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.

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.

AI/ML Overview

The provided text only contains very limited information regarding the device's testing and acceptance criteria. It focuses primarily on the predicate device, general device description, intended use, and a summary outlining what was tested rather than the specific quantitative acceptance criteria or the study proving these were met.

Here's what can be extracted based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
SQUID gradiometer sensitivity	Better than 3.5 fTrms/yHz at white frequency (to get clear signal from the magnetic field to voltage)
Dewar liquid capacity and boil-off rate	Minimal liquid capacity and boil-off rate (to get refill interval longer than 7 days)
Electronics filters	"analog filter: high pass, low pass, notch" (tested, but no specific performance metric given)
Electronics output amplifier	Output amplifier (tested, but no specific performance metric given)
Electronics automatic control of SQUID sensors	Automatic control of SQUID sensors (tested, but no specific performance metric given)
Software control	Controlling system (tested, but no specific performance metric given)
Software display	Display (tested, but no specific performance metric given)
Software signal processing	Signal processing (tested, but no specific performance metric given)
Software analysis (2D current map)	2D current map (tested, but no specific performance metric given)
Gantry movement	Gantry movement (tested by inspection of specification, but no specific numeric or descriptive performance metric given)
Bed movement	Bed movement (tested by inspection of specification, but no specific numeric or descriptive performance metric given)
Bed alignment	Bed alignment (tested by inspection of specification, but no specific numeric or descriptive performance metric given)

Missing Information: For many components, while "tested" is mentioned, specific numerical or descriptive acceptance criteria and their corresponding reported performance values are not provided. The text primarily states what was tested rather than the results against specific criteria.

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

Sample Size: Not specified. The document mentions "The MCG system test included the system and each component," implying a system-level and component-level testing rather than a clinical study with a patient test set.
Data Provenance: Not applicable, as there's no mention of patient data being used for a test set. This appears to be hardware and software functional testing rather than a clinical performance study.

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

Not applicable. There is no mention of a clinical test set requiring expert-established ground truth. The testing described is technical validation of hardware and software specifications.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or expert adjudication is described.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided text. The document describes technical testing of the device's hardware and software components.

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

Yes, this appears to be the type of study described, though it's a technical validation rather than a clinical performance study. The "MCG system test" focused on the performance of the system components (SQUID gradiometer, Dewar, Electronics, Software, Gantry, and Bed) in isolation, ensuring they meet their design specifications. There is no mention of human interaction or a human-in-the-loop performance evaluation.

7. Type of Ground Truth Used

Technical Specifications / Design Requirements: The ground truth for this testing appears to be the device's own design specifications and functional requirements for its various components (e.g., SQUID sensitivity, Dewar boil-off rate, filter types, software functionalities, gantry/bed movements).

8. Sample Size for the Training Set

Not applicable. The document does not describe any machine learning or AI component that would require a training set. The software testing mentioned is functional validation, not model training.

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

Not applicable. As there's no mention of a training set or AI model, this information is not relevant.

Summary

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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 GmbHForsthoehe 2621149 HamburgGermany
Official Correspondent:	Mr. Young Sam HurExecutive DirectorBiomagnetik Park GmbHPhone: +49 40 7900 5357E-mail: yshur@biomagnetik.com
US Agent (Contact):	German American Chamber of Commerce75 Broad Street, 21st FloorNew York, NY 10004 USAPhone: +1 (212) 974-8830E-mail: usagent@gaccny.com
Date Prepared:	December 12, 2012
Device(s) Identification:Device Trade Name:Common Name:	CS-MAGIIMagnetocardiograph
Classification of the device:Device Classification Name:Product Code:	ElectrocardiographDPS

Device Classification Name:	Electrocardiograph
Product Code:	DPS
Device Classification No.:	Part 870.2340
Panel:	Cardiovascular
Regulatory Status:	Class 2

. . . . . . . . . . . . . . . . . . . . . . .

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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: .

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.

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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.

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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

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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 intendedfor use as tool which non-invasively measures and displaysthe magnetic signals produced by the electric currents in theheart.

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)

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).