(260 days)
Not Found
No
The document describes image processing and guidance features but does not mention AI, ML, or related terms, nor does it provide details about training or test sets typically associated with AI/ML development.
No
The device is described as medical diagnostic software used for viewing, manipulating, and storing medical images, assisting in diagnosis, treatment planning, and image-guided solutions, rather than directly providing therapy.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the software is used for "diagnostic image viewing and postprocessing," "diagnostic review," and is "intended to assist the physician in diagnosis."
Yes
The device is explicitly described as "syngo Application Software" and its description focuses solely on its software functionalities for image viewing, manipulation, and communication. While it mentions deployment on various hardware systems, the device itself is the software component.
Based on the provided text, the "syngo Application Software" is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- syngo Application Software's Function: The description clearly states that the software is for "real-time viewing, image manipulation, communication, and storage of medical images and data" from imaging modalities like digital radiographic, fluoroscopic, interventional, and angiographic systems. It's used for "diagnostic image viewing and postprocessing" and "viewing and postprocessing during interventional procedures."
- No Specimen Analysis: There is no mention of the software analyzing biological specimens. Its input is medical images, not biological samples.
Therefore, the syngo Application Software falls under the category of medical imaging software, not an IVD.
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 postprocessing and for viewing and postprocessing 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 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 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 postprocessing techniques and OEM options.
Procedures that can be performed include: minimally invasive surgical procedures and minimally invasive tumor treatment.
Product codes
LLZ
Device Description
The "syngo Application Software" (VE30A) 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-quided 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 the evaluation of digital radiographic examinations, including diagnosis and/or treatment planning.
Siemens "syngo Application Software" (VE30A) is designed to work with digital radiographic, fluoroscopic, interventional, and angiographic systems.
Siemens Medical Solutions USA, Inc. hereby submits this Traditional 510(k) to request clearance to market the following modifications:
- Updated system Software VE21C to VE30A 1.
- A. Updated syngo Embolization Guidance feature for Radial Access
- B. Updated Configurable archive flags
- C. Overlay Protect Mode
- D. Manual 2D3D registration improvement
-
- Updated Indications for Use Statement
-
- Product Claims List
-
- Updated 510(k) Information
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" (VE30A) is within the same classification regulation and the intended use and the general Indications for Use Statement for Siemens' Medical Image Management and Processing System remains the same except for a minor grammatical change (inclusion of "Healthineers").
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital radiographic, fluoroscopic, interventional, and angiographic systems.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician in diagnosis, treatment control.
physician in the evaluation of digital radiographic examinations, including diagnosis and/or treatment planning.
healthcare professionals familiar with and responsible for the evaluation and postprocessing of medical images.
Clinical and hospital settings.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted for the "syngo Application Software" (VE30) during product development.
The Risk analysis was completed, and risk control was implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation of 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" (VE30) is safe and effective for intended users, uses, and use environments through the design control verification and validation process. No further risk mitigations are necessary.
Tests were conducted in support of the new/updated functionalities for the "syngo Application Software" (VE30): The updated syngo Embolization Guidance feature for Radial Access was tested for availability and basic flow to create and detect vessels. Configurable archive flags, Overlay Protect Mode, and Manual 2D3D registration improvement completed workflow were tested.
Performance tests were conducted to test the functionality of the "syngo Application Software" (VE30). These tests have been performed to assess the functionality of the Subject Device. The 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.
All updated and new syngo Application software features performance functionality has been tested and validated.
In summary, All conducted test results passed. Software validation data demonstrates that the Subject Device is as safe and effective when compared to the Predicate Device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a recognizable symbol of the agency's role in regulating and overseeing food and drug products in the United States.
December 20, 2023
Siemens Medical Solutions USA, Inc. % Patricia Jones Regulatory Affairs Professional 40 Liberty Boulevard MALVERN, PA 19355
Re: K230955
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: November 28, 2023 Received: November 28, 2023
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K230955
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 postprocessing and for viewing and postprocessing 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 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 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 postprocessing 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) |
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3
Image /page/3/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 graphic of orange dots.
510(k) Summary: syngo Application Software (VE30) 510(k) #: K230955
Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard. Malvern, PA 19355
Date of Preparation: November 28, 2023
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 Registration 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 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 Requlation: 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 510(k) Clearance K220433
4
Image /page/4/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 words is a graphic of orange dots arranged in a circular pattern.
Clearance Date 08/16/2022 Classification Name: Medical Image Management and Processing Svstem Classification Panel: Radiology 21 CFR §892. 2050 Classification Requlation: Device Class: Class II Product Code: LLZ Recall Information: This predicate device has not been the subject of any design-related recalls.
5. Device Description:
The "syngo Application Software" (VE30A) 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-quided 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 the evaluation of digital radiographic examinations, including diagnosis and/or treatment planning.
Siemens "syngo Application Software" (VE30A) is designed to work with digital radiographic, fluoroscopic, interventional, and angiographic systems.
Siemens Medical Solutions USA, Inc. hereby submits this Traditional 510(k) to request clearance to market the following modifications:
- Updated system Software VE21C to VE30A 1.
- A. Updated syngo Embolization Guidance feature for Radial Access
- B. Updated Configurable archive flags
- C. Overlay Protect Mode
- D. Manual 2D3D registration improvement
-
- Updated Indications for Use Statement
-
- Product Claims List
-
- Updated 510(k) Information
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" (VE30A) is within the same classification regulation and the intended use and the general Indications for Use Statement for Siemens' Medical Image Management and Processing System remains the same except for a minor grammatical change (inclusion of "Healthineers").
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 text is a graphic of orange dots arranged in a circular pattern.
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 postprocessing and for viewing and postprocessing 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 of the Siemens Healthineers 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 the diagnosis, treatment planning, and treatment control. It includes commercially available postprocessing techniques and OEM options.
Procedures that can be performed include 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" (VE21).
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:
6
Image /page/6/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 graphic of orange dots.
| Modifications | Subject Device
syngo Application Software (VE30)
K230955 | Predicate Device
syngo Application Software (VE21)
K220433 | Comparison
Results |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| New System
Software/
Changes | 1. Updated syngo Application Software from
VE21A to VE30A
A. Updated syngo Embolization Guidance
feature for Radial Access
B. Updated Configurable archive flags
C. Overlay Protect Mode
D. Manual 2D3D registration improvement | syngo Application Software VE21
Automatic identification of catheter only via
femoral access.
Archive flags not configurable
Overlay Mode
Manual 2D/3D Registration | Modified:
Software VE30 was updated to
support modifications 1A – D. All
Software modifications conform to
"Guidance for the content of
Premarket submission for software in
Medical Devices". Provided are all
required software testing and a Trace
Matrix which identifies all testing
pertinent to each modification.
Provided are Bench Test Summaries.
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. All test results
met all acceptance criteria. |
| IFU Statement | 2. Updated IFU Statement (Added "Healthineers"
to reflect the brand name "Siemens
Healthineers" and minor grammatical
changes). | IFU Statement | Modified:
The Indications for Use statement
was updated with minor grammatical
changes. (Added "Healthineers" to
reflect the brand name "Siemens
Healthineers") |
| Updated
510(k)
Information | 3. Updated 510(k) information for the Primary Predicate Device contains the following feature
approved via the non-filing justification process. | | The non-filing justification was
considered comparable and
approved as an additional |
| Modifications | Subject Device
syngo Application Software (VE30)
K230955 | Predicate Device
syngo Application Software (VE21)
K220433 | Comparison
Results |
| | Introduction of syngo Application Software VE23 for compatibility with ARTIS icono ceiling VE23. No new features have been introduced with syngo Application Software VE23. The system has been made compatible with the hosting system ARTIS icono ceiling VE23. This compatibility was tested and raised no new issues regarding the safety or effectiveness of the device. | | modification post 510(k) clearance and used as the selected predicated for the Subject Device. All software validation data demonstrates that the Subject Device is safe and effective when compared to the Predicate Device that is currently marketed for the same intended use. |
7
Image /page/7/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a cluster of orange dots.
The Subject Device modifications do not alter the fundamental scientific technology from the 510(k) cleared predicate device Siemens' "syngo Application Software" (VE21), K220433.
8
Image /page/8/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.
8. Nonclinical Performance Testing:
Non-clinical tests were conducted for the "syngo Application Software" (VE30) 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, labeling, 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 |
| 13-38 | Software/
Informatics | Application of risk
management for IT -
networks incorporating
medical devices - Part 1:
Roles, responsibilities, and
activities | 80001-1 | 2010 | IEC |
| 12-349 | Radiology | Digital Imaging and
Communications in Medicine
(DICOM) Set | PS 3.1 | 2022 | NEMA |
| 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 | 2900-2-1 | 2017 | ANSI UL |
Siemens claims conformance to the following performance standards:
9
Image /page/9/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 words is a graphic of orange dots arranged in a circular pattern.
| Recognition
Number | Product
Area | Title of Standard | Reference
Number
and Date | Publication
Date | Standards
Development
Organization |
|-----------------------|--------------------------|-----------------------------------------------------------------|---------------------------------|---------------------|------------------------------------------|
| | | Connectable Components of
Healthcare and Wellness
Systems | | | |
| 13-83 | Software/
Informatics | Principles for medical device
security - Risk management | TIR57 | 2016 | AAMI |
The modifications described in this Premarket Notification are 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" (VE30) during product development.
The Risk analysis was completed, and risk control was implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation of 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" (VE30) is 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 of the performance Testing Data:
Tests were conducted in support of the new/updated functionalities for the "syngo Application Software" (VE30): The updated syngo Embolization Guidance feature for Radial Access was tested for availability and basic flow to create and detect vessels. Configurable archive flags, Overlay Protect Mode, and Manual 2D3D registration improvement completed workflow were tested.
10
Image /page/10/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the text is a graphic of several orange circles of varying sizes.
Performance tests were conducted to test the functionality of the "syngo Application Software" (VE30). These tests have been performed to assess the functionality of the Subject Device. The 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:
All updated and new syngo Application software features performance functionality has been tested and validated.
In summary, All conducted test results passed. Software validation data demonstrates that the Subject Device is as safe and effective when compared to the Predicate Device.
The comparison of technological characteristics, 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 safely and effectively. 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 healthcare professionals familiar with and responsible for the evaluation and postprocessing of medical images.
10. Conclusion as to Substantial Equivalence:
The predicate device "syngo Application Software" (VE21), K220433, was cleared based on non-clinical supportive information. Similar non-clinical test results demonstrate that the subject device's "syngo Application Software" (VE30A) acceptance criteria are adequate for the intended use of the device. The comparison of technological characteristics, 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.