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 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).

AI/ML Overview

This FDA 510(k) summary describes a new software version (syngo MR E11A) for existing Siemens MAGNETOM Aera and MAGNETOM Skyra MRI systems. The primary focus of the document is to demonstrate substantial equivalence to previous versions and other cleared devices, rather than establishing new acceptance criteria for a novel device.

Therefore, the requested information regarding acceptance criteria, device performance, and specific study details (like sample size for test sets, expert qualifications, and adjudication methods) is largely not present for the overall system or its new features as this is an equivalence submission. The closest equivalent to "acceptance criteria" are the results of performance tests demonstrating the device performs as intended and is "substantially equivalent."

However, I can extract the available information regarding testing for the new features:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Test	Acceptance Criteria (Implied)	Reported Device Performance
New Coils	Perform as intended with appropriate SNR, image uniformity, and heating levels.	Tested for SNR, image uniformity, and heating. The results demonstrated the device performs as intended.
New/Modified Sequences & Algorithms	Perform as intended; maintain or improve image quality compared to predicate features.	Dedicated phantom testing conducted. Image quality assessments completed. In some cases, image quality was compared. The results demonstrated the device performs as intended.
Quiet Sequences	Meet specified acoustic noise levels.	Acoustic noise measurements performed. The results demonstrated the device performs as intended.
LiverLab (non-invasive liver evaluation)	Functional and accurate, potentially comparable to existing methods.	Validated with volunteer and phantom scans, and synthetic raw data. The results demonstrated the device performs as intended.
MyoMaps (myocardial MR relaxation times)	Functional and accurate.	Tested on volunteers after ECGs were applied. Compared to Thalassaemia Tools in a 100-person study. The results demonstrated the device performs as intended.
All other software features	Verified and validated as functional and safe.	Verified and validated. The results demonstrated the device performs as intended.
Overall System Compliance	Conform to relevant standards (IEC 62304:2006, IEC, NEMA, ISO 14971:2007).	Conforms to IEC 62304:2006, IEC, NEMA standards. Risk management in compliance with ISO 14971:2007.

2. Sample size used for the test set and the data provenance

MyoMaps Comparison Study:
- Sample Size: 100 persons.
- Data Provenance: Not specified, but involved "volunteers."
LiverLab Validation:
- Sample Size: Not specified beyond "volunteer" and "phantom scans."
- Data Provenance: Not specified, beyond "volunteer" and "phantom scans" and "synthetic raw data."
New Coils, Sequences, Algorithms, Acoustic Noise: Sample sizes not specified; phantom testing mentioned.
Clinical tests (overall device): No clinical tests were conducted to support the substantial equivalence argument beyond the provision of clinical images to support new coils and software features.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The document states that the images and spectra, "when interpreted by a trained physician, yield information that may assist in diagnosis." However, for validation studies, the specifics of expert involvement or ground truth establishment are not detailed.

4. Adjudication method for the test set

This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A MRMC study comparing human readers with and without AI assistance was not mentioned or performed as part of this submission. The "MyoMaps" feature was compared to "Thalassaemia Tools," which is a comparison of two tools, not a human-AI comparison.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

The document describes "LiverLab" validation using "volunteer as well as phantom scans, and synthetic raw data" and "MyoMaps" being "tested on volunteers." This suggests standalone performance evaluation for these specific features. However, detailed metrics of standalone performance are not provided, only that the "results... demonstrate that the device performs as intended."

7. The type of ground truth used

MyoMaps: The comparison was against "Thalassaemia Tools." For the "volunteers" testing, the method of establishing ground truth for myocardial MR relaxation times beyond direct measurement is not specified.
LiverLab: Validation involved "volunteer as well as phantom scans, and synthetic raw data." The ground truth for phantom scans would be known parameters. For volunteer scans, the ground truth source for liver evaluation is not explicitly stated (e.g., biopsy results, clinical diagnosis).
For other features (coils, sequences), the ground truth generally relies on physical measurements and expected image properties.

8. The sample size for the training set

This information is not provided in the document. The submission focuses on verification and validation of implemented features rather than detailing the development or training of algorithms.

9. How the ground truth for the training set was established

This information is not provided in the document. Given that details on a training set are absent, the method for establishing its ground truth is also not mentioned.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles forming the staff and a ribbon-like shape representing the snake.

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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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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.51 Valley Stream ParkwayMail Code D02Malvern, PA 19355, USA
Registration Number	2240869
Date Prepared	October 31, 2014
Manufacturer	Siemens AGHenkestrasse 127D-91052 Erlangen, GermanyRegistration Number: 3002808157
SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.Siemens MRI CenterHi-Tech Industrial park (middle)Gaoxin C. Ave., 2ndShenzhen 518057, P.R. CHINARegistration Number: 3004754211
Contact Person	Ms. Nadia SookdeoRegulatory Affairs Technical SpecialistSiemens HealthcareSiemens Medical Solutions USA, Inc.Customer Solutions Group51 Valley Stream ParkwayMail Code D02Malvern, PA 19355, USAPhone: (610) 448-4918Fax: (610) 448-1787
Device Name	Software syngo MR E11A for the MAGNETOM systems Aera/Skyra
Trade Names:	MAGNETOM AeraMAGNETOM 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	FDANumber and Date	Clearance	Productcode	Manufacturer
syngo MR D13A for theMAGNETOM systemsAera/Skyra(/Avanto/Verio)	K121434, clearedNovember 05, 2012		LNHLNI,MOS	Siemens AG

Reference Devices

Thalassaemia Tools cleared with K073194 on February 14, 2008

Product	FDAClearanceNumber and Date	Productcode	Manufacturer
syngo MR D13A for theMAGNETOM systemsAera/Skyra(/Avanto/Verio)	K121434, clearedNovember 05, 2012	LNHLNI,MOS	Siemens AG
Tim TX True Shape and syngoMR D13C for MAGNETOMSkyra	K123510 cleared May17, 2013	LNH	Siemens AG
Software update syngo MRD13A-AP-AA to syngo MR D13Afor MAGNETOM Aera/Skyra	K132831 clearedNovember 01, 2013	LNHLNI,MOS	Siemens AG
MAGNETOM Aera/Skyra, syngoMR D13A with additional localcoils	K133435 clearedDecember 12, 2013	LNH	Siemens AG
Thalassaemia Tools	K073194 cleared onFebruary 14, 2008	LLZ	CardiovascularImaging SolutionsLtd.
syngo.MR Neurology	K121459 cleared June22, 2012	LLZ,LNH	Siemens AG
syngo BreVis	K090038 cleared April29, 2009	LNH	Siemens AG
"MAGNETOM Artis CombiSuite" for the MAGNETOMsystems Aera/Skyra	K140253 clearedMarch 20, 2014	LNH,MOS	Siemens AG
MAGNETOM Spectra	K121160 cleared July16, 2012	LNH,LNI,MOS	Siemens ShenzhenMagneticResonance Ltd.

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Product	FDANumber and Date	Product code	Manufacturer
MAGNETOM Aera with syngoMR D13E	K132951 clearedNovember 15, 2013	LNH	Siemens AG
Pediatric 16, a 1.5T Tim Coil/Pediatric 16 a 3T Tim Coil forAera/Skyra with syngo MRE11A	K140998 cleared July11, 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

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.

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 ClearanceNumber and Date	Productcode	Manufacturer
syngo MR D13A for theMAGNETOM systemsAera/Skyra(/Avanto/Verio)	K121434, clearedNovember 05, 2012	LNHLNI, 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).

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
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).(b)
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.