SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO by SIEMENS MEDICAL SOLUTIONS, INC.

The MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A 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 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 software syngo MR D13A is the latest software version for four Siemens MR scanners: MAGNETOM Aera (1.5T), Skyra (3T), Avanto (1.5T), and Verio (3T). New scanners will be manufactured with this software version; existing scanners can be upgraded to this software version. The new software version includes new software sequences, applications, coils and other hardware for the four MAGNETOM scanners. While some new features (hardware and software) are only available for certain scanners (of the four listed), the basic syngo MR D13A software will run on each of the four MAGNETOM systems.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the device, based on the requested information.

It's important to note that the provided text is a 510(k) Summary for a software update to an existing Magnetic Resonance Diagnostic Device (MRDD). The focus of this type of submission is to demonstrate substantial equivalence to previously cleared predicate devices, rather than establishing de novo performance for an entirely new device. Therefore, the "acceptance criteria" and "study" described are primarily focused on verification and validation of the new software features and hardware components against established performance expectations for MRDDs, rather than a clinical effectiveness study to prove diagnostic accuracy from scratch.

Acceptance Criteria and Device Performance for Software syngo MR D13A

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category (Derived)	Reported Device Performance / Assessment
Device Performance (Coils)	Tested for SNR, image uniformity, and heating. Results demonstrate performance as intended.
Device Performance (Magnet)	Tested for SNR, geometric distortion, image uniformity, and slice profile/thickness/spacing. Results demonstrate performance as intended.
MP2RAGE Sequence	Dedicated phantom testing conducted. Results demonstrate performance as intended.
MNO Spectroscopy	Performance parameters phantom-tested. Results demonstrate performance as intended.
syngo ASL 3D	Tested using a dedicated phantom. Results demonstrate performance as intended.
MR Elastography	Tested using a dedicated phantom. Results demonstrate performance as intended.
T1 mapping with B1 correction	Phantom-tested. Results demonstrate performance as intended.
All Software Features (General)	Verified and validated. Results demonstrate performance as intended.
Substantial Equivalence	Demonstrated through comparison to legally marketed predicate devices. No new issues of safety or effectiveness introduced.
Safety and Effectiveness	Risk analysis (ISO 14971:2007), adherence to industry standards (IEC 60601-1 series), and conformity to FDA recognized/international standards (IEC, ISO, NEMA) for MR FDA Guidance.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated in terms of patient or image count. The testing involved various phantom studies.
Data Provenance: The testing appears to be primarily laboratory-based using phantoms. The document does not specify country of origin for any human data (as "clinical tests" were not conducted to support substantial equivalence). Clinical images were provided "to support the new coils as well as the new and modified software features," suggesting these were likely retrospective images acquired during routine clinical practice or for specific development purposes, but their source and specific sample size are not detailed.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The document globally refers to "trained physicians" interpreting images and/or spectra as part of the intended use, but this is not about establishing ground truth for the device's technical performance tests. For the nonclinical tests described, the "ground truth" would be established by engineering and physics measurements against design specifications and predicate device performance, not by clinical experts.

4. Adjudication Method for the Test Set

Not applicable/explicitly stated. The nonclinical tests relied on direct measurements and comparisons to engineering specifications and predicate device performance, not on subjective human adjudication of diagnostic outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states: "There were not any 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." This indicates that no MRMC study to assess human reader improvement with or without AI assistance was performed. The device is a software update to an MR scanner, not an AI-assisted diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in spirit. The described "nonclinical tests" are essentially standalone performance evaluations of the software sequences, hardware components (coils, magnet), and specific applications (MP2RAGE, MNO Spectroscopy, syngo ASL 3D, MR Elastography, T1 mapping). These tests assess the device's technical specifications and capabilities independently of human interpretation of diagnostic findings, ensuring the MR system, with the new software, generates high-quality images and data as intended.

7. The Type of Ground Truth Used

Technical/Physical Ground Truth: For the nonclinical tests (SNR, image uniformity, geometric distortion, slice profile, heating, etc.), the ground truth was established by objective physical measurements, comparison to established engineering specifications, and performance expected of predicate MR systems. For specific phantom tests, the phantom's known physical properties served as the ground truth.

8. The Sample Size for the Training Set

Not applicable/explicitly stated. The device is a software update for an MR scanner, not a machine learning or AI algorithm that typically requires a distinct "training set" of data in the same way. The software functionality would have been developed and tested iteratively, but the concept of a "training set" as understood in AI/ML contexts does not directly apply here.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As a software update for an MR scanner rather than an AI/ML diagnostic tool, a dedicated "training set" with established ground truth in the typical sense is not used. Software development and verification would involve internal testing against known specifications and desired outcomes during the development cycle.

Summary

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September 28, 2012

121434

510(k) Summary

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

General Information

Establishment	Siemens Medical Solutions USA, Inc.51 Valley Stream ParkwayMail Code D02Malvern, PA 19355, USARegistration Number 2240869	NOV	5	2012
Manufacturer	Siemens AGHenkestrasse 127D-91052 Erlangen, GermanyRegistration Number 8010024
	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. Michelle L. ByrneRegulatory Affairs Technical SpecialistSiemens Medical Solutions USA, Inc.51 Valley Stream ParkwayMail Code D02Malvern, PA 19355, USAPhone: (610) 448-4293Fax: (610) 448-1787E-mail: Michelle.L.Byrne@siemens.com
Device Name	Software syngo MR D13A for theMAGNETOM systems Aera/Skyra/Avanto/Verio
CFR Code	21 CFR § 892.1000
Classification	Class II
Product Codes	LNH, LNI, MOS
	Classification NameMagnetic Resonance Diagnostic Device, MRSpectroscopy, MR Coils

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Information Supporting Substantial Equivalence

DEVICE DESCRIPTION

Summary of New Features with syngo MR D13A:

Software

. New sequences for all four systems for body, neurological, abdominal, orthopedic, and cardiac imaging, and for spectroscopy
New or modified applications/software for all four systems: .
- Dot Engine improvements o
- Image processing and visualization improvements o
- o Mapping improvements
- Improved iPAT o
- Networked Scanner improvements 0
Dot Engines now available for MAGNETOM Avanto & Verio (previously for . Aera & Skyra with software syngo MR D11)
New Dot Engines for MAGNETOM Aera & Skyra .
Multi Nuclear Option now available for MAGNETOM Skyra (previously for . Avanto & Verio with software syngo MR B17)

Hardware

New coils for Aera & Skyra only: .
- o TxRx CP Head Coil
- o TxRx 15ch Knee Coil
- o 4 Channel Special Purpose Coil
New coils for Avanto & Verio only: .
- Sentinelle Vanguard Breast 16ch Coil o
- o Sentinelle Endo Array coil
. Modified Magnet, Skyra only

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INTENDED USE

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.

NONCLINICAL TESTS

The following performance testing was conducted on the subject device:

The coils were tested for SNR, image uniformity, and heating. .
The magnet was tested for SNR, geometric distortion, image uniformity . and slice profile/thickness/spacing.
Dedicated phantom testing was conducted on the MP2RAGE sequence. .
The performance parameters of MNO Spectroscopy were phantom-. tested.
syngo ASL 3D was tested using a dedicated phantom. .
MR Elastography was tested using a dedicated phantom. .
T1 mapping with B1 correction was phantom-tested. .
All 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

There were not any 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.

SUBSTANTIAL EQUIVALENCE

Software syngo MR D13A for the MAGNETOM systems Aera/Skyra/Avanto/Verio is substantially equivalent to the following predicate devices:

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September 28, 2012

	Predicate Device Name	Manufacturer	510(k)Number	FDA ClearanceDate
1	MAGNETOM Aera &MAGNETOM Skyra withsyngo® MR D11	SiemensMedicalSolutions	K111242	November 23, 2011
2	MAGNETOM Avanto &MAGNETOM Verio withsyngo® MR.B17	SiemensMedicalSolutions	K082427	November 7, 2008
3	MR-Touch	GE MedicalSystems LLC	K083421	July 24, 2009
4	3D ASL	GE MedicalSystems LLC.	K092925	January 6, 2010
5	TxRx 1.5T & 3T 15chKnee Coils	QualityElectrodynamics(QED)	K082636	September 25,2008
6	TxRx 1.5T & 3T CP HeadCoils	QualityElectrodynamics(QED)	K091114	May 1, 2009
7	Sentinelle Endo Coil	SentinelleMedical Inc	K103274	August 18, 2011
8	Sentinelle 16ch BreastCoil	SentinelleMedical Inc	K112112	August 25, 2011

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 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 MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A conform to the applicable FDA recognized and international IEC, ISO and NEMA standards with regards to performance and safety as recommended by the respective MR FDA Guidance Document.

SUBSTANTIAL EQUIVALENCE CONCLUSION

There are no changes to the Indications for Use for the subject device, compared to that of the predicate MAGNETOM scanners with software syngo MR D11 and syngo MR B17. The differences between the subject device and the predicate

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September 28, 2012

devices, which include the aforementioned new sequences, applications, coils, and hardware, give the systems greater capabilities than the predicate devices, but have the same technological characteristics as the predicate devices, are similar to the functionalities of the predicate devices, and do not introduce any new issues of safety or effectiveness.

Therefore, Siemens believes that the subject device, software version syngo MR D13A for MAGNETOM systems Aera, Skyra, Avanto, and Verio, is substantially equivalent to the predicate devices listed above.

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Image /page/5/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus features a staff with a snake winding around it, and the overall design is simple and bold.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Ms. Michelle L. Byrne Regulatory Affairs Technical Specialist Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway, D-02 MALVERN PA 19355

Re: K121434

Trade/Device Name: Software syngo MR D13A for the MAGNETOM systems Aera/Skyra/Avanto/Verio

Regulation Number: 21 CFR 892.1000

Regulation Name: Magnetic resonance diagnostic device

Regulatory Class: II

Product Code: LNH, LNI, and MOS

Dated: October 10, 2012

Received: October 11, 2012

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 (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industrv/support/index.html.

Sincerely Yours,

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 Section 4 Statement

510(k) Number (if known)

Software syngo MR D13A for the Device Names: MAGNETOM systems Aera/Skyra/Avanto/Verio

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.

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 IF NEEDED)

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

Aland D. Oken

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

510(k) K121434

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Software syngo MR D13A for the MAGNETOM systems Aera/Skyra/Avanto/Verio

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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.