(178 days)
Not Found
No
The summary describes a biomagnetic sensing device for recording and displaying cardiac magnetic fields. It mentions software for data analysis but does not include any terms or descriptions indicative of AI or ML technology being used for analysis or interpretation.
No
The device measures and displays magnetic signals from the heart as a "tool," indicating a diagnostic rather than therapeutic purpose.
No
The device is described as a "tool which non-invasively measures and displays the magnetic signals produced by the electric currents of the heart." It records and displays data but does not explicitly state that it diagnoses conditions or provides diagnostic interpretations. Its intended use is for measurement and display, rather than diagnosis.
No
The device description explicitly states that the system consists of hardware components including a patient table, a 6x6 array of magnetometers, and a shielding cylinder. While software is used for control and analysis, the core functionality relies on physical hardware for data acquisition.
Based on the provided information, the CardioFlux FAC Magnetocardiograph is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use states that the device "non-invasively measures and displays the magnetic signals produced by the electric currents of the heart." This describes a device that measures physiological signals directly from the body, not a device that analyzes samples (like blood, urine, or tissue) outside of the body.
- Device Description: The description details a system with a patient table, sensors placed on the body, and shielding. This is consistent with a non-invasive medical device used for in-vivo measurements.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the CardioFlux FAC Magnetocardiograph falls under the category of a non-invasive medical device for physiological measurement, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DPS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart
Indicated Patient Age Range
Adults (ranging in age from 23 to 77 for performance testing)
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Performance Testing (head-to-head against the predicate device)
Sample Size: Male and female adults ranging in age from 23 to 77.
Key Results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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:
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.
4
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 621/624
Biomagnetometer
(Predicate Device) | Similar | Different |
|------------------------------------------|--------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|---------|-----------|
| Installation | Fixed | Fixed | X | |
| Power Source | 100 - 120 V, 60 Hz | 110, 60 Hz | X | |
| Electromagnetic
shielding | Multilayer open-ended
cylindrical shielding
chamber surrounding
patient and sensor head | Multilayer closed shielding
room surrounding patient
and sensor head | X | |
| Sensor Array -
Patient
Positioning | Manual positioning of
sensor array; motor-driven
bed. | Manual positioning of
sensor array; motor-driven
bed. | X | |
| Magnetic Field
Detection | Magnetometer | Gradiometer | | X |
| Number of z-axis
Sensors | 36 | 7 | | X |
| Sensor Thermal
Control
Requirement | Yes | Yes | X | |
| Operating
System | Windows | Windows | X | |
| Platform | Dedicated computer for
data acquisition and Cloud-
based data storage and
processing | Dedicated computer | | X |
| Patient database | Yes | Yes | X | |
| Data acquisition | 1000 Hz | 1000 Hz | X | |
| Filtering | Digital | Digital | X | |
| Magnetic field
tracing | 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.