The Siemens MR-PET system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.

These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders.

The MR is intended to produce transverse, sagittal, coronal and oblique crossectional MR images, spectroscopic inages and/or spectra, and displays the internal structure and/or function of the human body. Other physical parameters derived from the images and or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their labeling. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MR safe biopsy needles.

The PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.

The combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fised PET and MR images due to precisely aligned MR and PET image coordinate systems.

Device Description

The subject device, syngo MR E11P system software, is being introduced for the Biograph mMR system.

The syngo MR E11P SW includes new sequences, new features and minor modifications of already existing features. A high level summary of the new sequences and features is included below.

Migrated sequences and features from the previously cleared secondary predicate devices MAGNETOM Verio with syngo MR D13A and Siemens E-line Software with MAGNETOM Skyra with syngo MR E11C (K153343) are not described separately as these are commercially available and no changes are introduced for this system.

Improvement in Attenuation Correction
Atlas-based bones in u-map generation
The bone attenuation map is computed based on a reqular 4-compartment (air, lung, fat, water) segmentation from a Dixon sequence. As improvement, the bone information is added to these u-maps with a model-based bone segmentation algorithm using continuous linear attenuation coefficients (LACs) for bone to represent the variation in cortical bone density in different anatomical areas.

The model consists of the most relevant bones in the body torso in terms of overall attenuation. It consists of the skull, spine, pelvis and femur bone as individual components.

MR based FoV extension for attenuation correction - (HUGE)
In this SW version syngo MR E11P the attenuation map can be improved by using an optional MR-based FoV extension technique. This technique requires an additional MR measurement optimized for distortion reduced acquisition of the patient's arms resting along the body at the edge of the FoV.

New and Modified Features
Multimodal (Elastic) Motion Correction (BodyCOMPASS)
Elastic motion correction is introduced to reduce the effect of blur induced by respiratory motion during a PET acquisition. As a basic principle, periodic motion information is collected by means of the MR as a 4D image series and used for PET to

. bin the PET counts into separate respiratory states
provide a mapping for each spatial position and each respiratory state to a . reference state, which can be used in the PET reconstruction

Hence, the resulting PET image combines the advantages of a gated PET image with reduced motion blur while preserving the signal-to-noise ratio of static non-gated reconstruction.

Improvement in DIXON fat water separation
In this SW version syngo MR E11P the DIXON reconstruction technique (fat/water separation) is improved. The improved algorithm is based on global optimization and thus minimizes the probability of local fat/water swaps where part of water image is wrongly assigned to fat image and/or vice versa.

Dot Cockpit (DotGO), including PET Workflow
The previously cleared DotGO with the Dot Cockpit and the MR only Dot Engines is now available on the Biograph mMR with syngo MR E11P. The configuration of PET workflows is now integrated into the Dot Cockpit for higher productivity.

This modification increases the robustness and usability for the clinical workflow with the new PET Planning Group. PET Planning Step and special reduced MR Parameter cards while still offering the full parameter access with detail views, PET and AC specific steps with their parameter cards.

Improved MR PET Workflow
With the software syngo MR E11P a set of protocols are included in order to run a clinical whole body workflow with 5 beds, AC, T1-, T2-, DWI-contrast, adjustments and SAR pauses in 45 minutes.

In this workflow the AC protocol is acquired in high resolution (1.3 mm * 1.3mm in plane) using CAIPIRINHA acceleration. Alternatively, an AC protocol in conventional resolution (2.6 mm * 2.6 mm in plane) using CAIPIRINHA acceleration is available in order to reduce the acquisition time for AC measurement in case T1-contrast is not requested from AC scan.

Other Software Improvements
NEMA NU 2:2012
As it is possible that routine NEMA testing may be required to retain ACR accreditation, Siemens has developed an optional software package which enables a Biograph mMR system user to quantify image quality for certain performances according to the most recent available NEMA standards.

Improvements in Retro Recon Task Card
In the RetroRecon Task Card of the Biograph mMR with syngo MR E11P, an additional identifier in the list of the parameter Attenuation Correction indicates gated u-Maps.

Furthermore a Tooltip for the Attenuation Correction parameter explains the identifier.

For respiratory gating a new Respiratory Curve Display shows the recorded cushion signal as well as the specified gates for some gating types.

Third Party Interface for AC
An Interface functionality is added to the synqo MR E11P software to import attenuation maps of third party components for hardware attenuation correction.

Other Modifications
Front Cover Panel Refresh for Biograph mMR
The Biograph mMR with syngo MR E11P will receive new system covers. The graphic design of the cover has been changed to give the systems an updated and more modern look to highlight the introduction of a new software version.

MaRS - technology for Biograph mMR
The modified control system of the Biograph mMR integrates the functions of the AMC (Advanced Measurement Control) and MRIR (MR Image Reconstructor) into one computer called MaRS (Measurement and Reconstruction System).

The MaRS system performs sequence control and image reconstruction without additional MRIR. The introduction of the MaRS was part of the secondary predicate device MAGNETOM Verio with syngo MR D13A (K121434). This is now updated to new computer hardware with this submission.

Physiological Monitoring Unit (PMU)
The Physiological Measurement Unit (PMU) was modified to improve the accuracy of triggers on the respiration signal. The PMU provides ECG, respiration and peripheral pulse as well as external trigger input to control of the MR imaging sequences for synchronization.

Syngo MR Software Features
Other features were included unchanged from the secondary predicate devices (K121434 and K153343). These features expand the Biograph mMR's MR scanning capabilities and update the feature set to be more similar to currently released Siemens MR software.

AI/ML Overview

Acceptance Criteria and Device Performance for Biograph mMR with syngo MR E11P system software (K163234)

Based on the provided FDA 510(k) summary, the acceptance criteria and supporting studies focus on demonstrating that the new syngo MR E11P software for the Biograph mMR system maintains the safety and effectiveness of the predicate device while introducing improvements and new features. The document highlights the substantial equivalence argument, rather than providing explicit numeric acceptance criteria and performance tables for specific clinical tasks. However, we can infer the performance goals and the studies conducted to support them.

1. Table of Acceptance Criteria and Reported Device Performance

As explicit numeric acceptance criteria and a detailed performance table are not provided in the 510(k) summary, the table below represents the implied acceptance criteria (based on the device's intended use and the nature of the modifications) and the general results reported for demonstrating substantial equivalence.

Feature/Area of Improvement	Implied Acceptance Criteria (Performance Goal)	Reported Device Performance (General Results)
New Sequences & Features	Equivalent or improved diagnostic performance compared to predicate in terms of image quality and clinical utility.	Sample clinical images taken for particular new and modified sequences demonstrated performance as intended. Image quality assessments of all new/modified sequences and algorithms were completed with satisfactory results, indicating performance as intended.
Attenuation Correction (Atlas-based bones in u-map generation)	Accurate and reliable bone attenuation maps for PET studies, minimizing artifacts and improving quantitative accuracy compared to previous 4-compartment segmentation.	Quantitative comparison study of attenuation maps of CT-based AC and MR-based AC method for whole-body PET/MR imaging combining Dixon-based soft-tissue segmentation and model-based bone estimation was conducted. While specific metrics are not given, the study supports the substantial equivalence, implying acceptable performance.
Attenuation Correction (MR based FoV extension - HUGE)	Accurate attenuation maps for extended FoV, accommodating patient anatomy (e.g., arms by the body) without truncation artifacts, comparable to established PET-based FoV extension.	Comparison study of an extended MR FoV and truncation correction (HUGE) with truncated data without FoV extension and additionally to an established approach of PET-based FoV extension was performed. The study supports the substantial equivalence, implying acceptable performance and comparable results to the reference.
Quantitative SUV Estimation with MR-based AC	Accurate and consistent SUV estimations using new MR-based AC methods, comparable to reference CT AC.	Quantitative comparison study of SUV estimation for MR-based AC methods to a reference CT AC comparing: standard Dixon 4-compartment segmentation alone, Dixon with a superimposed model-based bone compartment, and Dixon with a superimposed bone compartment and linear attenuation correction optimized specifically for brain tissue was conducted. The study results are cited as supportive of substantial equivalence, indicating acceptable SUV estimation performance for the new methods.
Multimodal (Elastic) Motion Correction (BodyCOMPASS)	Effective reduction of motion blur in PET images while preserving signal-to-noise ratio, improving image quality for diagnosis.	The feature aims to combine advantages of gated PET with reduced motion blur while preserving SNR of static non-gated reconstruction. Clinical images were provided to support substantial equivalence for this new software feature, implying successful demonstration of its intended effect.
Improved DIXON fat water separation	Minimized probability of local fat/water swaps, leading to more accurate and robust fat/water separation.	The improved algorithm is based on global optimization to minimize local fat/water swaps. Clinical images were provided to support substantial equivalence for this new software feature, implying successful demonstration of its intended effect.
General Software Performance (Workflow, Usability, Robustness)	Improved clinical workflow, reduced complexity, increased productivity, and enhanced usability.	The Dot Cockpit (DotGO) with PET workflow integration, improved MR PET workflow, and other software improvements are stated to increase robustness and usability, improve user workflow, and reduce complexity. These are qualitative improvements for which successful implementation and user experience (implied from V&V and clinical images) serve as evidence.
Safety and Compliance	Compliance with recognized medical device standards and risk management requirements.	Software verification and validation testing completed in accordance with FDA guidance. Risk management (ISO 14971:2007) was performed with mitigation measures. Conforms to IEC 62304:2006, IEC, and NEMA standards, as well as the FDA Guidance for MR Diagnostic Devices.

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

Test Set Sample Size: The document does not explicitly state the numerical sample size (e.g., number of patients, cases) for the clinical images used in the comparison studies. It mentions "Sample clinical images were taken for particular new and modified sequences" and "Additionally clinical images were provided to support the substantial equivalence for the new software features of the subject device." The quantitative comparison studies also imply a dataset, but the size is not specified.
Data Provenance: The provenance of the data (country of origin, retrospective/prospective) is not explicitly detailed. The manufacturer is Siemens Healthcare GmbH based in Erlangen, Germany, and Siemens Medical Solutions USA, Inc. is the establishment in the USA. It is common for such validation studies to involve data from internal research or collaborating institutions, but the document does not specify. The nature of "clinical images" and "quantitative comparison studies" suggests real patient data, likely retrospective or a mix, but this is not confirmed.

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 summary. While clinical images and quantitative comparisons were performed, the method of establishing ground truth and the involvement and qualifications of experts for defining "ground truth" are not described. It's likely that in the context of imaging system performance, "ground truth" for image quality and diagnostic accuracy would implicitly rely on expert assessment, but the details are omitted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided in the summary. Without details on expert involvement in ground truth establishment, no adjudication method can be inferred.

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 multi-reader multi-case (MRMC) comparative effectiveness study focusing on the improvement of human readers with AI assistance was not explicitly described in this 510(k) summary. The document describes improvements to the imaging system's software components (e.g., attenuation correction, motion correction, fat/water separation) that likely improve image quality and potentially diagnostic accuracy, but it doesn't quantify reader performance improvement with "AI assistance" in the sense of a decision support system. The listed studies are more focused on the technical performance and quantitative accuracy of the imaging system's outputs.

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

Yes, a form of standalone performance assessment was conducted for many of the technical improvements. The "Nonclinical Tests" section details:

"Image quality assessments of all new/modified sequences and algorithms, were completed."
The "Clinical Tests" section describes "Quantitative comparison study of attenuation maps of CT-based AC and MR-based AC method..." and "Quantitative comparison study of SUV estimation for MR-based AC methods..." These are direct technical evaluations of the algorithm's output (image quality, quantitative accuracy) independent of a human reader's diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The type of ground truth used varies based on the specific study:

For attenuation correction and SUV estimation studies: The ground truth appears to be established by comparison to established methods, specifically "reference CT AC." This implies that CT attenuation maps are considered the gold standard for comparison in these contexts.
For general image quality and new feature performance: The "ground truth" is likely based on visual assessment by experts (implied, though not stated) combined with quantitative metrics relevant to image quality (e.g., minimizing motion blur, reducing fat/water swaps) derived from predefined technical standards or expected outcomes.

8. The sample size for the training set:

This information is not provided in the summary. The document describes modifications and improvements to existing software components and introduces new sequences and features. While these often involve internal development and testing cycles that might use various datasets, specific training set sizes for machine learning components (if any, beyond the "atlas-based bones" model) are not detailed.

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

This information is not provided in the summary. Given the nature of the improvements (e.g., atlas-based bone models, global optimization for Dixon), it's likely that internal reference datasets and expert knowledge were used, but the specifics of their ground truth establishment are not disclosed. For the "atlas-based bones in u-map generation," the "model consists of the most relevant bones in the body torso" which implies a pre-defined anatomical model or a training process that derived this model from a dataset with defined bone attenuation properties. However, details are absent.

Summary

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

February 28, 2017

Siemens Medical Solutions USA, Inc. % Cordell L. Fields, Esq. Regulatory Affairs Specialist 65 Valley Stream Parkway MALVERN PA 19355

Re: K163234

Trade/Device Name: Biograph mMR with syngo MR E11P system software Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: OUO and LNH, LNI, KPS Dated: January 27, 2017 Received: January 30, 2017

Dear Mr. Fields:

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 O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K163234

Device Name

Biograph mMR with syngo MR E11P system software

Indications for Use (Describe)

These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.

FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publishime Services (301) 443-6740 EF

Siemens 510(k) Traditional Premarket Notification

November 15, 2016

syngo MR E11P Software for Siemens Healthcare GmbH MR Systems Biograph mMR

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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.40 Liberty BoulevardMail Code 65-1AMalvern, PA 19355, USARegistration Number: 2240869
Date Prepared	November 15, 2016
Manufacturer	Siemens Healthcare GmbHHenkestrasse 127Erlangen Bayern, Germany 91052Registration Number: 3002808157
Contact Person	Mr. Cordell L. Fields, Esq.Regulatory Affairs Technical SpecialistSiemens Medical Solutions USA, Inc.65 Valley Stream ParkwayMail Code 65-1AMalvern, PA 19355, USAPhone: (610) 448-6469Fax: (610) 640-4481
Device Name:	syngo MR E11P software for Biograph mMR
Trade name:	Biograph mMR with syngo MR E11P system software
Classification Name:	Tomographic Imager Combining Emission ComputedTomography with Nuclear Magnetic Resonance
Classification Panel:	Radiology
Regulation Number:	21 CFR § 892.120021 CFR § 892.1000
Device Class:	II
Primary Product Code:	QUQ

Siemens 510(k) Traditional Premarket Notification

November 15, 2016

syngo MR E11P Software for Siemens Healthcare GmbH MR Systems Biograph mMR

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Secondary Product Codes: LNH. LNI. KPS

II. Safety and Effectiveness Information Supporting Substantial Equivalence

Intended Use

The indications for use for the subject device are the same as the predicate device and are as follows:

The Siemens MR-PET system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.

These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders.

The MR is intended to produce transverse, sagittal, coronal and oblique crosssectional MR images, spectroscopic images and/or spectra, and displays the internal structure and/or function of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their labeling. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MR safe biopsy needles,

The combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.

Device Description

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The subject device, syngo MR E11P system software, is being introduced for the Biograph mMR system.

The syngo MR E11P SW includes new sequences, new features and minor modifications of already existing features. A high level summary of the new sequences and features is included below.

Improvement in Attenuation Correction

Atlas-based bones in u-map generation

The bone attenuation map is computed based on a reqular 4-compartment (air, lung, fat, water) segmentation from a Dixon sequence. As improvement, the bone information is added to these u-maps with a model-based bone segmentation algorithm using continuous linear attenuation coefficients (LACs) for bone to represent the variation in cortical bone density in different anatomical areas.

The model consists of the most relevant bones in the body torso in terms of overall attenuation. It consists of the skull, spine, pelvis and femur bone as individual components.

MR based FoV extension for attenuation correction - (HUGE)

In this SW version syngo MR E11P the attenuation map can be improved by using an optional MR-based FoV extension technique. This technique requires an additional MR measurement optimized for distortion reduced acquisition of the patient's arms resting along the body at the edge of the FoV.

New and Modified Features

Multimodal (Elastic) Motion Correction (BodyCOMPASS)

Elastic motion correction is introduced to reduce the effect of blur induced by respiratory motion during a PET acquisition. As a basic principle, periodic motion information is collected by means of the MR as a 4D image series and used for PET to

. bin the PET counts into separate respiratory states
provide a mapping for each spatial position and each respiratory state to a . reference state, which can be used in the PET reconstruction

Hence, the resulting PET image combines the advantages of a gated PET image with reduced motion blur while preserving the signal-to-noise ratio of static non-gated reconstruction.

Improvement in DIXON fat water separation

Siemens 510(k) Traditional Premarket Notification

November 15, 2016

syngo MR E11P Software for Siemens Healthcare GmbH MR Systems Biograph mMR

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In this SW version syngo MR E11P the DIXON reconstruction technique (fat/water separation) is improved. The improved algorithm is based on global optimization and thus minimizes the probability of local fat/water swaps where part of water image is wrongly assigned to fat image and/or vice versa.

Dot Cockpit (DotGO), including PET Workflow

The previously cleared DotGO with the Dot Cockpit and the MR only Dot Engines is now available on the Biograph mMR with syngo MR E11P. The configuration of PET workflows is now integrated into the Dot Cockpit for higher productivity.

Improved MR PET Workflow

With the software syngo MR E11P a set of protocols are included in order to run a clinical whole body workflow with 5 beds, AC, T1-, T2-, DWI-contrast, adjustments and SAR pauses in 45 minutes.

Other Software Improvements

NEMA NU 2:2012

As it is possible that routine NEMA testing may be required to retain ACR accreditation, Siemens has developed an optional software package which enables a Biograph mMR system user to quantify image quality for certain performances according to the most recent available NEMA standards.

Improvements in Retro Recon Task Card

In the RetroRecon Task Card of the Biograph mMR with syngo MR E11P, an additional identifier in the list of the parameter Attenuation Correction indicates gated u-Maps.

Furthermore a Tooltip for the Attenuation Correction parameter explains the identifier.

For respiratory gating a new Respiratory Curve Display shows the recorded cushion signal as well as the specified gates for some gating types.

Third Party Interface for AC

An Interface functionality is added to the synqo MR E11P software to import attenuation maps of third party components for hardware attenuation correction.

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Other Modifications

Front Cover Panel Refresh for Biograph mMR

The Biograph mMR with syngo MR E11P will receive new system covers. The graphic design of the cover has been changed to give the systems an updated and more modern look to highlight the introduction of a new software version.

MaRS - technology for Biograph mMR

The modified control system of the Biograph mMR integrates the functions of the AMC (Advanced Measurement Control) and MRIR (MR Image Reconstructor) into one computer called MaRS (Measurement and Reconstruction System).

Physiological Monitoring Unit (PMU)

The Physiological Measurement Unit (PMU) was modified to improve the accuracy of triggers on the respiration signal. The PMU provides ECG, respiration and peripheral pulse as well as external trigger input to control of the MR imaging sequences for synchronization.

Syngo MR Software Features

Other features were included unchanged from the secondary predicate devices (K121434 and K153343). These features expand the Biograph mMR's MR scanning capabilities and update the feature set to be more similar to currently released Siemens MR software.

Technological Characteristics

Software syngo MR E11P for Biograph mMR has the same technological characteristics as the primary predicate device Biograph mMR with syngo MR B20P (K133226, cleared November 12, 2013).

The subject device is substantially equivalent to the predicate devices with regard to the operational environment, programming language, operating system and performance.

syngo MR E11P SW conforms to the standard for software medical devices (IEC 62304:2006) and IEC as well as NEMA standards.

While syngo MR E11P SW offers new and modified SW features, the modified SW features with respect to the primary and secondary predicate devices have the same technological characteristics as the predicate device systems. Further, this submission

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includes minor hardware modifications and a cosmetic modification to the front cover panel. These do not represent a change in technological characteristics.

Nonclinical Tests

The following performance testing was conducted on the subject device

Sample clinical images were taken for particular new and modified sequences. ●
Acoustic noise measurements were performed for quiet sequences
o lmage quality assessments of all new/modified sequences and algorithms, were completed.
Software verification and validation testing was completed in accordance with the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"

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

The following studies were conducted to support the substantial equivalence argument:

Comparison study of an extended MR FoV and truncation correction (HUGE) with truncated data without FoV extension and additionally to an established approach of PET-based FoV extension.
. Quantitative comparison study of attenuation maps of CT-based AC and MRbased AC method for whole-body PET/MR imaging combining Dixon-based softtissue segmentation and model-based bone estimation.
. Quantitative comparison study of SUV estimation for MR-based AC methods to a reference CT AC comparing:
- standard Dixon 4-compartment segmentation alone,
- Dixon with a superimposed model-based bone compartment, and
- Dixon with a superimposed bone compartment and linear attenuation correction optimized specifically for brain tissue.

Additionally clinical images were provided to support the substantial equivalence for the new 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.

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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 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 synqo MR E11P software for the Biograph mMR, conforms 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, Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, 1998.

Substantial Equivalence

The subject device, Biograph mMR with syngo MR E11P, was developed from the previous software version VB20P. However, additional software features that were not part of this previous software version will now be migrated into syngo MR E11P. Therefore secondary predicate devices are listed below that support various sequences, software and workflow features as noted above.

Predicate Device Information

Primary Predicate Device	FDA ClearanceNumber	ProductCode	Manufacturer
Biograph mMR withSoftware syngo MR B20P	K133226, clearedNovember 12, 2013	OUO, LNH,LNI, KPS	Siemens AG /Siemens HealthcareGmbH
Secondary Predicate Device	FDA ClearanceNumber	ProductCode	Manufacturer
Software syngo MR D13A for theMAGNETOM Verio	K121434 clearedNovember 5, 2012	LNH, LNI,MOS	Siemens AG /Siemens HealthcareGmbH
Software syngo MR E11C for theMAGNETOM Skyra	K153343, clearedApril 15, 2016	LNH, LNI,MOS	Siemens AG /Siemens HealthcareGmbH

Conclusion as to Substantial Equivalence

syngo MR E11P software for the Biograph mMR has the same intended use and the same technological characteristics as the primary predicate device Biograph mMR with syngo MR B20P (K133226).

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The Biograph mMR is evolving with respect to the MANGETOM Verio with syngo MR D13A (K121434) and Siemens E line Software with MAGNETOM Skyra with syngo MR E11C (K153343). The new features on the Biograph mMR with syngo MR E11P make the system and software more user-friendly. These modifications improve the user's workflow and reduce the complexity of certain imaging procedures; providing additional output, information, and options to the user; and reduce image artifacts,

The differences between the subject device and the predicate devices, include incorporation / adaptation of cleared features from the MAGNETOM Skyra with syngo MR E11C (K153343), the MAGNETOM Verio with syngo MR D13 (K121434), and extensions of syngo MR B20P features (K133226), which give the Biograph mMR svstem better capabilities with respect to the predicate devices, but have the same technological characteristics as the predicate devices, and do not introduce any new issues of safety or effectiveness.

Therefore, Siemens believes that the subject device, Biograph mMR System with software syngo MR E11P is substantially equivalent to the predicate devices, Biograph mMR with syngo MR B20P, the MAGNETOM Verio with syngo MR D13A and MAGNETOM Skyra with syngo MR E11C.

Regulation Number and Section

§ 892.1200 Emission computed tomography system.

(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.