(76 days)
No
The document describes standard image post-processing tools and workflows, with no mention of AI, ML, or related concepts. The new features are algorithmic (arithmetic, motion correction, volume quantification) or workflow-based, not indicative of AI/ML.
No.
Explanation: The device is described as post-processing software for viewing, manipulating, and evaluating MR images from a diagnostic device, not for treating or diagnosing a disease directly.
No
Explanation: The device is described as "post-processing software/applications to be used for viewing and evaluating the designated images provided by a magnetic resonance diagnostic device." This indicates it processes data from a diagnostic device rather than being a diagnostic device itself.
Yes
The device description explicitly states that the syngo.MR post-processing applications are "software/applications" and details various software features and improvements. There is no mention of accompanying hardware components being part of the device itself.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this software is for post-processing and evaluating images provided by a magnetic resonance diagnostic device. It works with medical images, not biological samples.
- Intended Use: The intended use is for viewing, manipulating, and evaluating MR images, which are generated by an imaging modality, not from in vitro testing.
Therefore, this device falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The software comprising the syngo.MR post-processing applications is post-processing software/applications to be used for viewing and evaluating the designated images provided by a magnetic resonance diagnostic device. All of the software applications comprising the syngo.MR post-processing applications have their own indications for use.
syngo.MR General is a syngo based post-processing software for viewing, manipulating MR images.
syngo.MR Cardiology is a syngo based post-processing software for viewing, manipulating MR cardiac images.
syngo.MR Neurology is a syngo based post-processing software for viewing, manipulating MR neurological images.
Product codes (comma separated list FDA assigned to the subject device)
LLZ, LNH
Device Description
The syngo.MR post-processing applications are synqo based post-processing software/applications to be used for viewing and evaluating' MR images provided by a magnetic resonance diagnostic device and enabling structured evaluation of MR images.
With SMRVB20 there are some new features, improvements and changes within the syngo.MR post-processing applications.
Within syngo.MR General VB20 there are the following new features and improvements:
- Arithmetic tools (new): Addition, Division, Multiplication
- Motion Correction (Elastic) (new): A Motion Correction algorithm can ● be used to perform elastic motion correction for angiography series (pre/post) or within 4D Breast datasets.
- MR Combine feature (new): Composing is also available for axial series. ●
- MR Prostate workflow provides PI-RADS™ v2 reporting (improved) ●
- Harmonized MR Basic workflow (improved): Several basic workflows . for routine reading are consolidated in one MR Basic workflow.
- . MR Neurology workflow: The MR Neurology workflow merges the already cleared workflows of MR Head, MR Neuro Perfusion, and MR Neuro Dynamics.
- Easy Reading Layout in all workflows (improved): All workflows now include a viewing step with Easy Reading Layout.
- Improved result management (improved): Multiple export options for . findings in the interactive Findings details dialog
Within syngo.MR Cardiology VB20 there are the following new features and improvements:
- Volume Quantification Tool (new): Volume Quant provides the . capability to evaluate lesion volumes in the myocardium.
- . Improved Result Distribution (improvement): Segmentation images can be exported as a result series.
Within syngo.MR Neurology VB20 there are the following new features, changes and improvements:
- MR Neuro 3D workflow:
- Offline BOLD (new): offers the capability to run the GLM ● evaluations on raw BOLD data to generate fMRI statistical maps.
- . Offline DTI (new): offers the capability to generate TENSOR data together with all other diffusion maps (including b0. ADC. TraceW, FA, AD, RD) from raw diffusion series.
- DTI evaluation (new): offers quantitative evaluation of diffusion . parameters (FA, RD, AD, ADC, ...) using ROI, VOI, or voxels.
- . Neuro-specific Mean Curve Tool (minor improvement): The application svngo.MR Neuro Dynamics described in K151353 (and cleared August 07, 2015) is only available within syngo.MR Neuro Perfusion (neurospecific Mean Curve Tool), but no longer as a single application.
The syngo.MR Neuro Perfusion Engine Pro, described in K151353 (and cleared August 07, 2015), is therefore obsolete within SMRVB20, as all applications are already part of syngo.MR Neuro Perfusion Engine.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
magnetic resonance diagnostic device (MR images)
Anatomical Site
Cardiac, Neurological, Prostate, Breast, Head.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals familiar with and responsible for the evaluating and post-processing of MR images.
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)
Not Found
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 6, 2017
Siemens Medical Solutions USA, Inc. % Cordell L. Fields, Esq. Regulatory Affairs Specialist 40 Liberty Blvd. Mail Code 65-1A MALVERN PA 19355
Re: K163294
Trade/Device Name: syngo.MR General: syngo.MR Cardiology: syngo.MR Neurology Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 21, 2016 Received: November 22, 2016
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.
Sincerelv vours.
Michael D'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)
Device Name
syngo.MR General; syngo.MR Cardiology; syngo.MR Neurology
Indications for Use (Describe)
The software comprising the syngo.MR post-processing applications is post-processing software/applications to be used for viewing and evaluating the designated images provided by a magnetic resonance diagnostic device. All of the software applications comprising the syngo.MR post-processing applications have their own indications for use.
syngo.MR General is a syngo based post-processing software for viewing, manipulating MR images.
syngo.MR Cardiology is a syngo based post-processing software for viewing, manipulating MR cardiac images.
syngo.MR Neurology is a syngo based post-processing software for viewing, manipulating MR neurological images.
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 Publishing Services (301) 443-6740 EF
Traditional 510(k) Premarket Notification for: syngo.MR Post-Processing Applications Software VB20
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Section 5 510(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.
Date of Summary Preparation: November 16, 2016
I. General Information
| Importer / Distributor: | Siemens Medical Solutions USA, Inc.
51 Valley Stream Parkway
Mail Code D02
Malvern, PA 19355, USA |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration Number: | 2240869 |
| Manufacturer: | Siemens Healthcare GmbH
Henkestr. 127
D-91052 Erlangen, Germany |
| Registration Number: | 3002808157 |
| Contact Person: | Cordell L. Fields, Esq.
Regulatory Affairs Technical Specialist
Siemens Medical Solutions USA, Inc.
65 Valley Stream Pkwy
Mail Code 65-1A
Malvern, PA 19355, USA
Phone: (610) 448-6469
Fax: (610) 427-3465
Email: cordell.fields@siemens.com |
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Device Name and Classification
| Data | Details |
|---|---|
| Trade name / | |
| Device | |
| Proprietary | |
| Name: | syngo.MR General |
| syngo.MR General contains several MR Radiology | |
| workflows and MR specific Evaluation features. | |
| It covers single and engine applications: | |
| syngo.MR Readingsyngo.MR General Routinesyngo.MR Cardiac Readersyngo.MR Composingsyngo.MR General Enginesyngo.MR General Engine is the precondition for all other, | |
| advanced MR post-processing applications and Engines. | |
| syngo.MR Cardiology | |
| syngo.MR Cardiology covers single and engine | |
| applications: | |
| syngo.MR Cardiac 4D Ventricular Functionsyngo.MR Cardiac Flowsyngo.MR Cardio Engine | |
| syngo.MR Neurology | |
| syngo.MR Neurology covers single and engine | |
| applications: | |
| syngo.MR Neuro Perfusionsyngo.MR Neuro Perfusion Mismatchsyngo.MR Neuro fMRIsyngo.MR Tractographysyngo.MR Neuro Perfusion Enginesyngo.MR Neuro 3D Engine | |
| Classification | |
| Name: | Regulation Description: |
| Picture Archiving and Communication System (PACS) | |
| Classification | |
| Panel: | Radiology |
| Device | |
| Classification: | Class II devices |
| Regulation | |
| number: | 21 CFR § 892.2050 |
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| Data | Details |
|---|---|
| Product Code: | Primary: LLZ, Secondary: LNH |
| Data | Details |
|---|---|
| Trade name / | |
| Device | |
| Proprietary | |
| Name: | syngo.MR General |
| syngo.MR General contains several MR Radiology | |
| workflows and MR specific Evaluation features. | |
| It covers single and engine applications: | |
| • syngo.MR Reading | |
| • syngo.MR General Routine | |
| • syngo.MR Cardiac Reader | |
| • syngo.MR Composing | |
| • syngo.MR General Engine |
syngo.MR General Engine is the precondition for all
other, advanced MR post-processing applications and
Engines. |
| Trade name /
Device
Proprietary
Name | syngo.MR Cardiology
syngo.MR Cardiology covers single and engine
applications:
• syngo.MR Cardiac 4D Ventricular Function
• syngo.MR Cardiac Flow
• syngo.MR Cardio Engine |
| Trade name /
Device
Proprietary
Name | syngo.MR Neurology
syngo.MR Neurology covers single and engine
applications:
• syngo.MR Neuro Perfusion
• syngo.MR Neuro Perfusion Mismatch
• syngo.MR Neuro fMRI
• syngo.MR Tractography
• syngo.MR Neuro Perfusion Engine
• syngo.MR Neuro 3D Engine |
II. Safety and Effectiveness Information Supporting Substantial Equivalence
Intended Use
The software comprising the syngo.MR post-processing applications is postprocessing software/applications to be used for viewing and evaluating the
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designated images provided by a magnetic resonance diagnostic device. All of the software applications comprising the syngo.MR post-processing applications have their own indications for use.
syngo.MR General is a syngo based post-processing software for viewing, manipulating and evaluating MR images.
syngo.MR Cardiology is a syngo based post-processing software for viewing, manipulating and evaluating MR cardiac images.
syngo.MR Neurology is a syngo based post-processing software for viewing, manipulating, and evaluating MR neurological images.
Device Description
The syngo.MR post-processing applications are synqo based post-processing software/applications to be used for viewing and evaluating' MR images provided by a magnetic resonance diagnostic device and enabling structured evaluation of MR images.
With SMRVB20 there are some new features, improvements and changes within the syngo.MR post-processing applications.
Within syngo.MR General VB20 there are the following new features and improvements:
- Arithmetic tools (new): Addition, Division, Multiplication
- Motion Correction (Elastic) (new): A Motion Correction algorithm can ● be used to perform elastic motion correction for angiography series (pre/post) or within 4D Breast datasets.
- MR Combine feature (new): Composing is also available for axial series. ●
- MR Prostate workflow provides PI-RADS™ v2 reporting (improved) ●
- Harmonized MR Basic workflow (improved): Several basic workflows . for routine reading are consolidated in one MR Basic workflow.
- . MR Neurology workflow: The MR Neurology workflow merges the already cleared workflows of MR Head, MR Neuro Perfusion, and MR Neuro Dynamics.
- Easy Reading Layout in all workflows (improved): All workflows now include a viewing step with Easy Reading Layout.
- Improved result management (improved): Multiple export options for . findings in the interactive Findings details dialog
1 While viewing (i.e. assessing) of images from other vendors is always possible; for advanced post-processing applications, some of the post-processing steps may depend on information contained in private DICOM tags ,therefore evaluation and processing of images can´t be guaranteed for other vendors.
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Within syngo.MR Cardiology VB20 there are the following new features and improvements:
- Volume Quantification Tool (new): Volume Quant provides the . capability to evaluate lesion volumes in the myocardium.
- . Improved Result Distribution (improvement): Segmentation images can be exported as a result series.
Within syngo.MR Neurology VB20 there are the following new features, changes and improvements:
- MR Neuro 3D workflow:
- Offline BOLD (new): offers the capability to run the GLM ● evaluations on raw BOLD data to generate fMRI statistical maps.
- . Offline DTI (new): offers the capability to generate TENSOR data together with all other diffusion maps (including b0. ADC. TraceW, FA, AD, RD) from raw diffusion series.
- DTI evaluation (new): offers quantitative evaluation of diffusion . parameters (FA, RD, AD, ADC, ...) using ROI, VOI, or voxels.
- . Neuro-specific Mean Curve Tool (minor improvement): The application svngo.MR Neuro Dynamics described in K151353 (and cleared August 07, 2015) is only available within syngo.MR Neuro Perfusion (neurospecific Mean Curve Tool), but no longer as a single application.
The syngo.MR Neuro Perfusion Engine Pro, described in K151353 (and cleared August 07, 2015), is therefore obsolete within SMRVB20, as all applications are already part of syngo.MR Neuro Perfusion Engine.
General Safety and Effectiveness Concerns
The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device.
Risk Management is ensured via a Risk Analysis in compliance with ISO 14971:2007 to identify and provide mitigation to potential hazards in a Risk Analysis beginning early in the design phase and continuing throughout the development of the product. These risks are controlled via measures realized in software development, SW testing and product labeling. To minimize risks, Siemens adheres to recognized and established industry practices and standards. Furthermore, the operators are healthcare professionals familiar with and responsible for the evaluating and post-processing of MR images.
syngo.MR General, syngo.MR Cardiology and syngo.MR Neurology conform to the applicable FDA recognized and international IEC, ISO and NEMA
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standards with regards to performance and safety as recommended by the respective MR FDA Guidance Document.
| Rec.- No. | Product Area | Title of Standard | Ref.- No. & Date | Standards
Development
Organization |
|------------|--------------|----------------------------------------------------------------------------------------|-------------------------|------------------------------------------|
| 5-96 | General | Medical devices -
Application of usability
engineering to medical
devices | 62366-
1:2015 | AAMI ANSI
IEC |
| 5-40 | General | Medical devices - application of
risk management to medical
devices | 14971:
2007 | ISO |
| 13-
32 | Software | Medical device software -
Software life cycle
processes | 62304:2006 | AAMI ANSI
IEC |
| 12-
300 | Radiology | Digital Imaging and
Communications in
Medicine (DICOM) Set PS
3.1-3.20 (2011) | PS 3.1 -
3.20 (2016) | NEMA |
The standards conformed to are the following:
Substantial Equivalence
Each of the medical devices, syngo.MR General, syngo.MR Cardiology and syngo.MR Neurology, running with the herein described version SMRVB20 has the same Intended Use as the primary predicate device (see Table 1). The conclusions from the non-clinical data suggest that the additional features bear an equivalent safety and performance profile as that of the predicate device and also does not affect the Indications for use of it. Therefore syngo.MR General, syngo.MR Cardiology and syngo.MR Neurology are considered to be substantially equivalent to their primary predicate devices, which are current legally marketed devices.
Table 1: Predicate devices for syngo.MR General, syngo.MR Cardiology and syngo.MR Neurology
| Primary Predicate Device | FDA Clearance | Product Code | for Medical
Device syngo.x |
|--------------------------------------------------------------------|---------------------------------------|--------------|-------------------------------|
| syngo. MR Post-Processing
Software
(Version SMRVA16A) | K130749
cleared August 20,
2013 | LLZ, LNH | MR General
MR Cardiology |
| syngo. MR Post-Processing
Software Version
SMRVB10A | K151353
cleared August 07,
2015 | LLZ, LNH | MR Neurology
MR General |
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| Secondary Predicate
Device | FDA Clearance | Product
Code | for Medical
Device syngo.x |
|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|------------------|---------------------------------------------|
| syngo MR E11C Software for
Siemens MR Systems:
MAGNETOM Aera (1.5T),
MAGNETOM Skyra (3T) and
MAGNETOM
Prisma/Prismafit (3T) | K153343
cleared April 15,
2016 | LNH, LNI,
MOS | MR General
MR Neurology |
| syngo.via (VB10) | K150843
cleared April 24,
2015 | LLZ | MR General
MR Cardiology
MR Neurology |
Conclusion as to Substantial Equivalence
The syngo.MR post-processing applications are intended for similar indications as cleared in their according primary predicate devices.
In summary, Siemens is of the opinion that the syngo.MR post-processing applications do not raise new questions of safety or effectiveness and are substantially equivalent to the currently marketed primary predicate devices:
- syngo.MR Post-Processing Software, version SMRVA16A (K130749 . cleared August 20, 2013) for syngo. MR General and syngo.MR Cardiology
- syngo.MR Post-Processing Software, version SMRVB10A (K151353 . cleared August 07, 2015) for syngo.MR Neurology and syngo.MR General
There is new added functionality for the syngo.MR post-processing applications. The differences give the devices greater capabilities than the predicates, but the Intended Use, the basic technological characteristics and functionalities remain the same.
Therefore, Siemens believes that the subject device, the syngo.MR postprocessing applications syngo.MR General, syngo.MR Cardiology and syngo.MR Neurology, are substantially equivalent to their primary predicate devices listed above in Table 1.