(182 days)
Not Found
No
The document describes standard image processing and viewing software for medical images, with no mention of AI, ML, or related concepts. The performance studies focus on image overlay functionality, not AI/ML performance metrics.
No
The device is described as medical diagnostic software used for viewing, manipulating, and storing medical images for purposes such as diagnosis and treatment planning, rather than directly providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the software is used for "diagnostic image viewing and post processing" and "intended to assist the physician in diagnosis". The "Device Description" also refers to it as "medical diagnostic software".
No
The device description explicitly states that the software can be deployed on independent hardware such as a stand-alone workstation and is designed to work with various hardware systems (digital radiographic, fluoroscopic, interventional, and angiographic systems). While the software is a key component, it is not solely software and relies on and integrates with hardware for its intended use.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device's intended use: The syngo Application Software is described as medical software for viewing, manipulating, communicating, and storing medical images and data from imaging modalities like digital radiographic, fluoroscopic, interventional, and angiographic systems. It is used for diagnostic image viewing, post-processing, and image-guided procedures.
- Lack of mention of biological samples: The description focuses entirely on processing and utilizing medical images and associated data. There is no mention of analyzing biological samples from the human body.
Therefore, the syngo Application Software falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
LLZ
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. 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital radiographic, fluoroscopic, interventional, and angiographic systems, ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician, operating room, interventional cardiology, electrophysiology, interventional oncology, interventional radiology, interventional neuroradiology. 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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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. 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted for the "syngo Application Software" (VE21) during product development. 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. 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. 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. 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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
August 16, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, the FDA logo is displayed in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" written in a clear, sans-serif font. The overall design is clean and professional, reflecting the organization's role in public health and safety.
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
1
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
2
Indications for Use
510(k) Number (if known) K220433
Device Name syngo Application Software
Indications for Use (Describe)
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.
| 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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3
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.
-
- 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
-
- Legally Marketed Predicate Device Trade Name: syngo Application Software K190780 510(k) Clearance Clearance Date 09/12/2019
4
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:
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.
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.
5
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) |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Updated
Software-
Applications | 1. Updated syngo Application
Software (VE21) | Updated syngo Application Software
(VE20) |
| Comparison
Results | Modified:
syngo Application Software version (VE21) was updated to include:
syngo TrueFusion has been updated so that ultrasound B-mode and color
doppler images can continuously be overlaid onto fluoroscopy images. In
the previous software it was only possible to overlay ultrasound landmarks
and 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 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. | |
6
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(k
Information | 2. Updated 510(k) information for the predicate device contains the
following features approved via the internal non-filing justification
process, 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 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison
Results | The above listed non-filing justifications were considered comparable and
approved as additional modifications post 510(k) clearance and used as the
selected predicate for the Subject 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. |
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.
| Recognition
Number | Product
Area | Title of Standard | Reference
Number and
Date | Publication
Date | Standards
Development
Organization |
|-----------------------|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|---------------------|------------------------------------------|
| 5-125 | General | Medical devices -
Application of risk
management to
medical devices | 14971 | 2019 | ISO |
| 5-134 | General | Medical devices -
Symbols to be used
with medical device
labels, labelling, and
information to be
supplied - Part 1:
General
requirements | 15223-1 | 2021 | ISO |
| 13-97 | Software/
Informatics | Health software -
Part 1: General
requirements for
product safety | 82304-1 | 2016 | IEC |
| 13-79 | Software/
Informatics | Medical Device
Software -
Software life-cycle
process | 62304 | 2015 | IEC |
| 5-129 | General | Medical devices -
Part 1 Application of
usability engineering
to medical devices | 62366-1 | 2020 | IEC |
| Recognition
Number | Product
Area | Title of Standard | Reference
Number and
Date | Publication
Date | Standards
Development
Organization |
| 13-38 | Software/
Informatics | Application of risk
management for IT -
networks
incorporating
medical devices -
Part 1: Roles,
responsibilities, and
activities | 80001-1 | 2010 | IEC |
| 13-96 | Software/
Informatics | Standard for Safety,
Standard for
Software
Cybersecurity
Network-
Connectable
Products, Part 1:
General
Requirements | 2900-1 | 2017 | ANSI UL |
| 13-104 | Software/
Informatics | Standard for Safety,
Software
Cybersecurity for
Network-
Connectable
Products, Part 2-1:
Particular
Requirements for
Network
Connectable
Components of
Healthcare and
Wellness Systems | 2900-2-1 | 2017 | ANSI UL |
| 13-83 | Software/
Informatics | Principles for
medical device
security - Risk
management | TIR57 | 2016 | AAMI |
Siemens claims conformance to the following performance standards:
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Image /page/7/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. To the right of the word "Healthineers" is a cluster of orange dots.
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.
8
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.
9
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.