(72 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the description focuses on the hardware and basic data acquisition.
No
The device is described as detecting and displaying biomagnetic signals to enhance diagnostic capability, not to provide therapy.
Yes
The device "detects and displays biomagnetic signals" and "enhances the diagnostic capability by providing useful information". This clearly indicates its role in aiding diagnosis.
No
The device description explicitly mentions hardware components like "dc-SQUID axial gradiometer" and a "helmet shaped array" which are integral to the device's function of measuring magnetic signals.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- MEGvision Function: The MEGvision is described as a device that non-invasively detects and displays biomagnetic signals produced by electrically active nerve tissue in the brain. This is a measurement of activity within the body (in vivo), not an analysis of a specimen taken from the body.
- Intended Use: The intended use clearly states it detects and displays signals from the brain to enhance diagnostic capability. It does not mention analyzing bodily fluids or tissues.
Therefore, the MEGvision falls under the category of a medical device used for in vivo measurement and analysis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
OLX, OLY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained clinicians, trained technician
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
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 |
. .
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/