Siemens developed Cardiac Tagging pulse sequences for the Magnetom Vision and Impact Systems to allow for the non-invasive evaluation of cardiac wall motion and blood flow. Absence of tag deformation throughout the cardiac cycle is an indicator of dysfunctional myocardium which accompanies a variety of disease states. In addition, Cardiac Tagging may assist in differentiating between fixed thrombus and slowly flowing blood. Cardiac Tagging is intended as an add-on to routine MR imaging examinations of the heart and great vessels. Tagging may provide additional diagnostic information, which in the hands of a qualified physician, can be useful in the diagnosis of disease.

Device Description

The Magnetom Cardiac Tagging Techniques consist of software and sequences designed to apply a series of equally spaced saturation bands to generate a grid on a cardiac image, for use in cardiac evaluation.

AI/ML Overview

Here's an analysis of the provided text regarding the cardiac tagging device's acceptance criteria and studies:

Summary of Device Acceptance Criteria and Performance:

The provided 510(k) submission does not explicitly state specific numerical acceptance criteria or detail a dedicated study proving the device meets those criteria in the way a modern regulatory submission would for a novel device.

Instead, the submission focuses on demonstrating substantial equivalence to a previously cleared device (Siemens Magnetom Cardiac Cine Techniques, K900889) and ensuring that the new Cardiac Tagging feature does not negatively impact the existing safety and performance levels of the base MR systems (Magnetom Vision and Impact).

Therefore, the "acceptance criteria" here are implicitly tied to the performance characteristics of the predicate device and the safety parameters outlined by the FDA for MR Diagnostic Devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implicit)	Reported Device Performance
Safety Parameters (Unchanged by Tagging Feature):
- Static field strength	Unaffected by the modifications described within this notification.
- RF exposure	Unaffected by the modifications described within this notification.
Performance Levels (Unchanged by Tagging Feature):
- High contrast spatial resolution	Unaffected by the modifications described within this notification.
- Slice thickness	Unaffected by the modifications described within this notification.
- Geometric distortion	Unaffected by the modifications described within this notification.
- SNR (Signal-to-Noise Ratio)	Unaffected by the modifications described within this notification.
- Image uniformity	Unaffected by the modifications described within this notification.
Functional Equivalence:
- Non-invasive evaluation of cardiac wall motion and blood flow	The device is designed to "apply a series of equally spaced saturation bands to generate a grid on a cardiac image, for use in cardiac evaluation" and "allow for the non-invasive evaluation of cardiac wall motion and blood flow." It is deemed substantially equivalent to the predicate Siemens Magnetom Cardiac Cine Techniques (K900889), which presumably also offers non-invasive cardiac evaluation.
- Ability to identify dysfunctional myocardium	"Absence of tag deformation throughout the cardiac cycle is an indicator of dysfunctional myocardium which accompanies a variety of disease states." (Intended Use)
- Ability to differentiate fixed thrombus and flowing blood	"Cardiac Tagging may assist in differentiating between fixed thrombus and slowly flowing blood." (Intended Use)

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

The provided document does not describe a specific clinical "test set" or a study with a defined sample size to demonstrate the de novo performance of the Cardiac Tagging feature. The submission relies on the concept of substantial equivalence to an already cleared device. There is no mention of country of origin or whether data was retrospective or prospective, as no new clinical study data is presented for this specific feature as a primary means of establishing safety and effectiveness.

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

Not applicable, as no described test set with independently established ground truth is presented in this 510(k) summary.

4. Adjudication Method for the Test Set:

Not applicable, as no described test set requiring adjudication is presented.

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

No MRMC study is mentioned. The submission does not describe a study comparing human readers with and without AI assistance for this device.

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

Not explicitly described. The device is a "software and sequences designed to apply a series of equally spaced saturation bands to generate a grid on a cardiac image." While it performs an automated function, its "performance" is assessed in terms of its impact on the overall MR system's safety and fundamental image characteristics, and its intended use is to provide "additional diagnostic information, which in the hands of a qualified physician, can be useful in the diagnosis of disease." This implies it's an adjunct, not a standalone diagnostic.

7. Type of Ground Truth Used:

Not applicable, as no dedicated clinical study with independent ground truth is described for the Cardiac Tagging feature itself. The ground truth for the substantial equivalence argument is the established safety and effectiveness of the predicate device and the general regulatory standards for MR devices.

8. Sample Size for the Training Set:

Not applicable. This document describes a software feature for an MR system, not a machine learning or AI model in the modern sense that would require a distinct "training set" for model development. The software "applies a series of equally spaced saturation bands" and presumably follows deterministic algorithms, not learned patterns.

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

Not applicable, as there is no described training set.

In summary, this 510(k) submission primarily leverages the concept of substantial equivalence rather than presenting new clinical performance data for the Cardiac Tagging feature. The "acceptance criteria" are the established safety and performance levels of the core MR system and the predicate device, which the new feature is stated not to degrade.

Summary

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K97399

510 (k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. JAN - 2 1998 General Information. I.

Establishment: Siemens Medical Systems, Inc. · Address: 186 Wood Avenue South Iselin, N.J. 08830 · Registration Number: 2240869 Kathleen M. Rutherford • Contact Person: Manager, Regulatory Submissions (908) 321-4779 October 3, 1997 · Date of Summary Preparation: Device Name: Cardiac Tagging Techniques/ · Trade Name: MAGNETOM Vision, Impact Magnetic Resonance Diagnostic · Classification Name: Device, CFR § 892.1000 Class II · Classification: None established under Section · Performance Standards: 514 of the Food, Drug, and Cosmetic Act.

II. Safety and Effectiveness Information Supporting the Substantial Equivalence Determination.

Device Description:

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Intended Use

Siemens Cardiac Tagging pulse sequences for the Magnetom Vision and Impact systems allow for the non-invasive evaluation of cardiac wall motion and blood flow.

Technological Characteristics

The magnet, RF system, and gradient system of the Magnetom Vision and Impact configured with the Cardiac Tagging option are unchanged from that of the standard Magnetom Vision and Impact systems. Introduction of Cardiac Tagging will not affect the technological characteristics of the system, which allows presentation of images and other parameters based upon the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance.

General Safety and Effectiveness Concerns:

Operation of the MAGNETOM Vision and Impact systems with the new Cardiac Tagging feature is substantially equivalent to standard operation of the MAGNETOM Vision and Impact system. The following safety parameter action levels:

static field strength, ।
RF exposure, r

and performance levels:

high contrast spatial resolution, -
slice thickness, -
geometric distortion,
-SNR, and
image uniformity

specified by the FDA guidance document for MR Diagnostic Devices are unaffected by the modifications described within this notification.

Substantial Equivalence:

Siemens believes that, within the meaning of the Safe Medical Device Act of 1990, MR Cardiac Tagging Techniques are substantially equivalent to Siemens Magnetom Cardiac Cine Techniques which were originally described in premarket notification K900889 which received FDA clearance on 03/23/90.

Kathleen Rutherford
Signature

10/3/97

Date

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure, represented by three curved lines, positioned to the right of the department's name. The text "DEPARTMENT OF HEALTH & HUMAN" is arranged in a circular fashion around the left side of the logo, with "SERVICES - USA" completing the circle at the bottom.

JAN - 2 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kathleen Rutherford Manager, Regulatory Submissions Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830

Re: K973799

Cardiac Tagging Techniques for Magnetom Vision and Impact (MR accessory) Dated: October 3, 1997 Received: October 6, 1997 Regulatory Class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Ms. Rutherford:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the interestore) to 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). You may, therefore, market the device, subject to the general controls provisions of 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

h.J.Liau Yin

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) K17 3799 -----

Device Name: Cardiac Tagging

Indications for Use:

Cardiac Tagging is intended as an add-on to routine MR imaging examinations of the heart and great vessels. Tagging may provide additional diagnostic information, which in the hands of a qualified physician, can be useful in the diagnosis of disease.

(please do not write below this line- continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation

Prescription Use_

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Kilian Yi

(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number_

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.