Use of the Mag View Biomagnetometer is indicated for the patient whose physician believes that information about the magnetic fields produced by that patient's brain and information about the sources of those magnetic fields could contribute to diagnosis or therapy planning. The intended patient populations are neonates and those children with head circumferences of 50 cm or less.

Device Description

The Tristan Technologies MagView Biomagnetometer (hereinafter referred to as the "MagView") utilizes superconducting signal pickup coils and Superconducting Quantum Interference Devices (SQUIDs) to detect and amplify magnetic fields produced by electrical activity in brain. The MagView consists of a sensor unit, an electronics subsystem for preliminary amplification, filtering, and analog to digital conversion of the signals from each SOUID, an electronics rack containing power supplies to power the electronics subsystem, a computer to control the operation of the electronic subsystem and the SQUIDs and to acquire and store the signal values collected by the system.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding the Tristan Technologies MagView Biomagnetometer. It does not contain information about a study proving the device meets acceptance criteria in the typical sense of a clinical trial with performance metrics like sensitivity, specificity, etc., as would be expected for an AI/CAD-driven device today.

Instead, this submission focuses on demonstrating substantial equivalence to a previously legally marketed predicate device (Magnes 2500 WH Biomagnetometer System). This means the "acceptance criteria" and "study" are geared towards showing that the new device is as safe and effective as the predicate, based on technological characteristics and non-clinical testing.

Here's a breakdown of the requested information based on the provided text, and where gaps exist because the document is a 510(k) for substantial equivalence rather than a detailed performance study:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (MagView Biomagnetometer)
Technological Equivalence to Predicate:	Identical Technology: Utilizes superconducting signal pickup coils and SQUIDs to detect and amplify magnetic fields from brain activity.
- Method of operation
- Sensitivity of pickup coils	- Sensitivity of each pickup coil: 10 femtoTesla/√Hz or better. (Matches predicate)
- Bandwidth	- Bandwidth: 1 Hz to 1 kHz. (Matches predicate)
- Noise cancellation capability	- Second pickup coil array for noise cancellation is available. (Matches predicate)
- Cryogenics and housing	- Uses liquid helium cryogenics; vacuum container with helmet-like external shape. (Matches predicate)
- SQUID output processing (voltage, digitization)	- Output voltage proportional to magnetic field. Digitized with 24-bit precision at 5 kHz sample rate. (Predicate: 16-bit, 2 kHz) (Considered an improvement/equivalent)
- Data storage	- Digitized signals conveyed to computer hard drive. (Matches predicate)
Intended Use Equivalence to Predicate:	Identical Intended Use: Information about magnetic fields from the brain and source localization for diagnosis/therapy planning in neonates and children with head circumference ≤ 50 cm.
Safety Standards Compliance:	Complies with: IEC 60601-1:1988 + A1:1991 + A2:1995, IEC 60601-1-2:2007, IEC 61000-4-series, CISPR 11: 2010.
Non-clinical Performance (Magnetic Signal Detection):	Measured Sensitivity: Averaged over all primary channels, 10 femtoTesla/√Hz or better, over a bandwidth of 1Hz to 1 kHz. (Comparable to predicate)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable in the context of human subjects or clinical data. The "test set" here refers to the device itself and its components undergoing non-clinical technical testing.
Data Provenance: The testing was "non-clinical testing of the system" using "external calibrated signal sources." This implies laboratory-based, engineering validation rather than patient data. No country of origin for patient data is mentioned as no patient data was used for performance assessment in this submission. The testing appears to be "prospective" in the sense that the device was specifically tested to demonstrate its technical performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable. Ground truth for non-clinical technical performance (like magnetic sensitivity) is established by calibrated measurement tools and engineering principles, not human expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable. There is no human interpretation or decision-making process described that would require adjudication for this type of technical performance testing.

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

MRMC Study: No. This document describes a biomagnetometer, which is a measurement device for brain activity. It is not an AI/CAD device, and therefore, an MRMC study related to human reader performance with or without AI assistance is not relevant or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: The "non-clinical testing of the system" on its own demonstrates standalone technical performance (e.g., sensitivity, bandwidth) of the device components. There is no "algorithm" in the sense of an AI model being evaluated here. The device itself is the "standalone" entity being described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: For the non-clinical testing, the ground truth was provided by "external calibrated signal sources." This would involve known, precisely generated magnetic fields used to verify the device's measurement accuracy and sensitivity.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This device is a biomagnetometer, not a machine learning or AI algorithm that requires a training set of data.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

Summary of the "Study" mentioned for meeting "Acceptance Criteria":

The "study" referenced in the document is the non-clinical performance testing of the MagView Biomagnetometer. This testing involved:

Comparing the technological characteristics (method of operation, sensor sensitivity, bandwidth, cryogenics, output processing, etc.) of the MagView to those of the predicate device (Magnes 2500 WH).
Conducting direct measurements on the MagView using "external calibrated signal sources" to verify its magnetic signal detection performance (specifically, its sensitivity and bandwidth).
Ensuring compliance with relevant safety standards (IEC and CISPR).

The acceptance criteria were primarily defined by demonstrating that the MagView's technological characteristics and measured performance were either identical, equivalent, or improved compared to the predicate device, and that it met established safety standards. The conclusion was that the MagView is "as safe, as effective, and performs as well as the Magnes 2500 WH."

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

April 8, 2016

Tristan Technologies, Inc % Eugene Hirschkoff Consultant 3365 Calle Margarita Encinitas, California 92024

Re: K152184

Trade/Device Name: MagView Biomagnetometer Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLY Dated: August 3, 2015 Received: August 5, 2015

Dear Eugene Hirschkoff:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -S/^

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152184

Device Name MagView Biomagnetometer

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image contains the logo for Tristan Technologies. The logo consists of a blue icon on the left and the company name on the right. The icon is a rounded square with three vertical lines inside. The company name is written in blue, with "Tristan" on the top line and "Technologies" on the bottom line.

6191 Cornerstone Court East, Suite 107 San Diego, CA 92121 USA Phone: +1 (858) 550-2700 Fax: +1 (858) 550-2799 http://www.tristantech.com

510(k) SUMMARY

This 510(k) Summary is being submitted pursuant to the requirements of 21 CFR 807.92(c).

1.	Submitted By:	Tristan Technologies, Inc.6191 Cornerstone Ct., Ste 107San Diego, CA 92121(858) 550-2700Contact: Kevin Pratt, CEOPrepared: June 12, 2015
2.	Name of Device:	Trade Name: MagView BiomagnetometerCommon Name: Magnetic EncephalographClassification Name: 21CFR 882.1400 (Electroencephalograph)Product Code: OLY - Magnetoencephalograph

1. Substantial Equivalence:
  Conclusions drawn from the comparisons and testing summarized below demonstrate that the MagView Biomagnetometer is as safe, as effective, and performs as well as the Magnes 2500 WH Biomagnetometer System formerly manufactured and marketed by Biomagnetic Technologies, Inc., San Diego, CA, and is substantially equivalent to that predicate device.

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Description of Device: 4.
The Tristan Technologies MagView Biomagnetometer (hereinafter referred to as the "MagView") utilizes superconducting signal pickup coils and Superconducting Quantum Interference Devices (SQUIDs) to detect and amplify magnetic fields produced by electrical activity in brain. The MagView consists of a sensor unit, an electronics subsystem for preliminary amplification, filtering, and analog to digital conversion of the signals from each SOUID, an electronics rack containing power supplies to power the electronics subsystem, a computer to control the operation of the electronic subsystem and the SQUIDs and to acquire and store the signal values collected by the system.
న్. Intended Uses:
The Tristan Technologies MagView Biomagnetometer is intended for use 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 intended patient populations are neonates and infants and those children with head circumferences of 50 cm or less.

6. Technological Characteristics:

The Tristan Technologies MagView utilizes superconducting signal pickup coils and Superconducting Quantum Interference Devices (SQUIDs) to detect and amplify magnetic fields produced by electrical activity in brain. This is the identical method of operation as that in the predicate Magnes 2500 WH. The MagView sensor comprises a primary array of 270 passive superconducting pickup coils, each of which is connected to a SQUID, a second array of 114 pickup coils spaced behind the primary array, each of which is also connected to a SQUID. By contrast, the predicate device employs 148 primary pickup coils and a second array of 8 pickup coils spaced behind the primary array. The pickup coils in the MagView are distributed over the same area of the head of a patient as are the coils in the predicate device. The sensitivity of each pickup coil is 10 femtoTesla//V Hz in both the MagView and the Magnes 2500 WH,

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over a bandwidth from 1 Hz to 1 kHz. In both systems, the second pickup coil array spaced behind the primary array is available for noise cancellation purposes.

In both systems, the pickup coil arrays are contained within an evacuated housing along with an insulated container for the cryogen liquid helium. The pickup coil arrays and SQUIDs are refrigerated by solid thermal conduction to the cryogen. -For both the MagView and the predicate, the vacuum container is configured to have a helmet-like external shape at the bottom. This shape is sized and oriented to accommodate the positioning of the head of a human being lying in a supine position into the helmet-like shape. The shape of the MagView "helmet" is smaller than that of the predicate device, and will be appropriate for patients with smaller head sizes. However, the sensitivity of each pickup coil is the same for both devices.

The primary array of pickup coils in the MagView is positioned within the vacuum container so as to be in close proximity to the helmet-like shape, and thus when in use, to be in close proximity to the head of the human being. This is also the identical method used in the Magnes 2500 WH although the latter was capable of being positioned to accommodate heads of human beings in the seated position as well as in a supine position.

In both the MagView and the predicate device, the output of each SQUID is a voltage the value of which is proportional to the magnetic field at the corresponding pickup coil. The voltage from each SQUID is amplified, filtered and digitized by signal processing electronics. In the MagView, the signal from each SQUID is digitized with 24 bit precision at a sample rate of 5 kHz; in the Magnes 2500, the signal from each SQUID is digitized with 16 bit precision at a sample rate of 2 kHz. The digitized signals are conveyed to a computer hard drive. In both systems, a hard drive thus contains data comprising the voltage from each SQUID recorded as a function of time. This data is available to the user of the system for analysis and interpretation. While the MagView may be operated by a physician, it may also be operated by a technologist working under the direction and supervision of a physician.

The MagView system has been tested and shown to comply with the following safety standards:

IEC 60601-1:1988 + A1:1991 + A2:1995

IEC 60601-1-2:2007 Third Edition

IEC 61000-4-2:2008

IEC 61000-4-3:2010

IEC 61000-4-4:2012

IEC 61000-4-5:2014

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IEC 61000-4-6:2003

IEC 61000-4-11:2004

CISPR 11: 2010

In addition, non-clinical testing of the system was conducted on the MagView using external calibrated signal sources to demonstrate magnetic signal detection performance comparable to that of the predicate device. The sensitivity of the system, averaged over all primary channels, was measured to be 10 femtoTesla/V Hz or better, over a bandwidth of 1Hz to 1 kHz, the same sensitivity and bandwidth offered by the Magnes 2500 WH.

7. Conclusions:

Measurement of magnetic fields originating from electrical activity in the brain has been undertaken for at least the past 30 years. The Magnes 2500 is a commercial device which performs these measurements and which has been legally marketed under a 510(k) procedure in 1996. See K962317. The Tristan Technologies MagView Biomagnetometer uses identical technology and methodology as used by the Magnes 2500, with a different number and geometric arrangement of the pickup coils and SQUIDs and with updated computer hardware and software. The intended use and indications for use are identical to that of the Magnes 2500.

Conclusions drawn from the non-clinical performance testing described above demonstrate that the MagView is as safe, as effective, and performs as well as the Magnes 2500 WH. Therefore, Tristan Technologies submits that the MagView is substantially equivalent to the Magnes 2500 WH

Any questions regarding the 510(k) summary may be directed to the contact person noted.

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).