syngo via protoNeo 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 U.S.

Device Description

syngo®.via protoNeo, version VA10A, 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 imaqe data, as well as generate quantitative and qualitative data to support an authorized user in diagnosis and treatment planning.

syngo®.via protoNeo version VA10A 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 that has a network connection to the server.

AI/ML Overview

The provided document is a 510(k) summary for the syngo®.via protoNeo (Version VA10A) software. This document primarily focuses on demonstrating substantial equivalence to a predicate device (syngo.via VB10A) rather than presenting a detailed study with specific acceptance criteria and performance metrics in the way one might expect for an AI/ML diagnostic algorithm.

Here's an analysis based on the information provided, highlighting what's available and what's missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document in the format requested. The document states that "Verification and validation testing confirms that all software specifications have been implemented met the defined acceptance criteria." However, the specific acceptance criteria and the quantitative or qualitative results demonstrating that these criteria were met are not detailed.

The device is a Picture Archiving and Communication System (PACS) software, which is a viewing, communication, and storage solution for medical images. The acceptance criteria would likely be related to aspects like:

Image display accuracy: Ensuring images are displayed correctly without distortion or loss of information.
Data integrity: Confirming that images and associated data are stored and retrieved without corruption.
Performance (speed): Meeting specified requirements for image loading, manipulation, and processing times.
Functionality: Verification that all features (MPR, MIP, VRT, patient browser, ranges, export) work as intended.
Compatibility: Ensuring interoperability with various DICOM-compliant devices and operating systems.
Security: Compliance with cybersecurity requirements.

Since this is a 510(k) for a PACS, the "performance" isn't typically measured by clinical metrics like sensitivity or specificity for disease detection, but rather by the reliable functioning of its intended features.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided. The document mentions "Non-clinical testing was conducted for the device syngo.via protoNeo during product development" and "The modifications described in this Premarket Notification were supported with verification and validation testing." However, details regarding the specific test sets used, their sample sizes, or their provenance (e.g., country of origin, retrospective/prospective) are absent. These would typically be internal testing datasets.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided. Given that this is a PACS software and not a diagnostic AI algorithm, the concept of "ground truth" for a test set in the clinical diagnostic sense (e.g., presence or absence of a disease) doesn't directly apply. The testing would likely involve software engineers and quality assurance personnel verifying feature functionality against specifications. If clinical experts were involved, their role would be to validate the utility and accuracy of image display and manipulation features from a clinical perspective, but this is not detailed.

4. Adjudication Method for the Test Set

This information is not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not performed or reported. This type of study is specifically designed to evaluate the clinical effectiveness of a diagnostic tool, often an AI algorithm, by comparing human reader performance with and without the tool. The syngo®.via protoNeo is PACS software, not a diagnostic AI algorithm intended to provide primary diagnostic interpretations or assist human readers in a measurable way that would require an MRMC study for this 510(k). The purpose of this submission is to demonstrate substantial equivalence of a general imaging viewing and archiving system.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not directly applicable and therefore not reported in the context of a standalone diagnostic algorithm. The device, as PACS software, is inherently used by "trained professionals" (clinicians) who evaluate its output. Its performance is about its operational capabilities (displaying, storing, manipulating images) rather than an independent diagnostic decision.

7. Type of Ground Truth Used

The concept of "ground truth" as pathology, outcomes data, or expert consensus for disease detection is not relevant for this type of PACS software submission. The "ground truth" for the non-clinical performance testing would be the pre-defined software specifications and expected functional behavior, which are verified through various tests.

8. Sample Size for the Training Set

This information is not applicable and not provided. The syngo®.via protoNeo is a PACS software system with image viewing and manipulation functionalities based on traditional software engineering principles, not a machine learning or AI algorithm that requires a "training set" in the common sense.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided for the same reasons as #8.

Summary of Device and Evidence provided relevant to the prompt (based on interpretation of PACS software):

The document describes the syngo®.via protoNeo (Version VA10A) as a Picture Archiving and Communication System (PACS) software. Its primary functions are viewing, manipulation, communication, and storage of medical images (CT and MR).

Acceptance Criteria (Inferred from product type and description):

Acceptance Criteria Category	Reported Device Performance (Inferred/Stated)
Image Handling & Display	Stated: Supports viewing, manipulation, communication, and storage of medical images from digital image acquisition devices (CT, MR).
	Implied: Accurate display of images, allowing review, editing, and manipulation of image data.
Functionality	Stated Capabilities: Multiplanar reconstruction (MPR), Maximum Intensity Projection (MIP), Volume Rendering Technique (VRT) with edge and surface enhancements and control over rendering parameters, MPR Curved (Curved Planar Reformat, CPR), Region growing. Patient Browser with simplified search and clearer structure. Simplified ranges control panel. Export to other DICOM nodes.
	Implied Performance: All listed functionalities operate as specified.
Data Integrity & Storage	Stated: Receives, stores, and distributes images. Server provides central services including image processing and temporary storage, incorporating a local database.
	Implied Performance: Data is accurately stored and retrieved without corruption.
Interoperability	Stated: Conforms to NEMA PS3 Digital Imaging and Communications in Medicine (DICOM). Compatible with Microsoft Windows 7 (client) and Microsoft Windows Server 2012 R2 (server). Minimum network bandwidth 3 Mbits/second, 50 ms round-trip.
	Implied Performance: Seamless integration and communication with DICOM-compliant modalities and other systems within a healthcare institution.
Safety & Effectiveness	Stated: "Verification and validation testing confirms that all software specifications have been implemented met the defined acceptance criteria." Risk analysis conducted (ISO 14971:2007) and mitigation controls implemented. Conforms to cybersecurity requirements (prevent unauthorized access, modification, misuse, etc.). Device labeling contains instructions for use and necessary cautions/warnings. Output evaluated by clinicians to identify/intervene in malfunction. "Siemens believes that syngo.via protoNeo version VA10A is safe and effective as the identified predicate device and does not introduce new safety and effectiveness concerns."
Regulatory Compliance	Stated: Conforms to ISO 14971:2007, ANSI/AAMI ES 60601-1, IEC 62304:2006, IEC 62366-1:2015, IEC 10918-1:1994 + Technical Corrigendum 1:2005, IEC 15444-1:2005 + Technical Corrigendum 1:2007. Software verification and validation conducted according to FDA guidance for "Moderate Level of Concern."

Study Details:

Sample Size (Test Set) & Data Provenance: Not specified. Testing was "Non-clinical," conducted "during product development." These would be internal verification and validation datasets.
Number of Experts & Qualifications for Ground Truth: Not specified. Not directly applicable in the sense of clinical 'ground truth' for diagnosis.
Adjudication Method: Not specified.
MRMC Comparative Effectiveness Study: Not performed/reported.
Standalone Study: Not performed/reported in the sense of a standalone diagnostic algorithm. The device performance is its operational functionality.
Type of Ground Truth: Software specifications, functional requirements, and recognized industry standards (DICOM, various IEC/ISO standards).
Sample Size for Training Set: Not applicable (not an AI/ML algorithm requiring a training set).
Ground Truth for Training Set: Not applicable.

This 510(k) is for a foundational software system for medical image management, and the evidence provided aligns with the requirements for such a device, focusing on functional performance, safety, and substantial equivalence to existing similar systems. It does not involve the type of clinical efficacy studies typically required for novel diagnostic algorithms.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 11, 2016

Siemens Healthcare GmbH % Mr. Georg Bauer Responsible Third Party Official 510(k) TPR Deputy Program Manager TÜV SÜD America, Inc. 1775 old highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891

Re: K161685

Trade/Device Name: syngo®.via protoNeo (Version VA10A) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 14, 2016 Received: June 17, 2016

Dear Mr. Bauer:

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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D.'Hara

For

Robert 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) K161685

Device Name syngo®.via protoNeo (Version VA10A)

Indications for Use (Describe)

syngo via protoNeo 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 protoNeo 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 U.S.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CER 801 Subpart D)	☐ Over-The-Counter Use (21 CER 801 Subpart C)
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510(k) Summary

syngo®.via protoNeo (Version VA10A)

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: June 1, 2016

1. Submitter

Siemens Healthcare GmbH Henkestrasse 127 D-91052 Erlangen Germany

Establishment Registration Number 3002808157

2. Contact Person

Ms. Lauren Bentley Regulatory Affairs Manager Siemens Healthcare GmbH 40 Liberty Boulevard Mailcode: 65-3 Malvern, PA 19355 USA Email: lauren.bentley@siemens.com Telephone: +1 (610) 448 - 6104 Fax: +1 (610) 448 – 6557

3. Device Name and Classification

Trade Name:	syngo®.via protoNeo (Version VA10A)
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
510(k) Clearance:	K150843
Clearance Date:	April 24, 2015

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Classification Name:	Picture Archiving and Communication System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.2050
Device Class:	Class II
Product Code:	LLZ
Recall Information:	This predicate device has not been the subject of anydesign related recalls.

5. Device Description

This premarket submission addresses the Siemens syngo®.via protoNeo Version VA10A Picture Archiving and Communication System.

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. 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.

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

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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 synqo based software options.

syngo.via protoNeo 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

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:

	Subject Devicesyngo.via protoNeo VA10A	Predicate Devicesyngo.via VB10A
Manufacturer	Siemens Healthcare GmbH	Siemens AG
SoftwareArchitecture	Client-server architecture withenhanced business logic on theclient side.	Client-server architecture
Network Bandwidth	Minimum:3 Mbits/second, 50 ms round-trip	Minimum:1 Gbit ethernet3
Operating System	Client:Microsoft Windows 7Server:Microsoft WindowsServer 2012 R2	Client:Microsoft Windows 7 SP1 orMicrosoft Windows 8.1Server:Microsoft Windows Server2008 R2, or Microsoft WindowsServer 2012 R2
Patient Browser	Yes, with simplified searchfunctionality and clearerstructure of search results	Yes
Ranges	Yes, with a simplified rangescontrol panel.	Yes
Image Display	CT and MR	DICOM Ultrasound, XA, CT,MR, DX, DR and NuclearMedicine, including PET.
Imaging Algorithms	- Multiplanar reconstruction(MPR)- Maximum Intensity Projection(MIP)- Volume Rendering Technique	- Multiplanar reconstruction(MPR)- Maximum Intensity Projection(MIP)- Volume Rendering Technique

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	(VRT) with edge and surfaceenhancements and controlover rendering parameters- MPR Curved (Curved PlanarReformat, CPR)- Region growing	(VRT) with edge and surfaceenhancements and control overrendering parameters- MPR Curved- Region growing
Export Data Sets viaNetwork Means	Export to other DICOM nodes.	Export to Windows file system, orother DICOM nodes.

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

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.

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9. 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 VA10A is safe and effective as the identified predicate device and does not introduce new safety and effectiveness concerns.

10. 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.

In summary. Siemens is of the opinion that syngo.via protoNeo version VA10A 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).