syngo.via molecular imaging (MI) workflows comprise medical diagnostic applications for viewing, manipulation, quantification, analysis and comparison of medical images from single or multiple imaging modalities with one or more time-points. These workflows support functional data, such as position emission tomography (PET) or nuclear medicine (NM), as well as anatomical datasets, such as computed tomography (CT) or magnetic resonance (MR), syngo.via MI workflows can perform harmonization of SUV (PET) across different PET systems or different PET reconstruction methods.

syngo.via MI workflows are intended to be utilized by appropriately trained health care professionals to aid in the management of diseases, including those associated with oncology, neurology, and organ function. The images and results produced by the syngo.via MI workflows can also be used by the physician to aid in radiotherapy treatment planning.

Device Description

syngo.via MI Workflows is a multi-modality post-processing software only medical device, which is intended to be installed on common IT hardware. This hardware must fulfill the defined requirements. The hardware itself is not seen as part of the medical device.

The Siemens syngo.via platform (K191040) and the applications that reside on it are distributed via electronic medium. The Instructions for Use also delivered via electronic medium.

synqo.via molecular imaging (MI) workflows comprise medical diagnostic applications for viewing, manipulation, quantification, analysis and comparison of medical images from single or multiple imaging modalities with one or more time-points. These workflows support functional data, such as positron emission tomography (PET) or nuclear medicine (NM), as well as anatomical datasets, such as computed tomography (CT) or magnetic resonance (MR).

syngo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. syngo.via MI workflows are intended to be utilized by appropriately trained health care professionals to aid in the management of diseases, including those associated with oncology, cardiology, neurology, and organ function. The images and results produced by the syngo.via MI workflows can also be used by the physician to aid in radiotherapy treatment planning.

Scenium assists in the display and analysis of images within the MI Neurology workflow of 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 Analvsis
-Cortical Analysis
-Subtraction

The Scenium 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),

syngo MBF is a software only product intended for visualization, assessment and quantification of medical images: specifically providing quantitative blood flow measurements of PET images. The software is launched from the OpenApps Framework within the MI Cardiology workflow within syngo.Via MI Workflows. The application supports dynamic Rubidium – PET and dynamic Ammonia – PET images. The application provides visualization and measurement tools, for qualitative and quantitative visualization and assessment of the input data. It provides automatic and manual tools to orient and segment the myocardium. The software calculates measurements of myocardial blood flow, and provides tools, such as a database comparison workflow, for the Clinician to assess these results.

AI/ML Overview

The provided text describes modifications to the syngo.via MI Workflows software (specifically VB60A, Scenium VE40A, and syngo MBF VB30A versions) and asserts their substantial equivalence to a predicate device (syngo.via MI Workflows VB50A, Scenium VE30A, and syngo MBF VB20A, K201195). However, it does not contain a detailed description of acceptance criteria or a specific study proving the device meets those criteria in the typical sense of a clinical or performance validation study with quantitative metrics, expert adjudication, or MRMC data.

Instead, the document focuses on:

Regulatory Compliance: Adherence to FDA regulations (21 CFR 892.2050, 21 CFR Part 807.87(h)), recognized standards (ISO 14971, EN ISO 13485, IEC 62304, NEMA PS 3.1-3.20, IEC 62366-1, ISO 15223-1), and cybersecurity guidelines.
Functional Equivalence: Stating that the new features do not alter the existent technological characteristics or raise new issues of safety and effectiveness compared to the predicate device.
Verification and Validation (V&V): A general statement that "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."

Without specific performance metrics and a detailed study design provided in the given text, it is not possible to fully populate all components of your request. I will extract what information is present and indicate where information is Not Provided (NP).

Acceptance Criteria and Device Performance (as inferred from the document)

The document broadly states that "All testing has met the predetermined acceptance values." However, it does not explicitly define these "predetermined acceptance values" in a quantitative table. The primary acceptance criteria appear to be substantial equivalence, functional correctness, and adherence to safety and quality standards.

Acceptance Criteria (Inferred)	Reported Device Performance
Functional correctness of new features:	"functions work as designed"
- Updated syngo.CT LungCAD Integration	(Implied: Integrated correctly)
- Visualization of 4D data in all layouts	(Implied: Works as intended)
- FAST Ranges Enhancements	(Implied: Enhanced as intended)
- Auto Layout Improvements	(Implied: Improved as intended)
- Gaussian filtering of PET Data	(Implied: Works correctly)
- Interactive Spectral Imaging	(Implied: Works correctly)
- Usability Improvements	(Implied: Improved as intended)
- OpenApps framework for ISAs (Cedars, Corridor 4DM, syngo MBF)	(Implied: Framework supports ISAs)
- Spill-Over Factors (within syngo MBF)	(Implied: Implemented and works)
- Automatic window/level for each frame (within syngo MBF)	(Implied: Works correctly)
- Global Time Activity Curve (within syngo MBF)	(Implied: Works correctly)
- Calibrated I123-FP-CIT normal databases in Striatal Analysis	(Implied: Databases accurate and integrated)
Meet performance requirements and specifications	"performance requirements and specifications have been met"
Implement all hazard mitigations (ISO 14971)	"all hazard mitigations have been fully implemented"
Cybersecurity controls	"has specific cybersecurity controls to prevent unauthorized access, modifications, misuse or denial of use"
Compliance with relevant standards and regulations	"adheres to recognized and established industry standards," compliance with 21 CFR 820
Not raise new issues of safety and effectiveness	"do not raise any new issues of safety and effectiveness as compared to the predicate device."

Study Details:

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: NP (Not provided in the document. The document refers to "Verification and Validation activities" and "All testing" but does not specify the number of cases or datasets used for these tests.)
- Data Provenance: NP (Not provided. It is not stated where the data for testing originated from, e.g., country of origin, or if it was retrospective or prospective data.)
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: NP (Given the nature of the modifications described – mainly functional additions and improvements to existing workflows – it's unlikely a traditional "ground truth" for disease diagnosis was established for this specific submission beyond ensuring the software performs its intended technical functions. If expert review was part of the V&V, it is not detailed.)
- Qualifications of Experts: NP
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: NP (This type of adjudication is typically for establishing diagnostic ground truth, which is not the focus of the described V&V for these software updates.)
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:
- MRMC Study: No. The document describes software workflow updates for viewing, manipulation, quantification, and analysis of medical images. It does not introduce an "AI" component intended to directly assist or change clinical decision-making in a way that would necessitate an MRMC study demonstrating improved human reader performance. The software is a tool for professionals, not an AI diagnostic assistant.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: The V&V activities would have included testing of the software's algorithms and functions in a standalone manner to ensure they work as designed and meet specifications. However, specific metrics (e.g., accuracy, sensitivity, specificity for automated tasks) are NP for any specific algorithm. The "syngo MBF" module, for instance, calculates quantitative blood flow measurements, and its accuracy would have been part of the V&V, but no specific performance statistics are provided.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: For the nature of these software updates, the "ground truth" would likely be technical correctness and adherence to algorithmic specifications rather than clinical outcomes or pathology. For example, ensuring that a 4D visualization works as intended, or that quantitative measurements (e.g., SUV harmonization, blood flow measurements) are mathematically correct and consistent with reference values or established methodologies. Detailed information about exactly how this "ground truth" was established (e.g., through phantom studies, simulations, or comparison with established clinical software/manual calculations) is NP.
The sample size for the training set:
- Training Set Sample Size: NP. The document does not mention training sets, which implies that the updates are not based on a machine learning model that would require a distinct training phase. These are described as functional additions and improvements to existing software, not new AI/ML algorithms.
How the ground truth for the training set was established:
- Training Set Ground Truth: NP, as no specific training set for (ML/AI) models is implied.

Summary

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June 10, 2021.

Image /page/0/Picture/1 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Siemens Medical Solutions USA, Inc % Clayton Ginn Regulatory Affairs Specialist 810 Innovation Drive KNOXVILLE TN 37932

Re: K211459

Trade/Device Name: syngo.via MI WorkFlows VB60A Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH, LLZ Dated: May 10, 2021 Received: May 11, 2021

Dear Clayton Ginn:

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 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 (QS)

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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,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K211459

Device Name syngo.via MI Workflows VB60A

Indications for Use (Describe)

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)

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Section 05 510(k) Summary

K211459

as required by 21 CFR Part 807.87(h)

Identification of the Submitter

	Primary Contact:	Alternate Contact:
Submitter:	Clayton GinnRegulatory TechnicalSpecialistSiemens Medical SolutionsUSA, Inc.810 Innovation DriveKnoxville, TN 37932	Alaine MedioRegulatory TechnicalSpecialistSiemens Medical SolutionsUSA, Inc.810 Innovation DriveKnoxville, TN 37932
Telephone Number:	(865) 898-2692	(865) 206-0337
Fax Number:	(865) 218-3227	(865) 218-3227
Name / Address ofManufacturer	Siemens Medical Solutions USA, IncMolecular Imaging2501 N. Barrington RoadHoffman Estates, IL 60192USA
Date of Submission:	May 10th, 2021
Identification of the product
Device Proprietary Name:	syngo.via MI Workflows VB60A
Common Name:	Automated Radiological Image Processing Software
Code of FederalRegulations	21 CFR 892.2050
Classification Name:	Medical image management and processing system
Product Code:	QIH, LLZ
Classification Panel:	Radiology
Device Class:	Class II
Device Proprietary Name:	syngo.via MI Workflows VB50A
Common Name:	Automated Radiological Image Processing Software
Code of FederalRegulations	21 CFR 892.2050
Classification Name:	Picture archiving and communication system
Product Code:	QIH, LLZ
Classification Panel:	Radiology
Device Class:	Class II
Manufacturer:	Siemens Medical SolutionsUSA, inc.
510(k) Number:	K201195 (November 2020)

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Primary Predicate Device

syngo.via MI Workflows VB50A 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.

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Device Description

The Siemens syngo.via platform (K191040) and the applications that reside on it are distributed via electronic medium. The Instructions for Use also delivered via electronic medium.

Scenium consists of four workflows:

Database Comparison ।
-Striatal Analvsis
-Cortical Analysis
-Subtraction

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The modifications to syngo.via MI Workflows, Scenium, and syngo MBF software (K201195) include the following new features:

Workflow	Workflow-specific Features
MM Oncology	Updated syngo.CT LungCAD Integration (K203258)
MI Workflows(MI General,MI Cardiology,	Visualization of 4D data in all layoutsFAST Ranges EnhancementsAuto Layout ImprovementsGaussian filtering of PET DataInteractive Spectral ImagingUsability Improvements
MI Cardiology	OpenApps framework for ISAs (including Cedars, Corridor4DM, and syngo MBF)Spill-Over Factors (within syngo MBF)Automatic window/level for each frame (within syngo MBF)Global Time Activity Curve (within syngo MBF)
MI Neurology	Calibrated I123-FP-CIT normal databases in StriatalAnalysis (within Striatal Analysis workflow of Scenium)

Technological Characteristics

The syngo.via MI Workflows VB60A, Scenium VE40A, and syngo MBF VB30A software modifications are based on the commercially available synqo.via MI Workflows VB50A. Scenium VE30A, and syngo MBF VB20A software (K201195). The features introduced into these Clinical Applications do not alter the already existent technological characteristics within the commercially available predicate system.

svngo.via MI Workflows is intended to be run on the Siemens svngo.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 Single 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, has not changed.

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Indications for Use

svngo.via molecular imaging (MI) workflows comprise medical diagnostic applications for viewing, manipulation, quantification, analysis and comparison of medical images from single or multiple imaging modalities with one or more time-points. These workflows support functional data, such as positron emission tomography (PET) or nuclear medicine (NM), as well as anatomical datasets, such as computed tomography (CT) or magnetic resonance (MR). syngo.via MI workflows can perform harmonization of SUV (PET) across different PET systems or different PET reconstruction methods.

syngo.via MI workflows are intended to be utilized by appropriately trained health care professionals to aid in the management of diseases, including those associated with oncology, cardiology, neurology, and organ function. The images and results produced by the syngo.via MI workflows can also be used by the physician to aid in radiotherapy treatment planning.

The syngo.via MI Workflows VB60A Indications for Use is the same and, compared to the primary and reference devices, has not changed. The Indications for Use encompasses the Scenium and syngo MBF devices as used within the MI Neurology and MI Cardiology workflows.

Performance Testinq / 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 Requlations 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)

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Recognition Number 5-125: ISO, 14971:2019 Third Edition .
Recognition Number 5-114: IEC, 62366-1 Edition 1.0 2015 .
Recognition Number 5-117: ISO 15223-1 Third Edition 2016 ●

Statement Regarding Substantial Equivalence:

There are no differences in the Indications for Use, Intended Use or Fundamental Technological Characteristics of the syngo.via MI Workflows VB60A software as compared to the currently commercially available syngo.via MI Workflows software (K201195).

Both the current and predicate devices are used for viewing, manipulation, quantification, analysis and comparison of medical images from single or multiple imaging modalities with one or more time-points.

Additionally, the new features implemented within this release do not 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.

Regulation Number and Section

§ 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).