(169 days)
No
The document describes image processing and guidance features but does not mention AI, ML, or related terms. The performance studies focus on image quality metrics and algorithm validation, not AI/ML model performance.
No.
The device is described as diagnostic imaging software and provides image-guided solutions for diagnostic and treatment planning, but it does not directly provide therapy.
Yes
The "syngo Application Software" is explicitly defined as "medical diagnostic software" and is used for "diagnostic image viewing and post processing."
No
The device description explicitly states that the software "may be installed either on Siemens released PC hardware, on Siemens X-ray systems or on Siemens angiography systems," indicating it is not solely software and relies on specific hardware for its function.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: 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's used for diagnostic image viewing, post-processing, and image-guided procedures.
- Lack of Specimen Analysis: The description focuses entirely on processing and utilizing medical images obtained directly from the patient through imaging equipment. There is no mention of analyzing biological specimens.
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 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 diaming and treatment control. It includes commercially available post-processing techniques and OEM options.
Procedures that can be performed include: minimally invasive surgical procedures and minimally invasive turnor treatment.
Product codes
LLZ
Device Description
The "syngo Application Software" (VE2) is medical diagnostic software for realviewing. diagnostic review. image manipulation. optimization. time 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" (VE2) 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 three new optional software features: 1) syngo DynaCT Sine Spin; 2).syngo DynaCT Multiphase; and 3) syngo Embolization Guidance. These new features will be added to the existing "syngo Application Software" (VD20) which was cleared in K173611 on 16/03/2018. These new software features are the subjects of this submission.
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" (VE2) is within the same classification regulation 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.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician, operating room
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
Bench test 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.
A phantom study was performed to exclude a potential reduction in image quality over 10 runs.
The feeder detection algorithm was validated in a study of randomly selected clinical cases with the result that it is additionally suitable for prostate arteries.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted for the "syngo Application Software" (VE2) during product development.
The software features "syngo DynaCT Sine Spin", "syngo DynaCT Multiphase" and "syngo Embolization Guidance" performance functionality has been tested and validated. Verification and Validation testing in the form of Unit, Subsystem and System Integration testing as well as system validation testing were performed to evaluate the performance and functionality of the new features and software updates. All testable requirements in the Engineering Requirements Specifications keys, Subsystem Requirements Specifications keys, and the Risk Management Hazard keys have been successfully verified and traced in accordance with the Siemens product development (lifecycle) process. The software verification and regression testing have been performed successfully to meet their previously determined acceptance criteria as stated in the test plans.
The following bench testing was performed for the new features "syngo DynaCT Sine Spin", syngo Dyna3D High Speed and syngo DynaCT High Speed such as Homogeneity of reconstructed image, Spatial Resolution, Contrast to Noise Ratio, Geometric Distortion, Radiation Metrics CTDI, DAP, Artifact analysis, Gantry positioning accuracy, z-direction Resolution (Reconstructed section thickness).
Bench testing was performed for the new feature syngo DynaCT Multiphase. A phantom study was performed to exclude a potential reduction in image quality over 10 runs.
Bench testing was performed for the modified feature "syngo Embolization Guidance". The feeder detection algorithm was validated in a study of randomly selected clinical cases with the result that it is additionally suitable for prostate arteries.
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.
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
Siemens Medical Solution USA, Inc. % Ms. Patricia D. Jones Sr. Regulatory Affairs Specialist 40 Liberty Boulevard 65-1A MALVERN PA 19355
Re: K190780
Trade/Device Name: syngo Application Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: August 9, 2019 Received: August 13, 2019
Dear Ms. Jones:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
September 12, 2019
Image /page/0/Picture/10 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
1
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,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
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 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 diaming and treatment control. It includes commercially available post-processing techniques and OEM options.
Procedures that can be performed include: minimally invasive surgical procedures and minimally invasive turnor treatment.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | |
|---|---|---|
| ----------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.## DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
| FORM FDA 3881 (7/17) | |
|---|---|
| ---------------------- | -- |
Page 1 of 1
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510(k) Summary: "syngo Application Software"
Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355
Date Prepared: September 11, 2019
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, 65-1A Malvern, PA 19355 Establishment Registration Number: 2240869
Manufacturing Site:
Siemens Healthcare GmbH Siemensstr. 1 91301 Forchheim, Germany Establishment Registration Number: 3004977335
2. Contact Person:
Ms. Patricia D Jones Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Phone: (610) 448-6474 Email: patricia.d.iones@siemens-healthineers.com
3. Device Name and Classification:
Trade Name: Classification Name:
Classification Panel: Classification Regulation: Device Class: Product Code:
syngo Application Software Picture Archiving and Communications System Radiology 21 CFR §892. 2050 Class II LLZ
-
- Legally Marketed Predicate Device Trade Name: syngo Application Software
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510(k) Clearance Clearance Date Classification Name: Classification Panel: Classification Requlation: Device Class: Product Code: Recall Information:
K173611 03/16/2018 Picture Archiving and Communications 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" (VE2) is medical diagnostic software for realviewing. diagnostic review. image manipulation. optimization. time 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" (VE2) 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 three new optional software features: 1) syngo DynaCT Sine Spin; 2).syngo DynaCT Multiphase; and 3) syngo Embolization Guidance. These new features will be added to the existing "syngo Application Software" (VD20) which was cleared in K173611 on 16/03/2018. These new software features are the subjects of this submission.
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" (VE2) is within the same classification regulation 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.
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Image /page/5/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 words is a graphic of orange dots in a circular pattern.
The syngo Application Software can be deployed on independent hardware such as a stand-alone diagnostic review, post-processing, and reporting workstation. It can also be configured within a network to send and receive DICOM data.
Furthermore, the 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" (VD20).
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:
The table below provides comparison of the Subject Device modifications to the Predicate Device.
| Modification | Subject Device
syngo Application Software VE2 | Predicate Device syngo Application
Software VD20 (K173611) |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| syngo
DynaCT
syngo Sine
Spin | This is a new feature with a spherical
spiral trajectory with an additional
sinusoidal movement component in
Cran/Caud direction. The 3D trajectory
starts with a Cran/Caud angle of zero.
then goes to an angle of e.g. ten degrees
in Cran direction, goes back to zero in
the middle of the trajectory, then goes to | syngo DynaCT is an imaging software
used to obtain CT like images. It allows
the reconstruction of three-dimensional
volume data (consisting of tomographic
slices) out of two-dimensional projection
images acquired with a standard
angiographic C-arm device. It is also
used for imaging both high contrast |
| Modification | Subject Device | Predicate Device syngo Application
Software VD20 (K173611) |
| | syngo Application Software VE2 | |
| | ten degrees in Caud direction and back
to Cran/Caud zero at the end of the
trajectory. This allows better data
coverage resulting less cone beam
artifacts. | objects (vessels with iodine, bone) and
soft tissue as well as other internal body
structures for diagnosis, surgical
planning, interventional procedures and
treatment follow-up. |
| Comparison
& Results | Comparison: The differences between the syngo DynaCT Sine Spin and syngo
DynaCT is that the predicate device software feature does not have spherical spiral
trajectory, which is an additional sinusoidal movement component in Cran/Caud
direction. The reconstruction method is the same. | |
| | Results: Bench test 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. | |
| syngo
DynaCT
Multiphase | syngo DynaCT Multiphase can be used
to assess the collateral status with time
resolved DynaCT, depicting 10 different
time points within a period of 60 seconds.
| syngo DynaCT uses a single spin to
derive CT-like images. syngo DynaCT
Cardiac with ECG triggering uses four
consecutive DynaCT runs to optimize
the image quality for cardiac imaging. |
| Comparison
& Results | Comparison: The differences between the syngo DynaCT Multiphase and syngo
DynaCT (cardiac) is that the predicate device allows two runs (typically one mask
and one fill run) - four for DynaCT cardiac -The Subject Device feature allows ten
consecutive runs which results in depicting 10 different time points within a period of
60 seconds. The reconstruction method is the same | |
| | Results: Bench test 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. | |
| syngo
Embolization
Guidance | The modified syngo Embolization
Guidance in software VE2 allows the
proximal point to be set by user, thus
reducing automation, but increasing the
applicability of syngo Embolization
Guidance. The calculation method itself
remains as in the predicate device. The
algorithm was not changed. | syngo Embolization Guidance was
introduced to determine automatically
the feeder vessel for specific hepatic
lesions, e.g. a tumor. Part of this
automation relied on an automatic
detection of the proximal point for the
algorithm to know where to start the
search for the feeder vessels. |
| Comparison
& Results | Comparison: The differences between the modified syngo Embolization Guidance
VE2 and the Predicate Device syngo Embolization Guidance is the modified version
that allows the proximal point to be set by the user, thus reducing automation, but
increasing the applicability of the feature. The Subject Device automatically detects
the feeder vessel for specific hepatic lesions, e.g. a tumor. Part of this automation
relied on an automatic detection of the proximal point for the algorithm to know
where to start the search for the feeder vessels. | |
| | Results: Bench test 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. | |
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The Subject Device modifications do not alter the fundamental scientific technology from the 510(k) cleared predicate device Siemens' "syngo Application Software" (VD20), K173611
8. Nonclinical Performance Testing:
Non-clinical tests were conducted for the "syngo Application Software" (VE2) during product development.
| Recognition
Number | Product
Area | Title of Standard | Reference
Number and
Date | Publication
Date | Standards
Development
Organization |
|-----------------------|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|---------------------|------------------------------------------|
| 5-40 | General | Medical devices -
Application of risk
management to
medical devices | 14971 | 2012 | ISO |
| 13-97 | Software/
Informatics | Health software -
Part 1: General
requirements for
product safety | 82304-1 | 2017 | IEC |
| 13-32 | Radiology | Medical Device
Software -
Software life-
cycle process | 62304
AC | 2006
2008 | AAMI ANSI IEC |
| 5-114 | General | Medical devices -
Part 1 Application
of usability
engineering to
medical devices | 62366-1 | 2015 | 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 |
Siemens claims conformance to the following performance standards:
The modifications described in this Premarket Notification were 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. The performance data demonstrates continued conformance with
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special controls for medical devices containing software. Non-clinical tests were conducted on "synqo Application Software" (VE2) during product development.
The Risk analysis was completed, and risk control implemented to mitigate The testing results supports that all the software identified hazards. 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" (VE2) has been found to be safe and effective for intended users, uses and use environments through the design control verification and validation process. No further risk mitigations are necessary.
Siemens conforms to the cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Provided in this submission is a cybersecurity statement that considers IEC 80001-1:2010. The responsibility for compliance with IEC 80001-1-2010 is the hospital. Provided in the Software Section is the required cybersecurity information.
Performance Verification/Validation & Test Report Summaries:
The Software features "syngo DynaCT Sine Spin", "syngo DynaCT Multiphase" and "syngo Embolization Guidance" performance functionality has been tested and validated. Verification and Validation testing in the form of Unit, Subsystem and System Integration testing as well as system validation testing were performed to evaluate the performance and functionality of the new features and software updates. All testable requirements in the Engineering Requirements Specifications keys, Subsystem Requirements Specifications keys, and the Risk Management Hazard keys have been successfully verified and traced in accordance with the Siemens product development (lifecycle) process. The software verification and regression testing have been performed successfully to meet their previously determined acceptance criteria as stated in the test plans.
All verification and validation data demonstrate 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 following bench testing was performed for the new features "syngo DynaCT Sine Spin", syngo Dyna3D High Speed and syngo DynaCT High Speed such as
- Homogeneity of reconstructed image ●
- Spatial Resolution ●
- Contrast to Noise Ratio ●
- Geometric Distortion
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- Radiation Metrics CTDI, DAP ●
- Artifact analysis ●
- Gantry positioning accuracy ●
- . z-direction Resolution (Reconstructed section thickness)
Bench testing was performed for the new feature syngo DynaCT Multiphase. A phantom study was performed to exclude a potential reduction in image quality over 10 runs.
Bench testing was performed for the modified feature "syngo Embolization Guidance". The feeder detection algorithm was validated in a study of randomly selected clinical cases with the result that it is additionally suitable for prostate arteries.
The comparison of technological characteristic, non-clinical performance data, clinical images, Human Factor Usability data, and software validation data demonstrates that the Subiect Device is as safe, and effective when compared to the Predicate Device that is currently marketed for the same intended use.
Siemens claims conformance to the following table of FDA Guidance Documents for this 510(k) submission.
| FDA Guidance Document and Effective Date | |
|---|---|
| 1. | Guidance for Industry and FDA Staff – User Fees and Refunds for Premarket |
| Notification Submissions 510(k) | |
| Document issued on October 2, 2017 | |
| 2. | Guidance for Industry and Food and Drug Administration Staff: Refuse to |
| Accept Policy for 510(k)s | |
| Document issued on January 30, 2018 | |
| 3. | Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated |
| 510(k)s - Guidance for Industry and FDA Staff | |
| Document issued on August 12, 2005 | |
| 4. | Guidance for Industry and Food and Drug Administration Staff: The 510(k) |
| Program: Evaluating Substantial Equivalence in Premarket Notifications | |
| [510(k)] | |
| Document Issued on July 28, 2014 | |
| 5. | Guidance for Industry and FDA Staff: Guidance for the Submission |
| Premarket Notifications for Medical Image Management Devices | |
| Document Issued on July 27, 2000 | |
| 6. | Guidance for Industry and FDA Staff: Guidance for the Content of Premarket |
| Submission for Software in Medical Devices | |
| Document issued on May 11, 2005 | |
| 7. | Guidance for Industry and FDA Staff: Guidance for Off-The-Shelf Software |
| Use in Medical Devices | |
| Document issued on September 9, 1999 | |
| 8. | Guidance for Industry and FDA Staff: Applying Human Factors and Usability |
| Engineering to Medical Devices. | |
| Document issued February 3, 2016 | |
| 9. | Guidance for Industry and FDA Staff: Pediatric Information for X-ray |
| Imaging Device Premarket Notifications. | |
| Document issued on November 28, 2017 | |
| 10 | Guidance for Industry and FDA Staff: Content of Premarket Submissions for |
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| FDA Guidance Document and Effective Date | |
|---|---|
| Management of Cybersecurity in Medical devices. | |
| Document issued on October 2, 2014 | |
| 11 | Guidance for Industry and FDA Staff: Appropriate Use of Voluntary |
| Consensus Standards in Premarket Submission for Medical Devices | |
| Document issued on September 14, 2018 |
Summary of the performance Testing Data:
Performance tests were conducted to test the functionality of the "syngo Application Software" (VE2). 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.
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" (VD20), K173611, was cleared based on non-clinical supportive information and clinical images and data. Similar non-clinical test results demonstrate that the subject device "syngo Application Software" (VE2) acceptance criteria are adequate for the intended use of the device. The comparison of technological characteristic, non-clinical performance data, clinical images, and software validation data demonstrates that the subject device is as safe, and effective when compared to the predicate device that is currently marketed for the same intended