ELEKTA NEUROMAG WITH MAXFILTER by ELEKTA NEUROMAG OY

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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Elekta Neuromag® with MaxFilter 2.1, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Metric	Acceptance Criteria (Predicate)	Reported Device Performance (MaxFilter™ 2.1)	Supporting Evidence
Spatiotemporal Interference Elimination	No (Predicate K050035 had SSS only)	Yes (tSSS technology)	Performance testing, clinical study. Substantially equivalent measurement accuracy in clinical study with non-moving heads.
Source Localization Accuracy (Phantom)	Not explicitly stated but implied by substantial equivalence to K050035	Within 2 mm accuracy	Phantom testing
Graphical User Interface (GUI)	No (Predicate had command-line UI)	Yes	User friendliness enhancement; performs same software modules as command-line. No clinical utility impact.
Offline Averager Function	No (Predicate had online averager only)	Yes	User friendliness enhancement; same functionality as online version. No clinical utility impact.
Support for Internal Active Shielding (K081430)	No	Yes	Functional modification
Automated Detection of Bad Channels	Yes	Yes	Functional equivalence to predicate

Note: The 510(k) summary focuses on demonstrating substantial equivalence to the predicate device, K050035. The "acceptance criteria" for the new features are primarily that they provide enhanced functionality without negatively impacting the existing performance, and for the core function of MEG measurement, the new device maintains accuracy substantially equivalent to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The document mentions "clinical study" but does not detail the number of subjects or cases.
Data Provenance: Not explicitly stated. Given that Elekta Oy is based in Helsinki, Finland, and the 510(k) is for the US FDA, the clinical study could involve data from various countries. The document does not specify if it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the summary. The "clinical study" is mentioned for measurement accuracy with non-moving heads, but details about ground truth establishment by experts for localization or diagnostic capabilities are absent. The intended use states data "may then be interpreted by trained physicians," implying expert interpretation, but doesn't specify how ground truth for the study was established.

4. Adjudication Method for the Test Set

This information is not provided in the summary.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC study comparing human readers with and without AI assistance is not mentioned in the summary. The study focuses on the device's technical performance and substantial equivalence.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was implicitly done for the technical accuracy of the MaxFilter 2.1 algorithm. The document states "Performance testing consisted of software validation, phantom testing and clinical testing." The "within 2 mm accuracy of the source in a phantom" refers to the algorithm's performance in a controlled environment. However, this is not a "standalone performance" in terms of diagnostic effectiveness without human interpretation, as the device is intended for use by trained clinicians.

7. Type of Ground Truth Used

For phantom testing: The ground truth would be the known, precisely controlled source location within the phantom, allowing for direct comparison of the device's localization output to this known truth.
For clinical testing: The document states "provided substantially equivalent measurement accuracy in a clinical study with non-moving heads." This suggests that the ground truth for "measurement accuracy" in a clinical setting likely referred to established and accepted methods for assessing MEG signal quality and source localization, potentially compared against the predicate device's output or other established neurophysiological markers. However, specific details of how this clinical ground truth was established are not provided. It is not explicitly stated if pathology, expert consensus on clinical finding, or outcomes data were used as ground truth for clinical diagnostic performance.

8. Sample Size for the Training Set

The document does not explicitly mention a training set or its sample size. MaxFilter 2.1 is described as a modification to an existing product (K050035) with new algorithms (tSSS). The development of these algorithms would involve theoretical work and potentially internal data sets for optimization, but these are not referred to as a "training set" in a machine learning context within this 510(k) summary.

9. How the Ground Truth for the Training Set Was Established

As a training set is not explicitly referred to, the method for establishing its ground truth is not provided. The development of the tSSS algorithm would rely on established physics and signal processing principles for MEG data, rather than a "ground truth" derived from patient data in the way a machine learning model would.

Summary

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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

Trade Name: Elekta Neuromag® with MaxFilter 2.1 1.
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Common Name: Electroencephalograph (Magnetoencephalograph) 2.
Classification Name: Electroencephalograph, product codes OLX and OLY, 3. Regulation: 882.1400 Class of device: Class II.
The legally marketed device to which we are claiming equivalence [807.92(a)(3)] : 4. K041264, Elekta Neuromag®, K050035, Elekta Neuromag® with Maxwell Filter
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.

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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.
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Feature	PredicatedevicesK050035	Modified DeviceMaxFilter™ 2.1
Automated detection of bad channels	Yes	Yes
Support for Internal Active Shielding (K081430)	No	Yes
Interference elimination
Software shielding, interference eliminationwith spatial signal space separation (SSS)	Yes	Yes
Interference elimination with spatiotemporalsignal space separation (tSSS)	No	Yes
Offline averager function to process raw data filesTo improve user friendliness, online averagerthat 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 tocommand line user interface, also a graphicaluser interface is available in MaxFilter™ 2.1.Both user interfaces perform same softwaremodules (code) of the SSS technologies. Noclinical utility.	No	Yes

Comparison Table

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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.

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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

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Indications for Use

510(k) Number (if known): K09 | 393

OCT 2 6 2010

TM Device Name: Elekta Neuromag® with MaxFilter

Indications For Use:

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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Regulation Number and Section

§ 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).