(205 days)
Not Found
No
The description focuses on the hardware and signal processing aspects of magnetocardiography, with no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device measures and displays magnetic signals from the heart; it does not claim to treat or provide therapeutic benefits.
Yes
The device "measures and displays the magnetic signals produced by the electric currents of the heart" for "measurement and analysis in adult cardiology," indicating its role in providing information for diagnosis.
No
The device description explicitly lists multiple hardware components including a Dewar with SQUIDs, gantry, electronics, and power supply device, in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly 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 interacts with the patient's body directly to obtain physiological measurements.
- Device Description: The description details a system that uses sensors (SQUIDs) to detect magnetic fields generated by the heart. This is a non-invasive, external measurement technique.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue, etc.) that are taken from the body. IVD devices are specifically designed to perform tests on these types of samples outside of the body.
Therefore, the AM1000 is a non-invasive diagnostic device that measures physiological signals from the heart, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DPS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart
Indicated Patient Age Range
Adult
Intended User / Care Setting
Prescription Use only
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
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 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"
1
(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
2
Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
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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4
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 Kim |
| AMCG 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
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.
5
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.
6
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-PARK | |
| GMBH | 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 of
Comparison | MCG-S (AM1000)
(Subject Device) | CS-MAGII
(K121825) | Same | Similar | |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|---------|
| Regulation
Number No. | 21CFR 870.2340 | 21CFR 870.2340 | X | | |
| Product Code | DPS | DPS | X | | |
| 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. | The BMP MCG CS-
MAGII
Magnetocardiograph is
intended for use as tool
which non-invasively
measures and displays
the magnetic signals
produced by the electric
currents in the heart. | X | | |
| | Type of use | Prescription Use only | Prescription Use only | X | |
| | Description | 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 | The BMP MCG CS-
MAGII system will be
used for diagnostic
purposes in adult
cardiology.
Magnetocardiography
(MCG) is a non-
invasive, non-contact,
radiation-free | | X |
| Elements of
Comparison | | MCG-S (AM1000)
(Subject Device) | CS-MAGII
(K121825) | Same | Similar |
| | | 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 | multichannel body
surface mapping
technique to record
biomagnetic signals
from the heart generated
by the same ionic
currents underling the
electrocardiogram.
Compared to
electrocardiography
(ECG), MCG has
similar morphological
features such as T-, P-,
and Q-waves, and the
QRS complex. The
advantages of MCGs
over traditional EGGs
are increased sensitivity
to weak signals, lack of
distortion from
conductivity in body
tissues, and presentation
of direct current (DC)
component signals and
primary currents. | | |
| Elements of
Comparison | | MCG-S (AM1000)
(Subject Device) | CS-MAGII
(K121825) | Same | Similar |
| | 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. | | | | |
| Target
population | Adult | Adult | X | | |
| Configurations | Dewar, Gantry,
Electronics(Electric
module, DC Power filter
module, Power supply
device), Software | SQUID gradiometer,
Insert, Dewar,
Electronics, Software,
Gantry and Bed | | X | |
| Sensor Type | SQUID(DROS) | SQUID(DROS) | X | | |
| Shielded
Room | Required | Required | X | | |
| Cryogen Used | Liquid Helium | Liquid Helium | X | | |
| Helium
reliquefied
system | Not applicable | Not applicable | X | | |
| Operating
System | Windows 10 | Windows | X | | |
| Number of
SQUID
channels | 96 channels | 64 channels | | X | |
| SQUID
gradiometer
sensitivity | less than 10 fTrms/√Hz
(at 100 Hz) | 3.5 fTrms/√Hz (at 100
Hz) | | X | |
| Sampling rate | 1-10 kHz | 1 kHz | | X | |
| Elements of
Comparison | MCG-S (AM1000)
(Subject Device) | CS-MAGII
(K121825) | Same | Similar | |
| Liquid He
volume | 13 L | 40 L | | X | |
| Liquid He
Boil-off and
refill interval | about 4 days | 7 days | | X | |
| Liquid He
Boil-off Rate | less than 3.5 L/day | Average 4.41 L/day | | X | |
| Baseline | 50 mm | 70 mm | | X | |
| Sensing Coil
(Detecting
Coil) | 1st planar gradiometer
(X- and Y-component) | 1st axial gradiometer
(Z-component) | | X | |
Table 2. Comparison Table to Predicate Device
7
8
Confidential
9
Therefore, the differences between the subject device MCG-S(AM1000) and the predicate device do not raise new questions of the safety and effectiveness.
10
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.
11
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.