(778 days)
No
The description focuses on hardware components, signal processing, and basic computer processing for display, with no mention of AI or ML algorithms.
No
The device is described as "intenced for use in diagnostic procedures that require the measurement and display of extracranial magnetic fields," indicating its purpose is to diagnose, not treat, a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use in diagnostic procedures."
No
The device description explicitly lists multiple hardware components including sensor units, electronics subsystem, computer subsystem, magnetically shielded room, patient table, and gantry, indicating it is a hardware-based system with software components.
Based on the provided information, the Magnes II Biomagnetometer is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for "diagnostic procedures that require the measurement and display of extracranial magnetic fields and information about the electrical activity of the brain as inferred from those fields." This describes a diagnostic procedure performed on the patient, not on a sample taken from the patient.
- Device Description: The description details a system that interacts directly with the patient (patient table, gantry for sensor articulation) to measure magnetic fields produced by the brain. It does not mention analyzing biological samples like blood, urine, or tissue.
- Input Imaging Modality: The input is "Biomagnetic fields," which are measured directly from the patient.
- Anatomical Site: The anatomical site is the "Brain," indicating a direct interaction with the patient's body.
IVDs are devices intended for use in vitro (outside the living body) for the examination of specimens derived from the human body to provide information for diagnostic purposes. The Magnes II Biomagnetometer operates in vivo (within the living body) by measuring fields directly from the patient.
N/A
Intended Use / Indications for Use
"The Magnes II Biomagnetometer is intenced for use in diagnostic procedures that require the measurement and display of extracranial magnetic fields and information about the electrical activity of the brain as inferred from those fields."
Product codes
Not Found
Device Description
The Magnes II Biomagnetometer system utilizes superconducting signal pickup coils and Superconducting Quantum Interference Devices (SQUIDs) to detect and amplify magnetic fields produced by electrical activity in the brain. The signals are amplified, filtered and digitized by signal processing clectronics. The digitized signals are computer processed to produce displays of information about biomagnetic field strength, direction, and location.
The Magnes II Biomagnetometer system consists of: Two sensor units, one ganty mounted and one floor mounted, which house the superconducting components which are cooled to liquid helium winperature, an electronics subsystem for preliminary analog signal amplification, filtering, and analog-to-digital conversion, a computer subsystem "master analysis processor" to store, process, and display the data, a magnetically shielded room for interference reduction, a patient table for subject/patient support, and a gantry for articulation of the upper sensor.
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
Not Found
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
Nonclinical tests involve verification of basic physical principles associated with the technology. Typical examples are tests using "phantom" signal sources for localization accuracy, characterization of signal sensitivity, and system background noise relative to biomagnetic signals of interest.
Test results comparing the response of the second Magnes sensor relative to the original Magnes signal sensor indicate that there is no significant difference in the performance of the Magnes II Biomagnetometer system for the detection and display of biomagnetic signals.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
BIOMAGNETIC TECHNOLOGIES 2017 Parto Marghts Rive Son Daygo, 1.4 5.0371 3713 14 846 453-8300 22 373 455-4913
Kddl રહ
MAY 1 6 1996
51(K) SUMMARY
(a) (1) Submitted By: Biomagnetic Technologies, Inc. (BTi) 9727 Pacific Heights Blvd. San Diego. CA 92121
Telephone: (619) 453-6300 (619) 453-4913 Fax:
Eugene C. Hirschkoff, Ph.D. Contact: Director of Clinical Applications
Prepared: 15 May 1996
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Name of Device: (2)
Proprietary name: Device trade name: Magnes® II Biomagnetometer Magnetic Encephalograph -
(3) Substantial Equivalence:
The Magnes II Biomagnetometer system is substantially equivalent to the Magnes Biomagnetometer system currently manufactured and marketed by Biomagnetic Technologies, Inc. (Reference 510(k) K901215) -
(4) Description of Device:
The Magnes II Biomagnetometer system utilizes superconducting signal pickup coils and Superconducting Quantum Interference Devices (SQUIDs) to detect and amplify magnetic fields produced by electrical activity in the brain. The signals are amplified, filtered and digitized by signal processing clectronics. The digitized signals are computer processed to produce displays of information about biomagnetic field strength, direction, and location.
The Magnes II Biomagnetometer system consists of: Two sensor units, one ganty mounted and one floor mounted, which house the superconducting components which are cooled to liquid helium winperature, an electronics subsystem for preliminary analog signal amplification, filtering, and analog-to-digital conversion, a computer subsystem "master analysis processor" to store, process, and display the data, a magnetically shielded room for interference reduction, a patient table for subject/patient support, and a gantry for articulation of the upper sensor.
- Intended Uses: (2)
"The Magnes II Biomagnetometer is intenced for use in diagnostic procedures that require the measurement and display of extracranial magnetic fields and information about the electrical activity of the brain as inferred from those fields."
1
1
- Technological Characteristics: (6)
The Magnes II biomagnetometer system provides a second magnetic field sensor unit but is otherwise equivalent to the slandard Magnes Biomagnetometer system.
The same clectrical currents in the brain that produce electric voltages on the body surface also produce magnetic fields orthogonal to those currents. The magnetic fields are mathematically related to the electrical currents and voltages by the classical electromagnetic field equations of Maxwell, Lenz, and others.
The major technological difference between the Magnes II Biomagnetometer and conventional clectrical signal devices (EEG) is the use of superconducting magnetic field sensors. The magnetic field sensor detects and converts magnetic field energy to electrical signals without patient electrical contact. The electronic and computer subsystems are equivalent to processing systems in use by electrical signal devices.
- Nonclinical Tests and Results: (b) (1)
Nonclinical tests involve verification of basic physical principles associated with the Typical examples are tests using "phantom" signal sources for technology. localization accuracy, characterization of signal sensitivity, and system background noise relative to biomagnetic signals of interest.
Test results comparing the response of the second Magnes sensor relative to the original Magnes signal sensor indicate that there is no significant difference in the performance of the Magnes II Biomagnetometer system for the detection and display of biomagnetic signals.
- (2) Conclusions:
The addition of the second sensor to the Magnes Biomagnetometer system provides additional simultaneous coverage area for signal acquisition and reduction of overall recording time.
Measurement, display, and interpretation of biomagnetic ficids originating from electrical activity in the brain has been under development for at least the pass 30 years. Current technology has produced enhanced capability through implementation of multiple signal sensors. The Magnetometer system ropresents the latest implementation of this technology.
Any questions regarding the 510(k) summary may be directed to the contact person noted.