/o Kamm & Associates Mr. Daniel Kamm Principal Consultant P.O. Box 7007 Deerfield, Illinois 60015
APR 一9 2012
Re: K081430
Trade/Device Name: Elekta Neuromag® with internal active shielding Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLX, OLY, GWQ Dated (Date on orig SE ltr): June 30,2008 Received (Date on orig SE Itr): July 3, 2008
Dear Mr. Kamm:
This letter corrects our substantially equivalent letter of July 28, 2008.
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 (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.
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
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
for
MR.
DR.
DR.
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
Indications for Use
510(k) Number (if known):
Device Name: Elekta Neuromag@ with internal active shielding
Indications For Use:
illekta Neuromag® with active shielding 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 | AND/OR |
|---|---|---|
| (Part 21 CFR 801 Subpart D) |
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence on CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | K081430 |
|---|---|
| --------------- | --------- |
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