MAGNETOM AERA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH 24 RF CHANNEL

K141977 · Siemens Medical Solutions USA, Inc. · LNH · Nov 19, 2014 · Radiology

Device Facts

• Record ID: K141977
• Device Name: MAGNETOM AERA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH 24 RF CHANNEL
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LNH · Radiology
• Decision Date: Nov 19, 2014
• 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 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 vield 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 Aera/Skyra are MRI systems using syngo MR E11A software. Inputs include RF signals and magnetic field gradients; system transforms these into cross-sectional images/spectra. New features: LiverLab (non-invasive liver evaluation) and MyoMaps (myocardial relaxation time pixel maps). Dot Cockpit allows workflow customization. Used in clinical settings by trained physicians/technicians. Output displayed on workstation for diagnostic interpretation. Benefits include enhanced diagnostic capabilities for liver and cardiac tissue. System supports interventional procedures via MR-safe needles/displays. Software updates and hardware modifications (e.g., 24-channel configuration) improve performance over predicate.

Clinical Evidence

No clinical trials conducted. Evidence consists of bench testing, phantom scans, and volunteer imaging. MyoMaps validated against Thalassaemia Tools in a 100-person study. LiverLab validated via phantom and synthetic raw data. Image quality assessments performed for all new/modified sequences.

Technological Characteristics

Magnetic resonance diagnostic device. Software syngo MR E11A. Features include LiverLab and MyoMaps applications. Hardware includes new coils and 24-channel configuration for Skyra. Conforms to IEC 62304 (software), IEC 60601-1 (electrical/mechanical safety), and NEMA standards. Risk management per ISO 14971.

Indications for Use

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

• syngo MR D13A for the MAGNETOM systems Aera/Skyra(/Avanto/Verio) (K121434)

Reference Devices

• Thalassaemia Tools (K073194)
• Tim TX True Shape and syngo MR D13C for MAGNETOM Skyra (K123510)
• Software update syngo MR D13A-AP-AA to syngo MR D13A for MAGNETOM Aera/Skyra (K132831)
• MAGNETOM Aera/Skyra, syngo MR D13A with additional local coils (K133435)
• syngo.MR Neurology (K121459)
• syngo BreVis (K090038)
• MAGNETOM Artis Combi Suite for the MAGNETOM systems Aera/Skyra (K140253)
• MAGNETOM Spectra (K121160)
• MAGNETOM Aera with syngo MR D13E (K132951)
• Pediatric 16, a 1.5T Tim Coil/Pediatric 16 a 3T Tim Coil for Aera/Skyra with syngo MR E11A (K140998)

Submission Summary (Full Text)

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

November 19, 2014

Siemens Medical Solutions USA, Inc. % Ms. Nadia Sookdeo Regulatory Affairs Technical Specialist 51 Valley Stream Parkway MALVERN PA 19355

Re: K141977

Trade/Device Name: Software syngo MR E11A for the MAGNETOM systems Aera/Skyra Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, LNI, MOS Dated: October 31, 2014 Received: November 3, 2014

Dear Ms. Sookdeo:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara
for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known)

K141977

Device Name MAGNETOM Aera and MAGNETOM Skyra

#### Indications for Use (Describe)

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 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 vield 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.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

Prescription Use (Part 21 CFR 801 Subpart D)

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

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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 Safe Medical Device Act 1990 and 21 CFR § 807.92.

- I. General Information

| Establishment | Siemens Medical Solutions USA. Inc.<br>51 Valley Stream Parkway<br>Mail Code D02<br>Malvern, PA 19355, USA |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration Number | 2240869 |
| Date Prepared | October 31, 2014 |
| Manufacturer | Siemens AG<br>Henkestrasse 127<br>D-91052 Erlangen, Germany<br>Registration Number: 3002808157 |
| SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.<br>Siemens MRI Center<br>Hi-Tech Industrial park (middle)<br>Gaoxin C. Ave., 2nd<br>Shenzhen 518057, P.R. CHINA<br>Registration Number: 3004754211 | |
| Contact Person | Ms. Nadia Sookdeo<br>Regulatory Affairs Technical Specialist<br>Siemens Healthcare<br>Siemens Medical Solutions USA, Inc.<br>Customer Solutions Group<br>51 Valley Stream Parkway<br>Mail Code D02<br>Malvern, PA 19355, USA<br>Phone: [phone]<br>Fax: [phone] |
| Device Name | Software syngo MR E11A for the MAGNETOM systems Aera/Skyra |
| Trade Names: | MAGNETOM Aera<br>MAGNETOM Skyra |

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| Classification Name: |
|-----------------------|
| Classification Panel: |
| CFR Code: |
| Classification: |
| Product Code: |

Magnetic Resonance Diagnostic Device (MRDD) Radiology 21 CFR § 892.1000 Class II Primary: LNH, Secondary: LNI, MOS

Predicate Device

| Predicate Device Name | FDA<br>Number and Date | Clearance | Product<br>code | Manufacturer |
|------------------------------------------------------------------------|---------------------------------------|-----------|-----------------|--------------|
| syngo MR D13A for the<br>MAGNETOM systems<br>Aera/Skyra(/Avanto/Verio) | K121434, cleared<br>November 05, 2012 | | LNH<br>LNI,MOS | Siemens AG |

Reference Devices

Thalassaemia Tools cleared with K073194 on February 14, 2008

| Product | FDA<br>Clearance<br>Number and Date | Product<br>code | Manufacturer |
|------------------------------------------------------------------------------------|-----------------------------------------|-----------------|------------------------------------------------|
| syngo MR D13A for the<br>MAGNETOM systems<br>Aera/Skyra(/Avanto/Verio) | K121434, cleared<br>November 05, 2012 | LNH<br>LNI,MOS | Siemens AG |
| Tim TX True Shape and syngo<br>MR D13C for MAGNETOM<br>Skyra | K123510 cleared May<br>17, 2013 | LNH | Siemens AG |
| Software update syngo MR<br>D13A-AP-AA to syngo MR D13A<br>for MAGNETOM Aera/Skyra | K132831 cleared<br>November 01, 2013 | LNH<br>LNI,MOS | Siemens AG |
| MAGNETOM Aera/Skyra, syngo<br>MR D13A with additional local<br>coils | K133435 cleared<br>December 12, 2013 | LNH | Siemens AG |
| Thalassaemia Tools | K073194 cleared on<br>February 14, 2008 | LLZ | Cardiovascular<br>Imaging Solutions<br>Ltd. |
| syngo.MR Neurology | K121459 cleared June<br>22, 2012 | LLZ,<br>LNH | Siemens AG |
| syngo BreVis | K090038 cleared April<br>29, 2009 | LNH | Siemens AG |
| "MAGNETOM Artis Combi<br>Suite" for the MAGNETOM<br>systems Aera/Skyra | K140253 cleared<br>March 20, 2014 | LNH,<br>MOS | Siemens AG |
| MAGNETOM Spectra | K121160 cleared July<br>16, 2012 | LNH,<br>LNI,MOS | Siemens Shenzhen<br>Magnetic<br>Resonance Ltd. |

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| Product | FDA<br>Number and Date | Product code | Manufacturer |
|------------------------------------------------------------------------------------------------------|--------------------------------------|--------------|--------------|
| MAGNETOM Aera with syngo<br>MR D13E | K132951 cleared<br>November 15, 2013 | LNH | Siemens AG |
| Pediatric 16, a 1.5T Tim Coil/<br>Pediatric 16 a 3T Tim Coil for<br>Aera/Skyra with syngo MR<br>E11A | K140998 cleared July<br>11, 2014 | MOS | QED |

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II. Safety and Effectiveness Information Supporting Substantial Equivalence

#### Intended Use

The MAGNETOM systems [MAGNETOM Aera and MAGNETOM Skyra] 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 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 Description

The subject device, software syngo MR E11A for MAGNETOM Aera and MAGNETOM Skyra offers two new applications, LiverLab (an application of non-invasive liver evaluation) and MyoMaps (an application designed to provide a means to generate pixel maps for myocardial MR relaxation times). In addition, software syngo MR E11A makes the Dot Cockpit available for the user to modify and create Siemens Dot Engine workflows in a very intuitive way which supplements some of the support of an application specialist. The software syngo MR E11A also includes new and modified sequences as well as minor modifications of already existing features. In additional coils are offered and some hardware components have been modified.

Siemens Medical Solutions, USA Inc., intends to market MAGNETOM Aera and MAGNETOM Skyra with new software, syngo MR E11A. While syngo MR E11A offers additional capabilities with respect to the predicate device, the MAGNETOM Aera and MAGNETOM Skyra have the same technological characteristics as the predicate device (K121434; Cleared November, 5, 2012).

Furthermore, Siemens Medical Solutions, USA Inc., intends to market a new configuration of the MAGNETOM Skyra with 24 receive channels with software syngo MR E11A.

The MAGNETOM Aera and MAGNETOM Skyra will be offered ex-factory (new production) as well as in-field upgrades for the currently installed MAGNETOM Aera and MAGNETOM Skyra systems. The new MAGNETOM Skyra configuration with 24 receive channels will be offered as an ex-factory option (new production).

#### Technological Characteristics

MAGNETOM Aera/Skyra with syngo MR E11A and the predicate devices are substantially equivalent with regard to acquiring MR images steps/features.

MAGNETOM Aera/Skyra with syngo MR E11A and the predicate devices are substantially equivalent with regard to operational environment, programming language, operating system and performance

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# SIEMENS

MAGNETOM Aera/Skyra with syngo MR E11A and MAGNETOM Aera/Skyra with software syngo MR D13A, conform to the standard for software medical devices (IEC 62304:2006) and IEC as well as NEMA standards.

#### Nonclinical Tests

The following performance testing was conducted on the subject device:

- The coils were tested for SNR, image uniformity, and heating. .
- Dedicated phantom testing was conducted on particular new sequences. .
- . Acoustic noise measurements were performed for quiet sequences
- . Image quality assessments of all new/modified sequences and algorithms, were completed. In some cases a comparison of the image quality was made between the new/modified features and the predicate features.
- Features of LiverLab was validated with volunteer as well as phantom scans, and synthetic . raw data
- . MyoMaps was tested on volunteers after ECG's were applied. MyoMaps was compared to Thalassaemia Tools in a 100 person study
- All other software features were verified and validated. .

The results from each set of tests demonstrate that the device performs as intended and is thus substantially equivalent to the predicate devices to which it has been compared.

#### Clinical Tests

No clinical tests conducted to support the subject device and the substantial equivalence argument, however clinical images were provided to support the new coils as well as the new and modified software features of the subject device.

#### 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.

Risk management is ensured via a risk analysis in compliance with ISO 14971:2007 to identify and provide mitigation to potential hazards in a risk analysis beginning early in the design phase and continuing throughout the development of the product. These risks are controlled via measures realized in software development, SW testing and product labeling. To minimize risks, Siemens adheres to recognized and established industry practices and standards, such as the IEC 60601-1 series, to minimize electrical and mechanical risk. Furthermore, the operators are healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.

#### The MAGNETOM Aera and MAGNETOM Skyra with software syngo MR E11A

conform to the applicable FDA recognized and international IEC, ISO and NEMA standards with reqards to performance and safety as recommended by the respective MR FDA Guidance Document.

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#### Substantial Equivalence

MAGNETOM Aera and MAGNETOM Skyra with software syngo MR E11A are magnetic resonance diagnostic devices that include nearly all of the features of MAGNETOM Aera and MAGNETOM Skyra with syngo MR D13A.

| Predicate Device Name | FDA Clearance<br>Number and Date | Product<br>code | Manufacturer |
|-------------------------------------------------------------------------|---------------------------------------|-----------------|--------------|
| syngo MR D13A for the<br>MAGNETOM systems<br>Aera/Skyra(/Avanto/Verio) | K121434, cleared<br>November 05, 2012 | LNH<br>LNI, MOS | Siemens AG |

#### Conclusion as to Substantial Equivalence

MAGNETOM Aera and MAGNETOM Skyra with software syngo MR E11A have

the same intended use and the same basic technical characteristics as the

predecessor devices, MAGNETOM Aera and MAGNETOM Skyra with syngo MR D13A, with respect to the magnetic resonance features and functionalities. MAGNETOM Aera/Skyra with software syngo MR E11A will be used for acquiring MR imaqes (transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra). The predicate devices, MAGNETOM Aera/Skyra with software syngo MR D13A, are also capable of acquiring MR images (transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra).

The differences between the subject device and the predicate device, which include the aforementioned new and modified software and hardware features (mainly software), give the subject device greater capabilities than the predicate device. While there are some technological characteristics which vary with respect to the predicate device, the conclusions from the nonclinical data suggest that the features (of different technological characteristics with respect to the predicate device) bear an equivalent safety and performance profile as that of the predicate and reference devices.

MAGNETOM Aera/Skyra with software syngo MR E11A is similar to the functionalities of the predicate and reference devices, and does not introduce any new issues of safety or effectiveness. Therefore, Siemens is of the opinion that MAGNETOM Aera/Skyra with syngo MR E11A does not raise new questions of safety or effectiveness and is substantially equivalent to the currently marketed device MAGNETOM Aera/ Skyra with software syngo MR D13A (K121434 cleared on November 5, 2012).