The syngo Application Software is a medical software for real-time viewing, image manipulation, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing and for viewing and post processing during interventional procedures.

The syngo Application Software can be deployed on independent hardware such as a stand-alone diagnostic review, postprocessing, and reporting workstation. It can also be configured within a network to send and receive DICOM data. Furthermore, the syngo Application Software can be deployed on systems Angiography system family. It provides image guided solutions in the operating room, for image guided surgery, by Image Fusion and by navigation systems, image guided solutions in interventional cardiology and image guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology.

The syngo Application Software can also be combined with fluoroscopy systems or Radiographic systems.

The syngo Application Software can be configured with a variety of syngo or Windows-based software options, which are intended to assist the physician in diagnosis, treatment control. It includes commercially available post-processing techniques and OEM options.

Procedures that can be performed include: minimally invasive surgical procedures and minimally invasive tumor treatment.

Device Description

The syngo Application Software is medical diagnostic software for real-time viewing, diagnostic review, post-processing, image manipulation, optimization, communication, reporting and storage of medical images and data on exchange media. It provides image guided solutions in the operating room, for image guided surgery, by Image Fusion and by navigation systems, image guided solutions in interventional cardiology and electrophysiology and image guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. It can be deployed with a variety of syngo or Windows based software options, which are intended to assist the physician in evaluation of digital radiographic examinations, including diagnosis and/or treatment planning.

Siemens syngo Application Software is designed to work with digital radiographic, fluoroscopic, interventional and angiographic systems. The software platform with common software architecture, syngo application packages and basic services is the same as used with the syngo Application Software (K153346).

AI/ML Overview

The document provides information on the Siemens syngo Application Software, which is an update to a previously cleared device. The focus of the provided text is on demonstrating the substantial equivalence of the updated software features to the predicate device.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the acceptance criteria are generally described as "clinically accepted" and that "all acceptance criteria have been met." The reported device performance is qualitative, focusing on whether the updated automated features raise new issues of safety or effectiveness.

Feature Update	Acceptance Criteria	Reported Device Performance and Comparison
syngo EVAR Guidance	Updated automated feature does not raise any new issues of safety or effectiveness.	No new issues of safety or effectiveness. System Software Validation and testing was conducted.
syngo CTO Guidance	Updated automated feature does not raise any new issues of safety or effectiveness.	No new issues of safety or effectiveness. Validation and testing was conducted.
Automatic model-based LA segmentation	Updated automated feature does not raise any new issues of safety or effectiveness.	No new issues of safety or effectiveness. Validation and testing was conducted.
Improvements of DynaCT image quality	Improved image quality does not raise any new issues of safety or effectiveness.	No new issues of safety or effectiveness. Validation and testing was conducted.

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

The document does not specify a distinct "test set" with a particular sample size or data provenance (country of origin, retrospective/prospective). The evaluations seem to be part of the overall "Verification and Validation" process conducted during product development. The statement "All results are clinically accepted by either a board certified cardiologist or radiologist" suggests that clinical data was involved, but the specifics are not detailed.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document states: "All results are clinically accepted by either a board certified cardiologist or radiologist." This indicates that at least two experts (a cardiologist and a radiologist) were involved in evaluating the results. Their qualification is "board certified." The document does not specify how many individual experts were consulted or if specific experience levels (e.g., "10 years of experience") were required beyond board certification.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for establishing ground truth for a test set (e.g., 2+1, 3+1). The phrase "clinically accepted by either a board certified cardiologist or radiologist" suggests an expert review process, but the specific decision-making protocol is not detailed. It's possible that consensus was reached, or individual expert opinions were considered sufficient for acceptance.

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

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance. The focus is on the performance of the software updates themselves and their safety and effectiveness compared to the predicate device, not on their impact on human reader performance.

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

The document implies a standalone evaluation of the algorithm's performance as part of the "Verification and Validation testing." The descriptions of "Automatic segmentation of the aorta and vessel tree," "Automatic centreline extraction," and "Automatic model-based LA segmentation" suggest that the algorithmic output was assessed directly. However, it's not explicitly stated as a separate "standalone study." The acceptance criteria focus on whether these automated features raise new safety or effectiveness issues, which inherently involves evaluating their output.

7. Type of Ground Truth Used

The ground truth appears to be expert consensus/clinical acceptance. The statement "All results are clinically accepted by either a board certified cardiologist or radiologist" points to human expert interpretation as the basis for assessing the software's output. There is no mention of pathology or outcomes data being used as ground truth.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set for the updated software features.

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

The document does not provide any information on how the ground truth for the training set was established for the updated software features.

Summary

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

November 16, 2016

Siemens Medical Solutions USA, Inc. % Ms. Patricia Jones Sr. Regulatory Affairs Specialist 40 Liberty Boulevard 65-1A MALVERN PA 19355

Re: K162541

Trade/Device Name: syngo Application Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 3, 2016 Received: November 4, 2016

Dear Ms. Jones:

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/Resourcesfor You/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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

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

510(k) Number (if known)

K162541

Device Name

syngo Application Software

Indications for Use (Describe)

The syngo Application Software can also be combined with fluoroscopy systems or Radiographic systems.

The syneo Application Software can be configured with a variety of syngo or Windows-based software options, which are intended to assist the physician in diagnosis, treatment control. It includes commercially available post-processing techniques and OEM options.

Procedures that can be performed include: minimally invasive surgical procedures and minimally invasive tumor treatment.

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."

FORM FDA 3881 (8/14)

Page 1 of 1

PSC Polisbioz Services (3)1) 443-6749

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510(k) Summary: synqo Application Software

Siemens Medical Solutions USA, Inc. Company: 40 Liberty Boulevard, 65-1A Malvern, PA 19355

November 3, 2016 Date Prepared:

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

1. General Information: Importer / Distributor: Siemens Medical Systems USA. Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Establishment Registration Number: 2240869
  Manufacturing Site: Siemens Healthcare GmbH Siemensstr. 1 91301 Forchheim, Germany Establishment Registration Number: 3004977335

2. Contact Person:

Ms. Patricia D Jones Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Phone: (610) 448-6474 Fax: (610) 640-4481 Email: patricia.d.jones@siemens.com

1. Device Name and Classification: Trade Name: syngo Application Software Classification Name: Picture Archiving and Communications system Classification Panel: Radiology 21 CFR §892. 2050 Classification Regulation:
  Device Class: Product Code:

Class II LLZ

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SIEMENS

Legally Marketed Predicate Device 4.
syngo Application Software Trade Name: 510(k) Clearance K153346 Clearance Date March 4, 2016 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 has not been the subject of any design related recalls.

Device Description: 5.

Siemens Medical Solutions USA, Inc. hereby submits this Traditional 510(k) to request clearance for updated software features to the syngo Application Software.

Proposed Device Modifications:

1. Updated software feature syngo EVAR Guidance
1. Updated software feature syngo CTO Guidance
1. Updated software feature: Automatic model-based LA segmentation
1. Further Improvement of syngo DynaCT image quality
1. Proposed new product claims associated with device

The "syngo Application Software" may be installed either on Siemens released PC hardware or on Siemens X-ray systems also known as Siemens Angiography Systems. The combination of syngo Application Software and the Siemens released PC Hardware will be marketed as components of the syngo X Workplace.

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The syngo Application Software is within the same classification requlation and the intended use and the general Indications for Use Statement for Siemens' Picture Archiving and Communications System.

6. Indications for Use:

The syngo Application Software is a medical software for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing and for viewing and post processing during interventional procedures.

The syngo Application Software can be deployed on independent hardware such as a stand-alone diagnostic review, post-processing, and reporting workstation. It can also be configured within a network to send and receive DICOM data. Furthermore, the synqo Application Software can be deployed on systems of the Siemens Angiography system family. It provides image quided solutions in the operating room, for image quided surgery, by Image Fusion and by navigation systems, image quided solutions in interventional cardiology and electrophysiology and image quided solutions for interventional oncology, interventional radiology, and interventional neuroradiology.

The syngo Application Software can also be combined with fluoroscopy systems or Radiographic systems.

The syngo Application Software can be configured with a variety of syngo or Windows-based software options, which are intended to assist the physician in diagnosis, treatment planning and treatment control. It includes commercially available post-processing techniques and OEM options.

Procedures that can be performed include: minimally invasive surgical procedures and minimally invasive tumor treatment.

7. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device:

The subject device is comparable to general Indications for Use for medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media. The subject device has the same intended use, functionality, technology and is considered substantially equivalent to the commercially available Siemens' syngo Application Software.

All Software components of the subject device are the same as the one from the predicate device except for three updated software applications 1) synqo EVAR guidance and 2) syngo CTO Guidance and two further improved software

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applications 3) Automatic model-based LA seqmentation and 4) DynaCT: further improvement of image quality. The table below provides comparison of the Subject Device modification to the Predicate Device.

Subject and Predicate Device Comparison Information
Property	Subject Device:syngo Application Software	Predicate Device:syngo Application Software(K153346)	ComparisonResults
UpdatedSoftware-Applications	syngo EVAR Guidance:Automatic segmentation of theaorta and vessel treeAutomatic identification andmarking of anatomical structures	Manual segmentation of theaorta using punchingfunctionality, manual markingof anatomical structures usingsyngo Toolbox functionality	Updated automatedfeature does not raiseany new issues ofsafety oreffectiveness. SystemSoftware Validationand testing wasconducted
	syngo CTO Guidance:Automatic centreline extractionWarp view of CT data set	Manual marking of coronarysegments using syngo ToolboxfunctionalityVRT display of CT data set	Updated automatedfeature does not raiseany new issues ofsafety oreffectiveness.Validation and testingwas conducted
Updatedsoftwarefeature:	Automatic model-based LAsegmentation	One click LA segmentation	Updated automatedfeature does not raiseany new issues ofsafety oreffectiveness.Validation and testingwas conducted.
Furthermodifications:	Improvements of DynaCT imagequality:Reduce cupping and cappingartifactsImprove visualization ofintracranial soft-tissue	Standard Image quality:Visualization of intracranialsoft-tissue	Improved imagequality does not raiseany new issues ofsafety oreffectiveness.Validation and testingwas conducted.

The Subject Device modifications do not alter its fundamental scientific technology from the 510(k) cleared predicate device Siemens' syngo Application Software.

8. Nonclinical Performance Testing:

Non-clinical tests were conducted for the syngo Application Software during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.

Siemens claims conformance to the following performance standards: 14971; 60601-1-6; 62304; 62366; and NEMA PS3.

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

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conformance with special controls for medical devices containing software. Nonclinical tests were conducted on the syngo Application Software during product development.

The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports 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.

The Human Factor Usability Validation showed no safety relevant functions that need to be validated with a summative usability validation according to the IEC and FDA Guidelines. The syngo Application Software has been found to be safe and effective for intended users, uses and use environments through the design control verification and validation process. No further risk mitigations are necessary.

Siemens 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. Provided in this submission is a cybersecurity statement that considers IEC 80001-1:2010. The responsibility for compliance with IEC 80001-1-2010 is the hospital. Provided in the Software Section, is the required cybersecurity information.

Summary:

Verification and Validation testing was conducted on the following device software modifications: 1) Updated software feature syngo EVAR Guidance 2) Updated software feature syngo CTO Guidance 3) Updated software feature: Automatic model-based LA segmentation as part of synqo LA segmentation 4) Further Improvement of syngo DynaCT image quality All results are clinically accepted by either a board certified cardiologist or radiologist - all acceptance criteria have been met. All software validation data demonstrates that the subject device is as safe, and effective when compared to the predicate device that is currently marketed for the same intended use.

Performance tests were conducted to test the functionality of the syngo Application Software. These tests have been performed to assess the overall system functionality of the subject device. Results of all conducted testing and clinical assessment were found acceptable and do not raise any new issues of safety or effectiveness.

9. General Safety and Effectiveness Concerns:

Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner.

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Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing. To minimize electrical hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing. Furthermore the operators are health care professionals familiar with and responsible for the evaluating and post processing of medical images.

10. Conclusion as to Substantial Equivalence:

The predicate device was cleared based on non-clinical supportive information and clinical images and data. Similar non-clinical test results demonstrate that syngo Application Software acceptance criteria are adequate for the intended use of the device. The comparison of technological characteristic, non-clinical performance data, clinical images, and software validation data demonstrates that the subject device is as safe, and effective when compared to the predicate device that is currently marketed for the same intended use.

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).