The CardioFlux FAC Magnetocardiograph is intended for use as a tool which non-invasively measures and displays the magnetic signals produced by the electric currents of the heart.

Device Description

The CardioFlux FAC Magnetocardiograph (MCG) is a biomagnetic sensing device that can record and display the magnetic fields generated by cardiac electrical activity. The CardioFlux FAC hardware connects to the Faraday™ Analytical Cloud (FAC) to allow access to a patient database and software for data analysis. The CardioFlux FAC MCG system consists of a patient table, a 6 x 6 array of optically pumped magnetometers covering roughly an area of 400 square centimeters and a shielding cylinder to reduce ambient electromagnetic interference during a patient scan. CardioFlux FAC is primarily controlled via software applications on a local computer. Data are displayed as 36 superimposed cardiocycles and magnetic field maps.

AI/ML Overview

The provided text does not contain detailed acceptance criteria and the results of a specific study proving the device meets those criteria, as one would typically find in a detailed clinical performance study report. Instead, it describes a 510(k) summary for the CardioFlux FAC Magnetocardiograph, which focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

Here's a breakdown of the information that is available, and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy against a gold standard) for the device's diagnostic performance. Instead, it discusses the device's ability to record magnetic signals and qualitative and quantitative agreement with the predicate device.

Reported Device Performance (from "Performance Testing"):

Ability to record human cardiac biomagnetic signals: The device was able to record these signals from male and female adults.
Agreement with predicate device: "Analysis of the magnetic field traces of each volunteer showed excellent qualitative and quantitative agreement between data acquired with the proposed device and data acquired with the predicate."

2. Sample Size Used for the Test Set and Data Provenance

The text states: "Performance Testing (head-to-head against the predicate device) to determine the ability of CardioFlux FAC to record human cardiac biomagnetic signals from male and female adults ranging in age from 23 to 77."

Sample Size: Not explicitly stated as a number of participants. It says "each volunteer" but does not quantify the total number of volunteers.
Data Provenance: Not specified (e.g., country of origin). It's a prospective head-to-head performance test.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided. The performance test focused on comparing the device's output to a predicate device's output, not on an "expert ground truth" in a diagnostic context.

4. Adjudication Method for the Test Set

This information is not provided. As "expert ground truth" is not mentioned, an adjudication method for that purpose would not be applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study is not mentioned. The performance testing described is a technical comparison of signal acquisition between the proposed device and the predicate, not a study involving human readers and diagnostic accuracy.

6. Standalone (Algorithm Only) Performance

The document describes the device's ability to "non-invasively measures and displays the magnetic signals produced by the electric currents of the heart." The performance testing focused on the device's ability to record these signals and its agreement with the predicate. This implies a standalone capability for signal acquisition and display, but not for diagnostic interpretation against a clinical ground truth.

7. Type of Ground Truth Used

The "ground truth" for the performance testing was essentially the measurements obtained from the legally marketed predicate device (Tristan Technologies Model 621/624 Biomagnetometer K151135). The assessment was based on "qualitative and quantitative agreement" between the proposed device's magnetic field traces and the predicate's traces. This is a technical (measurement) ground truth, not a clinical diagnostic ground truth like pathology or outcomes data.

8. Sample Size for the Training Set

This information is not provided. The document describes the device as a biomagnetic sensing device that records and displays signals, with software for data analysis. It does not mention a machine learning component requiring a training set in the context of diagnostic interpretation.

9. How the Ground Truth for the Training Set Was Established

This information is not provided (see point 8).

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence for a new medical device mainly through technological comparison and non-clinical performance testing against a predicate device. It confirms the device's ability to acquire signals similar to the predicate but does not include the detailed clinical performance study information (such as diagnostic accuracy, specific acceptance criteria for performance metrics, expert adjudication, or MRMC studies) that would be needed to answer all parts of your request in a typical AI/diagnostic device context.

Summary

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March 15. 2019

Genetesis Inc. Robert Sokolowski VP Clinical, Quality and Regulatory 5412 Courseview Drive, Suite 150 Mason, Ohio 45040

Re: K182571

Trade/Device Name: CardioFlux FAC Magnetocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: February 8, 2019 Received: February 13, 2019

Dear Robert Sokolowski:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn

(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Arielle Drummond -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182571

Device Name

CardioFlux FAC Magnetocardiograph

Indications for Use (Describe)

The CardioFlux FAC Magnetocardiograph is intended for use as a tool which non-invasively measures and displays the magnetic signals produced by the electric currents of the heart.

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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510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

DATE: September 10, 2018

SUBMITTER:

Genetesis Inc. 5412 Courseview Drive Suite 150 Mason, OH 45040 Phone: 224-575-5577

PRIMARY CONTACT PERSON:

Robert Sokolowski, PhD VP Clinical, Quality and Regulatory Genetesis Inc. Suite 150 Mason, OH 45040 Phone: 224-575-5577

DEVICE:

TRADE NAME: CardioFlux FAC Magnetocardiograph COMMON NAME: Magnetocardiograph DEVICE CLASS: Class II CLASSIFICATION NAME: Electrocardiograph (21 CFR 870.2340) PRODUCT CODE: DPS

PREDICATE DEVICE(S):

K151135 Tristan Technologies Model 621/624 Biomagnetometer

DEVICE DESCRIPTION:

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INDICATIONS FOR USE:

The CardioFlux FAC Magnetocardiograph is intended for use as a tool which non-invasively measures and displays the magnetic signals produced by the electric currents of the heart.

DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

The indications for use of Genetesis' CardioFlux FAC MCG system are the same as those of the predicate devices without the additional statement that it is intended for fetal measurements.

Technological Comparison

The table below identifies technological similarities and differences between the proposed CardioFlux FAC MCG system and the Tristan 621/624 Biomagnetometer (K151135).

	CardioFlux FAC MCG(Proposed Device)	Model 621/624Biomagnetometer(Predicate Device)	Similar	Different
Installation	Fixed	Fixed	X
Power Source	100 - 120 V, 60 Hz	110, 60 Hz	X
Electromagneticshielding	Multilayer open-endedcylindrical shieldingchamber surroundingpatient and sensor head	Multilayer closed shieldingroom surrounding patientand sensor head	X
Sensor Array -PatientPositioning	Manual positioning ofsensor array; motor-drivenbed.	Manual positioning ofsensor array; motor-drivenbed.	X
Magnetic FieldDetection	Magnetometer	Gradiometer		X
Number of z-axisSensors	36	7		X
Sensor ThermalControlRequirement	Yes	Yes	X
OperatingSystem	Windows	Windows	X
Platform	Dedicated computer fordata acquisition and Cloud-based data storage andprocessing	Dedicated computer		X
Patient database	Yes	Yes	X
Data acquisition	1000 Hz	1000 Hz	X
Filtering	Digital	Digital	X
Magnetic fieldtracing	Available for each sensor	Available for each sensor	X

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Summary of Non-clinical Tests

The CardioFlux FAC Magnetocardiograph complies with voluntary standards for electrical safety and electromagnetic compatibility. The following data were provided in support of the substantial equivalence determination:

Risk analysis developed in accordance with ISO 14971:2007
. Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
. Electrical safety and electromagnetic compatibility testing per IEC 60601-1:2005 (3ºd Edition) with US deviations per AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012 standard and IEC 60601-1-2: 2014 standards, respectively.
. Performance Testing (head-to-head against the predicate device) to determine the ability of CardioFlux FAC to record human cardiac biomagnetic signals from male and female adults ranging in age from 23 to 77. Analysis of the magnetic field traces of each volunteer showed excellent qualitative and quantitative agreement between data acquired with the proposed device and data acquired with the predicate.

CONCLUSION:

The differences between the Genetesis CardioFlux FAC MCG system and its predicate device do not introduce a new intended use and do not raise new issues of safety and effectiveness. Verification and Validation testing demonstrated that no adverse effects have been introduced by these differences and that the device performs as intended.

In conclusion, from the results of nonclinical testing described, the CardioFlux FAC MCG system is substantially equivalent to the legally marketed predicate device.

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).