syngo.via protoNeo supports interpretation and evaluation of examinations within healthcare institutions network, 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

Device Description

syngo®.via protoNeo, version VA20, is a medical software system that provides tools and features to cover the radiological tasks of reading images. The system receives, stores and distributes images from digital image acquisition devices such as computer tomography and magnetic resonance scanners. The system has workplaces which can be used to review, edit, and manipulate image data, as well as generate quantitative and qualitative data to support an authorized user in diagnosis and treatment planning.

syngo®.via protoNeo version VA20 is a software only medical device. It defines recommended configurations for the hardware to run on. The hardware itself is not seen as a medical device and is not within the scope of this 510(k) submission.

syngo®.via protoNeo is based on a client-server architecture. The server processes and renders the data from the connected modalities. The server provides central services including image processing and temporary storage while incorporating the local database. The client provides the user interface for interactive image viewing and processing and can be installed and stored on each workplace which is connected to the server over a network. Since the majority of the data processing is performed by the server, the client can be installed on standard off-the-shelf computers with a variety of monitor types. Using the industry standard application virtualization infrastructure, the client systems can also be distributed as a virtual application.

AI/ML Overview

The provided text describes a 510(k) premarket notification for syngo®.via protoNeo (Version VA20). It states that no clinical studies were carried out for this device. All performance testing was conducted in a non-clinical fashion as part of verification and validation activities. Therefore, it is important to note that the acceptance criteria and study details below are based on non-clinical performance testing and software verification and validation, not a clinical study involving human subjects or expert readers making diagnostic decisions.

Here's a breakdown of the information based on the provided document:

Acceptance Criteria and Reported Device Performance

Since no clinical study was performed, there are no specific performance metrics like sensitivity, specificity, or AUC reported from a clinical standpoint. The device relies on demonstrating substantial equivalence to its predicate device (syngo®.via protoNeo, K161685) through non-clinical performance testing and conforming to established standards.

The acceptance criteria are implicitly tied to the successful completion of the non-clinical verification and validation activities, demonstrating that:

The software functions as intended.
The software meets defined specifications.
The changes introduced in VA20 do not introduce new safety or effectiveness concerns compared to the predicate.
The device conforms to relevant industry standards (e.g., DICOM, ISO 14971, AAMI ES 60601-1, IEC 62304, IEC 62366-1, IEC 10918-1, IEC 15444-1).

The reported device performance, in this context, is that the system successfully passed these non-clinical tests and met the internal acceptance parameters for software functionality, image display, image manipulation algorithms, quantitative algorithms, automatic self-tests, dual monitor support, series navigator, and cybersecurity.

Acceptance Criteria (Implicit from V&V)	Reported Device Performance
Functional Equivalence: Device performs functions of intended use (viewing, manipulation, communication, storage of medical images) as per specifications.	Verification and validation testing confirms all software specifications have been implemented and met the defined acceptance criteria.
Image Display: Correct display of various DICOM modalities (Ultrasound, XA, RF, CT, MR, DX, CR, Nuclear Medicine, PET) and fused view.	Successful display of specified modalities.
Imaging Algorithms: Correct operation of MPR, MIP, VRT, CPR (with threshold based contour and stenosis display), Region Growing, Edge enhancement.	Algorithms operate as designed and specified during non-clinical testing.
Quantitative Algorithms: Accurate distance, angle, area, and pixel value evaluation, including SUV and Volume measurement enhancements.	Algorithms provide accurate measurements as designed during non-clinical testing.
Automatic Self-tests: Proper functioning of client installer checks, version checks, DICOM parser checks, and handling of missing image data.	Self-tests successfully detect and manage specified conditions.
Dual Monitor Support & Series Navigator: Proper functionality as new features.	Features operate correctly.
Cybersecurity: Secure login, encrypted client-server communication, and prevention of unauthorized access/modification/misuse.	Cybersecurity measures are implemented and demonstrate conformance by preventing unauthorized access, modification, misuse, denial of use or unauthorized use of information stored, accessed or transferred.
Conformance to Standards: Compliance with NEMA PS3.1-3.20 (DICOM), ISO 14971, ANSI/AAMI ES 60601-1, AAMI ANSI IEC 62304, IEC 62366-1, IEC 10918-1, IEC 15444-1.	Conformance to all listed standards is claimed.
Risk Analysis: Identified hazards mitigated, and controls verified.	Risk analysis conducted, mitigation controls implemented, and verified by V&V testing.
Software Level of Concern: Documentation for Moderate Level of Concern software included and compliant.	Documentation successfully submitted and deemed compliant with special controls.
No New Safety/Effectiveness Concerns: Device does not introduce new risks compared to predicate.	Siemens believes no new safety or effectiveness concerns are introduced.

Study Details Based on Provided Document:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not applicable. The document states, "No clinical studies were carried out for syngo.via protoNeo VA20. All performance testing was conducted in a non-clinical fashion as part of the verification and validation activities for the medical device." This implies testing was done on synthetic or de-identified datasets within the development environment, not a "test set" of clinical cases in the traditional sense.
- Data Provenance: Not applicable for a clinical test set. Non-clinical testing data provenance is not specified (e.g., country of origin, retrospective/prospective). It would typically be internal testing data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical test set was used, and therefore, no medical experts were involved in establishing ground truth for such a set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no clinical test set was used.
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:
- No MRMC comparative effectiveness study was done. The document explicitly states "No clinical studies were carried out."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone clinical performance study was done. The testing was non-clinical software verification and validation. The device itself is a Picture Archiving and Communication System (PACS) software solution intended for use by trained professionals, where the output is evaluated by clinicians.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical verification and validation, the "ground truth" would be the expected functional behavior and computed results based on the software's design specifications and algorithm definitions. This is established by the development team and subject matter experts in software engineering and medical imaging, comparing the software's output to known correct outputs or behaviors for specific inputs (e.g., pixel values, geometric calculations, image rendering). It is not expert consensus, pathology, or outcomes data from clinical cases.
The sample size for the training set:
- Not applicable. This device is a PACS solution, not a machine learning or AI algorithm that typically requires a large training set of annotated data for model development. Its functionality is based on established imaging algorithms and software engineering principles.
How the ground truth for the training set was established:
- Not applicable, as there is no mention of a training set or machine learning model development in the traditional sense for this PACS system.

Summary

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November 20, 2017

Siemens Healthcare GmbH % Dawn Tibodeau Third Party 510(k) Project Coordinator TUV SUD America Inc. 1775 Old Highway 8 NW NEW BRIGHTON, MN 55112

Re: K173378

Trade/Device Name: syngo®.via protoNeo (Version VA20) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: October 23, 2017 Received: October 30, 2017

Dear Dawn Tibodeau:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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Page 2 - Dawn Tibodeau

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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,

Michael D. O'Hara 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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K173378

Device Name syngo®.via protoNeo (Version VA20)

Indications for Use (Describe)

syngo.via protoNeo 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 protoNeo supports interpretation and evaluations within healthcare institutions' network, 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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

syngo®.via protoNeo (Version VA20)

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 19, 2017

1. Submitter

Siemens Healthcare GmbH Henkestrasse 127 D-91052 Erlangen Germany

Establishment Registration Number 3002808157

2. Contact Person

Mr. Abhineet Johri Regulatory Affairs Manager Siemens Healthcare GmbH 40 Liberty Boulevard Mail code: 65-3 Malvern, PA 19355 USA Email: abhineet.johri@siemens.com Telephone: +1 (484) 680 - 8723 Fax: +1 (610) 448 – 6557

3. Device Name and Classification

Trade Name:	syngo®.via protoNeo (Version VA20)
Classification Name:	Picture Archiving and Communication 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 protoNeo
510(k) Clearance:	K161685

©Siemens Healthcare GmbH, 2017

40 Liberty Boulevard Malvern, PA 19355-9998 USA

Tel.: +1-888-826-9702 www.usa.siemens.com/healthcare

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Clearance Date: Classification Name: Classification Panel: CFR Section: Device Class: Product Code: Recall Information:

July 11, 2016 Picture Archiving and Communication System Radiology 21 CFR §892.2050 Class II LLZ This predicate device has not been the subject of any design related recalls.

5. Device Description

This premarket submission addresses the Siemens syngo®.via protoNeo Version VA20 Picture Archiving and Communication System.

The quality of displayed images highly depends on the quality and settings of monitors, graphics cards, and graphics drivers. It is the customer's responsibility that client monitors are compatible with graphics cards and graphics drivers. It is also the customer's responsibility to use suitable monitors for diagnostic purposes.

In the United States, monitors (displays) should not be used for diagnosis, unless the monitor (display) has specifically received 510(k) clearance for this purpose.

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syngo®.via protoNeo and its predicate device have the same fundamental technical characteristics.

6. Intended Use

syngo.via protoNeo 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 protoNeo supports interpretation and evaluation of examinations within healthcare institutions network, 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

7. Summary of Differences Between the Subject Device and the Predicate Device

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

Functionality	syngo®.via protoNeoversion VA20	syngo®.via protoNeoversion VA10A(K161685)
Patient Browser	Yes, Import, Query and retrieveavailable	Yes
Image Display	DICOM Ultrasound, XA, RF, CT,MR, DX, CR and NuclearMedicine, including PET.Fused view.	CT and MR
Imaging Algorithms	- Multiplanar reconstruction(MPR)- Maximum Intensity Projection(MIP)- Volume Rendering Technique(VRT) with edge and surfaceenhancements and controlover rendering parameters- MPR Curved (Curved PlanarReformat, CPR) with thresholdbased contour and stenosisdisplay- Region growing- Edge enhancement( UnsharpMasking Technique)	- Multiplanar reconstruction(MPR)- Maximum Intensity Projection(MIP)- Volume Rendering Technique(VRT) with edge and surfaceenhancements and controlover rendering parameters- MPR Curved (Curved PlanarReformat, CPR)- Region growing

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QuantitativeAlgorithms	Distance, angle, area, and pixelvalue evaluation including SUVand Volume measurementenhancements	Distance, angle, area, and pixelvalue evaluation.
Automatic self tests	- Client installer checks that theclient has supported version of.NET framework- A version check for compatibilitybetween client and server onevery start-up- DICOM parser checks if theimage object is corrupted- If there is image missing in avolume, show the accordingmessage to the user and thenload the data to 2D view only	- Client installer checks that theclient's has supported version of.NET framework- A version check forcompatibility between client andserver on every start-up- DICOM parser checks if theimage object is corrupted- If there is image missing in avolume, do not load the data andask the user to check datasource
Dual monitor support	Yes	No
Series navigator	Yes	No
Cyber security	Login with encryptionClient-server communicationencrypted	Login with encryption

8. Clinical Testing

No clinical studies were carried out for syngo.via protoNeo VA20. All performance testing was conducted in a non-clinical fashion as part of the verification and validation activities for the medical device.

9. Non-Clinical Performance Testing

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

Siemens claims conformance to the following standards:

. NEMA PS3.1-3.20. 2016: Digital Imaging and Communications in Medicine (DICOM)
ISO 14971:2007 .
ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012, clauses 14.11 and 14.13 .
. AAMI ANSI IEC 62304: 2006
IEC 62366-1:2015 .
. IEC 10918-1:1994 + Technical Corrigendum 1:2005
IEC 15444-1:2005 + Technical Corrigendum 1:2007 .

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Software Verification and Validation

In accordance with the FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, documentation is included within this submission for software of a Moderate Level of Concern. Non-clinical Testing was conducted during product development. Evidence provided within this submission demonstrates conformance with special controls for medical devices containing software.

Cybersecurity considerations related to syngo.via protoNeo are included within this submission. Siemens conforms to cybersecurity requirements by implementing a means to prevent unauthorized access, modification, misuse, denial of use or unauthorized use of information stored, accessed or transferred from a medical device to an external recipient.

A risk analysis, in compliance with ISO 14971:2007, for syngo.via protoNeo was conducted and mitigation controls were implemented for identified hazards. Verification and validation testing confirms that all software specifications have been implemented met the defined acceptance criteria. Further, documentation is provided to support the claim of substantial equivalence.

10. Safety and Effectiveness Information

Device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of this device. Risk management was implemented throughout the development process to control potential hazards.

The device does not come into contact with the patient and is only used by trained professionals. The output of the device is evaluated by clinicians, providing for sufficient review to identify and intervene in the event of a malfunction.

Siemens believes that syngo.via protoNeo version VA20 is safe and effective as the identified predicate device and does not introduce new safety and effectiveness concerns.

11. Conclusion as to Substantial Equivalence

The comparison of intended use, technological characteristics, performance specifications, device hazards as well as verification and validation results demonstrate that syngo.via protoNeo is safe, effective and performs as well as the predicate device.

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In summary, Siemens is of the opinion that syngo.via protoNeo version VA20 does not introduce any new significant potential safety risks and 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).