Who is the manufacturer of MEGVISION, MODEL EQ1000C SERIES?

Eagle Technology, Inc. filed the 510(k) submission for MEGVISION, MODEL EQ1000C SERIES (K040051).

What is the FDA product code for MEGVISION, MODEL EQ1000C SERIES?

OLX. It is classified under 21 CFR 882.1400 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for MEGVISION, MODEL EQ1000C SERIES?

510(k) clearance (submission type: Traditional).

What are the predicate devices for MEGVISION, MODEL EQ1000C SERIES?

CTF Whole-Cortex MEG System (K971329).

Who can help prepare an FDA 510(k) submission like MEGVISION, MODEL EQ1000C SERIES?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MEGVISION, MODEL EQ1000C SERIES

K040051 · Eagle Technology, Inc. · OLX · Mar 24, 2004 · Neurology

Device Facts

Record ID	K040051
Device Name	MEGVISION, MODEL EQ1000C SERIES
Applicant	Eagle Technology, Inc.
Product Code	OLX · Neurology
Decision Date	Mar 24, 2004
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1400
Device Class	Class 2

Intended 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.

Device Story

MEGvision measures magnetic signals from intercellular dendritic currents in brain cortex; utilizes helmet-shaped array of up to 320 dc-SQUID axial gradiometers; signals processed via PCs and data acquisition software; system uses superconducting flux transformer coupled with dc-SQUID driven by digitally controlled analog flux-locked loop circuit; output displayed for clinician interpretation to localize active nerve tissue; used in clinical settings; aids diagnostic capability by correlating functional activity with anatomical brain structure.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Liquid helium-cooled dewar. Sensing: 64-320 dc-SQUID axial gradiometers. Energy: Superconducting flux transformer, digitally controlled analog flux-locked loop. Form factor: Floor-mounted fixed gantry with helmet-shaped sensor array. Connectivity: Ethernet networking. Software: Data acquisition software on PC platform.

Indications for Use

Indicated for non-invasive detection and display of biomagnetic signals from electrically active brain nerve tissue to assist trained clinicians in localizing active areas relative to brain anatomy.

Regulatory Classification

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.

Predicate Devices

CTF Whole-Cortex MEG System (K971329)

Reference Devices

Neuromag-122 (K962764)

Related Devices

K971329 — CTF SYSTEMS INC, WHOLE-CORTEX MEG SYSTEM (WITH OPTIONAL EEG SUBSYSTEM) · Ctf Systems, Inc. · Nov 20, 1997
K962764 — NEUROMAG-122 · Philips Medical Systems (Cleveland), Inc. · Oct 31, 1996
K984401 — NEUROMAG VECTORVIEW · Philips Medical Systems (Cleveland), Inc. · Dec 30, 1998
K030737 — OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275 · Ctf Systems (2001), Inc. · Oct 10, 2003
K041264 — ELEKTA OY · Elekta Neuromag OY · Aug 10, 2004

Submission Summary (Full Text)

{0}------------------------------------------------ K 040051 1/3 # 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 MEG System" | K971329 | CTF Systems, Inc | K962764 . . Neuromag- 1 22 1 Neuromag Ltd. {1}------------------------------------------------ K(4.0051) . 2/3 Eagle Technology , Inc. 3 pages ## 807.92 (a)(4) ## 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. #### 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 MEG System" (K971329) | Neuromag Ltd. "Neuromag-122" (K962764) | |---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | No. of SQUID detectors/ channels for MBG data: | 64 to 320 | 64 to 200 | 122 | | Operating Principle | Superconducting flux transformer coupled with dc-SQUID driven by digitally controlled analog flux locked loop circuit | Superconducting flux transformer coupled with dc-SQUID controlled by digital flux-locked loop | Superconducting flux transformer coupled with dc-SQUID controlled by analog flux-locked loop | | No. of auxiliary channels for other types of data | 166 | 88 | 166 | | Gradiometer: | 1 axial first order gradiometer per location | 1 axial first order gradiometer per location | 2 orthogonal planar first order gradiometers per location | | Intersensor spacing | 20mm to 25mm (160 sensor configuration) | 32 mm (150 sensor configuration) | 43-44 mm | | Gradiometer placement | 64 to 320 location distributed across the helmet shaped lower tip of a dewar | 64 to 200 locations distributed across the helmet shaped lower tip of a dewar (optional Caucasian or Oriental head shape) | 61 locations distributed across the helmet shaped lower tip of a dewar. | | | Eagle Technology, Inc. MEGvision | CTF Systems, Inc. "Whole-Cortex MEG System" (K971329) | Neuromag Ltd. "Neuromag-122" (K962764) | | Cryogen used: | Liquid helium | Liquid helium | Liquid helium | | Coverage | One acquisition to cover entire head | One acquisition to cover entire head | One acquisition to cover entire head | | Gantry | Floor mounted fixed gantry. | Floor mounted, standard gantry is fixed. Optional gantry tilts to 90 degrees | Floor mounted, standard gantry tilts up to 30 degrees. Optional gantry tilts to 45 degrees | | Patient Position | Lying on back | Seated, or lying on back with optional bed | Seated or supine. Optional chair insert for children | | Head Position Indicator | Included | Included | Available | | Computer | Personal Computer with Wind | HP workstation with UNIX environment | HP workstation with UNIX environment | | Networking Capabilities | Ethernet connections to other network system available | Ethernet connections to other workstations included | Ethernet connections to other workstations available | | Magnetically Shielded Room Accessories | Interior DC lights, video camera and two-way intercom for patients | Interior DC lights, video camera and monitor and two-way intercom for monitoring patients | Video monitor and two- way intercom for monitoring patients | | Intended 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 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 CTF "Whole-Cortex MEG System", 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. | The Neuromag-122 system is intended for use as a magnetoencephalographic (MEG) device which non- invasively detects and displays biomagnetic signals produced by electrically active nerve tissues 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. | #### TABLE 1.1 Comparison to the Predicate Devices {2}------------------------------------------------ {3}------------------------------------------------ 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. {4}------------------------------------------------ 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 {5}------------------------------------------------ # 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 Page 8 510(k) Number_ Ko 4 00 5/