(103 days)
No
The document describes image processing algorithms and model-based segmentation, but does not explicitly mention or describe the use of AI or ML techniques.
No
Explanation: The device is described as a diagnostic imaging system used to aid in the detection, localization, and diagnosis of diseases and disorders, not for treating them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is intended "to aid in the detection, localization, and diagnosis of diseases and disorders." Both the MR and PET components are described as providing information for this purpose.
No
The device is described as "syngo MR E11P system software" for the "Biograph mMR system," which is a combined MR-PET system. The description details software features that enhance the functionality of the physical MR and PET hardware, including improvements in attenuation correction, motion correction, and workflow. It also mentions modifications to the physical system covers and the integration of hardware components like the MaRS system and the Physiological Monitoring Unit (PMU). This indicates the software is an integral part of a larger hardware system, not a standalone software-only device.
Based on the provided text, the Siemens MR-PET system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, outside of the body. They provide information about a person's health status, including diagnosis, monitoring, or screening.
- Device Function: The Siemens MR-PET system is an imaging system that uses magnetic resonance and positron emission tomography to create images of the internal structure and function of the human body in vivo (within the living body). It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states that the system is used to "aid in the detection, localization, and diagnosis of diseases and disorders" by providing "high resolution physiologic and anatomic information acquired simultaneously and isocentrically." This is achieved through imaging the patient directly.
Therefore, the Siemens MR-PET system falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
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 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 fused PET and MR images due to precisely aligned MR and PET image coordinate systems.
Product codes
OUO, LNH, LNI, KPS
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR), Positron Emission Tomography (PET)
Anatomical Site
Human body (Head, torso including skull, spine, pelvis and femur bone)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Appropriately trained health care professionals; clinical workflow
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- Image 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus with three intertwined snakes forming a triple helix. The emblem is positioned to the right of the text, which is arranged in a circular pattern around the emblem. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
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.
1
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
2
Image /page/2/Picture/0 description: The image shows the word "SIEMENS" in large, bold, teal-colored letters. The letters are evenly spaced and appear to be a sans-serif font. The background is plain white, which makes the word stand out.
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)
Device Name
Biograph mMR with syngo MR E11P system software
Indications for Use (Describe)
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.
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
3
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 Boulevard
Mail Code 65-1A
Malvern, PA 19355, USA
Registration Number: 2240869 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | November 15, 2016 |
| Manufacturer | Siemens Healthcare GmbH
Henkestrasse 127
Erlangen Bayern, Germany 91052
Registration Number: 3002808157 |
| Contact Person | Mr. Cordell L. Fields, Esq.
Regulatory Affairs Technical Specialist
Siemens Medical Solutions USA, Inc.
65 Valley Stream Parkway
Mail Code 65-1A
Malvern, PA 19355, USA
Phone: (610) 448-6469
Fax: (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 Computed
Tomography with Nuclear Magnetic Resonance |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR § 892.1200
21 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
4
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 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 fused PET and MR images due to precisely aligned MR and PET image coordinate systems.
Device Description
5
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
Siemens 510(k) Traditional Premarket Notification
November 15, 2016
syngo MR E11P Software for Siemens Healthcare GmbH MR Systems Biograph mMR
6
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.
7
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.
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
8
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.
9
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 Clearance
Number | Product
Code | Manufacturer |
|--------------------------------------------------|---------------------------------------|-----------------------|--------------------------------------------|
| Biograph mMR with
Software syngo MR B20P | K133226, cleared
November 12, 2013 | OUO, LNH,
LNI, KPS | Siemens AG /
Siemens Healthcare
GmbH |
| Secondary Predicate Device | FDA Clearance
Number | Product
Code | Manufacturer |
| Software syngo MR D13A for the
MAGNETOM Verio | K121434 cleared
November 5, 2012 | LNH, LNI,
MOS | Siemens AG /
Siemens Healthcare
GmbH |
| Software syngo MR E11C for the
MAGNETOM Skyra | K153343, cleared
April 15, 2016 | LNH, LNI,
MOS | Siemens AG /
Siemens Healthcare
GmbH |
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).
10
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.