Predicate Devices

K901215A

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard MEG device and does not mention any AI or ML components or functionalities.

Therapeutic

No
The device is intended for diagnostic purposes, specifically to detect and display biomagnetic signals to enhance diagnostic capability by locating active nerve tissue. It does not treat or alleviate a disease or condition.

Diagnostic

Yes
The device is described as enhancing "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 its role in aiding diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly mentions hardware components like "122 SQUID planar gradiometers," "medical super-computers," and a "helmet shaped array," indicating it is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device 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-122 Function: The Neuromag-122 system is described as a magnetoencephalographic (MEG) device that non-invasively detects and displays biomagnetic signals produced by electrically active nerve tissue in the brain. This involves measuring magnetic fields outside the body, not analyzing samples taken from the body.

Therefore, the Neuromag-122 falls under the category of a medical device used for diagnostic purposes, but not specifically an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

# Intended Use / Indications for Use
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.

# Product codes (comma separated list FDA assigned to the subject device)
OLY, OLT

# Device Description
This device integrates 122 SQUID planar gradiometers with medical super-computers and data intracelly long 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 which 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
Magnetoencephalographic (MEG)

# 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.
Biomagnetic Technologies Magnes Single (K901215A)

# 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

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).

Summary

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OCT 31 1986

Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters and numbers. The sequence appears to be 'K962764'. The characters are written in a bold, dark font, which makes them easily readable against the white background. The style of writing suggests a casual or informal context.

SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)

General Information 1.

| Classification: | Class II
Magnetoencephalograph |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Magnetoencephalographic (MEG) Device |
| Proprietary Name: | Neuromag-122 |
| Establishment Registration: | Manufacturer:
Neuromag Ltd.
P.O. Box 357
00511 Helsinki, Finland
Phone: +358-0-394 101
Fax: +358-0-3941 203
FDA Facility Registration: # 9680891
United States Representative:
Picker International, Inc.
595 Miner Road
Highland Heights, OH 44143
FDA Owner Number: #1580240 |
| Performance Standards | No applicable performance standards have been
issued under section 514 of the Food, Drug and
Cosmetic Act. |

2. Intended Uses

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.

3. Device Description

This device integrates 122 SQUID planar gradiometers with medical super-computers and data intracelly long 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 which

PICKER INTERNATIONAL, INC.	(MSD)	7/15/96
----------------------------	-------	---------

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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-122 is substantially equivalent to the Biomagnetic Technologies Magnes Single (K901215A) in safety and effectiveness. The following chart has been compiled to demonstrate Neuromag-122's substantial equivalence to this device.

| Parameter | Neuromag-122 | Biomagnetic Technologies
Magnes Single (K901215A) |
|----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| No. of SQUID detectors /
channels for MEG data | 122 | 37 |
| No. of auxiliary channels for
other types of data (e.g EEG) | 166
(typically use 32 for EEG) | 51 |
| Gradiometer | Two orthogonal planar-first-
order gradiometers per
location | First order axial gradiometer |
| Intersensor spacing | 43-44 mm | 20 mm |
| Gradiometer placement | 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). | Positioned in a circular array
(diameter 14.4 cm) over a
concave spherical surface
with a 12.2 cm radius of
curvature. |
| Cryogen Used | Liquid Helium | Liquid Helium |
| Coverage | One acquisition to cover
entire head | Six to ten acquisitions to
cover entire head. |
| Gantry | Floor mounted, standard
gantry tilts up to 30°.
Optional gantry tilts to 45°. | Suspended from ceiling,
gantry can tilt up to 45°. |
| Patient Position | Seated or Supine. Optional
chair insert for children. | Seated or Lying on back or
side. |
| Head Position Indicator | Available | Available |

SUBSTANTIAL EQUIVALENCE CHART

PICKER INTERNATIONAL, INC.

(MSI)

ﮯ

7/15/96

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| Computer | Hewlett Packard workstation
with UNIX environment. | SUN workstation with the
UNIX environment |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Networking Capabilities | Ethernet connections to other
workstations available | Ethernet connections to other
workstations available |
| Magnetic Shielded Room
Accessories | Video monitor and two-way
intercom for monitoring
patients. | Interior DC lights, video
cameras, and two-way
intercom for monitoring
patients |
| Intended Use | Based on the product literature: The Magnes Single non-
invasively detects small biomagnetic signals produced by the
brain and provides information about the location of
electrically active nerve tissue responsible for producing these
signals. The data is presented to the physicians in an MEG
image, from which they may draw information about the
location of critical brain functions relative to brain anatomy. | 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. |

.

,

7/15/96

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is facing to the right, and its wings are curved upwards. The logo is simple and clean, and it is easily recognizable.

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

Elaine K. Keeler, Ph.D. Picker International, Inc. 5500 Avion Park Drive Highland Heights, Ohio 44143

Re: K962764 Trade/Device Name: Neuromag-122 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLY, OLT Dated (Date on orig SE ltr): October 11, 1996 Received (Date on orig SE ltr): October 15, 1996 APR - 9 2012

Dear Ms. Keeler:

This letter corrects our substantially equivalent letter of October 31, 1996.

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 - 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Image /page/4/Picture/6 description: The image shows a signature in black ink on a white background. The signature appears to be cursive and somewhat stylized. The first letter is a large loop that extends downward, and the subsequent letters are smaller and more compact, forming a shape that resembles the letters 'for'.

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

510(k) Number (if known): K9112764

Device Name: Neuromag-122

Indications for Use:

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 chhances the diagnostic capability by providing 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)

(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number	K962764

Prescription Use (Per 21 CFR 801.109)	OR	Over-The-Counter Use (Optional Format 1-2-96)
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