BABYMEG BIOMAGNETOMETER SYSTEM

K133419 · Tristan Technologies, Inc. · OLY · Jul 21, 2014 · Neurology

Device Facts

• Record ID: K133419
• Device Name: BABYMEG BIOMAGNETOMETER SYSTEM
• Applicant: Tristan Technologies, Inc.
• Product Code: OLY · Neurology
• Decision Date: Jul 21, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended Use

Use of the Artemis 123 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 location of the sources of those magnetic fields could contribute to diagnosis or therapy planning.

Device Story

Artemis 123 Biomagnetometer detects and amplifies magnetic fields generated by brain electrical activity; utilizes array of 135 superconducting pickup coils and SQUIDs housed in evacuated, liquid helium-cooled container. System includes sensor unit, electronics subsystem for amplification/filtering/digitization, power supply rack, computer for control/data acquisition, and patient table for supine positioning. Operated by physician or technologist in hospital/clinic. Output consists of digitized voltage signals proportional to magnetic fields, stored on hard drive for user analysis/interpretation. Provides data for source localization to aid clinical decision-making and therapy planning.

Clinical Evidence

Bench testing only. Performance evaluated using a prototype at Children's Hospital of Philadelphia. Noise spectra recorded in a magnetically shielded room showed characteristic form equivalent to the predicate, with noise levels <10 fT/√Hz above 100 Hz. Source localization accuracy validated using a phantom with two dipolar sources (40 Hz driving current); system localized sources within 5 mm of actual locations, equivalent to predicate performance.

Technological Characteristics

Superconducting magnetometry; 135 passive superconducting pickup coils (gradiometer design); dc SQUID amplifiers; liquid helium refrigeration via solid thermal conduction; 24-bit/channel digitization at 5 kHz; PC workstation; IEC 60601-1 compliant.

Indications for Use

Indicated for patients whose physician requires information regarding magnetic fields produced by the brain and the location of their sources to assist in diagnosis or therapy planning.

Regulatory Classification

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.

Predicate Devices

• Magnes 2500 WH Biomagnetometer System (K962317)

Submission Summary (Full Text)

{0}------------------------------------------------

:

6185 Cornerstone Court East, Suite 106 San Diego, CA 92121 USA . Phone: [phone] Fax: [phone] http://www.tristantech.com

# 510(k) SUMMARY

K133419 JUL 2 1 2014

882.1400)

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

| 1. | Submitted By: | Tristan Technologies, Inc. | |
|-----------------|-----------------|------------------------------------------------|--|
| | | Eugene C Hirschkoff, consultant | |
| | | 6185 Cornerstone Ct., Ste 106 | |
| | | San Diego, CA 92121 | |
| | | [phone] | |
| Contact Person: | | Douglas N. Paulson, Ph.D. | |
| | | Tristan Technologies, Inc. | |
| | | 6185 Cornerstone Ct., Stc. 106 | |
| | | San Diego, CA 92121 | |
| | | [phone] | |
| | Date prepared: | July 17, 2014 | |
| 2. | Name of Device: | Trade Name: Artemis 123 Biomagnetometer | |
| | | Common Name: Magnetic Encephalograph | |
| | | Regulation Name: Electroencephalograph (21 CFR | |
| | | Product Code: OLY | |

{1}------------------------------------------------

- 3. Predicate device:
The Artemis 123 Biomagnetometer is substantially equivalent to the Magnes 2500 WH Biomagnetometer System formerly manufactured and marketed by Biomagnetic Technologies, Inc., San Diego, CA. K962317

- 4. Description of Device:
The Tristan Technologies Artemis 123 Biomagnetometer (hereinafter referred to as the "Artemis 123") utilizes superconducting signal pickup coils and Superconducting Quantum Interference Devices (SQUIDs) to detect and amplify magnetic fields produced by electrical activity in brain. The Artemis 123 consists of a sensor unit, an electronics subsystem for preliminary amplification, filtering, and analog to digital conversion of the signals from each SQUID, 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, and a patient table which accommodates and facilitates the optimal positioning of the head of a human being adjacent to the sensor unit

#### ડ. Indications for Use:

The Tristan Technologies Artemis 123 Biomagnetometer is indicated 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 ficids could contribute to diagnosis or therapy planning.

#### 6. Substantial Equivalence:

The Tristan Technologies Artemis 123 utilizes superconducting signal pickup coils and Superconducting Quantum Interference Devices (SQUIDs) to detect and amplify magnetic fields produced by electrical activity in brain. . The sensor comprises an array of 135 passive superconducting pickup coils, cach of which is connected to a SQUID. The array is contained within an evacuated housing along with an insulated container for the cryogen liquid helium. The pickup coils and SQUIDs are refrigerated by solid thermal conduction to the cryogen. This is the identical technologies and methods of operation as used in the predicate device, the Magnes 2500 WH. The vacuum container is configured to have a helmet-like external shape at the top. 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 pickup coils are positioned within the vacuum container to 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

{2}------------------------------------------------

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.

For both the Artemis 123 and the Magnes 2500 WH, the output of cach SQUID is a voltage the value of which is proportional to the magnetic ficld at the corresponding The voltage from each SQUID is amplified, filtered and digitized by pickup coil. signal processing electronics. The digitized signals are conveyed to a computer hard drive. The 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. The Artemis 123 as well as the Magnes 2500 WH may be operated by a physician, it may also be operated by a technologist working under the direction and supervision of a physician.

The following is a tabular comparison of the features and characteristics of the Magnes 2500 WH and the Artemis 123.

| Element<br>Indications for use | Magnes 2500 WH<br>Use of the Magnes 2500 WH<br>is indicated for the<br>patient whose physician<br>believes that inform-<br>ation about the<br>magnetic fields<br>produced by the<br>patient's brain and<br>information about<br>the location of the<br>sources of those<br>magnetic fields could<br>contribute to diagnosis<br>or therapy planning. | Artemis 123<br>Use of the Artemis 123<br>is indicated for the<br>patient whose physician<br>believes that inform-<br>ation about the<br>magnetic fields<br>produced by the<br>patient's brain and<br>information about<br>the location of the<br>sources of those<br>magnetic fields could<br>contribute to diagnosis<br>or therapy planning. |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Underlying technology | Superconducting<br>magnetometry | Superconducting<br>magnetometry |
| Detector<br>architecture | 148 pickup coils<br>arranged in<br>helmet configuration | 123 pickup coils<br>arranged in<br>helmet configuration |
| | 13 offset pickup coils | 12 offset pickup coils |

{3}------------------------------------------------

| | as reference channels | as reference channels |
|---------------------------------|-----------------------------------------------------------------|----------------------------------------------------|
| Pickup coil design | Two sets of magnetometer<br>coils | One set of<br>gradiometer coils |
| Average coil-to-coil<br>spacing | 25 mm | 25 mm |
| Superconducting<br>amplifiers | dc SQUID | de SQUID |
| Refrigeration method | Solid conduction from<br>liquid helium | Solid conduction from<br>liquid helium |
| Data flow | SQUID output<br>digitized, stored on<br>hard drive | SQUID output<br>digitized, stored on<br>hard drive |
| Data acquisition | 16 bits/channel<br>2 kHz sample rate | 24 bits/channel<br>5 kHz sample rate |
| Host computer | Sun SPARCStation 20<br>Sun operating system | PC workstation<br>MS Windows |
| Software | Proprietary data<br>acquisition software;<br>LabView® libraries | LabVIEW® based<br>acquisition software |
| Sensitivity | 10 femtoTesla/ $\sqrt$ Hz<br>average over channels | 10 femtoTesla/ $\sqrt$ Hz<br>average over channels |
| Patient interface | Provided patient table<br>patient supine or<br>seated | Provided patient table<br>patient supine |
| Where used | Hospital or clinic | Hospital or clinic |
| Safety standard | IEC-60601-1 | IEC 60601-1 |

### 7. Non-clinical test results

A prototype of the Artemis 123 was installed at the Children's Hospital of Philadelphia for research use only. Non-clinical tests of the device performance were conducted by hospital staff. These results were published in the pecr-reviewed journal Frontiers Human Neuroscience on 3 March 2014. Those results demonstrate the of technological equivalence of the Artemis 123 to the Magnes 2500 with respect to sensitivity in a hospital environment and with respect to source localization in a phantom magnetic source.

{4}------------------------------------------------

To compare the sensitivity of the Artemis 123 in a hospital environment to that of the predicate device, the system was activated in the empty magnetically shielded room (MSR) and noise spectra of the output of all channels were recorded. The spectra of all channels were averaged together and that average spectrum is presented in the reference above. The average noise showed the same characteristic form as that of the Magnes 2500, with the noise level above 100 Hz being well below the specification of 10 fT/vHz.

A second non-clinical test was conducted to record the magnetic ficld produced by a phantom containing two dipolar sources at known locations. The dipolar sources were each activated with a 40 Hz driving current, the magnetic field values recorded for cach of the Artemis 123 channels, and those values fit to the model of a single The results was a determination of the location of cach dipole to dipole source. within 5 mm of the actual location. This performance is also equivalent to the localization of dipoles in a phantom with the Magnes 2500 WH system.

#### 8. Conclusions:

The Artemis 123 uses the identical underlying technology as the Magnes 2500 WH, employing superconducting pickup coils to measure and record the magnetic field at an array of locations around the surface of the head of a patient and placing the recorded values into a storage device for later review and examination by a user. The materials and methods used to construct the two systems are the same. The method of use of the two systems is the same. The indications for use of the Artemis 123 are the same as that of the Magnes 2500 WH. The primary difference between the two systems is the smaller physical size of the helmet of the Artemis 123 compared with that in Magnes 2500 WH. The sensitivity of the two systems in a noisy hospital environment is equivalent. The ability of each system to localize a dipolar source in a phantom is also equivalent. For these reasons, Tristan Technologies submits that the Artemis 123 is substantially equivalent to the Magnes 2500 WH.

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

{5}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 21, 2014

Tristan Technologies, Inc. % Dr. Eugene C. Hirschkoff 3365 Calle Margarita Encinitas. CA 92024

Re: K133419

> Trade/Device Name: Artemis 123 Biomagnetometer Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OL.Y Dated: June 2, 2014 Received: June 17, 2014

Dear Dr. 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. Insting 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 vou: 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 is 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{6}------------------------------------------------

Page 2 - Dr. Eugene Hirschkoff

forth in 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 [phone] or [phone] 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" (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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

Carlos L. Pena -5

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

Enclosure

{7}------------------------------------------------

### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K133419

Device Name Artemis 123 Biomagnetometer

Indications for Use (Describe)

Use of the Aremis 123 Biomagnetometer is indicated for the patient whose 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.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Carlos L. Pena -S

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."