syngo.via MI WorkFlows, Scenium, syngo MBF

K211459 · Siemens Medical Solutions USA, Inc. · QIH · Jun 10, 2021 · Radiology

Device Facts

• Record ID: K211459
• Device Name: syngo.via MI WorkFlows, Scenium, syngo MBF
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: QIH · Radiology
• Decision Date: Jun 10, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

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 Story

Multi-modality post-processing software; installed on standard IT hardware. Inputs: PET, NM, CT, MR image datasets. Operation: software-based visualization, manipulation, quantification, and comparison of functional/anatomical images. Features: Scenium (neurology workflow for striatal/cortical analysis, database comparison, subtraction); syngo MBF (cardiology workflow for myocardial blood flow measurement, segmentation, and database comparison). Used in clinical settings by trained healthcare professionals. Output: processed images, quantitative measurements, and analysis results displayed on workstation. Clinical utility: aids disease management (dementia, Parkinson's, epilepsy, oncology, cardiology) and radiotherapy planning. Benefits: enables integrated visualization of multi-modality data, automated quantification, and standardized SUV harmonization across systems.

Clinical Evidence

Bench testing only. Verification and validation activities confirmed software functions as designed, performance requirements met, and hazard mitigations implemented. Testing included requirement traceability, component integration, and system-level validation against predetermined acceptance values.

Technological Characteristics

Software-only medical device; runs on standard IT hardware. Supports PET, NM, CT, MR modalities. Features include Gaussian filtering, 4D data visualization, and automated segmentation/quantification. Complies with IEC 62304 (software lifecycle), ISO 14971 (risk management), and NEMA PS 3.1-3.20 (DICOM).

Indications for Use

Indicated for trained healthcare professionals to manage diseases (oncology, cardiology, neurology, organ function) via viewing, manipulation, quantification, and analysis of PET, NM, CT, and MR images. Used to aid radiotherapy treatment planning.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• syngo.via MI Workflows VB50A (K201195)

Reference Devices

• syngo.via platform (K191040)
• syngo.CT LungCAD (K203258)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------|----------------------------------------------------------------|
| <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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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 Ginn<br>Regulatory Technical<br>Specialist<br>Siemens Medical Solutions<br>USA, Inc.<br>810 Innovation Drive<br>Knoxville, TN 37932 | Alaine Medio<br>Regulatory Technical<br>Specialist<br>Siemens Medical Solutions<br>USA, Inc.<br>810 Innovation Drive<br>Knoxville, TN 37932 |
| Telephone Number: | [phone] | [phone] |
| Fax Number: | [phone] | [phone] |
| Name / Address of<br>Manufacturer | Siemens Medical Solutions USA, Inc<br>Molecular Imaging<br>2501 N. Barrington Road<br>Hoffman Estates, IL 60192<br>USA | |
| 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 Federal<br>Regulations | 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 Federal<br>Regulations | 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 Solutions<br>USA, 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

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.

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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<br>(MI General,<br>MI Cardiology, | Visualization of 4D data in all layouts<br>FAST Ranges Enhancements<br>Auto Layout Improvements<br>Gaussian filtering of PET Data<br>Interactive Spectral Imaging<br>Usability Improvements |
| MI Cardiology | OpenApps framework for ISAs (including Cedars, Corridor<br>4DM, and syngo MBF)<br>Spill-Over Factors (within syngo MBF)<br>Automatic window/level for each frame (within syngo MBF)<br>Global Time Activity Curve (within syngo MBF) |
| MI Neurology | Calibrated I123-FP-CIT normal databases in Striatal<br>Analysis (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.