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 electrophysiology 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 includes minimally invasive surgical procedures and minimally invasive tumor treatment.

Device Description

The "syngo Application Software" (VE21) is medical diagnostic software for realtime 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" (VE21) is designed to work with digital radiographic, fluoroscopic, interventional, and angiographic systems.

AI/ML Overview

This document describes the syngo Application Software (VE21), which is a medical software for viewing, manipulating, and storing medical images. The submission is for an updated version (VE21) which includes an updated feature called syngo TrueFusion.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a quantitative format for the syngo Application Software (VE21). Instead, it describes functional changes and verification that these changes meet expected behavior.

The key acceptance criteria and reported performance for the updated syngo TrueFusion feature are described as follows:

Acceptance Criteria (Implied)	Reported Device Performance
syngo TrueFusion update: Successful overlay of ultrasound B-mode and color doppler images onto fluoroscopy images.	"The test results passed and concluded that the syngo TrueFusion image overlay functionality corresponds to the clinical workflow to utilize ultrasound images with X-ray image information."
syngo TrueFusion update: Maintenance of ultrasound image overlay functionality when stand parameters of the imaging system change and/or if X-ray is acquired.	"Overlay Images Volume and Overlay Image Change Stand X-ray verifies that the ultrasound images were sent from US system and that the US image overlay is working if the stand parameters of the imaging system change and / or if X-ray is acquired. All conducted test result passed."
Overall software functionality, safety, and effectiveness in comparison to the predicate device.	"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." and "The testing results supports that all the software specifications have met the acceptance criteria." and "Results of all conducted testing were found acceptable and do not raise any new issues of safety or effectiveness."

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

The document does not provide a specific sample size for the test set used for the updated syngo TrueFusion feature. It mentions "Bench tests were conducted" and "The following test were conducted...: Overlay Images Volume and Overlay Image Change Stand X-ray." but does not quantify the number of cases or images tested.

The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. Given that it refers to "Bench tests" and "software validation data," it implies internal testing rather than a clinical study with patient data.

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

The document does not mention the use of experts or the establishment of ground truth by experts for the test set. The validation appears to be based on functional testing against predefined specifications and clinical workflow expectations, rather than a diagnostic accuracy study needing expert-labeled ground truth.

4. Adjudication Method for the Test Set

No adjudication method is mentioned as there's no indication of a diagnostic accuracy study involving multiple readers and a ground truth establishment process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study is mentioned. The submission focuses on the functional updates of existing software and claims substantial equivalence to the predicate device based on non-clinical performance and software validation. There is no information about human readers improving with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The testing described (bench tests, software validation) focuses on the syngo Application Software (VE21) as a standalone software product's functionality in performing its specified tasks (e.g., image overlay). While it's software for human interpretation and use in interventional procedures, the performance testing discussed is of the software's functionality itself, rather than an AI algorithm's diagnostic performance in isolation on a set of cases. The document does not describe specific "algorithm-only" performance metrics in the context of, for example, a diagnostic AI.

7. The Type of Ground Truth Used

The ground truth for the functional testing appears to be based on predefined software specifications and expected clinical workflow behavior. The document states, "The test results passed and concluded that the synqo TrueFusion image overlay functionality corresponds to the clinical workflow..." This implies that the software's output was compared against what is considered correct and clinically acceptable by the developers based on internal standards and design. There is no mention of pathology, expert consensus on patient cases, or outcomes data as ground truth.

8. The Sample Size for the Training Set

The document describes an updated software feature for an existing application. It does not refer to the development or training of a new AI model with a distinct training set. If there are underlying machine learning components within syngo TrueFusion (which isn't explicitly stated but could be inferred from image fusion), the sample size for any training data is not provided. The focus is on the verification and validation of the software update itself.

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

Since there is no mention of a distinct training set or an AI model training process, there is no information on how its ground truth might have been established. The submission focuses on verifying the functional correctness of software updates rather than the performance of a newly trained AI model.

Summary

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August 16, 2022

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Siemens Medical Solution USA, Inc. % Patricia Jones Regulatory Affairs Professional 40 Liberty Boulevard MALVERN PA 19355

Re: K220433

Trade/Device Name: syngo Application Software Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: July 7, 2022 Received: July 11, 2022

Dear Patricia 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Laurel Burk, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220433

Device Name syngo Application Software

Indications for Use (Describe)

Procedures that can be performed includes 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)

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K220433

Image /page/3/Picture/1 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a cluster of orange dots.

510(k) Summary: syngo Application Software (VE21)

Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, Malvern, PA 19355

Date of Preparation: August 11, 2022

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, Malvern, PA 19355 Establishment Reqistration Number: 2240869

Manufacturing Site: Siemens Healthcare GmbH Siemensstr. 1 91301 Forchheim. Germany Establishment Registration Number: 3004977335

2. Contact Person:

Ms. Patricia D Jones Regulatory Affairs Professional Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Phone: (678) 575-8832 Email: patricia.jones@siemens-healthineers.com

3. Device Name and Classification:

Trade Name: Classification Name:

Classification Panel: Classification Regulation: Device Class: Product Code:

syngo Application Software Medical Image Management and Processing System Radiology 21 CFR §892. 2050 Class II LLZ

1. Legally Marketed Predicate Device Trade Name: syngo Application Software K190780 510(k) Clearance Clearance Date 09/12/2019

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Image /page/4/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a cluster of orange dots of varying sizes.

Classification Name:

Classification Panel: Classification Requlation: Device Class: Product Code: Recall Information:

Medical Image Management and Processing 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:

Siemens "syngo Application Software" (VE21) is designed to work with digital radiographic, fluoroscopic, interventional, and angiographic systems.

Siemens Medical Solutions USA, Inc. hereby submits this 510(k) to request clearance to market the updated optional post-processing software feature: 1) Updated syngo TrueFusion; and 2) Updated 510(k) Information for the predicate device. The updated feature is included in this submission for syngo Application Software (VE21).

The "syngo Application Software" may be installed either on Siemens released PC hardware, on Siemens X-ray systems or on Siemens angiography systems, The "syngo Application Software" (VE21) is within the same classification requlation and the intended use and the general Indications for Use Statement for Siemens' Picture Archiving and Communications System remains the same.

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.

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Image /page/5/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern.

Furthermore, the syngo Application Software can be deployed on systems of the Siemens 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 electrophysiology 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 planning and treatment control. It includes commercially available post-processing techniques and OEM options.

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

Summary of Technological Characteristics of the Subject Device as 7. Compared with the Predicate Device:
The subject device has the same intended use as the predicate device. Besides the proposed device modifications, the Subject Device has the same functionality and technology. Therefore the subject device is considered substantially equivalent to the commercially available Siemens' "syngo Application Software" (VE20).

All software components of the subject device are the same as the ones from the predicate device except for the new optional software applications as presented in the table below:

Property	Subject Device:"syngo Application Software" (VE21)	Predicate Device:"syngo Application Software" (VE20)(K190780)
UpdatedSoftware-Applications	1. Updated syngo ApplicationSoftware (VE21)	Updated syngo Application Software(VE20)
ComparisonResults	Modified:syngo Application Software version (VE21) was updated to include:syngo TrueFusion has been updated so that ultrasound B-mode and colordoppler images can continuously be overlaid onto fluoroscopy images. Inthe previous software it was only possible to overlay ultrasound landmarksand heart valve models.The syngo TrueFusion (VE21) conforms to FDA Software Guidance document.Bench tests were conducted and were found acceptable and did not raise anynew issues of safety or effectiveness. All software validation datademonstrates that the Subject Device is as safe and effective when comparedto the Predicate Device that is currently marketed for the same intended use.

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Image /page/6/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the text is a graphic of orange dots arranged in a circular pattern.

Update 510(kInformation	2. Updated 510(k) information for the predicate device contains thefollowing features approved via the internal non-filing justificationprocess, which are applicable to the subject device are:• 3rd Party Software name change from Quant to QuantWeb• Added "Send to Quant" button• Name change from syngo Needle Guidance to myNeedle Guide
ComparisonResults	The above listed non-filing justifications were considered comparable andapproved as additional modifications post 510(k) clearance and used as theselected predicate for the Subject Device. All software validation datademonstrates that the Subject Device is as safe and effective when comparedto the Predicate Device that is currently marketed for the same intended use.

The Subject Device modifications do not alter the fundamental scientific technology from the 510(k) cleared predicate device Siemens' "syngo Application Software" (VE20), K190780.

8. Nonclinical Performance Testing:

Non-clinical tests were conducted for the "syngo Application Software" (VE21) during product development.

RecognitionNumber	ProductArea	Title of Standard	ReferenceNumber andDate	PublicationDate	StandardsDevelopmentOrganization
5-125	General	Medical devices -Application of riskmanagement tomedical devices	14971	2019	ISO
5-134	General	Medical devices -Symbols to be usedwith medical devicelabels, labelling, andinformation to besupplied - Part 1:Generalrequirements	15223-1	2021	ISO
13-97	Software/Informatics	Health software -Part 1: Generalrequirements forproduct safety	82304-1	2016	IEC
13-79	Software/Informatics	Medical DeviceSoftware -Software life-cycleprocess	62304	2015	IEC
5-129	General	Medical devices -Part 1 Application ofusability engineeringto medical devices	62366-1	2020	IEC
RecognitionNumber	ProductArea	Title of Standard	ReferenceNumber andDate	PublicationDate	StandardsDevelopmentOrganization
13-38	Software/Informatics	Application of riskmanagement for IT -networksincorporatingmedical devices -Part 1: Roles,responsibilities, andactivities	80001-1	2010	IEC
13-96	Software/Informatics	Standard for Safety,Standard forSoftwareCybersecurityNetwork-ConnectableProducts, Part 1:GeneralRequirements	2900-1	2017	ANSI UL
13-104	Software/Informatics	Standard for Safety,SoftwareCybersecurity forNetwork-ConnectableProducts, Part 2-1:ParticularRequirements forNetworkConnectableComponents ofHealthcare andWellness Systems	2900-2-1	2017	ANSI UL
13-83	Software/Informatics	Principles formedical devicesecurity - Riskmanagement	TIR57	2016	AAMI

Siemens claims conformance to the following performance standards:

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The modifications described in this Premarket Notification is supported with verification and validation testing.

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, and "Off-The-Shelf Software Use in Medical Devices" is also included as part of this submission. Non-clinical tests were conducted on "syngo Application Software" (VE21) during product development.

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Image /page/8/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a cluster of orange dots of varying sizes.

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. "syngo Application Software" (VE21) 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 necessarv.

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 of the performance Testing Data:

The following test were conducted in support of the updated syngo TrueFusion modification: Overlay Images Volume and Overlay Image Change Stand X-ray. The test results passed and concluded that the synqo TrueFusion image overlay functionality corresponds to the clinical workflow to utilize ultrasound images with X-ray image information.

Performance tests were conducted to test the functionality of the "syngo Application Software" (VE21). These tests have been performed to assess the functionality of the Subject Device. Results of all conducted testing were found acceptable and do not raise any new issues of safety or effectiveness.

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 Verification/Validation & Test Report Summaries:

The updated syngo Application software feature "syngo TrueFusion" performance functionality has been tested and validated.

In summary, the following conducted testing: Overlay Images Volume and Overlay Image Change Stand X-ray verifies that the ultrasound images were sent from US system and that the US image overlay is working if the stand parameters of the imaging system change and / or if X-ray is acquired. All conducted test result passed. Software validation data demonstrates that the Subject Device is as safe and effective when compared to the Predicate Device.

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Image /page/9/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots.

The comparison of technological characteristic, non-clinical performance data, Human Factor Usability data, 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.

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. 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. 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 "syngo Application Software" (VE20), K190780, was cleared based on non-clinical supportive information. Similar non-clinical test results demonstrate that the subject device "syngo Application Software" (VE21) acceptance criteria are adequate for the intended use of the device. The comparison of technological characteristic, non-clinical performance data 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).