The MEGvision 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.

Device Description

The MEGvision integrates up to 320 dc-SQUID axial gradiometer with PCs and data acquisition software in order to measure the magnetic signals generated by the intercellular dendritic currents. These detectors positioned in a helmet shaped array give the user the ability to record the electrical activity of the entire surface of the brain cortex simultaneously without having to move the position of the sensor array.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the MEGvision EQ1000C Series device:

Important Note: The provided 510(k) summary focuses almost entirely on establishing substantial equivalence to predicate devices based on technological characteristics and intended use. It does not contain specific acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity) derived from a clinical or analytical study, nor does it describe a study specifically designed to prove such performance criteria were met. The core of this submission is a comparison of technical specifications.

Therefore, the following information is extracted and inferred based on the document's content. Many sections will indicate that the information is "Not provided" because the document doesn't detail performance-based testing against acceptance criteria in the way a clinical performance study would.

Acceptance Criteria and Device Performance

Since the submission is primarily focused on demonstrating substantial equivalence through technological comparison, there are no explicit performance "acceptance criteria" presented in the traditional sense (e.g., a specific sensitivity or specificity threshold). Instead, the "acceptance" is implied by the similarity of the new device's technological characteristics and intended use to those of the legally marketed predicate devices.

The "reported device performance" is essentially the device's technological specifications, which are implicitly accepted as equivalent if they fall within comparable ranges or offer similar functionality to the predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Predicate Comparison)	Reported Device Performance (MEGvision EQ1000C Series)
Number of SQUID detectors/channels for MEG data: Comparable to predicate devices (64-200 for CTF, 122 for Neuromag).	64 to 320 (Higher range than predicates but includes predicate ranges)
Operating Principle: Superconducting flux transformer coupled with dc-SQUID.	Superconducting flux transformer coupled with dc-SQUID driven by digitally controlled analog flux locked loop circuit (Similar to CTF's digital flux-locked loop and Neuromag's analog flux-locked loop)
Number of auxiliary channels for other types of data: Comparable to predicate devices (88 for CTF, 166 for Neuromag).	166 (Matches Neuromag, higher than CTF)
Gradiometer Type: Similar to predicate devices (axial first order for CTF, orthogonal planar first order for Neuromag).	1 axial first order gradiometer per location (Matches CTF Systems)
Intersensor Spacing: Comparable to predicate devices (32 mm for CTF, 43-44 mm for Neuromag).	20mm to 25mm (160 sensor configuration) (Provides denser coverage than predicates)
Gradiometer Placement: Locations distributed across a helmet-shaped lower tip of a dewar for entire head coverage.	64 to 320 location distributed across the helmet shaped lower tip of a dewar (Similar principle to predicates)
Cryogen Used: Liquid helium.	Liquid helium (Matches predicates)
Coverage: One acquisition to cover the entire head.	One acquisition to cover entire head (Matches predicates)
Gantry Type: Floor mounted.	Floor mounted fixed gantry. (Similar to predicates, but predicates offer tilting options)
Patient Position: Lying on back or seated.	Lying on back (More restricted than predicates, which offer seated/supine options)
Head Position Indicator: Included.	Included (Matches predicates)
Computer System: A computer system capable of processing MEG data.	Personal Computer with Windows (Differs from predicates' HP workstation with UNIX, but implies equivalent processing capability)
Networking Capabilities: Ethernet connections.	Ethernet connections to other network system available (Matches predicates)
Magnetically Shielded Room Accessories: Basic amenities for patient monitoring (lights, camera, intercom).	Interior DC lights, video camera and two-way intercom for patients (Similar to predicates)
Intended Use: Non-invasively detects and displays biomagnetic signals from electrically active nerve tissue in the brain, interpreted by clinicians for localization relative to brain anatomy, enhancing diagnostic capability.	The MEGvision 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. (Identical wording to both predicate devices)

Study Details:

As noted, the provided 510(k) summary does not describe a performance effectiveness study as might be expected for an AI or imaging diagnostic device. The basis for substantial equivalence is primarily a technological comparison to predicate devices, where the MEGvision EQ1000C Series demonstrates comparable or superior technological characteristics for the same intended use.

Here's a breakdown of the specific points based on the available text:

2. Sample size used for the test set and the data provenance

Not provided. The document describes the technological characteristics of the device and compares them to predicate devices. It does not mention a specific test set of patient data or any clinical studies to evaluate performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable / Not provided. Since no specific test set or clinical study is described for performance evaluation, there is no mention of experts or ground truth establishment in this context. The intended use states the data is to be "interpreted by trained clinicians," implying human experts will always be in the loop.

4. Adjudication method for the test set

Not applicable / Not provided. No test set or performance evaluation study is described.

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

No, a MRMC comparative effectiveness study was not done based on this document. This device is a direct measurement instrument (MEG device), not an AI-assisted diagnostic tool that would typically involve improving human reader performance. The document focuses on the device's technical specifications.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable / No. The device is a measurement system; it's explicitly stated that the data should be "interpreted by a trained clinician." There's no AI algorithm that operates standalone described in this document.

7. The type of ground truth used

Not provided. As there's no described performance study, there's no mention of the type of ground truth used. The device's output is intended to provide "information about the location relative to brain anatomy of active nerve tissue," which would historically be correlated with other clinical findings, electrophysiology, or anatomical imaging.

8. The sample size for the training set

Not provided. This device is hardware for signal acquisition; it does not involve a training set as a machine learning model would.

9. How the ground truth for the training set was established

Not applicable. No training set is involved for this type of device.

In summary, this 510(k) submission establishes substantial equivalence primarily through a detailed comparison of the new device's technical specifications and intended use against those of legally marketed predicate MEG devices. It does not contain information about a clinical performance study with acceptance criteria, test sets, or ground truth establishment, which would typically be seen for devices that perform an analytical or diagnostic function independent of human interpretation or that incorporate AI/machine learning.

Summary

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K 040051

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510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR¶807.92(a).

807.92(a)(1)

807.92(a)(1)	Submitter Information
Name:	Eagle Technology, Inc.
Address:	1-2-23 Hirosaka, Kanazawa, Ishikawa, Japan 920-1331
Phone:	+81-76-263-3636
Facsimile:	+81-76-294-6745
Contact Person:	Hideyuki Fujihira
Date:	1/5/2004
807.92(a)(2)
Trade Name:	MEGvision EQ1000C Series
Common Name:	Magnetoencepholographic (MEG) Device
Classification Name(s):	Electroencephalograph
Classification Number:	21CFR882.1400 OLX, OLY
807.92(a)(3)	Predicate Device(s)
Device Name	510(k) #	Manufacturer
CTF "Whole-Cortex MEGSystem"	K971329	CTF Systems, Inc

K962764

. .

Neuromag- 1 22

Neuromag Ltd.

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K(4.0051) . 2/3

Eagle Technology , Inc.

3 pages

807.92 (a)(4)

Device Description

807.92(a)(5)

Intended Use(s)

The MEGvision non-invasively measures the magnetoencephalographic (MEG) signals produced by the electrical activities by the tissue activities of the brain. These signals, position, direction, and sensitivity of the sensors are acquired and displayed, and may be interpreted by trained clinicians to help localize these active areas. The locations may be correlated to anatomical structure of the brain.

807.92(a)(6)

Technological Characteristics

	Eagle Technology,Inc.MEGvision	CTF Systems, Inc."Whole-Cortex MEGSystem" (K971329)	Neuromag Ltd."Neuromag-122"(K962764)
No. of SQUIDdetectors/ channelsfor MBG data:	64 to 320	64 to 200	122
Operating Principle	Superconducting fluxtransformer coupled withdc-SQUID driven bydigitally controlled analogflux locked loop circuit	Superconducting fluxtransformer coupled withdc-SQUID controlled bydigital flux-locked loop	Superconducting fluxtransformer coupled withdc-SQUID controlled byanalog flux-locked loop
No. of auxiliarychannels for othertypes of data	166	88	166
Gradiometer:	1 axial first ordergradiometer per location	1 axial first ordergradiometer per location	2 orthogonal planar firstorder gradiometers perlocation
Intersensor spacing	20mm to 25mm(160 sensor configuration)	32 mm(150 sensor configuration)	43-44 mm
Gradiometerplacement	64 to 320 locationdistributed across thehelmet shaped lower tip ofa dewar	64 to 200 locationsdistributed across thehelmet shaped lower tip ofa dewar (optionalCaucasian or Oriental headshape)	61 locations distributedacross the helmet shapedlower tip of a dewar.
	Eagle Technology,Inc.MEGvision	CTF Systems, Inc."Whole-Cortex MEGSystem" (K971329)	Neuromag Ltd."Neuromag-122"(K962764)
Cryogen used:	Liquid helium	Liquid helium	Liquid helium
Coverage	One acquisition to coverentire head	One acquisition to coverentire head	One acquisition to coverentire head
Gantry	Floor mounted fixedgantry.	Floor mounted, standardgantry is fixed. Optionalgantry tilts to 90 degrees	Floor mounted, standardgantry tilts up to 30degrees. Optional gantrytilts to 45 degrees
Patient Position	Lying on back	Seated, or lying on backwith optional bed	Seated or supine. Optionalchair insert for children
Head PositionIndicator	Included	Included	Available
Computer	Personal Computer with Wind	HP workstation with UNIXenvironment	HP workstation with UNIXenvironment
NetworkingCapabilities	Ethernet connections toother network systemavailable	Ethernet connections toother workstations included	Ethernet connections toother workstationsavailable
MagneticallyShielded RoomAccessories	Interior DC lights, videocamera and two-wayintercom for patients	Interior DC lights, videocamera and monitor andtwo-way intercom formonitoring patients	Video monitor and two-way intercom formonitoring patients
Intended Use	The MEGvision isintended for use as amagnetoencephalographic(MEG) device which non-invasively detects anddisplays biomagneticsignals produced byelectrically active nervetissue in the brain. Wheninterpreted by a trainedclinician, the data enhancesthe diagnostic capability byproviding usefulinformation about thelocation relative to brainanatomy of active nervetissue responsible forcritical brain functions.	The CTF "Whole-CortexMEG System", is intendedfor use as amagnetoencephalographic(MEG) device which non-invasively detects anddisplays biomagneticsignals produced byelectrically active nervetissue in the brain. Wheninterpreted by a trainedclinician, the data enhancesthe diagnostic capability byproviding usefulinformation about thelocation relative to brainanatomy of active nervetissue responsible forcritical brain functions.	The Neuromag-122system is intended for useas amagnetoencephalographic(MEG) device which non-invasively detects anddisplays biomagneticsignals produced byelectrically active nervetissues in the brain. Wheninterpreted by a trainedclinician, the data enhancesthe diagnostic capability byproviding usefulinformation about thelocation relative to brainanatomy of active nervetissue responsible forcritical brain functions.

TABLE 1.1 Comparison to the Predicate Devices

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized eagle emblem. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The eagle is depicted with three curved lines forming its body and wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Eagle Technology, Inc. c/o Mr. Lewis Fisher Eagle Technology North America, LLC 25 Bisbee Court, Suite B Santa Fe, New Mexico 87508

Re: K040051

Trade/Device Name: MEGvision EO 1000C Series Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLX, OLY Dated (Date on orig SE ltr): January 5, 2004 Received (Date on orig SE ltr): January 12, 2004

APR - 9 2012

Dear Mr. Fisher:

This letter corrects our substantially equivalent letter of March 24, 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, listing 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. Lewis Fisher

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

દ

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Kesia Alexander

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): K040051

Device Name: MEGvision EQ1000C Series

Indications For Use: The MEGvision 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 technician, 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.

Prescription Use XX (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)

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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510(k) Number_ Ko 4 00 5/

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).