AMCG's MCG-S will be used for purpose of measurement and analysis in adult cardiology. Magnetocardiography (MCG) is a non-invasive, non-contact, radiation-free, multichannel body surface mapping technique to record biomagnetic signals of X- and Y-components from the heart generated by the same ionic currents underling the electrocardiogram. This system consists of Dewar with 96-channel SQUIDs, gantry, electronics, power supply device, and software. 48 of these SQUID sensors are used for detecting the X-components, and the remaining 48 sensors are for the Y-components of the magnetic field. The device does not measure and/or display the magnetic field in the Z-component. The system increases the output signal of the SQUID by applying the DROS (Double Relaxation Oscillation SQUID) method to increase the measurement sensitivity of the cardiac magnetic field signal, and a wide range of channel area is applied to measure the magnetic field area throughout the heart within a short time. In addition, in order to minimize the mechanical vibration of the sensor, the sensor is installed in a vacuum area, and Dewar, which has excellent noise shielding and insulation performance, is applied. The system is controlled through noise-free optical fiber signals and can control, measure, process and analyze signals through software.

AI/ML Overview

The provided text describes the 510(k) summary for the MCG-S (AM1000) device, demonstrating its substantial equivalence to a predicate device (CS-MAGII, K121825). However, it does not contain information about specific acceptance criteria and a study proving the device meets those criteria in the way typically expected for a clinical performance study involving human subjects or AI performance metrics.

Instead, the performance data section focuses on bench testing, electromagnetic compatibility, electrical safety, and software verification and validation. There is no mention of a study involving patients, clinicians, ground truth established by experts, or AI performance metrics like sensitivity, specificity, or AUC.

Here's a breakdown based on your request, highlighting the absence of certain information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists performance tests conducted and states that they "met the internal criteria." However, the specific numerical acceptance criteria for each test are not provided, nor are the reported numerical device performance results beyond the qualitative statement of "met internal criteria."

Acceptance Criteria Category	Specific Acceptance Criteria (Not provided in detail)	Reported Device Performance (Qualitative)
Bench Testing	(e.g., Specific sensitivity values, boil-off rates, accuracy thresholds)	Met internal criteria
- Sensitivity Test	Not specified	Met internal criteria
- L-He Boil-off Rate Test	Not specified	Met internal criteria
- Dimensional Test	Not specified	Met internal criteria
- Sensor Operation Test	Not specified	Met internal criteria
- Accuracy Test	Not specified	Met internal criteria
- Heart Positioning Test	Not specified	Met internal criteria
- Heart Rate Measurement Test	Not specified	Met internal criteria
- Sensor Calibration Test	Not specified	Met internal criteria
Electromagnetic Compatibility	Compliance with IEC 60601-1-2	Met requirements
Electrical Safety	Compliance with IEC 60601-1	Met requirements
Software Verification & Validation	Adherence to FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."	Documentation provided and testing conducted

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

Sample Size: Not applicable in the context of this submission, as there's no mention of a test set involving patient data for clinical performance evaluation. The performance tests appear to be technical/engineering in nature (e.g., sensitivity of the SQUID, helium boil-off rates).
Data Provenance: Not applicable.

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

Number of Experts: Not applicable. There is no mention of experts involved in establishing ground truth for a clinical test set.
Qualifications: Not applicable.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. There is no mention of a test set requiring adjudication.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done.
Effect Size: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Standalone Study: No, a standalone study assessing an algorithm's performance without human-in-the-loop was not done, as the device is a magnetocardiograph (hardware with embedded software for measurement and display), not an AI algorithm for diagnosis or interpretation that would typically require such a study for its "standalone" performance. The software verification and validation relate to the proper functioning of the device's control, measurement, processing, and analysis functions, not necessarily AI-driven diagnostic interpretation.

7. Type of Ground Truth Used:

Type of Ground Truth: Not applicable in the context of clinical performance. The "ground truth" for the reported performance tests would be the established engineering specifications and measurement standards for each technical test (e.g., a calibrated reference for sensitivity, a controlled environment for boil-off rate).

8. Sample Size for the Training Set:

Sample Size: Not applicable. The document does not describe a machine learning algorithm or AI component that would require a "training set" in the conventional sense for diagnostic model development.

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

Ground Truth Establishment: Not applicable, as there is no mention of a training set for an AI algorithm.

In summary:

This 510(k) submission focuses on demonstrating substantial equivalence primarily through technical specifications, safety (electrical and electromagnetic compatibility), and basic functionality (sensor performance, heart rate measurement, etc.) against a predicate device. It does not present a clinical performance study with defined acceptance criteria for diagnostic accuracy, expert-established ground truth, or AI-specific performance metrics. The device is described as a tool to measure and display magnetic signals, implying that its performance evaluation revolves around the accuracy and reliability of these physical measurements rather than algorithmic interpretation for diagnosis.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

AMCG Co., Ltd. Soyeon Kim Senior Regulatory Affairs F8, 156, Seochojungang-ro, Seocho-gu Seoul, 06605 Korea, South

Re: K232823

Trade/Device Name: Mcg-s (am1000) Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: February 26, 2024 Received: February 26, 2024

Dear Soyeon Kim:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Kimberly

For: Jennifer Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices

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Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K232823

Device Name

MCG-S (AM1000)

Indications for Use (Describe)

AM1000 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

This 510(k) Summary is being submitted in according with requirement of 21 CFR Part 807.92.

Submitter's Name	AMCG Co., Ltd.
Submitter's Address	F8, 156, Seochojungang-ro, Seocho-gu, Seoul,Republic of Korea
Submitter's Telephone number	+82-2-598-8001
Contact Person	Soyeon KimAMCG Co., Ltd.+82-2-598-8001
Date Summary was Prepared	September 08, 2023
Trade or Proprietary Name	MCG-S (AM-1000)
Common or Usual Name	Magnetocardiograph
Classification	Class II per 21 CFR §870.2340
Product Code	DPS
Classification Panel	Cardiovascular

1. Device Description

This system consists of Dewar with 96-channel SQUIDs, gantry, electronics, power supply device, and software. 48 of these SQUID sensors are used for detecting the X-components, and the remaining 48 sensors are for the Y-components of the magnetic field. The device does not measure and/or display the magnetic field in the Z-component.

The system increases the output signal of the SQUID by applying the DROS (Double Relaxation Oscillation SQUID) method to increase the measurement sensitivity of the cardiac magnetic field signal, and a wide range of channel area is applied to measure the magnetic field area throughout the heart within a short time. In addition, in order to minimize the mechanical vibration of the sensor, the sensor is installed in a vacuum area, and Dewar, which has excellent noise shielding and insulation performance, is applied.

The system is controlled through noise-free optical fiber signals and can control, measure, process and analyze signals through software.

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2. Indications for Use

AM1000 is intended for use as a tool which non-invasively measures and displays the magnetic signals produced by the electric currents of the heart.

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3. Technological Characteristics

MCG-S(AM1000) is substantially equivalent in terms of indications for use, technical characteristics, and performance to predicate device (K121825) .

K number	Proprietary Name	Manufacturer	Predicate Type
K121825	CS-MAGII	BIOMAGNETIK-PARKGMBH	Predicate device

Similar or different technical characteristics exist to MCG-S (AM1000), a predicate device.

The following technological differences exist between the subject and predicate device:

Elements ofComparison	MCG-S (AM1000)(Subject Device)	CS-MAGII(K121825)	Same	Similar
RegulationNumber No.	21CFR 870.2340	21CFR 870.2340	X
Product Code	DPS	DPS	X
Indicationsfor use	AM1000 is intended foruse as a tool which non-invasively measures anddisplays the magneticsignals produced by theelectric currents of theheart.	The BMP MCG CS-MAGIIMagnetocardiograph isintended for use as toolwhich non-invasivelymeasures and displaysthe magnetic signalsproduced by the electriccurrents in the heart.	X
	Type of use	Prescription Use only	Prescription Use only	X
	Description	AMCG's MCG-S willbe used for purpose ofmeasurement andanalysis in adultcardiology.Magnetocardiography(MCG) is a non-invasive, non-contact,radiation-free	The BMP MCG CS-MAGII system will beused for diagnosticpurposes in adultcardiology.Magnetocardiography(MCG) is a non-invasive, non-contact,radiation-free		X
Elements ofComparison		MCG-S (AM1000)(Subject Device)	CS-MAGII(K121825)	Same	Similar
		multichannel bodysurface mappingtechnique to recordbiomagnetic signals ofX- and Y-componentsfrom the heart generatedby the same ioniccurrents underling theelectrocardiogram.This system consists ofDewar with 96-channelSQUIDs, gantry,electronics, powersupply device, andsoftware. 48 of theseSQUID sensors are usedfor detecting the X-components, and theremaining 48 sensorsare for the Y-components of themagnetic field. Thedevice does not measureand/or display themagnetic field in the Z-component.The system increasesthe output signal of theSQUID by applying theDROS (DoubleRelaxation OscillationSQUID) method toincrease themeasurement sensitivityof the cardiac magneticfield signal, and a widerange of channel area isapplied to measure themagnetic field areathroughout the heart	multichannel bodysurface mappingtechnique to recordbiomagnetic signalsfrom the heart generatedby the same ioniccurrents underling theelectrocardiogram.Compared toelectrocardiography(ECG), MCG hassimilar morphologicalfeatures such as T-, P-,and Q-waves, and theQRS complex. Theadvantages of MCGsover traditional EGGsare increased sensitivityto weak signals, lack ofdistortion fromconductivity in bodytissues, and presentationof direct current (DC)component signals andprimary currents.
Elements ofComparison		MCG-S (AM1000)(Subject Device)	CS-MAGII(K121825)	Same	Similar
	within a short time. Inaddition, in order tominimize themechanical vibration ofthe sensor, the sensor isinstalled in a vacuumarea, and Dewar, whichhas excellent noiseshielding and insulationperformance, is applied.The system is controlledthrough noise-freeoptical fiber signals andcan control, measure,process and analyzesignals throughsoftware.
Targetpopulation	Adult	Adult	X
Configurations	Dewar, Gantry,Electronics(Electricmodule, DC Power filtermodule, Power supplydevice), Software	SQUID gradiometer,Insert, Dewar,Electronics, Software,Gantry and Bed		X
Sensor Type	SQUID(DROS)	SQUID(DROS)	X
ShieldedRoom	Required	Required	X
Cryogen Used	Liquid Helium	Liquid Helium	X
Heliumreliquefiedsystem	Not applicable	Not applicable	X
OperatingSystem	Windows 10	Windows	X
Number ofSQUIDchannels	96 channels	64 channels		X
SQUIDgradiometersensitivity	less than 10 fTrms/√Hz(at 100 Hz)	3.5 fTrms/√Hz (at 100Hz)		X
Sampling rate	1-10 kHz	1 kHz		X
Elements ofComparison	MCG-S (AM1000)(Subject Device)	CS-MAGII(K121825)	Same	Similar
Liquid Hevolume	13 L	40 L		X
Liquid HeBoil-off andrefill interval	about 4 days	7 days		X
Liquid HeBoil-off Rate	less than 3.5 L/day	Average 4.41 L/day		X
Baseline	50 mm	70 mm		X
Sensing Coil(DetectingCoil)	1st planar gradiometer(X- and Y-component)	1st axial gradiometer(Z-component)		X

Table 2. Comparison Table to Predicate Device

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Confidential

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Therefore, the differences between the subject device MCG-S(AM1000) and the predicate device do not raise new questions of the safety and effectiveness.

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4. Performance Data

MCG-S(AM1000) has been extensively tested in Electromagnetic Compatibility and Electrical Safety, and bench testing.

1) Electromagnetic Compatibility and Electrical Safety

The electromagnetic and electrical safety of MCG-S(AM1000) was tested according to IEC 60601-1 and IEC 60601-1-2 to guarantee that the device meets electromagnetic compatibility and electrical safety requirements.

2) Software

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."

3) Performance

Performance tests were conducted to evaluate the basic performance. Following tests were performed and met the internal criteria.

. Sensitivity Test
L-He Boil-off Rate Test
. Dimensional Test
Sensor Operation Test
Accuracy Test
. Heart Positioning Test
Heart Rate Measurement Test
Sensor Calibration Test

5. Summary of Substantial Equivalence

Based on the comparison, we have demonstrated that MCG-S (AM1000) has been shown to be as safe and effective for the proposed Indications for Use as the legally marketed predicate device. Therefore, we conclude that the proposed MCG-S (AM1000) is substantially equivalent to those predicate device.

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6. Conclusion

The results of safety and performance tests demonstrate the substantial equivalence of MCG-S (AM1000). There are some differences with the predicate device, however, the differences between the subject device MCG-S (AM1000) and the predicate device do not raise new questions of the safety and effectiveness. Therefore, MCG-S (AM1000) is substantially equivalent to the predicate device and does not raise any new issues regarding safety or efficacy when compared to its 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).