(246 days)
Not Found
No
The summary describes standard signal processing and display, with no mention of AI or ML algorithms for analysis or interpretation.
No.
The device's intended use is to non-invasively measure and display magnetic signals from the heart, which is a diagnostic function, not a therapeutic one.
Yes
The device "measures and displays the magnetic signals produced by the electric currents in the heart," which is a diagnostic function, and the "Summary of Performance Studies" mentions "Clinical data was also used as part of the indication for substantial equivalence to 5-lead ECG," suggesting its use in a diagnostic context.
No
The device description explicitly mentions "an array of magnetic detectors with data acquisition hardware/software" and "The detectors are housed in a vertically adjustable holder. The patient bed moves horizontally". This indicates the device includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The CMI Magnetocardiograph directly measures magnetic signals produced by the electrical activity of the heart within the body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it "non-invasively measures and displays the magnetic signals produced by the electric currents in the heart." This is a direct measurement of a physiological process, not an analysis of a biological sample.
Therefore, the CMI Magnetocardiograph falls under the category of a medical device that performs a non-invasive measurement, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CMI 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)
74 DPS
Device Description
This device integrates an array of magnetic detectors with data acquisition hardware/software for the purpose of measuring the magnetic signals generated by the electrical current flowing in the heart. The detectors are housed in a vertically adjustable holder. The patient bed moves horizontally in orthogonal directions allowing the acquisition of multiple datasets for different locations above the torso. Three standard ECG electrodes are placed on each wrist and one ankle of the subject to provide a reference signal for synchronization of multiple MCG datasets.
The MCG data is preprocessed and displayed as either real time traces, averaged traces, or as multi-dimensional color 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
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device was tested by the Underwriters Laboratories and found to comply with requirements for fire, casualty and shock hazards covering UL equipment Class 1, and judged to be eligible for Classification and Follow-Up Service. The result is that CardioMag Imaging, Inc. (CMI) is authorized to use the UL marking, and is assigned UL # 51LB. Underwriters Laboratories also conducted Electromagnetic Compatibility Testing, the result being a Compliance Certificate given to CMI. Details can be found in Appendix D.
Extensive on-site testing at clinical sites shows that the device performs to specifications in a clinical environment. Clinical data was also used as part of the indication for substantial equivalence to 5-lead ECG (Appendix H).
Bench tests are applied to all units which leave CMI to be used for R&D investigations. Results of the bench testing are reviewed to assess pass or failure of the components and the system.
Each new version of the software is tested in accordance with FDA guidelines. Results of performance testing for the latest version of the software are documented in Appendix C.
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
033488
JUL - 7 2004
510(k) Summary for CMI Magnetocardiograph
SPONSOR 1.
CardioMag Imaging, Inc. 450 Duane Avenue, Schenectady, New York 12304
Contact Person: Steve Karr, Ph.D. 518 381 1000, ext.37 e-mail: skarr(@cardiomag.com Telephone:
Date Prepared: June 29, 2004
2. Device Name
CMI Magnetocardiograph Proprietary Name: Common/Usual Name: magnetocardiograph Classification Name: to be determined
3. PREDICATE DEVICES
| Hewlett Packard, model 1511B | ECG | K760542 |
|---|---|---|
| Neuromag-122 | magnetoencephalograph | K962764 |
4. DEVICE DESCRIPTION
This device integrates an array of magnetic detectors with data acquisition hardware/software for the purpose of measuring the magnetic signals generated by the electrical current flowing in the heart. The detectors are housed in a vertically adjustable holder. The patient bed moves horizontally in orthogonal directions allowing the acquisition of multiple datasets for different locations above the torso. Three standard ECG electrodes are placed on each wrist and one ankle of the subject to provide a reference signal for synchronization of multiple MCG datasets.
The MCG data is preprocessed and displayed as either real time traces, averaged traces, or as multi-dimensional color maps.
1
5. INTENDED USE
The CMI Magnetocardiograph is intended for use as tool which non-invasively measures and displays the magnetic signals produced by the electric currents in the heart.
Technological Characteristics and Substantial Equivalence 6.
The CMI Magnetocardiograph is substantially equivalent to the Hewlett Packard ECG [510(k) number K760542] and the Neuromag Ltd. Magnetoencephalograph (MEG) called the Neuromag-122 [510(k) number K962764] in safety and effectiveness. Two tables, H.1 and H.2, are presented to illustrate the similarities and differences between the CMI Magnetocardiograph and its predicates.
| Parameter | CMI Magnetocardiograph | Hewlett Packard ECG |
|---|---|---|
| No. of detectors or channels | 9 | 5 |
| Detector (or Sensor) | SQUID - no contact to subject | Electrode - contacts subject |
| Signal detected non-invasively | magnetic | Electrical |
| Waveform morphology | Similar to ECG | |
| Coverage | Four acquisitions to cover | |
| entire heart | One acquisition | |
| Patient position | Supine | Supine or standing |
Comparison Tables
| Table | H.2 |
|---|---|
| ------- | ----- |
| Parameter | CMI Magnetocardiograph | Neuromag-122 MEG |
|---|---|---|
| No. of SQUID | ||
| detectors/channels | 9 (36 effective via re- | |
| positioning) | 122 | |
| Signal detected | magnetic | Magnetic |
| Operating Principle | Superconducting flux | |
| transformer coupled with | ||
| DC-SQUID controlled by | ||
| analog flux-locked loop | Superconducting flux | |
| transformer coupled with | ||
| DC-SQUID controlled by | ||
| analog flux-locked loop | ||
| Gradiometer | Second order | Two orthogonal planar-first |
| order gradiometers per | ||
| location | ||
| Intersensor Spacing | 40 mm | 43-44 mm |
| Magnetic field localization | Yes | Yes |
| Cryogen Used | Liquid Helium | Liquid Helium |
| Gantry | Floor mounted | Floor mounted |
| Coverage | Four acquisitions to cover | One acquisition to cover |
2
| entire heart | entire head | |
|---|---|---|
| Patient position | Supine | Sitting or supine |
| Magnetically shielded room | Not required | Required |
The basis for equivalence to the 5-lead Electrocardiograph predicate is that the CMI Magnetocardiograph produces magnetic waveforms (or traces) very similar in morphology to the electrical waveforms produced by the 5-lead Electrocardiograph, both waveforms emanating from the human heart. Data, taken from human subjects, is presented in Appendix H (Substantial Equivalence Information) to support this claim.
The basis for equivalence to the Magnetoencephalograph is that the Magnetoencephalograph (MEG) predicate and the magnetocardiograph (MCG) both use very similar technology (SQUIDs) and both measure the magnetic field emanating from a source - they are functionally equivalent. Appendix H presents data to support this claim.
Safety
The CMI Magnetocardiograph uses liquid Helium cooled sensors, which are housed in a thermally insulated cryostat, the outside temperature of which is at ambient temperature. In the highly unlikely event of the accidental rapid evaporation of the cryogen, the flow of gas would be upward, away from the subject. Refill of the cryostat is easily accomplished following the instructions and illustrations in the hardware manual. Since the device is entirely passive, does not touch the subject, and is housed in an electrically neutral fiberglass housing, the system is at least as safe as electrical ECG systems for both the operator and the subject. Comparable to the Neuromag-122 MEG system, the sensors make no contact to the subject. During a pilot study involving hundreds of subjects, there are no instances of any discomfort or pain to the patient, nor have any safety issues arisen while obtaining cardiac data from a subject.
7. PERFORMANCE TESTING
The device was tested by the Underwriters Laboratories and found to comply with requirements for fire, casualty and shock hazards covering UL equipment Class 1, and judged to be eligible for Classification and Follow-Up Service. The result is that CardioMag Imaging, Inc. (CMI) is authorized to use the UL marking, and is assigned UL # 51LB. Underwriters Laboratories also conducted Electromagnetic Compatibility Testing, the result being a Compliance Certificate given to CMI. Details can be found in Appendix D.
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4/4
Extensive on-site testing at clinical sites shows that the device performs to specifications in a clinical environment. Clinical data was also used as part of the indication for substantial equivalence to 5-lead ECG (Appendix H).
Bench tests are applied to all units which leave CMI to be used for R&D investigations. Results of the bench testing are reviewed to assess pass or failure of the components and the system.
Each new version of the software is tested in accordance with FDA guidelines. Results of performance testing for the latest version of the software are documented in Appendix C.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 7 2004
CardioMag Imaging, Inc. c/o Steve Karr, Ph.D. Program Manager 450 Duane Avenue Schenectady, NY 12304
Re: K033488
Trade Name: CMI Magnetocardiograph, Model 2409 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: 74 DPS Dated: April 9, 2004 Received: April 12, 2004
Dear Dr. Karr:
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 for associated in 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such 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
5
Page 2 - Steve Karr, Ph.D.
CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and my Jourse of substantial equivalence of your device to a legally premated predicated device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
KO33488 510(k) Number (if known):
Device Name:_CMI 2409 Magnetocardiograph
Indications For Use:
The CMI Magnetocardiograph is intended for use as a tool that 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
Cver-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)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K03348...
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