SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEM

K993731 · Siemens Medical Solutions USA, Inc. · LNH · Dec 23, 1999 · Radiology

Device Facts

• Record ID: K993731
• Device Name: SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEM
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LNH · Radiology
• Decision Date: Dec 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended 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 (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 Story

The MAGNETOM Symphony with Sonata Gradients is a whole-body magnetic resonance imaging (MRI) scanner. It utilizes magnetic resonance to detect spatial distribution of protons (hydrogen nuclei) in the body. The system transforms these signals into transversal, sagittal, coronal, and oblique images. Operated by trained professionals in clinical settings, the device provides diagnostic information to physicians for clinical decision-making. The Sonata Gradients feature higher gradient amplitudes compared to the standard MAGNETOM Symphony, allowing for faster imaging performance. The output images assist physicians in diagnosing internal structures of the head and body. The device benefits patients by providing non-invasive diagnostic imaging.

Clinical Evidence

Bench testing only. Evaluation included safety parameters (maximum static field, dB/dt, RF power deposition, acoustic noise) and performance metrics (specification volume, signal-to-noise, image uniformity, geometric distortion, slice profile/thickness/gap, and high-contrast spatial resolution) to demonstrate substantial equivalence.

Technological Characteristics

Whole-body MRI scanner featuring Sonata Gradients with increased gradient amplitudes. Operates via magnetic resonance imaging principles. Safety parameters evaluated include static magnetic field, dB/dt, RF power deposition, and acoustic noise levels. Performance metrics include spatial resolution, image uniformity, and geometric distortion. System is a Class II diagnostic device.

Indications for Use

Indicated for use as a whole body diagnostic imaging device to produce transversal, sagittal, coronal, and oblique images of internal head or body structures based on proton density, T1, T2, and flow properties.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• MAGNETOM Symphony System

Submission Summary (Full Text)

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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 [phone] [phone]
#### 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

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.

## • 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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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.

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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