MAGNETOM SYSTEMS - I-CLASS AND T-CLASS RELEASES

K062454 · Siemens Medi Cal Solutions, Inc. · LNH · Nov 3, 2006 · Radiology

Device Facts

• Record ID: K062454
• Device Name: MAGNETOM SYSTEMS - I-CLASS AND T-CLASS RELEASES
• Applicant: Siemens Medi Cal Solutions, Inc.
• Product Code: LNH · Radiology
• Decision Date: Nov 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The MAGNETOM Systems - I-class and T-class releases are indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. These images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis. They may also be used for imaging during interventional procedures performed with MR compatible devices such as, in room display and safe biopsy needles.

Device Story

MAGNETOM Systems (I-class and T-class) are MRI diagnostic devices utilizing syngo MR B15 software/hardware. Systems acquire transverse, sagittal, coronal, and oblique cross-sectional images and spectroscopic data; display internal structure/function of head, body, or extremities. Operated by trained clinicians in clinical settings; used for diagnostic imaging and interventional procedures (e.g., biopsy). Output interpreted by physicians to assist in clinical diagnosis. Device provides structural/functional visualization; aids in procedural guidance. Safety managed via risk analysis, verification, and validation testing.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, risk analysis, and verification/validation of the software and hardware upgrade.

Technological Characteristics

Magnetic resonance diagnostic device (MRDD). Software/hardware upgrade (syngo MR B15). Conforms to FDA-recognized NEMA standards for performance/safety and international IEC standards for MRI safety. Connectivity includes standard MR imaging interfaces.

Indications for Use

Indicated for patients requiring magnetic resonance imaging (MRI) or spectroscopy of the head, body, or extremities for diagnostic purposes. Includes use during interventional procedures with MR-compatible devices. No specific age or gender contraindications provided.

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 Avanto (K032428)
• MAGNETOM Espree (K041112)
• MAGNETOM Symphony a Tim System (K050199)
• MAGNETOM Trio a Tim System (K050200)

Reference Devices

• syngo MR 2006A (K052164)

Submission Summary (Full Text)

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Section 1: 510(k) Summary

## 510(k) Summary Section 1:

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. Bereich Med<br>Henkestrasse 127<br>D-91052 Erlangen. Germany |
| Registration Number | 8010024 |
| Contact Person | Ms. Judy Campbell<br>Technical Specialist, Regulatory Submissions<br>51 Valley Stream Parkway<br>Malvern. PA 19355<br>Phone: [phone]<br>Fax: [phone] |
| Device Name | Trade Name:<br>MAGNETOM Systems -- I-class and T-class releases |
| Classification Name: | Magnetic Resonance Diagnostic Device |
| CFR Section: | 21 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.

## Intended Use

The MAGNETOM Systems - I-class and T-class releases are indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. These images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis.

They may also be used for imaging during interventional procedures performed with MR compatible devices such as, in room display and safe biopsy needles.

The MAGNETOM systems -- I-class and T-class releases are based on the syngo MR B15 software upgrade will be available for the following MAGNETOM Family systems:

| System | FDA Clearance<br>Number | FDA Clearance Date |
|-----------------------------------|-------------------------|--------------------|
| MAGNETOM Avanto | K032428 | October 16, 2003 |
| MAGNETOM Espree | K041112 | July 21, 2004 |
| MAGNETOM Symphony a Tim<br>System | K050199 | February 18, 2005 |
| MAGNETOM Trio a Tim System | K050200 | February 28, 2005 |

Siemens Medical Solutions, Inc., intends to offer a software and hardware upgrade syngo MR B15. The indications for use will stay exactly the same, with respect to the previous software versions mentioned in the comparison matrix.

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## Substantial Equivalence

The systems 1.5 T MAGNETOM Avanto, Espree, Symphony a Tim System and the 3 T MAGNETOM Trio a Tim System, I-class and T-class releases with syngo MR B15 are substantially equivalent to the following cleared medical devices:

| System | FDA Clearance<br>Number | FDA Clearance Date |
|-----------------------------------|-------------------------|--------------------|
| MAGNETOM Avanto | K032428 | October 16, 2003 |
| MAGNETOM Espree | K041112 | July 21, 2004 |
| MAGNETOM Symphony a Tim<br>System | K050199 | February 18, 2005 |
| MAGNETOM Trio a Tim System | K050200 | February 28, 2005 |

with software platform syngo MR 2006A that was described in premarket nonification K052164 that received FDA clearance on October 4, 2005.

General Safety and Effectiveness Concerns:

The introduction of the MAGNETOM systems - I-class and T-class releases with syngo MR B15 has no significant effect on the MR safety and performance parameters.

Siemens Medical Solutions is adding an upgrade in software and hardware 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. To minimize electrical and mechanical hazards, Siemens adheres to recognized and established industry practices and standards.

The MAGNETOM Systems will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the international IEC standard for safety issues with Magnetic Resonance Imaging Devices. This will assure that the performance of this device can be considered safe and effective with respect to the currently available MAGNETOM systems.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

NOV -3 2006

Ms. Judith Campbell Technical Specialist, Regulatory Submissions Siemens Medical Solutions, Inc. 51 Valley Stream Parkway MALVERN PA 19355

Re: K062454

> Trade/Device Name: MAGNETOM Systems - I-class and T-class releases Regulation Number: 21 CFR §892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: August 17, 2006 Received: August 22, 2006

Dear Ms. Campbell:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Bocation of the device is substantially equivalent (for the indications for releved above and nave acternment and one icate devices marketed in interstate commerce ass stated in the encreases to the Medical Device Amendments, or to devices that prov to may 20, 1970, and charge with the provisions of the Federal Food, Drug, and Cosmetic nat (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 oontrols provisions ince, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If your device is onastired (600 more) additional controls. Existing major regulations affecting your Apploral), it may of subject of additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/3/Picture/10 description: The image is a circular logo with the text "FDA Centennial" and the years "1906 - 2006". The logo is black and white and has a simple design. The letters "FDA" are prominently displayed in the center of the logo. The word "Centennial" is written below the letters "FDA". The years "1906" and "2006" are written above the letters "FDA".

Protecting and Promoting Public Health

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Page 2 -

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dr. 3 issuates of a basicines with other requirements of the Act that I DA has made a decemination and Joinistered by other Federal agencies. You must of any Federal statutes and regulations and limited to: registration and listing (21 comply with an the Act 3 requirements) and 801); good manufacturing practice requirements as set CFR Part 807), laboling (21 CFR Part 820); and if applicable, the electronic form in the quanty systems (QD) regalation (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 his letter will anow you to oegin manceang your a
premarket notification. The FDA finding of substantial equivalence of your device to a legally premarket hotheadon. The PDA mailing sification 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 If you desire specific arree for your do 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" ATSO, prease note the regulation other general information on your responsibilities under (21CFK Tall 607.77). Tod may obtain offer government
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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices ()ffice of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 3: Indications for Use

## Section 3: Indications for Use Statement

510(K) Number (if known): K062454

Device Name: MAGNETOM Systems – I-Class and T-Class Releases

Indications for Use:

The MAGNETOM Systems -- I-class and T-class releases are indicated for use as magnetic The MAGNE I OM Systems - I-class and 1 chass retuss rensverse, sagittal, coronal and oblique resonance diagnostic devices (MRDD) that s and/or spectra, and that display the internal cross sectional mages, spectronoople hadges, or extremities. These images and/or spectra, structure and/or lunchon of the nead, 6007, or extention that may assist in diagnosis.

They may also be used for imaging during interventional procedures performed with MR They may anso oo ased for thing and safe biopsy and safe biopsy needles.

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

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Concurrepee of CDRH, Office of Device Evaluation

Prescription Use V

Over-The-Counter Use

Siemens 510(k) Premarket Notification Page 12 Shellens From Systems - 1-class and T-class releases with syngo MR B15 noallyn (Division Sign-Off Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.