(30 days)
Not Found
No
The summary describes post-processing techniques based on physical principles of X-ray attenuation at different energies. It explicitly states no changes in fundamental scientific technology compared to predicate devices and does not mention AI, ML, or related concepts. The performance studies focus on validating the accuracy of these physical measurements and comparisons to predicate devices, not on training or evaluating AI/ML models.
No.
This device is a post-processing application for CT images, designed to visualize information from dual-energy CT scans. It aids in diagnosis by providing improved visualization and characterization of materials within the body, but it does not directly treat or alleviate a medical condition.
Yes
The device processes CT images to visualize information based on different X-ray spectra, enabling functions like "Brain Hemorrhage," "Gout Evaluation," "Kidney Stones" differentiation, and "Bone Removal." While it states that "Only a well-trained radiologist can make the final diagnosis under consideration of all available information," its primary purpose is to provide specific, chemically-driven information about anatomical regions to aid in identifying conditions, which directly supports diagnosis.
Yes
The device is described as a "post-processing application" and "software application" that operates on a "client/server platform." While it processes images from a CT scanner, the device itself is presented as a software component for image manipulation and analysis, not a hardware device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples (blood, urine, tissue, etc.) outside of the body. This device processes CT images, which are generated from the patient's body using X-rays.
- The intended use is image post-processing and visualization. The device helps radiologists interpret CT scans by highlighting different materials based on their energy-dependent attenuation.
- The device description focuses on software for image manipulation and display. It describes post-processing application classes and tools for improving visualization.
- The performance studies involve phantom testing and retrospective clinical studies based on image analysis. There is no mention of analyzing biological samples.
Therefore, syngo.CT Dual Energy is a medical imaging software application, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
syngo.CT Dual Energy is designed to operate with CT images based on two different X-ray spectra.
The various materials of an anatomical region of interent attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials, syngo.CT Dual Energy combines images acquired with low and high energy spectra to visualize this information. Depending on the region of interest, contrast agents may be used.
The general functionality of the syngo.CT Dual Energy application is as follows:
- · Monoenergetic
- · Brain Hemorrhage
- Gout Evaluation
- Lung Vessels
- · Heart PBV
- · Bone Removal
- · Lung Perfusion
- · Liver VNC
- · Monenergetic Plus
- Virtual Unenhanced
- · Bone Marrow
- · Hard Plaques
- Rho/Z
- · Kidney Stones*
- · SPR (Stopping Power Ratio)
- · SPP (Spectral Post-Processing Format)
The availability of each feature is depending on the Dual Energy scan mode.
*)Kidney Stones is designed to support the visualization of the chemical composition of kidney stones and especially the differentiation between uric acid and non-uric acid stones. For full identification of the kidney stone additional information should be considered such as patient history and urine testing. Only a well-trained radiologist can make the final diagnosis under consideration of all available information. The accuracy of identification is decreased in obese patients.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
Dual energy offers functions for qualitative and quantitative post-processing evaluations. Dual energy CT can be used to improve the visualization of the chemical composition of various materials in the human body when compared to single energy CT. Depending on the organ of interest, the user can select and modify different application classes or parameters and algorithms.
syngo.CT Dual Energy is a post-processing application consisting of several postprocessing application classes that can be used to improve visualization of various energy dependent materials in the human body. This software application is designed to operate on the most recent version syngo.via client/server platform, which supports preprocessing and loading of datasets by syngo.via depending on configurable rules.
-
- Monoenergetic
-
- Brain Hemorrhage
- Gout Evaluation 3.
-
- Lung Vessels
-
- Heart PBV
- Bone Removal 6.
-
- Lung Perfusion
-
- Liver VNC
-
- Monoenergetic Plus
-
- Virtual Unenhanced
-
- Bone Marrow
-
- Hard Plaques
-
- Rho/Z
-
- Kidney Stones
-
- SPR (Stopping Power Ratio)
-
- SPP (Spectral Post-Processing format)
These application classes are designed for specific clinical tasks, so that algorithms, additional tool buttons, the use of colored overlay images and image representation (for example MPR or maximum intensity projection) is optimized correspondingly.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Brain, Lung, Heart, Liver, Bone, Kidney, general anatomical regions of interest.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Performance tests were conducted to test the functionality of the syngo.CT Dual Energy post-processing application. A phantom-based validation has been conducted to show that both features SPR (Stopping Power Ratio) and SPP (Spectral Post-Processing Format) operate as intended.
For SPR, the report shows that the SPR feature can reproduce the theoretical SPR values of the phantom inserts used from Dual Energy CT scans. The evaluation is described and validated in the report "Detailed Description of the DE application "DirectSPR" as part of the medical product "Syngo.CT Dual Energy", Version VB40".
Regarding the SPP evaluation, the combination of the SPP-generation process produces equivalent results to the reference method based on functionality available in the predicate device(s). This means also that the information in the SPP-format (including all hidden data) was correctly calculated. Hence, two new modules introduced to support the new SPP data format, "SPP Generation Unit" and "ISI Preparation Unit", which are part of syngo.CT Dual Energy are working as specified. The evaluation is described and evaluated in the report "Detailed Description and Bench Tests for the Feature "SPP/ISI"".
Furthermore, phantom bench testing and clinical validation in a retrospective study was conducted to test the functionality of the remaining application classes Rho/Z and Kidney Stones. Retrospective clinically validated studies were conducted to test the performance for applications classes Monoenergetic Plus, Bone Removal, Liver VNC, and Hard Plaques, as well as the predicate device application classes. These studies demonstrate that the subject device performs as well as the predicate device applications that were tested using the same methods. Supportive articles that demonstrate the usability of the application classes are provided to support device performance and functionality.
Non-clinical tests and clinical validation have been conducted to establish the proficiency of the features of the subject device. The results of these tests demonstrate that the subject device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 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.
Siemens Medical Solutions, USA, Inc. % Ms. Cynthia Busch Regulatory Affairs Specialist 2501 N. Barrington Road HOFFMAN ESTATES, IL 60192
Re: K191468
Trade/Device Name: syngo.CT Dual Energy Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: May 29, 2019 Received: June 3, 2019
Dear Ms. Busch:
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
July 3, 2019
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. Division 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
2
Indications for Use
510(k) Number (if known) K191468
Device Name syngo.CT Dual Energy
Indications for Use (Describe)
syngo.CT Dual Energy is designed to operate with CT images based on two different X-ray spectra.
The various materials of an anatomical region of interent attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials, syngo.CT Dual Energy combines images acquired with low and high energy spectra to visualize this information. Depending on the region of interest, contrast agents may be used.
The general functionality of the syngo.CT Dual Energy application is as follows:
- · Monoenergetic
- · Brain Hemorrhage
- Gout Evaluation
- Lung Vessels
- · Heart PBV
- · Bone Removal
- · Lung Perfusion
- · Liver VNC
- · Monenergetic Plus
- Virtual Unenhanced
- · Bone Marrow
- · Hard Plaques
- Rho/Z
- · Kidney Stones*
- · SPR (Stopping Power Ratio)
- · SPP (Spectral Post-Processing Format)
The availability of each feature is depending on the Dual Energy scan mode.
*)Kidney Stones is designed to support the visualization of the chemical composition of kidney stones and especially the differentiation between uric acid and non-uric acid stones. For full identification of the kidney stone additional information should be considered such as patient history and urine testing. Only a well-trained radiologist can make the final diagnosis under consideration of all available information. The accuracy of identification is decreased in obese patients.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
Image /page/4/Picture/0 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 text is a graphic of orange dots arranged in a circular pattern.
510(K) SUMMARY FOR SYNGO.CT DUAL ENERGY
as required by 21 CFR Part 807.87(h)
I. Identification of the Submitter
Importer/Distributor Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number 2240869
Manufacturing Site
Siemens Healthcare GmbH Siemensstr 1 D-91301 Forchheim, Germany
Establishment Registration Number 3004977335
Submitter Contact Person:
Cynthia Busch Regulatory Affairs Specialist 2501 North Barrington Road Hoffman Estates, IL 60192-2061 Phone: (847) 643-6818 Email: cynthia.busch(@siemens-healthineers.com
Alternate Contact Person:
Alaine Medio Regulatory Project Manager 810 Innovation Drive Knoxville, TN 37932 Phone: (865) 206-0337 Email: alaine.medio@siemens-healthineers.com
Date of Submission : May 29, 2019
II. Device Name and Classification
Product Name: syngo.CT Dual Energy Propriety Trade Name: syngo.CT Dual Energy Classification Name: Computed Tomography X-ray System Classification Panel: Radiology 21 CFR §892.1750 CFR Section: Device Class: Class II Product Code: 90 JAK
5
e
III. Predicate Device
Primary Predicate Device:
| Trade Name: | syngo.CT Dual Energy |
|---|---|
| 510(k) Number: | K150757 |
| Clearance Date: | 08/11/2015 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR § 892.1750 |
| Device Class: | Class II |
| Product Code: | 90 JAK |
| Recall: | There have been no recalls for this device |
Reference Predicate Device:
| Trade Name: | syngo.CT Single Source Dual Energy |
|---|---|
| 510(k) Number: | K150745 |
| Clearance Date: | 08/11/2015 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | 90 JAK |
| Recall: | There have been no recalls for this device |
Reference Predicate Device:
| Trade Name: | syngo.CT Single Source Dual Energy (twin beam |
|---|---|
| 510(k) Number: | K163289 |
| Clearance Date: | 02/09/2017 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR § 892.1750 |
| Device Class: | Class II |
| Product Code: | 90 JAK |
| Recall: | There have been no recalls for this device |
IV. Device Description
Dual energy offers functions for qualitative and quantitative post-processing evaluations. Dual energy CT can be used to improve the visualization of the chemical composition of various materials in the human body when compared to single energy CT. Depending on the organ of interest, the user can select and modify different application classes or parameters and algorithms.
syngo.CT Dual Energy is a post-processing application consisting of several postprocessing application classes that can be used to improve visualization of various energy dependent materials in the human body. This software application is designed to operate on the most recent version syngo.via client/server platform, which supports preprocessing and loading of datasets by syngo.via depending on configurable rules.
6
Image /page/6/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 pattern.
-
- Monoenergetic
-
- Brain Hemorrhage
- Gout Evaluation 3.
-
- Lung Vessels
-
- Heart PBV
- Bone Removal 6.
-
- Lung Perfusion
-
- Liver VNC
-
- Monoenergetic Plus
-
- Virtual Unenhanced
-
- Bone Marrow
-
- Hard Plaques
-
- Rho/Z
-
- Kidney Stones
-
- SPR (Stopping Power Ratio)
-
- SPP (Spectral Post-Processing format)
These application classes are designed for specific clinical tasks, so that algorithms, additional tool buttons, the use of colored overlay images and image representation (for example MPR or maximum intensity projection) is optimized correspondingly.
Modifications
syngo.CT Dual Energy modifications with software version SOMARIS/8 VB40 are as follows:
-
- The merge of the three already cleared post-processing Dual Energy applications into one application called syngo.CT Dual Energy:
-
- Update of the Indications for Use statement because of the aforementioned combination
-
- Enhancement to image output and alternate image format:
- SPP (Stopping Power Ratio) O
- SPR (Spectral Post-Processing Format) ೧
-
- Workflow Improvements:
- Provide Dual Energy results with Rapid Results Technology for other o Workflows.
- Provide Dual Energy results as input for other rapid results technology O types.
V. Indications for Use
syngo.CT Dual Energy is designed to operate with CT images based on two different X-ray spectra.
The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials. syngo.CT Dual Energy combines images acquired with low and high energy spectra to visualize this information. Depending on the region of interest, contrast agents may be used.
The general functionality of the syngo.CT Dual Energy application is as follows:
7
Image /page/7/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 arranged in a circular pattern.
-
- Monoenergetic
-
- Brain Hemorrhage
- Gout Evaluation 3.
- Lung Vessels 4.
- Heart PBV 5.
-
- Bone Removal
-
- Lung Perfusion
-
- Liver VNC
-
- Monoenergetic Plus
-
- Virtual Unenhanced
-
- Bone Marrow
-
- Hard Plaques
-
- Rho/Z
-
- Kidney Stones*
-
- SPR (Stopping Power Ratio)
-
- SPP (Spectral Post-Processing Format)
The availability of each feature is depending on the Dual Energy scan mode.
*) Kidney Stones is designed to support the visualization of the chemical composition of kidney stones and especially the differentiation between uric acid and non-uric acid stones. For full identification of the kidney stone additional clinical information should be considered such as patient history and urine testing. Only a well-trained radiologist can make the final diagnosis under consideration of all available information. The accuracy of identification is decreased in obese patients.
VI. Comparison of Technological Characteristics with the Predicate Device
syngo.CT Dual Energy is a post-processing application operating on the multi-user syngo.via client/server platform. The subject syngo.CT Dual Energy provides the same evaluation, reporting and visualization tools, and functionality as the predicate devices. This includes image processing and visualization tools such as basic visualization of various energy dependent materials in the human body and VRT visualization.
The differences between the above referenced predicate devices are described at a high-level in the next table below:
| | Subject Device | Primary
Predicate
Device | Reference
Predicate
Device | Reference
Predicate
Device | |
|----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Siemens
syngo, CT Dual
Energy | Siemens
syngo.CT Dual
Energy
(K150757) | Siemens
syngo.CT
Single Source
Dual Energy
(K150745) | Siemens
syngo.CT
Single Source
Dual Energy
(twin beam)
(K163289) | Comparison
Results |
| Input Data | | | | | |
| Feature | Subject Device
Siemens
syngo,CT Dual
Energy | Primary
Predicate
Device
Siemens
syngo.CT Dual
Energy
(K150757) | Reference
Predicate
Device
Siemens
syngo.CT
Single Source
Dual Energy
(K150745) | Reference
Predicate
Device
Siemens
syngo.CT
Single Source
Dual Energy
(twin beam)
(K163289) | Comparison
Results |
| Data
Acquisition
Mode | The subject
device unifies
all three data
acquisition
modes
acquiring
images from
Dual Source
scanners, Dual
Energy Single
Source, and
Twin Beam
scanners. | The software
analyzes Dual
Source Dual
Energy images
acquired with
Dual Source
scanners. | The software
analyzes Dual
Spiral Dual
Energy images
acquired with
Dual Spiral
Single Source
scanners. | The software
analyzes Twin
Beam Dual
Energy images
acquired with
Twin Beam
Single Source
scanners. | Equivalent
The subject
device data
acquisition
mode supports
all acquisition
modes of the
three
predicates:
single source
and dual
source
scanner image
acquisitions. |
| Image
Processing
and
Evaluation | MPR, MIP,
VRT, thick
MPR, thin MIP,
fused VRT,
tinted VRT | MPR, MIP,
VRT, thick
MPR, thin MIP,
fused VRT,
tinted VRT | MPR, MIP,
VRT, thick
MPR, thin MIP,
fused VRT,
tinted VRT | MPR, MIP,
VRT, thick
MPR, thin MIP,
fused VRT,
tinted VRT | Same |
| Provide
Dual
Energy
results also
as input for
other
Rapid
Results
Technology
types | Dual Energy
result images
generated with
Rapid Results
Technology can
be used as input
for other types
of Rapid
Results
Technology
(e.g. organ
ranges). | The output
images from all
Dual Energy
application
classes can
manually be
processed on
syngo.via with
the available
platform tools
(e.g. organ
ranges). | The output
images from all
Dual Energy
application
classes can
manually be
processed on
syngo.via with
the available
platform tools
(e.g. organ
ranges). | The output
images from all
Dual Energy
application
classes can
manually be
processed on
syngo.via with
the available
platform tools
(e.g. organ
ranges). | Extended
The subject
device
improves
workflow but
does not
change the
results that
can be
generated. |
| Provide
Dual
Energy
results with
Rapid
Results
Technology
also for
other
Workflows. | The generation
of Dual Energy
automatic
archiving
ranges is
separated from
the Dual Energy
application and
can be obtained
for any
syngo.via
workflow. | The generation
of Dual Energy
automatic
archiving
ranges is only
possible within
the Dual Energy
workflow. | The generation
of Dual Energy
automatic
archiving
ranges is only
possible within
the Dual Energy
workflow. | The generation
of Dual Energy
automatic
archiving
ranges is only
possible within
the Dual Energy
workflow. | Extended
The subject
device
improves
workflow but
does not
change the
results that
can be
generated. |
| | Subject Device | Primary
Predicate
Device | Reference
Predicate
Device | Reference
Predicate
Device | |
| Feature | Siemens
syngo,CT Dual
Energy | Siemens
syngo.CT Dual
Energy
(K150757) | Siemens
syngo.CT
Single Source
Dual Energy
(K150745) | Siemens
syngo.CT
Single Source
Dual Energy
(twin beam)
(K163289) | Comparison
Results |
| SPR
(Stopping
Power
Ratio) | The Rapid
Result
Technology
output type SPR
allows for the
calculation of
stopping power
images, which
show the
expected energy
loss of protons
in the material
at each voxel
position. | The application
class Rho/Z
provides all the
necessary
information that
enables simple
calculation of
SPR-images.
These images
can be
calculated
offline by
starting from
Rho-images and
applying a very
small correction
based on Z. | The application
class Rho/Z
provides all the
necessary
information that
enables simple
calculation of
SPR-images.
These images
can be
calculated
offline by
starting from
Rho-images and
applying a very
small correction
based on Z. | N/A – not
supported by a
TwinBeam
scan. | Extended
The subject
device merges
the output
images of an
already
cleared
algorithm in a
simple way. |
| SPP
(Spectral
Post-
Processing
Format) | syngo.CT Dual
Energy uses
low/high energy
images for all
calculations.
Together with
intermediate
processing
results these
images can be
stored in SPP
images and also
extracted from
them. | syngo.CT Dual
Energy uses
low/high energy
images for all
calculations.
Intermediate
processing
results are
stored as
separate series
in the database. | syngo.CT Dual
Energy uses
low/high energy
images for all
calculations.
Intermediate
processing
results are
stored as
separate series
in the database. | syngo.CT Dual
Energy uses
low/high energy
images for all
calculations.
Intermediate
processing
results are
stored as
separate series
in the database. | Similar
An alternative
image format
is introduced.
which
contains the
same
information as
images series
that were
previously
available. |
8
9
The subject device syngo.CT Dual Energy does not have changes in fundamental scientific technology compared to the predicate devices. The post-processing software functionality remains unchanged from the subject device and the predicate devices. The operating principle and the scientific technology are same; therefore, Siemens believes that syngo.CT Dual Energy application is substantially equivalent to the predicate devices.
VII. Performance Data
Software Verification and Validation Testing
Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission.
Non-Clinical / Clinical Testing Summary
syngo.CT Dual Energy is designed to fulfill the requirements of the following safety and performance standards:
10
Image /page/10/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 arranged in a circular pattern.
| Recognition
Number | Product
Area | Title of Standard | Publication
Date | Standards
Development
Organization |
|-----------------------|--------------------------|------------------------------------------------------------------------------------------------------------|---------------------|------------------------------------------|
| 12-300 | Radiology | Digital Imaging and Communications in
Medicine (DICOM) Set; PS 3.1 – 3.20 | 06/27/2016 | NEMA |
| 13-32 | Software | Medical Device Software -Software Life
Cycle Processes; 62304:2006 (1st Edition) | 08/20/2012 | AAMI, ANSI,
IEC |
| 5-40 | Software/
Informatics | Medical devices – Application of risk
management to medical devices; 14971
Second Edition 2007-03-01 | 08/20/2012 | ISO |
| 5-95 | General I
(QS/RM) | Medical devices - Part 1: Application of
usability engineering to medical devices
IEC 62366-1:2015 | 06/27/2016 | IEC |
Performance tests were conducted to test the functionality of the syngo.CT Dual Energy post-processing application. A phantom-based validation has been conducted to show that both features SPR (Stopping Power Ratio) and SPP (Spectral Post-Processing Format) operate as intended.
For SPR, the report shows that the SPR feature can reproduce the theoretical SPR values of the phantom inserts used from Dual Energy CT scans. The evaluation is described and validated in the report "Detailed Description of the DE application "DirectSPR" as part of the medical product "Syngo.CT Dual Energy", Version VB40".
Regarding the SPP evaluation, the combination of the SPP-generation process produces equivalent results to the reference method based on functionality available in the predicate device(s). This means also that the information in the SPP-format (including all hidden data) was correctly calculated. Hence, two new modules introduced to support the new SPP data format, "SPP Generation Unit" and "ISI Preparation Unit", which are part of syngo.CT Dual Energy are working as specified. The evaluation is described and evaluated in the report "Detailed Description and Bench Tests for the Feature "SPP/ISI"".
Furthermore, phantom bench testing and clinical validation in a retrospective study was conducted to test the functionality of the remaining application classes Rho/Z and Kidney Stones. Retrospective clinically validated studies were conducted to test the performance for applications classes Monoenergetic Plus, Bone Removal, Liver VNC, and Hard Plaques, as well as the predicate device application classes. These studies demonstrate that the subject device performs as well as the predicate device applications that were tested using the same methods. Supportive articles that demonstrate the usability of the application classes are provided to support device performance and functionality.
Non-clinical tests and clinical validation have been conducted to establish the proficiency of the features of the subject device. The results of these tests demonstrate that the subject device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence.
General Safety and Effectiveness Concerns
The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device. Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled during development, verification and validation testing. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.
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VIII. Conclusions
syngo.CT Dual Energy has the same intended use and similar indication for use as the predicate devices. The technological characteristics such as image visualization, operating platform, and image manipulation are the same as the predicate devices. The comparison of technological characteristics, non-clinical performance data, and software validation demonstrates that the subject device is as safe and effective when compared to the predicate devices that are currently marketed for the same intended use. For the subject device, syngo.CT Dual Energy, Siemens used the same testing with the same workflows as used to clear the primary predicate device. Siemens considers syngo.CT Dual Energy to be as safe, as effective, and with performance substantially equivalent to the commercially available predicate devices.