The MAGNETOM SYMPHONY with the Sonata Gradients is a whole body scanner with higher gradient amplitudes. The MAGNETOM SYMPHONY with the Sonata Gradients is indicated for use as diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the MAGNETOM SYMPHONY with the Sonata Gradients reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin lattice relaxation time (T1), spin-spin relaxation time (T") and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

Device Description

The MAGNETOM SYMPHONY with the Sonata Gradients is a whole body scanner with higher gradient amplitudes.

AI/ML Overview

The Siemens Medical Systems, Inc. Sonata Gradients for the MAGNETOM SYMPHONY System is a Magnetic Resonance Diagnostic Device. The provided text outlines the safety and effectiveness testing conducted to support its substantial equivalence to the commercially available MAGNETOM Symphony System.

Here's an analysis of the acceptance criteria and study as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary mentions several safety and performance levels that were evaluated, using the FDA guidance document for MR Diagnostic Devices. It largely focuses on demonstrating that the new Sonata Gradients do not significantly change these levels and remain below levels of concern.

Category	Acceptance Criteria (Action/Performance Level)	Reported Device Performance
Safety	Maximum Static Field	Not significantly changed; remains below the level of concern.
	Rate of Change of Magnetic Field (dB/dt)	Not significantly changed; remains below the level of concern.
	RF Power Deposition	Not significantly changed; remains below the level of concern.
	Acoustic Noise Levels	Not significantly changed; remains below the level of concern.
Performance	Specification Volume	Not explicitly detailed, but implied to be acceptable.
	Signal to Noise	Not explicitly detailed, but implied to be acceptable.
	Image Uniformity	Not explicitly detailed, but implied to be acceptable.
	Geometric Distortion	Not explicitly detailed, but implied to be acceptable.
	Slice Profile, Thickness, and Gap	Not explicitly detailed, but implied to be acceptable.
	High Contrast Spatial Resolution	Not explicitly detailed, but implied to be acceptable.

Note: The document explicitly states that for safety parameters, the new levels are "not significantly changed and, in the case of safety, parameters remain below the level of concern." For performance levels, it generally implies that the system's performance remains acceptable without providing specific numerical thresholds or results. This is common for 510(k) submissions focusing on substantial equivalence, where the primary goal is to show the new device is as safe and effective as a predicate, rather than establishing absolute performance benchmarks.

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

The document states, "Laboratory testing were performed to support this claim of substantial equivalence and to show that the technological differences do not raise any new questions pertaining to safety and effectiveness."

Sample Size for Test Set: Not specified. The document refers to "laboratory testing" which typically involves phantom studies and perhaps limited human volunteer scans for an MRI system. No patient-specific test set size is mentioned.
Data Provenance: Not specified. Given it's "laboratory testing," it would be internally generated data during development and verification, likely in the United States (where Siemens Medical Systems, Inc. is located for this submission). It is a prospective evaluation as it's testing the new device.

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

Not applicable. The study described focuses on technical performance parameters of an MRI system (e.g., field homogeneity, signal-to-noise ratio, acoustic noise) rather than diagnostic accuracy or clinical interpretation. Therefore, there is no mention of experts establishing a diagnostic ground truth for a test set of images. The "ground truth" for these technical parameters would be established through calibrated measurement equipment and engineering standards.

4. Adjudication Method for the Test Set

Not applicable for the reasons stated above. The evaluation is of the system's physical and technical characteristics, not the interpretation of medical images by human readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study was not conducted or reported. The study focuses on the technical specifications and safety aspects of the MRI system with new gradients, not on its comparative diagnostic effectiveness with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense. The "laboratory testing" described is a standalone evaluation of the device's physical and technical performance. The MRI system itself, with its new gradients, is the "algorithm only" in this context, demonstrating its technical capabilities without direct human interpretive input being measured as an outcome.

7. The Type of Ground Truth Used

The ground truth used for this type of evaluation is primarily physical measurements and engineering standards. For example:

Physical measurements from probes and sensors for static magnetic field, dB/dt, RF power deposition, and acoustic noise levels.
Measurements using phantoms (standardized test objects) for specification volume, signal-to-noise ratio, image uniformity, geometric distortion, slice profile, and high contrast spatial resolution.
Compliance with pre-defined technical specifications and safety thresholds.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI algorithm submission that would require a separate training set. The "device" here is a hardware component (gradients) for an MRI system.

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

Not applicable, as there is no training set mentioned or implied for this submission.

Summary

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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.

I. General Information.

Establishment:

. Address: Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, N.J. 08830
Registration Number: 2240869
Contact Person: Mr. Jamie Yieh Technical Specialist, Regulatory Submissions (732) 321-4625 (732) 321-4841

Date of Summary Preparation: 11/3/99

Device Name:

Trade Name: Sonata Gradients
· Classification Name: Magnetic Resonance Diagnostic Device, CFR § 892.1000
· Classification: Class II
· Performance Standards: None established under Section 514 the Food, Drug, and Cosmetic Act.

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II. Safety and Effectiveness Information Supporting Substantial Equivalence.

• Device Description:

· Intended Use

• Technological Characteristics

The MAGNETOM Symphony with the new Sonata Gradients is substantially equivalent to the MAGNETOM Symphony System.

· General Safety and Effectiveness Concerns:

Operation of the MAGNETOM Symphony with the new Sonata Gradients is substantially equivalent to the commercially available MAGNETOM Symphony System. The following are the safety parameter with action levels:

Maximum Static Field ●
Rate of Change of Magnetic Field .
. RF Power Deposition
Acoustic Noise Levels .

and performance levels

. Specification Volume
. Signal to Noise
. Image Uniformity
Geometric Distortion .
Slice Profile, Thickness and Gap .
High Contrast Spatial Resolution .

specified by the FDA guidance document for MR Diagnostic Devices were evaluated within this notification. The reduction in the minimum rise time of the system will affect both the acoustic noise level and the rate of change in the magnetic field strength (dB/dt), as well as certain performance levels with the system. However, the new levels are not significantly changed and, in the case of safety, parameters remain below the level of concern.

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• Substantial Equivalence:

Laboratory testing were performed to support this claim of substantial equivalence and to show that the technological differences do not raise any new questions pertaining to safety and effectiveness.

Kathleen M. Rutherford

Manager, Regulatory Submissions

11/3/99
Date

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 3 1999

Jamie Yieh Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, New Jersey 08830

RE:

K993731 Sonata Gradients for Magnetom Symphony MRI System Dated: November 3, 1999 Received: November 4, 1999 Regulatory Class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Ms. Yieh:

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 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). 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 (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 requirements, 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 the Electronic Product 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel C. Schultz, M.D.

APT Daniel G. Schultz, M.D. Acting 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) _____________________________________________________________________________________________________________________________________________________

Sonata Gradients for the MAGNETOM SYMPHONY System Device Name:

Indications for Use:

The MAGNETOM SYMPHONY with the Sonata Gradients is a whole body scanner with higher gradient amplitudes. The MAGNETOM SYMPHONY with the Sonata Gradients is indicated for use as diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the MAGNETOM SYMPHONY with the Sonata Gradients reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin lattice relaxation time (TI), spin-spin relaxation time (T") and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

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

Concurrence of CDRH, Office of Device Evaluation Prescription Use V OR Over-The-Counter Use (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi 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.