(66 days)
No
The document describes image processing, analysis, and comparison tools, including automated analysis through quantification and comparison with databases, but it does not explicitly mention the use of AI or ML technologies. The focus is on providing analytical tools and workflows for clinicians.
No.
The device is described as a "medical diagnostic application" and "diagnostic software" that provides analytical tools to help users "assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations." Its primary function is image viewing, manipulation, and analysis for diagnosis and follow-up, not for administering therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "syngo.via MI Workflows are medical diagnostic applications." It further elaborates on their use for viewing, manipulating, and comparing medical images to aid in assessing and documenting changes in morphological or functional activity at diagnostic and therapy follow-up examinations.
Yes
The device description explicitly states that syngo.via MI Workflows is a "software-only medical device".
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: IVDs are designed to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- This device analyzes medical images: The description clearly states that syngo.via MI Workflows and Scenium are medical diagnostic applications for viewing, manipulating, and analyzing medical images from various modalities (PET, SPECT, CT, MR). They process image data, not biological samples.
The device's function is to aid clinicians in interpreting medical images for diagnosis and follow-up, which falls under the category of medical imaging software, not IVD.
N/A
Intended Use / Indications for Use
syngo.via MI Workflows are medical diagnostic applications for viewing, manipulation, 3D-visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The apports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR.
syngo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. syngo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. syngo via MI Workflows can perform harmonization of SUV (PET) across different PET systems or different reconstruction methods.
syngo.via MI workflows support the interpretation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.
Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo.via MI Workflows are a complement to these standard procedures.
Scenium
The Scenium display and analysis software has been developed to aid the Clinician in the assessment and quantification of pathologies taken from PET and SPECT scans.
The software is deployed via medical imaging workplaces and is organized as a series of workflows which are specific to use with particular drug and disease combinations.
The software aids in the assessment of human brain scans enabling automated analysis through quantification of mean pixel values located within standard regions of interest. It facilitates comparison with existing scans derived from FDGPET, amyloid-PET, and SPECT studies, calculation of uptake ratios between regions of interest, and subtraction between two functional scans.
Product codes
LLZ
Device Description
syngo.via MI Workflows is a software-only medical device which will be delivered on CD-ROM / DVD to be installed onto the commercially available Siemens syngo.via software platform (K191040) by trained service personnel.
syngo.via MI Workflows is a medical diagnostic application for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaqinq modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering.
syngo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. syngo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. They additionally support the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology (Oncology), Nuclear Medicine and Cardiology environments.
Scenium display and analysis software sits within the MI Neurology workflow within syngo.via MI Workflows. This software enables visualization and appropriate rendering of multimodality data, providing a number of features which enable the user to process acquired image data.
Scenium consists of four workflows:
- -Database Comparison
- -Striatal Analysis
- Cortical Analysis -
- -Subtraction
These workflows are used to assist the clinician with the visual evaluation, assessment and quantification of pathologies, such as dementia (i.e., Alzheimer's), movement disorders (i.e., Parkinson's) and seizure analysis (i.e., Epilepsy).
The modifications to the syngo.via MI Workflows and Scenium (MI Neurology) software (K173897 and K173597) include the following new features:
Workflow: MM Oncology; Workflow-specific Features: Interactive Trending, Hybrid VRT / MIP ranges, Spine and Rib labelling
Workflow: MI Neurology (Scenium); Workflow-specific Features: Factory Normals Database for DaTscan™, Export Subtraction and Z-score Images as DICOM, Z-score Image Overlay and Threshold Improvements
Workflow: MI Reading / SPECT Processing; Workflow-specific Features: Renal Enhancements (extrapolation of Ti/2), Integrate Image Registration Activity
Workflow: MI Cardiology; Workflow-specific Features: No updates / changes to third party applications within MI Cardiology or workflow functionality.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
PET, SPECT, CT, MR
Anatomical Site
Human brain scans
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinician; healthcare institutions, such as Radiology, Nuclear Medicine and Cardiology environments.
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)
K173897 (December 2017)
Reference Device(s)
K173597 (November 2017)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well.
July 19, 2019
Siemens Medical Solutions USA, Inc. % Ms. Veronica Padharia Regulatory Affairs Specialist 2501 N. Barrington Road HOFFMAN ESTATES IL 60192
Re: K191309
Trade/Device Name: syngo.via MI Workflows VB40A, Scenium Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: June 17, 2019 Received: June 20, 2019
Dear Ms. Padharia:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K191309
Device Name syngo.via MI Workflows VB40A, Scenium
Indications for Use (Describe)
syngo.via MI Workflows
syngo.via MI Workflows are medical diagnostic applications for viewing, manipulation, 3D- visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The apports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR.
syngo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. syngo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. syngo via MI Workflows can perform harmonization of SUV (PET) across different PET systems or different reconstruction methods.
syngo.via MI workflows support the interpretation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.
Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo.via MI Workflows are a complement to these standard procedures.
Scenium
The Scenium display and analysis software has been developed to aid the Clinician in the assessment and quantification of pathologies taken from PET and SPECT scans.
The software is deployed via medical imaging workplaces and is organized as a series of workflows which are specific to use with particular drug and disease combinations.
The software aids in the assessment of human brain scans enabling automated analysis through quantification of mean pixel values located within standard regions of interest. It facilitates comparison with existing scans derived from FDGPET, amyloid-PET, and SPECT studies, calculation of uptake ratios between regions of interest, and subtraction between two functional scans.
Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D)
escription Use (Part 21 CFR 601 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
as required by 21 CFR Part 807.87(h)
Identification of the Submitter
| Primary Contact: | Alternate Contact: | |
|---|---|---|
| Submitter: | Veronica Padharia | |
| Regulatory Technical | ||
| Specialist | ||
| Siemens Medical Solutions | ||
| USA, Inc. | ||
| 810 Innovation Drive | ||
| Knoxville, TN 37932 | Clayton Ginn | |
| Regulatory Technical | ||
| Specialist | ||
| Siemens Medical Solutions | ||
| USA, Inc. | ||
| 810 Innovation Drive | ||
| Knoxville, TN 37932 | ||
| Telephone Number: | (630) 877–5761 | (865) 898-2692 |
| Fax Number: | (847) 304-6023 | (865) 218-3019 |
| Name / Address of | ||
| Manufacturer | Siemens Medical Solutions USA, Inc | |
| Molecular Imaging | ||
| 2501 N. Barrington Road | ||
| Hoffman Estates, IL 60192 | ||
| USA | ||
| Date of Submission: | May 13th 2019 | |
| Identification of the product | ||
| Device Proprietary Name: | syngo.via MI Workflows VB40A, | |
| Scenium | ||
| Common Name: | Image Processing Software | |
| Classification Name: | Picture Archiving and Communication System per 21 CFR | |
| 892.2050 | ||
| Product Code: | LLZ | |
| Classification Panel: | Radiology | |
| Device Class: | Class II |
4
Primary Predicate Device
| Device Proprietary Name: | syngo.via MI Workflows VB30A |
|---|---|
| Common Name: | Image Processing Software |
| Classification Name: | Picture Archiving and Communication System per 21 CFR |
| 892.2050 | |
| Product Code: | LLZ |
| Classification Panel: | Radiology |
| Device Class: | Class II |
| Manufacturer: | Siemens Medical Solutions |
| USA, inc. | |
| 510(k) Number: | K173897 (December 2017) |
Reference Predicate Device
| Device Proprietary Name: | Scenium VE20A |
|---|---|
| Common Name: | Image Processing Software |
| Classification Name: | Picture Archiving and Communication System per 21 CFR |
| 892.2050 | |
| Product Code: | LLZ |
| Classification Panel: | Radiology |
| Device Class: | Class II |
| Manufacturer: | Siemens Medical Solutions |
| USA, Inc. | |
| 510(k) Number: | K173597 (November 2017) |
syngo.via MI Workflows VB30A is deemed the primary predicate device due to it being the most similar to the device under review of this submission with respect to indications for use and technical characteristics. Scenium VE30A is considered a reference device because it is a subset of the primary predicate device's indications for use and technical characteristics included within this submission.
5
Device Description
syngo.via MI Workflows is a software-only medical device which will be delivered on CD-ROM / DVD to be installed onto the commercially available Siemens syngo.via software platform (K191040) by trained service personnel.
syngo.via MI Workflows is a medical diagnostic application for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaqinq modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering.
syngo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. syngo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. They additionally support the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology (Oncology), Nuclear Medicine and Cardiology environments.
Scenium display and analysis software sits within the MI Neurology workflow within syngo.via MI Workflows. This software enables visualization and appropriate rendering of multimodality data, providing a number of features which enable the user to process acquired image data.
Scenium consists of four workflows:
- -Database Comparison
- -Striatal Analysis
- Cortical Analysis -
- -Subtraction
These workflows are used to assist the clinician with the visual evaluation, assessment and quantification of pathologies, such as dementia (i.e., Alzheimer's), movement disorders (i.e., Parkinson's) and seizure analysis (i.e., Epilepsy).
The modifications to the syngo.via MI Workflows and Scenium (MI Neurology) software (K173897 and K173597) include the following new features:
| Workflow | Workflow-specific Features |
|---|---|
| MM Oncology | Interactive Trending |
| Hybrid VRT / MIP ranges | |
| Spine and Rib labelling | |
| MI Neurology (Scenium) | Factory Normals Database for DaTscan™ |
| Export Subtraction and Z-score Images as DICOM | |
| Z-score Image Overlay and Threshold Improvements | |
| MI Reading / SPECT | |
| Processing | Renal Enhancements (extrapolation of T1/2) |
| Integrate Image Registration Activity | |
| MI Cardiology | No updates / changes to third party applications within MI |
| Cardiology or workflow functionality. |
Technological Characteristics
The syngo.via MI Workflows VB40A software modifications are based on the commercially
6
available syngo.via MI Workflows VB30A software (K173897) and Scenium VE20A (K173597). The features introduced into these Clinical Applications had no impact on the technological characteristics already present in the commercially available predicate system.
syngo.via MI Workflows is intended to be run on the Siemens syngo.via software platform (K191040) either alone or with other advanced commercially cleared applications.
Intended Use
An individual software program, or group of programs, routines, or algorithms that add specific image processing and/or analysis capabilities to a positron emission tomography (PET) and Sinqle Photon Emission Computed Tomography (SPECT) imaging system configuration. A basic set of application programs and routines is included with such computer controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some application software routines or groups of routines (packages) must be combined with specific hardware or firmware accessories or configurations in order to function as intended. Application program packages are typically identified by a proprietary name and "version" or "upgrade" number.
The intended use for syngo.via MI Workflows is the same and, compared to the primary and reference devices, have not changed.
Indications for Use
syngo.via MI Workflows
syngo.via MI Workflows is a medical diagnostic application for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR.
syngo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disiointedly, syngo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. syngo.via MI Workflows can perform harmonization of SUV (PET) across different PET systems or different reconstruction methods.
syngo.via MI workflows support the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.
Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo.via MI Workflows are a complement to these standard procedures.
7
Scenium, within the MI Neurology Workflow
The Scenium display and analysis software has been developed to aid the Clinician in the assessment and quantification of pathologies taken from PET and SPECT scans.
The software is deployed via medical imaging workplaces and is organized as a series of workflows which are specific to use with particular drug and disease combinations.
The software aids in the assessment of human brain scans enabling automated analysis through quantification of mean pixel values located within standard regions of interest. It facilitates comparison with existing scans derived from FDGPET, amyloid-PET, and SPECT studies, calculation of uptake ratios between regions of interest, and subtraction between two functional scans.
As stated above in the section describing predicate marketed devices, syngo.via MI Workflows VB30A is deemed the primary predicate device due to it being the most similar to the device under review of this submission with respect to indications for use and technical characteristics. Scenium VE30A is considered a reference predicate device because it is a subset of the primary predicate device's indications for use and technical characteristics.
Performance Testing / Safety and Effectiveness
The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device.
Risk Management has been ensured via risk analyses in compliance with ISO 14971 to identify and provide mitigation to potential hazards beginning early in the design cycle and continuing throughout the development of the product. Siemens Medical Solutions, USA Inc. adheres to recognized and established industry standards for development including EN ISO 13485 and IEC 62304.
Cybersecurity information in accordance with FDA Guidance documents issued October 2, 2014 has been provided. The Clinical Applications software has specific cybersecurity controls to prevent unauthorized access, modifications, misuse or denial of use. Additionally, controls are enabled to prevent the unauthorized use of information that is stored, accessed or transferred between the Clinical Applications software and external devices.
Verification and Validation activities have been successfully performed on the software package, including assurance that functions work as designed, performance requirements and specifications have been met, and that all hazard mitigations have been fully implemented. All testing has met the predetermined acceptance values. Traceability of the requirements specified in the requirement specifications and functional specifications is ensured during component integration, software validation and system testing.
The device is designed and manufactured in accordance with Quality System Regulations as outlined in 21 CFR 820. The FDA recognized standards are listed as follows:
- Recognition Number 13-79: IEC 62304 Edition 1.1 2015-06 ●
- Recognition Number 12-300: NEMA PS 3.1 3.20 (2016) ●
- Recognition Number 5-40: ISO 14971:2007 Second Edition
- o Recognition Number 5-114: IEC 62366-1 Edition 1.0 2015
8
- Recognition Number 5-117: ISO 15223-1 Third Edition 2016 .
Statement Regarding Substantial Equivalence:
There are no differences in the Indications for Use or Fundamental Technological Characteristics of the syngo.via MI Workflows software as compared to the currently commercially available software (K173897 and K173597). Both the current and predicate devices are used for viewing, manipulation, 3D- visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points
Additionally, there have been no changes that raise any new issues of safety and effectiveness as compared to the predicate device. Based on this information, as well as the documentation in support of the modifications, it is Siemens opinion that the syngo.via MI Workflows software-with the modifications outlined in this application-is substantially equivalent to the predicate device.