(324 days)
Use of the Magnes 2500 WH is indicated for the patient whose physician believes that information about the magnetic fields produced by that patient's brain and information about the location of the sources of those magnetic fields could contribute to diagnosis or therapy planning.
The Magnes 2500 WH biomagnetometer (hereafter "Magnes 2500 WH") comprises a magnetic sensor for detecting and measuring the magnetic fields produced by the human brain, along with the 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. The sensor utilizes an array of superconducting magnetic field pickup coils arranged in such a manner as to sense the magnetic fields over the portion of the skull enclosing the brain. For each such coil, a superconducting quantum interference device (SQUID) is used to detect the current induced in that coil by the brain magnetic field and produce a voltage proportional to the magnetic flux change. Conventional electronic and computer circuitry is used to amplify, filter, digitize, store and display the result of the measurement. The sensor includes an insulated reservoir of liquid helium as a refrigerant for cooling the superconducting components - pickup coils, SQUIDs, and interconnecting leads - to temperatures below their superconducting transition temperature. Heat is conducted from these superconducting elements along thermally conductive pathways into the helium reservoir. Provided as part of the Magnes 2500 WH biomagnetometer are the following ancillary items: Magnetically shielded room, comprised primarily of nickel-rich alloy and aluminum sheeting, to provide shielding from environmental sources of magnetic or ff noise. Manually operated non-magnetic gantry to place the sensor over the head of the patient in either a seated or supine position. Non-magnetic patient table with hydraulic elevation, to support the patient securely in either seated or supine position. Non-magnetic patient monitoring and communication devices, including video monitor, intercom, and head motion detector. Head shape and head position measurement system, to provide head shape and location relative to the sensor for data modeling and display. Computer workstation, operator console, and software to control system operation, data acquisition and storage, and data analysis and display. Sensory stimulus systems, to provide stimulation of the patient's somatosensory, auditory, y sumulus systems, to pro for magnetic measurement of evoked response.
The acceptance criteria and study proving the device meets them are described below. However, it's important to note that this 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study against predefined acceptance criteria for a novel device. The "acceptance criteria" here are implicitly linked to the performance of the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit, based on predicate device Magnes II) | Reported Device Performance (Magnes 2500 WH) |
|---|---|
| Technological Characteristics | |
| - Magnetic Field Measurement (Sensor Coils): Equivalent performance in detecting brain magnetic fields with magnetometer coils as the predicate's gradiometer coils. | - Bench Test 1 (Dipolar Source in Head Phantom): Waveforms measured with Magnes 2500 WH (magnetometer coils) and Magnes II (gradiometer coils) showed no significant difference for both normal alignment and presence of artificial magnetic noise conditions. - Bench Test 2 (Dipole Localization in Head Phantom): No significant difference in localized dipole parameters (physical location, strength, or orientation) between Magnes 2500 WH and Magnes II in multiple trials. |
| - Refrigeration Method: No material difference in sensitivity. | - Fixed Source Sensitivity Test: Sensitivity of various channels in Magnes 2500 WH (solid thermal conduction) showed no material difference when the helium reservoir was full versus nearly empty. This was compared to a similar test on a Magnes II (direct immersion). |
| - Head Position Measurement: No significant difference in relative location of reference points. | - Head Position Measurement Test: Repetitive measurements of reference points on a head phantom using the Magnes 2500 WH's new positioning system and the Magnes II's system showed no significant difference in the relative locations of the reference points. |
Study Details:
Since this is a 510(k) for substantial equivalence, the "study" described is a series of non-clinical comparative tests.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in terms of number of patients or distinct head phantom configurations. The tests involved:
- A head phantom with a dipolar source.
- A fixed magnetic source.
- A head phantom for position measurement.
- Data Provenance: The tests were non-clinical bench tests conducted by the manufacturer, Biomagnetic Technologies, Inc. This implies a controlled laboratory environment. The country of origin of the data is therefore the USA (where the company is based). The data is prospective in the sense that these tests were performed specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable (N/A). For these non-clinical bench tests demonstrating substantial equivalence, the "ground truth" was established by the physical setup of the experiments (e.g., a known dipolar source in a head phantom, a fixed magnetic source, reference points on a head phantom). The comparison was against the performance of a predicate device, not against expert interpretation of a complex clinical scenario.
4. Adjudication Method for the Test Set
- Not applicable (N/A). There was no human interpretation or adjudication required for the output of these technical performance tests. The comparison was based on quantitative measurements and waveform analysis.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This 510(k) pertains to a non-AI medical device (a biomagnetometer) and focuses on substantial equivalence based on technological characteristics, not on the impact of AI assistance on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, in essence, standalone performance was assessed. The tests directly evaluated the physical performance of the Magnes 2500 WH hardware and its signal processing against the Magnes II. This is a "device-only" evaluation in a controlled setting, which can be considered analogous to standalone performance for a software algorithm, though it's for hardware.
7. The Type of Ground Truth Used
- The "ground truth" in these comparative non-clinical tests was established by:
- Known physical parameters: The characteristics of the dipolar source in the head phantom (strength, location, orientation).
- Known physical configuration: The fixed magnetic source and reference points on the head phantom.
- Comparative measurement: The performance of the predicate device (Magnes II) served as the benchmark for "truthfulness" in some comparisons.
8. The Sample Size for the Training Set
- Not applicable (N/A). This device is not an AI/ML algorithm that requires a training set. It is a measurement device where its operation is based on fundamental physics and engineering principles, not learned patterns from data.
9. How the Ground Truth for the Training Set was Established
- Not applicable (N/A). As stated above, there is no training set for this type of device.
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BIOMAGNETIC TECHNOLOGIES 9727 Pacific Heights Blvd. San Diego, CA 92121-3719 Tel 619 453-6300 Fax 619 453-4913
MAY - 7 1997
510(k) Summary
This 510(k) Summary is being submitted pursuant to the requirement of 21 CF 807.92(c).
Biomagnetic Technologies, Inc. Submitted By: 1. 9727 Pacific Heights Blvd San Diego, CA 92121
Telephone: (619)453-6300
Fax: (619)453-4913
Contact: Eugene C Hirschkoff, Ph.D. Director, Clinical Applications
Date prepared: April 23, 1996
Magnetic Encephalograph Device trade name: 2. Magnes 2500 WH biomagnetometer Proprietary name:
Substantial equivalence is claimed to the Magnetometer, manufactured and 3. marketed by Biomagnetic Technologies, Inc. (Reference 510(k) K941553)
Description of Device: The Magnes 2500 WH biomagnetometer (hereafter "Magnes 2500 4. WH") comprises a magnetic sensor for detecting and measuring the magnetic fields produced by the human brain, along with the 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.
The sensor utilizes an array of superconducting magnetic field pickup coils arranged in such a manner as to sense the magnetic fields over the portion of the skull enclosing the brain. For each such coil, a superconducting quantum interference device (SQUID) is used to detect the current induced in that coil by the brain magnetic field and produce a voltage proportional to the magnetic flux change. Conventional electronic and computer circuitry is used to amplify, filter, digitize, store and display the result of the measurement. The sensor includes an insulated reservoir of liquid helium as a refrigerant for cooling the superconducting components - pickup coils, SQUIDs, and interconnecting leads - to temperatures below their superconducting transition temperature. Heat is conducted from these superconducting elements along thermally conductive pathways into the helium reservoir.
Provided as part of the Magnes 2500 WH biomagnetometer are the following ancillary items:
Magnetically shielded room. comprised primarily of nickel-rich alloy and aluminum sheeting, to provide shielding from environmental sources of magnetic or ff noise
Manually operated non-magnetic gantry to place the sensor over the head of the patient in either a seated or supine position
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- Non-magnetic patient table with hydraulic elevation, to support the patient securely in either seated or supine position
- Non-magnetic patient monitoring and communication devices, including video monitor, intercom, and head motion detector
- Head shape and head position measurement system, to provide head shape and location relative to the sensor for data modeling and display
- Computer workstation, operator console, and software to control system operation, data acquisition and storage, and data analysis and display
- Sensory stimulus systems, to provide stimulation of the patient's somatosensory, auditory, y sumulus systems, to pro for magnetic measurement of evoked response
Results of the measurement of magnetic fields produced by the brain are available in tabular form results of the measurances of magineer intour props of lines of equal magnetic field values, and as equivalent single current dipoles.
The Magnes 2500 WH is intended for use in diagnostic procedures that Intended Use: ડે. require the measurement and display of extracranial magnetic fields and information about the electrical activity in the brain as inferred from those fields.
Technological Characteristics: The Magnes 2500 WH operates with the same principles 6. of operation as the predicate device, the Magnetometer. Magnetic field changes or operator as an processaring pickup coils, those currents are detected and converted to monec ourceme in superconducting quantum interference devices or SQUIDs, and those voltages are voluted, filtered, digitized, stored, analyzed and displayed for use by a physician. The primary allipinist, Interest, digitized, stored, and the Magnes 2500 WH is that the latter features 148 pickup coils distributed over the entire surface of the skull overlying cortical tissue while the 146 pickup couls usunous over and covering a circular area approximately 15 cm in diameter.
Because the cryogenic container housing the pickup coils is by necessity rigid and head sizes and shares vary from patient to patient, the distance from some of the pickup coils to the skull of a patient may be greater than with the Magnes II. To compensate for this, the pickup coils are purchived as magnetometers rather than axial gradiometers as in the Magnes II. Magnetometer coils offer greater sensitivity to brain sources of magnetic fields than gradiometer coils but at the expense of greater sensitivity to extrinsic magnetic noise. A secondary set of pickup coils, spatially separated from the primary pickup coils, are used to detect magnetic noise and subtract it from the primary signals, creating the functional equivalent of an axial gradiometer.
The Magnes II refrigerates one set of the superconducting components of the sensor by immersing them directly in liquid helium, the other by solid thermal conduction. In the Magnes 2500 WH, all of the superconducting components are refrigerated by solid thermal conductors which thermally connect each such component to the liquid helium reservoir.
In the Magnes II, the position of the patient's head was measured using a third-party position indicator system which operated by essentially measuring the mutual inductance between small receiver coils mounted on the patient's head or in a wand and a low level ff transmitter coil mounted on one sensor housing. In the Magnes 2500 WH, the same principle of operation is
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employed, but small very low level transmitter coils are mounted on the patient's head and the field enployed, but shall very tow sured by the biomagnetometer pickup coils themselves.
The substantial equivalence between the Magnes II and Magnes Non-clinical tests: 7. 2500 WH was verified by comparative non-clinical tests of each of the technological characteristics which are different, as described in 6) above.
To demonstrate the substantial equivalence of the magnetometer pickup coils as used in the Magnes 10 we to the gradiometer colls as used in the Magnes II, two bench tests were run. In the first, a dipolar source in a head phantom was activated and measured with each of the sensors, both in a uponal source in a near proment of the factory and in the presence of artificially produced magnetic une normal allionent carnomical of the waveform as measured with each sensor were then compared for both conditions. The waveforms showed no significant difference from each other, in either operating condition.
As a second test of this characteristic, the dipole in the head phantom was localized using the Magnes II and Magnes 2500 WH sensors in a number of trials. There was no significant Magines II and magnes 2000 h parameters between the two sensors - physical location, strength, or orientation.
To demonstrate the substantial equivalence of the method of refrigeration, the magnetic field 10 dealed by a fixed source was detected by representative pickup coils in the Magnes 2500 WH produced by a naked some e reservoir was full and when it was nearly empty. A similar test was which the nemail lover in all roce of a Magnes II, in which the direct immersion method of refrigeration is used. Sensitivity of the various channels was compared for these two operating conditions and no material difference measured.
Finally, to demonstrate the substantial equivalence of the methods of measuring head position, repetitive measurements of the location of reference points on a head phantom were conducted with the positioning system in the Magnes II and with the new approach taken in the Magnes 2500 WH. No significant difference between the relative locations of the reference points was found.
The comparative non-clinical tests produced no significant differences Conclusion: 8. between those elements of the Magnes II and the correspondent elements of the Magnes 2500 WH for which there has been some in technological approach. Since all other elements of the two systems are technologically the same, we conclude that the Magnes 2500 WH is substantially equivalent to the predicate Magnes system.
Please direct any questions concerning this 510(k) Summary to the contact person noted above.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Eugene C. Hirschkoff, Ph.D. Director of Clinical Applications Biomagnetic-Technologies 9727 Pacific Heights Boulevard San Diego, California 92121-3719
Re: K962317
Trade/Device Name: Magnes 2500 WH Biomagnetometer Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLY Dated (Date on orig SE ltr): March 5, 1997 Received (Date on orig SE ltr): March 6, 1997
Dear Mr. Hirschkoff:
This letter corrects our substantially equivalent letter of May 7, 1997.
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.
APR - 9 2012
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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/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.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kesia Alexander
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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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510(k) Number (if known): K962317
Jacc Name: Magnes 2500 WH Biomagnetometer
Indications For Use:
11 ---
Use of the Magnes 2500 WH is indicated for the patient whose physician believes that information about the magnetic fields produced by that patient's brain and information about the location of the sources of those magnetic fields could contribute to diagnosis or therapy planning.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Luticia Zimmerman
(Division Sign-Off Division of Cardiovasguages and Neurological Deyic
510(k) Number K962317
'rescription Use
Per CFR 801.109)
OR
Over-The-Counter Use
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حساب
(Optional Format 1-2-96)
§ 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).