SYNGO MR B17

K082427 · Siemens Medical Solutions USA, Inc. · LNH · Nov 7, 2008 · Radiology

Device Facts

• Record ID: K082427
• Device Name: SYNGO MR B17
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LNH · Radiology
• Decision Date: Nov 7, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The MAGNETOM systems described above are indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and / or spectra, and that displays the internal structure and / or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. The MAGNETOM systems described above may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-safe biopsy needles.

Device Story

MAGNETOM systems (Avanto, Espree, Symphony, Trio, Verio) utilize software syngo MR B17 to perform magnetic resonance imaging. Device acquires raw MR signals; transforms signals into transverse, sagittal, coronal, oblique cross-sectional images, or spectroscopic data. Operated by trained clinicians/technicians in clinical settings. Output displayed for physician interpretation to assist in diagnosis of head, body, or extremity structures/functions. Supports interventional procedures via MR-compatible needles/displays. Software update B17 provides improved applications for oncology, neurology, orthopaedics, and cardio-vascular imaging. Benefits include enhanced diagnostic visualization and procedural guidance.

Clinical Evidence

No clinical data provided. Safety and effectiveness established through risk analysis, software verification, and validation testing.

Technological Characteristics

Magnetic resonance diagnostic device; software-based image processing and sequence control. Conforms to international IEC and ISO standards. Connectivity via standard MR system architecture. Software update B17 includes oncology, neurology, orthopaedics, and cardio-vascular imaging sequences.

Indications for Use

Indicated for patients requiring diagnostic MR imaging of head, body, or extremities; produces cross-sectional images, spectroscopic images, and derived physical parameters; supports interventional procedures using MR-compatible devices. No specific age or gender contraindications listed beyond standard MR safety precautions.

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 Verio (K072237)
• MAGNETOM Systems - I and T-class releases (K062454)

Submission Summary (Full Text)

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## 5 510(k) Summary NOV - 7 2008

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92.

## I. General Information

| Establishment | Siemens Medical Solutions. Inc.<br>51 Valley Stream Parkway<br>Malvern. PA 19355 |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration Number | 2240869 |
| Manufacturer | Siemens AG.<br>Henkestrasse 127<br>D-91052 Erlangen. Germany |
| Registration Number | 8010024 |
| Contact Person | Elizabeth Lazaro<br>Regulatory Technical Specialist.<br>51 Valley Stream Parkway<br>Malvern, PA 19355<br>Phone: [phone]<br>Fax: [phone] |
| Device Name | |
| Trade name | MAGNETOM Systems with software syngo MR B1 |
| Classification Name | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| Regulation number: | 21 CFR § 892.1000 |
| Device Class: | II |
| Product Code: | LNH |

## Summary Device Description

The software update syngo MR B17 offers additional and improved applications for MAGNETOM Systems. It includes sequences and image processing functions for oncology, neurology, orthopaedics and cardio-vascular imaging.

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II. Safety and Effectiveness Information Supporting Substantial Equivalence.

MAGNETOM Systems:

MAGNETOM Avanto MAGNETOM Espree MAGNETOM Symphony a Tim System MAGNETOM Trio a Tim System MAGNETOM Verio

with software syngo MR B17

### Intended Use

The MAGNETOM systems described above are indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and / or spectra, and that displays the internal structure and / or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The MAGNETOM systems described above may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-safe biopsy needles

### Performance Standards

None established under Section 514 the Food. Drug. and Cosmetic Act.

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## Substantial Equivalence

Siemens believes that the MAGNETOM systems with software syngo MR B17 are substantially equivalent to the following cleared medical devices:

| Predicate<br>Device Name | Predicate<br>Software Name | FDA Clearance<br>Number | FDA Clearance<br>Date |
|-------------------------------------------------|----------------------------|-------------------------|-----------------------|
| MAGNETOM<br>Verio | software syngo MR<br>B15V | K072237 | Oct 10, 2007 |
| MAGNETOM<br>Systems - I and<br>T-class releases | software syngo MR<br>B15 | K062454 | Nov 3, 2006 |

## General Safety and Effectiveness Concerns:

The introduction of the MAGNETOM systems with software syngo MR B17 has no significant concerns of safety and efficacy.

Siemens is adding a software upgrade to the currently available MAGNETOM Systems. The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device.

Risk management is ensured via Risk Analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing.

The MAGNETOM Systems with software syngo MR B17 will conform to the measurement of safety and performance parameters to the international IEC and ISO standards, where applicable.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or birds in flight, representing the department's mission to protect and promote the health and well-being of Americans.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Elizabeth Lazaro Regulatory Technical Specialist Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway MALVERN PA 19533

Re: K082427

Trade/Device Name: Magnetom Systems: Magnetom Avanto, Magnetom Espree, Magnetom Symphony a Tim System, Magnetom Trio a Tim System and Magnetom Verio with software Syngo MR B17

Regulation Number: 21 CFR 892,1000

Regulation Name: Magnetic resonance diagnostic device

· Regulatory Class: II

Product Code: LNH

Dated: August 22, 2008

Received: August 22, 2008

#### Dear Ms. Lazaro:

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.

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.

**NOV - 7 200**

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#### Page 2

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); 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) 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|----------------|---------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

hope M. Zhang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K082427

Magnetom Systems:

MAGNETOM Avanto MAGNETOM Espree MAGNETOM Symphony a Tim System MAGNETOM Trio a Tim System MAGNETOM Verio with software syngo MR B17

#### Indications for Use:

The MAGNETOM systems described above are indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The MAGNETOM systems described above may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR-safe biopsy needles.

Prescription Use
(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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Helu Remu
(Division Sign-Off)

Division of Reproductive, Abdominal Radiological Devices 510(k) Number

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