MAGNETOM AERA AND MAGNETOM SKYRA

K111242 · Siemens Medical Solutions USA, Inc. · LNH · Nov 23, 2011 · Radiology

Device Facts

• Record ID: K111242
• Device Name: MAGNETOM AERA AND MAGNETOM SKYRA
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LNH · Radiology
• Decision Date: Nov 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The MAGNETOM Aera and the MAGNETOM Skyra systems 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. Other physical parameters derived from the images and/0r 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 Aera and the MAGNETOM Skyra systems 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 Aera (1.5T) and Skyra (3T) are magnetic resonance diagnostic devices. Systems acquire MR signals to produce cross-sectional images, spectroscopic images, and spectra of head, body, and extremities. Modifications include updated software (syngo MR D11), new imaging sequences, applications, and specialized coils/adapters. Operated by trained clinicians in clinical settings; output interpreted by physicians to assist in diagnosis. Supports interventional procedures using MR-compatible accessories like biopsy needles. Benefits include enhanced diagnostic visualization of internal structures and functions.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, risk analysis, and adherence to recognized international safety and performance standards for MR diagnostic devices.

Technological Characteristics

Magnetic resonance imaging system; 1.5T (Aera) and 3T (Skyra) field strengths. Includes specialized coils and adapters. Software-driven image acquisition and processing. Conforms to IEC 60601-1 series for electrical/mechanical safety and ISO 14971 for risk management. Connectivity via syngo MR D11 software platform.

Indications for Use

Indicated for patients requiring diagnostic magnetic resonance imaging (MRI) or spectroscopy of the head, body, or extremities. Used for structural and functional imaging, including interventional procedures with 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

• Siemens MAGNETOM Aera (1.5T) and MAGNETOM Skyra with syngo® MR D11A (K101347)
• Siemens MAGNETOM Skyra (3T) with syngo® MR D11A (K101347)
• syngo® MR B17 Software update (K082427)
• Siemens MAGNETOM Verio (3T) (K072237)
• Siemens MAGNETOM Espree (1.5T) (K041112)
• Specialty coils for MAGNETOM Aera and MAGNETOM Skyra (K103275)
• Sentinelle Vanguard Breast Coils (K100113)

Submission Summary (Full Text)

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NOV 2 3 2011

KII1242

Section 5 Statement of Conformity | | | | | |

# Section 5 - 510(k) Summary

This 510(k) summary is being submitted in accordance with 21 CFR § 807.92.

## 1.1 General Information

| Establishment | Siemens Medical Solutions USA, Inc.<br>51 Valley Stream Parkway<br>Mail Code D02<br>Malvern, PA 19355, USA<br>Registration Number 2240869 |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Siemens AG<br>Henkestrasse 127<br>D-91052 Erlangen, Germany<br>Registration Number 8010024<br><br>SIEMENS MINDIT MAGNETIC RESONANCE LTD.<br>Siemens MRI Center, Hi-Tech<br>Industrial park (middle)<br>Gaoxin C. Ave., 2nd<br>Shenzhen 518057, P.R. CHINA<br>Registration Number 3004754211 |
| Contact Person | Ms. Michelle L. Byrne<br>Regulatory Affairs Technical Specialist<br>Siemens Medical Solutions USA, Inc.<br>51 Valley Stream Parkway<br>Mail Code D02<br>Malvern, PA 19355, USA<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Device Name | MAGNETOM Aera and MAGNETOM Skyra with<br>syngo MR D11<br><br>Please note: syngo MR D11 is the broad name for the<br>software version; it includes all iterations of the software<br>(i.e. the previously cleared software version |

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Classification Name: CFR Code: Classification: Product Code:

Magnetic Resonance Diagnostic Device 21 CFR § 892.1000 Class II LNH

## 1.2 Safety and Effectiveness Information Supporting Substantial Equivalence

#### Device Description

The software and some of the hardware of the previously cleared MAGNETOM Aera and MAGNETOM Skyra have been modified and updated. The updates enable new options, including sequences, applications, coils and coil adapters, for MAGNETOM Aera and MAGNETOM Skyra.

#### Substantial Equivalence

The modified MAGNETOM Aera and MAGNETOM Skyra are substantially equivalent to the following predicate devices:

| Predicate Device Name | 510(k) Number | FDA Clearance<br>Date |
|---------------------------------------------------------------------------|---------------|-----------------------|
| Siemens MAGNETOM Aera (1.5T)<br>and MAGNETOM Skyra with<br>syngo® MR D11A | K101347 | October 1, 2010 |
| Siemens MAGNETOM Skyra (3T)<br>with syngo® MR D11A | K101347 | October 1, 2010 |
| syngo® MR B17 Software update | K082427 | November 7, 2008 |
| Siemens MAGNETOM Verio (3T) | K072237 | October 10, 2007 |
| Siemens MAGNETOM Espree<br>(1.5T) | K041112 | July 21, 2004 |
| Specialty coils for MAGNETOM<br>Aera and MAGNETOM Skyra | K103275 | January 11, 2011 |
| Sentinelle Vanguard Breast Coils | K100113 | April 22, 2010 |

#### Safety and Effectiveness

The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device.

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Risk Management is ensured via a risk analysis in compliance with ISO 14971:2007 to identify and provide mitigation to potential hazards beginning early in the design cycle and continuing throughout the development of the product. Siemens Medical Solutions USA, Inc. and Siemens AG adhere to recognized and established industry standards, such as the IEC 60601-1 series, to minimize electrical and mechanical hazards.

The modified MAGNETOM Aera and MAGNETOM Skyra conform to the applicable FDA recognized and international IEC, ISO and NEMA standards with regards to performance and safety as required by the respective MR FDA Guidance Document.

#### Intended Use

The MAGNETOM Aera and the MAGNETOM Skyra systems 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.

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 Aera and the MAGNETOM Skyra systems 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.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

NOV 2 3 2011

Ms Mitchelle L. Byrne Regulatory Affairs Technical Specialist Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway, Mail Code D02 MALVERN PA 19355

Re: K111242

Trade/Device Name: MEGNETOM Aera and MAGNETOM Skyra Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: November 17, 2011 Received: November 18, 2011

Dear Ms. Byrne:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Section 4 - Indications for Use Statement

510(k) Number (if known) _K111242_

MAGNETOM Aera and MAGNETOM Skyra Device Names:

#### Indications for Use

The MAGNETOM systems described above 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.

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.

AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Arachnol D'O'Hara

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k<111242

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