(68 days)
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 epileptic activity within the brain. The localization information provided by MEG may be used, in conjunction with other diagnostic data, in neurosurgical planning.
This premarket notification represents modifications made to our current product. Internal active shielding has been added to enhance the signal to noise ratio. The internal active shielding system is a magnetic shielding technique intended to be an integrated, optional part of Elekta Neuromag® magnetoencephalograph. 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.
The provided 510(k) summary for the "Elekta Neuromag® with internal active shielding" does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and the comprehensive study design.
This submission focuses on demonstrating substantial equivalence to predicate devices (K041264 and K050035) based on modifications to an existing product (the addition of internal active shielding to enhance the signal-to-noise ratio). The "performance" section briefly states that "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 effectiveness, and is therefore substantially equivalent to our predicate devices." However, it does not elaborate on specific acceptance criteria, study methodologies, sample sizes, or ground truth establishment.
Here's a breakdown of what can be extracted and what is missing:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Safety | No new issues of safety are identified due to the modification. |
| Effectiveness | No new issues of effectiveness are identified due to the modification. |
| Signal-to-Noise Ratio Enhancement | "Internal active shielding has been added to enhance the signal to noise ratio." (This is the primary technical modification and its intended benefit, implying an improvement over the non-shielded version, though no quantifiable metrics or targets are provided in this summary.) |
| Substantial Equivalence | The device is deemed substantially equivalent to predicate devices (K041264, K050035). |
| Dynamic Range Increase | "The internal active shielding system increases the dynamic range of the magnetometers." (Implied positive performance, but no specific values or targets given.) |
| Attenuating Interference | The system delivers a cancellation field for "attenuating the interference." (Implied effectiveness in reducing external magnetic interference.) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document mentions "clinical testing" but provides no details on participant numbers or types.
- Data Provenance: Not specified. No information about country of origin or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Number of Experts & Qualifications: Not specified. The document states that MEG signals "may then be interpreted by trained physicians to help localize these active areas," but does not detail how ground truth was established for any specific test sets used to validate the device's performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified.
5. 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
- MRMC Study: Not applicable. This device is an electroencephalograph/magnetoencephalograph, not an AI-powered diagnostic tool. The submission does not discuss AI assistance or human reader improvement with AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable as this is a medical device for signal acquisition and display, not an AI algorithm. The device's output is "interpreted by a trained clinician."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not specified for any performance testing. The intended use describes that MEG helps "localize active areas" which "may then be correlated with anatomical information of the brain," and identifies "regions of epileptic activity" or "visual, auditory, somatosensory, and motor cortex." This suggests that the ground truth for localization would typically involve clinical correlation (e.g., with fMRI, intracranial EEG, surgical outcomes, or known functional areas), but the submission does not detail how this was applied in their specific "clinical testing."
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. As this is not an AI/ML device, there would not be a "training set" in the conventional sense for algorithm development.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. Same reason as above.
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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.
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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.
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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.
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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
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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 |
|---|---|
| --------------- | --------- |
Page 1 of 1
§ 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).