(21 days)
Not Found
No
The summary describes a MEG device that measures and displays biomagnetic signals. It mentions integration with super-computers and data acquisition software but does not mention any AI/ML algorithms for data processing, interpretation, or analysis. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device is described as a diagnostic tool used to detect and display biomagnetic signals to enhance diagnostic capability, not to provide therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section states that "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." This indicates that the device aids in diagnosis.
No
The device description explicitly states it integrates hardware components (306 sensor elements, super-computers) with data acquisition software.
Based on the provided information, the Neuromag Vectorview system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Neuromag Vectorview's function: The description clearly states that the device "non-invasively detects and displays biomagnetic signals produced by electrically active nerve tissue in the brain." This is a measurement of a physiological signal directly from the body, not an analysis of a sample taken from the body.
- Intended Use: The intended use describes the device as a "magneto encephalographic (MEG) device" which is a neuroimaging technique, not an in vitro test.
Therefore, the Neuromag Vectorview system falls under the category of a medical device used for diagnostic purposes, but specifically for in vivo (within the living body) measurement, not in vitro (in glass/outside the body) testing.
N/A
Intended Use / Indications for Use
The Neuromag Vectorview system is intended for use as a magneto encephalographic (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 Vectorview is intended for use as a magneto encephalographic (MEG) device which noninvasively 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 the viding 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, GWQ
Device Description
This device integrates 306 sensor elements, including planar gradiometers and magnetometers, with medical super-computers and data acquisition software in order to measure the differences in the magnetic signals generated by the intracellular dendritic currents. These detectors are positioned in a helmet shaped array that gives the user the ability to record the electrical activity of the entire surface of the brain simultaneously without having to move the position of the probe.
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 clinician
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
DEC 30 1998
SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)
1. General Information
| Classification: | Class II
Magnetoencephalograph |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Magnetoencephalographic (MEG) Device |
| Proprietary Name: | Vectorview |
| Establishment Registration: | Manufacturer:
Neuromag Ltd.
P.O. Box 357
00511 Helsinki, Finland
Phone: +358-9-394 101
Fax: +358-9-3941 203
FDA Facility Registration: #9680891
United States Representative:
Picker International, Inc.
World Headquarters
595 Miner Road
Highland Heights, Ohio 44143
FDA Owner Number: #1580240
FDA Registration Number: #1525965 |
No applicable performance standards have been Performance Standards: issued under section 514 of the Food, Drug and Cosmetic Act.
2. Intended Uses
The Neuromag Vectorview system does not change the existing intended use and indications for use for the Neuromag-122 as defined below.
The Neuromag Vectorview system is intended for use as a magneto encephalographic (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.
【- | PICKER INTERNATIONAL, INC. (VECTOR) 12/01/98
1
Device Description 3.
This device integrates 306 sensor elements, including planar gradiometers and magnetometers, with medical super-computers and data acquisition software in order to measure the differences in the magnetic signals generated by the intracellular dendritic currents. These detectors are positioned in a helmet shaped array that gives the user the ability to record the electrical activity of the entire surface of the brain simultaneously without having to move the position of the probe.
Safety and Effectiveness 4.
The Neuromag Vectorview is substantially equivalent to the Neuromag-122 in safety and effectiveness. The following chart has been compiled to demonstrate this equivalence.
| Parameter | Neuromag Vectorview | Predicate Device
Neuromag-122 (K962764) |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| No. of SQUID sensor
elements | 102 | 61 |
| No. of channels for MEG
data | 306 | 122 |
| No. of auxiliary channels
for other types of data (e.g
EEG) | 144
(typically 64 for EEG) | 134
(typically use 32 for EEG) |
| Coil Configuration | Two orthogonal planar-first-
order gradiometers and one
magnetometer per location | Two orthogonal planar-first-order
gradiometers per location |
| Intersensor spacing | 34-35 mm | 43-44 mm |
| Sensor element placement | 102 locations distributed
across helmet-shaped lower tip
of dewar, shape based on
anatomy (standard
EN960:1994). Inside
dimensions 222 mm (length) x
181 mm (width) x 209 mm
(depth). | Sixty-one locations distributed across
helmet-shaped lower tip of dewar.
Radius of curvature of helmet is 83
mm (front-portion) and 91 mm (back-
portion). |
| Cryogen Used | Same. | Liquid Helium |
| Coverage | Same. | One acquisition to cover entire head |
| Gantry | Floor mounted. Dewar helmet
is either tilted 30° for seated
position or horizontal (180°)
for supine position. | Floor mounted, standard gantry tilts
up to 30°. Optional gantry tilts to 45°. |
Substantial Equivalence Chart
PICKER INTERNATIONAL, INC. (VECTOR) 12/01/98
2
| Parameter | Neuromag Vectorview | Predicate Device
Neuromag-122 (K962764) |
|---------------------------------------|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient Position | Same. | Seated or Supine. Optional chair
insert for children. |
| Head Position Indicator | Same. | Available |
| Computer | Same. | Hewlett Packard workstation with
UNIX environment. |
| Networking Capabilities | Same. | Ethernet connections to other
workstations available |
| Software | Same. | Data Acquisition, Display plotting and
Signal processor for continuous data. |
| Magnetic Shielded Room
Accessories | Same. | Video monitor and two-way intercom
for monitoring patients. |
| Intended Use & Indications
for Use | Same. | The Neuromag-122 system is intended
for use as a magneto encephalographic
(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. |
12/01/98
(VECTOR)
I - 3
,
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Elaine K. Keeler, Ph.D. Manager, MR Clinical Science Picker International, Inc. 595 Miner Road Highland Heights, Ohio 44143
APR - 9 2012
Re: K984401
Trade/Device Name: Neuromag Vectorview Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLX, OLY, GWQ Dated (Date on orig SE Itr): December 7, 1998 Received (Date on orig SE ltr): December 9, 1998
Dear Ms. Keeler:
This letter corrects our substantially equivalent letter of December 30, 1998.
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 - Ms. Elaine K. Keeler
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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/4/Picture/6 description: The image shows a stylized, handwritten letter 'J' in black ink on a white background. The 'J' has a flowing, cursive style with a prominent loop at the bottom and a curved stroke extending from the top. The stroke at the top of the 'J' appears to form a small, connected 'or' or 'ar' shape, adding a unique flourish to the letter.
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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Page 1 of 1
. 2
510(k) Number (if known): K984401
Device Name: Vectorview
Indications for Use:
4-1 - 1
The Vectorview is intended for use as a magneto encephalographic (MEG) device which noninvasively 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 the viding useful information about the location relative to brain anatomy of active nerve tissue responsible for critical brain functions.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark McMullen
for
Cyma (Division Sign-Off)
cre Division of General Restorative Devices
510(k) Number. K984401
× Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)