(30 days)
Magnes® 2500 WH MEG
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on magnetic field measurement and display.
No.
The device is intended for diagnostic procedures, specifically for measuring and displaying magnetic fields and electrical activity in the brain, which is a diagnostic rather than a therapeutic function.
Yes
Justification: The "Intended Use / Indications for Use" section explicitly states "The Magnes®3600 WH MEG is intended for use in diagnostic procedures".
No
The device description explicitly states it consists of a "magnetic sensor for detecting and measuring magnetic fields produced by the human brain, along with auxiliary equipment," indicating it includes hardware components beyond just software.
Based on the provided information, the Magnes®3600 WH MEG is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that the Magnes®3600 WH MEG measures extracranial magnetic fields and infers information about electrical activity in the brain directly from the patient. It does not process samples like blood, urine, or tissue.
- The device description focuses on measuring magnetic fields produced by the human brain. This is a direct measurement from the patient, not an analysis of a biological sample.
Therefore, the Magnes®3600 WH MEG falls under the category of a medical device used for diagnostic purposes, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Magnes®3600 WH MEG is intended for use in diagnostic procedures that require the measurement and display of extracranial magnetic fields and information about the electrical activity in the brain as inferred from those fields.
Product codes (comma separated list FDA assigned to the subject device)
OLX, OLY, GWQ
Device Description
The Magnes® 3600 WH MEG consists of a magnetic sensor for detecting and measuring magnetic fields produced by the human brain, along with auxiliary equipment required to perform the measurements in a conventional medical facility environment and to display the results of the measurements to physicians in a variety of ways.
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
physicians in a conventional medical facility environment
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)
Because the specifications, performance characteristics, and intended uses of the Magnes® 3600 WH MEG are the same as the Magnes® 2500 WH MEG no performance data were required.
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.
Magnes® 2500 WH MEG
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 - 3 1999
SECTION 11
510(k) SUMMARY
BIOMAGNETIC TECHNOLOGIES, INC MAGNES® 3600 WHOLE HEAD MEG
This 510(k) summary of safety and effectiveness for the Magnes® 3600 WH MEG is submitted in accordance with the requirements of SMDA 1990 and follows guidance from the Office of Device Evaluation concerning the organization and content of a 510(k) summary.
| Applicant: | Biomagnetic Technologies, Inc. 9727 Pacific Heights Blvd. San Diego, CA 92121-3719 |
|---|---|
| Address (Manufacturer): | Biomagnetic Technologies, Inc. 9727 Pacific Heights Blvd. San Diego, CA 92121-3791 |
| Contact Person: | Eugene C. Hirschkoff, Ph.D. Vice President, Engineering (619) 458-5617 |
| Telephone: | (619) 453-6300 (619) 453-4913 (Fax) |
| Preparation Date: | October 1999 |
| Device Trade Name: | Magnes® 3600 Whole Head Magnetoencephalograph (MEG) |
| Common Name: | Electroencephalograph; biomagnetometer |
| Classification Name: | Electroencephalograph |
| Class: | Class II |
| Legally marketed predicate device: | Magnes® 2500 WH MEG |
| Description of Device: | The Magnes® 3600 WH MEG consists of a magnetic sensor for detecting and measuring magnetic fields produced by the human brain, along with auxiliary equipment required to perform the measurements in a conventional medical facility environment and to display the results of the measurements to physicians in a variety of ways. |
1
- The Magnes®3600 WH MEG is intended for use in diagnostic procedures Intended Use: that require the measurement and display of extracranial magnetic fields and information about the electrical activity in the brain as inferred from those fields.
- Because the specifications, performance characteristics, and intended uses Performance Data: of the Magnes® 3600 WH MEG are the same as the Magnes® 2500 WH MEG no performance data were required.
- CONCLUSION: Based on the foregoing, Biomagnetic Technologies, Inc., believes that the Magnes® 3600 WH MEG is substantially equivalent to the Magnes® 2500 WH MEG.
2
Image /page/2/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 eagle or bird symbol in the center. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR - y 20i2
Eugene C. Hirschkoff, Ph.D. Vice President, Engineering Biomagnetic Technologies, Inc. 9727 Pacific Heights Boulevard San Diego, California 92121
Re: K993708
Trade/Device Name: Magnes® 3600 Whole Head Magnetic Encephalograph Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLX, OLY, GWQ Dated (Date on orig SE Itr): November 2, 1999 Received (Date on orig SE ltr): November 3, 1999
Dear Mr. Hirschkoff:
This letter corrects our substantially equivalent letter of December 3, 1999.
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.
3
Page 2 - Mr. Eugene C. Hirschkoff
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/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.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kesia Alexander
Image /page/3/Picture/7 description: In this image, there is a signature on the left side of the image. To the right of the signature, there is a title that says "Director". The text is left-aligned and in a serif font. The image is in black and white.
Malvina B. Eydelman, M.D. Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 7
INDICATIONS FOR USE STATEMENT
K 99310f 510(k) Number (if known):
Device Name: Magnes® 3600 Whole Head (WH) Magnetic Encephalograph (MEG)
Indications for Use Statement:
The Magnes®3600 WH MEG is intended for use in diagnostic procedures that require the measurement and display of extracranial magnetic fields and information about the electrical activity in the brain as inferred from those fields.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Prescription Use J (Per 21 CFR 801.109)
OR Over-
Stephen Rhode
Over-The Counter Use __
(Division Sign-C Division of General Restorative Devices K993708 510(k) Number