syngo.via View&GO is a software solution intended to be used for Viewing, communication, and storage of medical images. It can be used as a stand-alone device or together with a variety of cleared and unmodified syngo based software options.

syngo.via View&GO supports interpretation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. The system is not intended for the displaying of digital mammography images for diagnosis in the US.

Device Description

Siemens Healthcare GmbH intends to market the Picture Archiving and Communications System, syngo.via View&GO, software version VA10A. This 510(k) submission describes several modifications to the previously cleared predicate device, syngo.via, software version VB10A.

syngo.via View&GO is a software only medical device, which is delivered by download to be installed on common IT hardware. This hardware has to fulfil the defined requirements. Any hardware platform that complies to the specified minimum hardware and software requirements and with successful installation verification and validation activities can be supported. The hardware itself is not seen as part of the medical device syngo.via View&GO and therefore not in the scope of this 510(k) submission.

syngo.via View&GO provides tools and features to cover the radiological tasks preparation for reading, reading images and support for reporting 4. syngo.via View&GO supports DICOM formatted images and objects.

syngo.via View&GO is a standalone viewing and reading workplace. This is capable of rendering the data from the connected modalities for the post processing activities. syngo.via View&GO provides the user interface for interactive image viewing and processing with a limited short term storage which can be interfaced with any Long term storage (e.g. PACS) via DICOM.

syngo.via View&GO is based on Microsoft Windows operating systems.

syngo.via View&GO supports various monitor setups and can be adapted to a range of image types by connecting different monitor types.

The subject device and the predicate device share fundamental scientific technology.

AI/ML Overview

The provided text describes a 510(k) premarket notification for syngo.via View&GO (Version VA10A), a Picture Archiving and Communications System (PACS). However, it does not contain the detailed information required to answer all parts of your request, specifically regarding a clinical study with detailed acceptance criteria, sample sizes, expert involvement, and ground truth establishment.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (syngo.via VB10A) through comparisons of intended use, technological characteristics, and non-clinical performance testing. It highlights that syngo.via View&GO is a simplified version of the predicate device, with some functionalities removed.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

The document states: "The testing results support that all the software specifications have met the acceptance criteria." However, it does not provide a specific table of acceptance criteria or quantitative performance metrics for the device’s functionality. It mentions "non-clinical tests were conducted for the device syngo.via View&GO during product development" to assess functionality, but the results themselves are not detailed in terms of specific performance against defined criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The testing described is "non-clinical" and focuses on software verification and validation, not clinical performance using a specific test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as the document does not describe a clinical study with expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as the document does not describe a clinical study.

5. 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

This information is not provided. The device is a PACS system for viewing, manipulation, communication, and storage of medical images, and "no automated diagnostic interpretation capabilities like CAD are included." Therefore, an MRMC study assessing AI assistance is not applicable to this device based on the provided information.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The document primarily describes a "software only medical device" that is a "standalone viewing and reading workplace" intended for use by medical professionals. The software itself is a standalone system in terms of its architecture (compared to the client-server predecessor), but its intended use involves human interpretation. It does not describe a standalone algorithmic performance study in the context of diagnostic interpretation, as it explicitly states it has no CAD functionalities.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided as there is no description of a clinical study that required ground truth establishment. The testing mentioned is "non-clinical" for software functionality.

8. The sample size for the training set

This information is not provided. The document describes a PACS system which displays existing medical images. It does not mention any machine learning or AI components that would require a "training set" of data in the typical sense for diagnostic algorithms.

9. How the ground truth for the training set was established

This information is not provided, as there is no mention of a training set or ground truth establishment for such a set.

Summary of what is available from the document:

The provided document describes a non-clinical performance testing approach for a PACS system, syngo.via View&GO. The "study" (non-clinical testing) aims to demonstrate that modifications to a previously cleared predicate device (syngo.via VB10A) do not introduce new safety risks and that the new device remains substantially equivalent for its intended use.

Acceptance Criteria & Performance: The document states that "all the software specifications have met the acceptance criteria" based on non-clinical verification and validation testing. However, specific quantitative acceptance criteria and detailed performance metrics are not provided.
Study Type: Non-clinical software verification and validation testing.
Sample Size/Data Provenance: Not applicable for a typical clinical test set as described. The testing focuses on software functionality, not clinical performance on a dataset of patient cases.
Expert/Ground Truth/Adjudication: Not applicable, as it's a non-clinical software validation without diagnostic AI features.
MRMC Study: Not applicable, as the device does not have AI diagnostic interpretation capabilities.
Standalone Performance: The device is described as a "standalone viewing and reading workplace" in terms of its architecture, but not in the context of an algorithm performing diagnoses without human involvement.
Training Set/Ground Truth for Training: Not applicable/not mentioned, as there are no AI components requiring training.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are simple and professional in appearance.

September 7, 2018

Siemens Healthcare GmbH % Alexander Schapovalov Responsible Third Party Reviewer TÜV SÜD America Inc. 1775 Old Highway 8 NEW BRIGHTON, MN 55112

Re: K182208

Trade/Device Name: syngo.via View&GO (Version VA10A) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: August 2, 2018 Received: August 15, 2018

Dear Alexander Schapovalov:

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jeff Rodgers

for Robert A. 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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Indications for Use

510(k) Number (if known) K182208

Device Name syngo.via View&GO (Version VA10A)

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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510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

Date prepared: July 18, 2018

1. Submitter: Siemens Healthcare GmbH Henkestrasse 127 91052 Erlangen Germany
  Establishment Registration Number: 3004977335

2. Contact Person:

Mr. Elango Alampalayam Rangappan Regulatory Affairs Manager Siemens Healthcare GmbH, Siemensstr. 1 91301 Forchheim Germany E-mail: ar.elango@siemens-healthineers.com Telephone: +49 (9191) 18-4429 Fax: +49 (9191) 18-4404

3. Device Name and Classification:

Trade Name:	syngo.via View&GO (Version VA10A)
Classification Name:	Picture Archiving and Communications System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.2050
Device Class:	Class II
Product Code:	LLZ

4. Legally Marketed Predicate Device:

Trade Name:	syngo.via
510(k) Clearance:	K150843
Clearance Date:	April 24, 2015
Classification Name:	Picture Archiving and Communications System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.2050
Device Class:	Class II
Product Code:	LLZ
Recall Information:	This predicate device doesn't have any opendesign related recalls.

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5. Device Description:

syngo.via View&GO is based on Microsoft Windows operating systems.

syngo.via View&GO supports various monitor setups and can be adapted to a range of image types by connecting different monitor types.

The subject device and the predicate device share fundamental scientific technology.

6. Indications For Use:

syngo.via View&GO is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a stand-alone device or together with a variety of cleared and unmodified syngo based software options.

syngo.via View&GO supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.

The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.

14 Support for reporting is provided in the clipboard functionality so that the image with measurements and annotations can be copied to any 3td party reporting tools.

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7. Summary of Similarities and Differences between the Subject Device and the Predicate Device:

The similarities and differences between the subject device in this premarket notification and the predicate device are summarized in the following comparison table:

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15 Rib Labeling as a functionality was already covered by a 510(k) clearance with device SYNGO, CT BONE READING, K123584.

16 Rib Labeling as a functionality was already covered by a 510(k) clearance with device SYNGO, CT BONE READING, K123584.

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8. Non-clinical Performance Testing:

Non-clinical tests were conducted for the device syngo.via View&GO during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.

Siemens Healthcare GmbH claims conformance to the following standards:

NEMA PS 3.1 3.20 (2016), Digital Imaging and Communication in Medicine (DI--COM)
ISO IEC 10918-1:1994 + Technical Corrigendum 1:2005 (JPEG) -
ISO/IEC 15444-1:2016 (JPEG 2000) -
ISO 14971:2007 -
IEC 62304:2006-05+AMD1:2015-06 -
IEC 82304:2016-10 -
-IEC 62366-1:2015-02
IEEE 333.2.1-2015 -

Software Verification and Validation:

Software documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on the device syngo.via View&GO during product development.

The Risk Analysis was completed and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.

Siemens Healthcare GmbH conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Contained in Section B of this submission are our cybersecurity considerations as they relate to the device syngo.via View&GO.

Summary:

Performance tests were conducted to test the functionality of the device syngo.via View&GO. These tests have been performed to assess the functionality of the subject device. Results of all conducted testing were found acceptable in supporting the claim of substantial equivalence.

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9. Safety and Effectiveness Information:

Software specifications, design descriptions, hazard analysis, and labeling information are submitted in support of this premarket notification. The device labeling contains instructions for use with cautions to provide for safe and effective use of the device.

The results of the hazard analysis combined with the appropriate preventive measures taken indicate the device is of moderate level of concern, as per the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005).

10. Conclusion as to Substantial Equivalence:

The predicate device was cleared based on non-clinical supportive information. The comparison of technological characteristics, device hazards, non-clinical performance data, and software validation data demonstrates that the subject device performs comparably to and is as safe and effective as the predicate device that is currently marketed for the same intended use.

In summary, we are of the opinion that the subject device syngo.via View&GO, software version VA10A, does not introduce any new significant potential safety risks and is substantially equivalent to and performs as well as 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).

	Subject devicesyngo.via View&GO VA10A	Predicate devicesyngo.via VB10A	Comparison
Intended use	syngo.via View&GO is a software solution in-tended to be used for viewing, manipulation,communication, and storage of medical images.	syngo.via is a software solution intended to beused for viewing, manipulation, communica-tion, and storage of medical images.	Same
	It can be used as a stand-alone device or togeth-er with a variety of cleared and unmodifiedsyngo based software options.	It can be used as a stand-alone device or togeth-er with a variety of cleared and unmodifiedsyngo based software options.
	syngo.via View&GO supports interpretationand evaluation of examinations withinhealthcare institutions, for example, in Radiolo-gy, Nuclear Medicine and Cardiology environ-ments.	syngo.via supports interpretation and evaluationof examinations within healthcare institutions,for example, in Radiology, Nuclear Medicineand Cardiology environments.
	The system is not intended for the displaying ofdigital mammography images for diagnosis inthe U.S.	The system is not intended for the displaying ofdigital mammography images for diagnosis inthe U.S.

Software archi-tecture	Standalone workplace system that is logicallybroken down to syngo.via View&GO subsys-tems syngo modules.	Client-server architecture that is logically bro-ken down to syngo.via subsystems syngo mod-ules.	syngo.viaView&GO is astandalone work-place rather syn-go.via is based onClient-Server ar-chitecture
Image commu-nication	Standard network protocols like TCP/IP andstandard communication protocol DICOM.	Standard network protocols like TCP/IP andstandard communication protocol DICOM. Ad-ditional fast image transfer protocol for use in-side syngo.via between the client and server.	There is no inter-nal communica-tion as the subjectdevice is astandalone soft-ware system.
Imaging algo-rithms	- Multiplanar reconstruction (MPR)- Maximum and Minimum Intensity Projec-tion (MIP/MinIP)- Volume Rendering Technique (VRT) withadditional edge and surface enhancementsand control over rendering parameters- Shaded Surface Display (SSD)- Digitally Reconstructed Radiograph- Editor functionality (e.g. ClipBox)- Registration- Anatomical registration- Region growing- Automatic Spine Labeling, also for ribs in CTthorax scans 15 ("Rib labeling")	- Multiplanar reconstruction (MPR)- Maximum and Minimum Intensity Projec-tion (MIP/MinIP)- Volume Rendering Technique (VRT) withadditional edge and surface enhancementsand control over rendering parameters- Shaded Surface Display (SSD)- Digitally Reconstructed Radiograph- Editor functionality (e.g. ClipBox)- Registration- Anatomical registration- Region growing- Automatic Spine Labeling, also for ribs in CTthorax scans 16 ("Rib labeling")	Same
Quantitativealgorithms	Distance and angle measurements	Distance and angle measurements	Same
Supported Im-age GeneratingModalities	CT Image (Computed Tomography)- MR Image (Magnetic Resonance)- NM Image (Nuclear Medicine)- XA Image (X-Ray Angiography)- US Image (Ultrasound)- DX Image (Digital Radiography)- DICOM secondary capture objects	CT Image (Computed Tomography)- MR Image (Magnetic Resonance)- NM Image (Nuclear Medicine)- XA Image (X-Ray Angiography)- US Image (Ultrasound)- DX Image (Digital Radiography)- DICOM secondary capture objects	Same
Image dataCompression	Receive & Store:Images are received and stored as receivedwithout any change in the compression format.Display:Images are displayed as received without anychange in the compression.Lossy compression images are displayed withan indication to the user with the compressionratio.Export:To DICOM Node: Images are sent as per theDICOM negotiation. Uncompressed is pre-ferred and lossy compression is not supported.To Exchangeable media: Images exported asstored in the local storage.Supported Compressions for export: losslesscompression algorithms, JPEG, JPEG 2000and RLE.	Receive & Store:Images are received and stored as receivedwithout any change in the compression format.Display:The images are displayed as received withoutany change in the compression.Lossy compression images are displayed withan indication to the user with the compressionratio.Export:To DICOM Node and Exchangeable media:Images are sent as per the DICOM negotiationand depending on Compression settings. Lossycompression is not supported.Supported Compressions for export: losslesscompression algorithms, JPEG, JPEG 2000 andRLE.	syngo.via has theoption to config-ure the Imagecompression typefor export butsyngo.viaView&GO is nothaving the optionto configure.
Operating systems	Workplace:Microsoft Windows 7 – 64 bit SP1Microsoft Windows 10 – 64 bit	Client:Microsoft Windows XP, Microsoft WindowsVista, or Microsoft Windows 7Server:Microsoft Windows Server 2008 R2	There is no sepa-rate server in syn-go.via View&GO.
Software functionality	Graphical user interface with reduced colorpalette, clearer structure and text labels onicons.Online help system provided in terms of theelectronic user documents delivered as part ofthe installation of the medical device.Reporting functionality is not included in thesyngo.via View&GO however the support forcreation of reports with any 3rd party tool byenabling clipboard functionality.Patient browser with simplified search func-tionality, clearer structure of search results, un-limited search results, periodic updates ofsearch results.Range pre-sets are not supported.Suggested spine labels to be confirmed by user.	Graphical user interface with reduced colorpalette, clearer structure and text labels onicons.Online help system with improved search, in-dexing, filtering, library function, documentcollections, and user-generated content.Reporting with additional functionality to cre-ate one page reports, insert snapshot images,customize reports, and data export in variousformats.Patient browser with simplified search func-tionality, clearer structure of search results, un-limited search results, periodic updates ofsearch results, image preview and flexiblefloating patient browser window.Supports anatomical range pre-sets, support forspine ranges, and annotations as graphicaloverlays.Suggested spine labels to be confirmed by user,and additional smart placement of labels, alsoin inter-vertebra regions, support of 2D images,	syngo.viaView&GO is asimplified versionof syngo.viawithout the fol-lowing key func-tionalities whichare present insyngo.via:● Worklist han-dling● Task flow● Reporting● Findings Nav-igator
	and additional smart placement of labels, alsoin inter-vertebra regions, support of 2D images,support of multi-series studies, and added sup-port for rib labels.Basic printing with paper is supported.Configurable settings for image text.Added textual and graphical annotations, im-proved placement of measurement text, andchanged numbering of markers.	support of multi-series studies, and added sup-port for rib labels.Printing with additional options for rearrangingimages, adding annotations, full/customizedimage text, print size and orientation.Configurable settings for image text.Added textual and graphical annotations, im-proved placement of measurement text, andchanged numbering of markers.
Impact on Image Generating Devices	None.syngo.via View&GO is a pure post processingsoftware and there is no influence on the imagegenerating devices.	Nonesyngo.via is a pure post processing softwareand no influence on the image generating de-vices.	NA as both thedevices doesn'timpact the Imagegenerating devices.
CAD Functionalities	None.No automated diagnostic interpretation capa-bilities like CAD are included. All image dataare to be interpreted by trained personnel.	None.No automated diagnostic interpretation capa-bilities like CAD are included. All image dataare to be interpreted by trained personnel.	NA as both thedevices doesn'tsupport any CADfunctionalities.
Software self-test / checks	Intimate the user in case the data transfer is in-terrupted to the connected DICOM node.Hardware / Operating system compatibilitycheck during Installation.	Indicates the user in case that data comingfrom an interface cannot be assigned to a taskflow to assign it manually.In case of a data mismatch due to incorrect or	Additional checksare there in syngo.via as syn-go.via has the ad-ditional function-
	Medical device validation supports the end us-er to qualify their system for the clinical use.	inconsistent use of DICOM rules the adminis-trator can change the data transfer protocol andpatient identification rules.	alities like work-flow handling,task flow, report-ing.
Cyber Securi-ty	- User access control- Audit trails- Documentation of system security infor-mation, Network traffic & Firewall control- Support of virus / malware protection.	- User access control- Audit trails- Documentation of system security infor-mation, Network traffic & Firewall control- Support of virus / malware protection.- System Hardening	syngo.viaView&GOdoesn't providethe extensive sys-tem hardeningwhich is providedby syngo.via.
Hardware	Hardware is not understood as part of the med-ical device, but needs to comply with the min-imum requirements as specified by syngo.viaView&GO.	Hardware is not understood as part of the med-ical device, but needs to comply with the min-imum requirements as specified by syngo.via.	Same