(263 days)
Not Found
No
The document describes a standard magnetocardiography system and its components. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The software is described as performing signal processing and analysis, but this is a common function in medical devices and does not inherently imply AI/ML.
No.
The device is described as measuring and displaying magnetic signals from the heart for diagnostic purposes, not for treating any condition.
Yes
The "Device Description" explicitly states, "The BMP MCG CS-MAG II system will be used for diagnostic purposes in adult cardiology."
No
The device description explicitly lists multiple hardware components (SQUID gradiometer, Insert, Dewar, Electronics, Gantry, and Bed) in addition to the software. The performance studies also include testing of these hardware components.
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 in the heart." This describes a device that interacts with the patient's body directly to obtain physiological signals.
- Device Description: The description further emphasizes that it's a "non-invasive, non-contact, radiation-free, multichannel body surface mapping technique to record biomagnetic signals from the heart." This reinforces the idea of a device used externally on the patient.
- IVD Definition: In vitro diagnostics (IVDs) are medical devices that are used to examine specimens, such as blood, urine, or tissue, that have been taken from the human body. They are used to provide information for diagnosis, monitoring, or screening.
This device does not analyze specimens taken from the body. It directly measures a physiological signal from the patient's heart. Therefore, it falls under the category of a non-invasive diagnostic device rather than an IVD.
N/A
Intended Use / Indications for Use
The BMP MCG CS-MAG II Magnetocardiograph is intended for use as tool which non-invasively measures and displays the magnetic signals produced by the electric currents in the heart.
Product codes (comma separated list FDA assigned to the subject device)
DPS
Device Description
The BMP MCG CS-MAG II system will be used for diagnostic purposes in adult cardiology. Magnetocardiography (MCG) is a non-invasive, non-contact, radiation-free, 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 ECGs 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
heart
Indicated Patient Age Range
adult
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The MCG system test included the system and each component to support the device's claims: SQUID gradiometer, Insert, Dewar, Electronics, Software, Gantry and Bed by inspection form for each component, The SQUID gradiometer was tested especially for sensitivity better than 3.5 fTrms/yHz at white frequency to get clear signal from the magnetic field to voltage. The Dewar was tested with minimal liquid capacity and boil-off rate to get refill interval longer than 7 days. The electronics were tested for "analog filter: high pass, low pass, notch" and output amplifier and automatic control of SQUID sensors. The Software was tested for controlling system, display, signal processing and analysis especially for 2D current map. Gantry and Bed were tested by inspection of their specification - Gantry movement, Bed movement and Bed alignment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
MAR: 1 1 2013
510(k) Summary of Safety and Effectiveness
In accordance with the requirements of the Safe Medical Device Act, Biomagnetik Park GmbH herewith submits a Summary of Safety and Effectiveness.
| Submitter Information: | Biomagnetik Park GmbH
Forsthoehe 26
21149 Hamburg
Germany |
|-------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Mr. Young Sam Hur
Executive Director
Biomagnetik Park GmbH
Phone: +49 40 7900 5357
E-mail: yshur@biomagnetik.com |
| US Agent (Contact): | German American Chamber of Commerce
75 Broad Street, 21st Floor
New York, NY 10004 USA
Phone: +1 (212) 974-8830
E-mail: usagent@gaccny.com |
| Date Prepared: | December 12, 2012 |
| Device(s) Identification:
Device Trade Name:
Common Name: | CS-MAGII
Magnetocardiograph |
| Classification of the device:
Device Classification Name:
Product Code: | Electrocardiograph
DPS |
| Device Classification Name: | Electrocardiograph |
|---|---|
| Product Code: | DPS |
| Device Classification No.: | Part 870.2340 |
| Panel: | Cardiovascular |
| Regulatory Status: | Class 2 |
. . . . . . . . . . . . . . . . . . . . . . .
1
K121825
Predicate device: Device Trade Name: Applicant: 510(k) No.:
CMI Magnetocardiograph CardioMag Imaging, Inc. K033488
The Biomagnetik Park CS-MAG II Magnetocardiograph is considered substantial equivalent to the CMI Magnetocardiograph. There is no significant difference in intended use or technology.
Device Description: .
The BMP MCG CS-MAG II system will be used for diagnostic purposes in adult cardiology. Magnetocardiography (MCG) is a non-invasive, non-contact, radiation-free, 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 ECGs 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.
Intended Use:
The BMP MCG CS-MAG II Magnetocardiograph is intended for use as tool which non-invasively measures and displays the magnetic signals produced by the electric currents in the heart.
Summary of performed tests to support device claims
The MCG system test included the system and each component to support the device's claims: SQUID gradiometer, Insert, Dewar, Electronics, Software, Gantry and Bed by inspection form for each component, The SQUID gradiometer was tested especially for sensitivity better than 3.5 fTrms/yHz at white frequency to get clear signal from the magnetic field to voltage. The Dewar was tested with minimal liquid capacity and boil-off rate to get refill interval longer than 7 days. The electronics were tested for "analog filter: high pass, low pass, notch" and output amplifier and automatic control of SQUID sensors. The Software was tested for controlling system, display, signal processing and analysis especially for 2D current map. Gantry and Bed were tested by inspection of their specification - Gantry movement, Bed movement and Bed alignment.
Conclusion:
Biomagnetik Park GmbH believes that the MCG CS-MAG II magnetocardiograph is substantially equivalent to the currently legally marketed device. It does not introduce new indications for use, has the same technological characteristics and does not introduce new potential hazards or safety risks.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
March 11, 2013
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -- WO66-G609 Silver Spring, MD 20993-0002
Biomagnetik Park GmbH c/o Mr. Nick Burmester Prosystem AG Beim Strohhause 27 Hamburg GERMANY
Re: K121825
、
Trade/Device Names: CS-MAG II Regulatory Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (Two) Product Code: DPS Dated: February 19, 2013 Received: February 21, 2013
Dear Mr. Burmester:
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, 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.
3
Page 2 – Mr. Nick Burmester
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Owen P. Faris -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
| 510(k) number (if known): | K121825 |
|---|---|
| Device Name: | CS-MAG II |
| Indications For Use: | The BMP MCG CS-MAG II Magnetocardiograph is intended |
| for use as tool which non-invasively measures and displays | |
| the magnetic signals produced by the electric currents in the | |
| heart. |
Prescription Use x (Part 21 CFR 801 Subpart D)
. .
AND/OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Owen P. Faris -S
2013.03.11
16:17:38 -04'00'
:.
510(k)