(199 days)
Not Found
No
The summary describes post-processing algorithms based on dual-energy CT data and does not mention AI or ML.
No.
The device is a post-processing application for CT images, designed to improve the visualization of chemical composition within anatomical regions. It provides diagnostic information to a trained radiologist, but it does not directly treat or cure medical conditions.
Yes
The “Intended Use / Indications for Use” section states that the device provides information on chemical composition, and features like "Brain Hemorrhage" and "Kidney Stones" are listed. The description for Kidney Stones explicitly mentions "visualization of the chemical composition of kidney stones and especially the differentiation between uric acid stones," which directly indicates a diagnostic purpose. It also states that a "well-trained radiologist can make the final diagnosis upon consideration of all available information."
No
The device is described as a "post-processing application" that works with data from Computed Tomography X-Ray Systems. While it is software, it is dependent on and processes data from a specific hardware modality (CT scanner), and the description focuses on the post-processing of images generated by that hardware. It is not a standalone software device that performs its intended function without direct interaction with or processing of data from a medical device hardware component.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). This device processes images acquired of the human body using a CT scanner.
- The intended use and device description clearly state that it's a post-processing application for CT images. It manipulates and visualizes data from the CT scan itself, not from a biological sample.
- The performance studies involve image interpretation by radiologists, not laboratory analysis of biological specimens.
Therefore, this device falls under the category of medical imaging software or a medical image processing device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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:
- · Monoenergetic 1)
- · Brain Hemorrhage 1)
- · Gout Evaluation 1)
- · Lung Vessels 1)
- · Heart PBV
- · Bone Removal
- · Lung Perfusion 1)
- · Lung Mono 1 )
- · Liver VNC 1)
- · Monoenergetic Plus 1)
- · Virtual Unenhanced 1)
- Bone Marrow
- · Hard Plaques
- Rho/Z
- · Kidney Stones 1) 2)
- · SPR (Stopping Power Ratio)
- · SPP (Spectral Post-Processing Format) 1)
- · Optimum Contrast 1)
The availability of each feature depends on the Dual Energy scan mode.
-
This functionality supports data from Siemens Healthineers Photon-Counting CT scanners acquired in QuantumPlus modes.
-
Kidney Stones is designed to support the visualization of the chemical composition of kidney stones and especially the differentiation between 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 upon 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. syngo.CT Dual Energy is a post-processing application consisting of several post-processing application classes that can be used to improve the visualization of the chemical composition of various energy dependent 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.
Different body regions require specific tools that allow the correct evaluation of data sets. syngo.CT Dual Energy provides a range of application classes that meet the requirements of each evaluation type. The different application classes for the subject device can be combined into one workflow.
The modifications for the software version SOMARIS/8 VB80 are listed in section 7.
Mentions image processing
syngo.CT Dual Energy is a post-processing application consisting of several post-processing application classes that can be used to improve the visualization of the chemical composition of various energy dependent materials in the human body when compared to single energy CT.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography X-Ray System
Anatomical Site
anatomical region of interest (e.g., brain, lung, heart, bone, liver, kidney)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Only a well-trained radiologist can make the final diagnosis upon consideration of all available information.
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
DE Brain Hemorrhage for Photon-Counting CT:
We performed a two-reader study to assess the clinical performance of the application class DE Brain Hemorrhage on photon-counting CT (PCCT) data, comparing the reading results on VNC and Iodine images with later follow-up data. The study demonstrated that DE Brain Hemorrhage can provide complementary visualization of iodine and overlay maps as demonstrated in a two reader study where 24 of 28 features were identified by both readers. Of all 28 features, 19 were assessed to be pure hemorrhage, 6 to be pure iodine staining, and 3 to be a mix of both, hemorrhage and iodine.
Lung Mono for Dual Source Dual Energy:
A two-reader study on twenty cases of suspected pulmonary embolisms was performed. The test demonstrated adequate agreement between the position of obstructing clots and the location of perfusion defects in the Lung Mono maps. Thus, the Lung Mono maps can provide complementary visualization for the purposes of identifying and locating perfusion defects caused by obstructing clots. Lung Mono images should not be interpreted alone.
Lung Analysis (Lung PBV, Lung Mono, and Lung Vessels) for Photon-Counting CT:
A two-reader study on 33 cases of suspected pulmonary embolisms was performed to assess the performance of Lung PBV, Lung Mono, and Lung Vessel maps.
The test demonstrated that the three image types visualize reduced local iodine content, either in the lung parenchyma or in the lung arteries. The test was based on obstructing clots, which are the cause of pulmonary embolism and can be identified in conventional CT images by trained radiologists.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Verification and Validation
Software Documentation for Enhanced documentation Level per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Device Software Functions" issued on June 14, 2023, is also included as part of this submission. The Risk Analysis was completed, and risk control implemented to mitigate identified hazards. The testing supports that all software specifications have met the acceptance criteria. Testing for verification and validation support the claim of substantial equivalence.
Summary of Performance Testing
DE Brain Hemorrhage for Photon-Counting CT:
Study type: two-reader study.
Sample size: 28 features (19 pure hemorrhage, 6 pure iodine staining, 3 mix of both).
Key results: 24 of 28 features were identified by both readers. The application provides complementary visualization of iodine and overlay maps.
Lung Mono for Dual Source Dual Energy:
Study type: two-reader study.
Sample size: twenty cases of suspected pulmonary embolisms.
Key results: Demonstrated adequate agreement between the position of obstructing clots and the location of perfusion defects in the Lung Mono maps. Provides complementary visualization for identifying and locating perfusion defects caused by obstructing clots.
Lung Analysis (Lung PBV, Lung Mono, and Lung Vessels) for Photon-Counting CT:
Study type: two-reader study.
Sample size: 33 cases of suspected pulmonary embolisms.
Key results: The three image types visualize reduced local iodine content, either in the lung parenchyma or in the lung arteries. The test was based on obstructing clots, which are the cause of pulmonary embolism and can be identified in conventional CT images by trained radiologists.
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.
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January 3, 2025
Siemens Medical Solutions USA, Inc. % Kenny M Bello Regulatory Affairs Professional 810 Innovation Drive KNOXVILLE, TN 37932
Re: K241757
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: December 5, 2024 Received: December 5, 2024
Dear Kenny M Bello:
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.
1
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).
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 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-regulatory
2
assistance/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 Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241757
Device Name sygno.CT Dual Energy
Indications for Use (Describe)
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:
- · Monoenergetic 1)
- · Brain Hemorrhage 1)
- · Gout Evaluation 1)
- · Lung Vessels 1)
- · Heart PBV
- · Bone Removal
- · Lung Perfusion 1)
- · Lung Mono 1 )
- · Liver VNC 1)
- · Monoenergetic Plus 1)
- · Virtual Unenhanced 1)
- Bone Marrow
- · Hard Plaques
- Rho/Z
- · Kidney Stones 1) 2)
- · SPR (Stopping Power Ratio)
- · SPP (Spectral Post-Processing Format) 1)
- · Optimum Contrast 1)
The availability of each feature depends on the Dual Energy scan mode.
-
This functionality supports data from Siemens Healthineers Photon-Counting CT scanners acquired in QuantumPlus modes.
-
Kidney Stones is designed to support the visualization of the chemical composition of kidney stones and especially the differentiation between 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 upon 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.
4
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Image /page/5/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 word "Healthineers" is a graphic of orange dots.
510(k) Summary for K241757
syngo.CT Dual Energy (VB80)
1. Identification of the Submitter
| Submitter / Primary Contact Person | Kenny M Bello | |
|---|---|---|
| Regulatory Affairs | ||
| monsuru.bello@siemens-healthineers.com | ||
| +1(202) 856-6099 | ||
| Secondary Contact Person | Clayton Ginn | |
| Regulatory Affairs | ||
| clayton.ginn@siemens-healthineers.com | ||
| +1 (865) 898-2692 | ||
| Submitter Address | Siemens Medical Solutions, Inc. USA | |
| Molecular Imaging | ||
| 810 Innovation Drive | ||
| Knoxville, TN 37932 | ||
| Establishment Registration Number: 1034973 | ||
| Legal Manufacturer | Siemens Healthcare GmbH | |
| Siemensstr 1 | ||
| D-91301 Forchheim, Germany | ||
| Establishment Registration Number: 3004977335 | ||
| Importer/Distributor | Siemens Medical Solutions USA, Inc. | |
| 40 Liberty Boulevard | ||
| Malvern, PA 19355 | ||
| Establishment Registration Number: 2240869 |
2. 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 |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
3. Predicate Devices
Predicate Device:
| Trade Name: | syngo.CT Dual Energy |
|---|---|
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| K-Number: | K232155 |
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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 word "Healthineers" is a cluster of orange dots.
4. Device Description
Dual energy offers functions for qualitative and quantitative post-processing evaluations. syngo.CT Dual Energy is a post-processing application consisting of several post-processing application classes that can be used to improve the visualization of the chemical composition of various energy dependent 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.
Different body regions require specific tools that allow the correct evaluation of data sets. syngo.CT Dual Energy provides a range of application classes that meet the requirements of each evaluation type. The different application classes for the subject device can be combined into one workflow.
The modifications for the software version SOMARIS/8 VB80 are listed in section 7.
5. Indications for Use
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:
- Monoenergetic 1)
- · Brain Hemorrhage 1)
- · Gout Evaluation 1)
- Lung Vessels 1)
- Heart PBV
- Bone Removal
- · Lung Perfusion 1)
- Lung Mono 1)
- Liver VNC 1)
- · Monoenergetic Plus 1)
- Virtual Unenhanced 1)
- Bone Marrow
- Hard Plaques
- Rho/Z
- Kidney Stones 1) 2)
- SPR (Stopping Power Ratio)
- · SPP (Spectral Post-Processing Format) 1)
- · Optimum Contrast 1)
The availability of each feature depends on the Dual Energy scan mode.
-
- This functionality supports data from Siemens Healthineers Photon-Counting CT scanners acquired in QuantumPlus modes.
7
Image /page/7/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 arranged in a pattern.
-
- Kidney Stones is designed to support the visualization of the chemical com 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 upon consideration of all available information. The accuracy of identification is decreased in obese patients.
| Subject Device | Predicate Device |
|---|---|
| syngo.CT Dual Energy | syngo.CT Dual Energy |
| (SOMARIS/8 VB80) | (SOMARIS/8 VB71) |
| The various materials of an anatomical region of interest | The various materials of an anatomical region of interest |
| have different attenuation coefficients, which depend on the | have different attenuation coefficients, which depend on the |
| used energy. These differences provide information on the | used energy. These differences provide information on the |
| chemical composition of the scanned body materials. | chemical composition of the scanned body materials. |
| syngo.CT Dual Energy combines images acquired with low | syngo.CT Dual Energy combines images acquired with low |
| and high energy spectra to visualize this information. | and high energy spectra to visualize this information. |
| Depending on the region of interest, contrast agents may be | Depending on the region of interest, contrast agents may be |
| used. | used. |
| The general functionality of the syngo.CT Dual Energy | The general functionality of the syngo.CT Dual Energy |
| application is as follows: | application is as follows: |
| • Monoenergetic 1) | • Monoenergetic 1) |
| • Brain Hemorrhage 1) | • Brain Hemorrhage |
| • Gout Evaluation 1) | • Gout Evaluation 1) |
| • Lung Vessels 1) | • Lung Vessels |
| • Heart PBV | • Heart PBV |
| • Bone Removal | • Bone Removal |
| • Lung Perfusion 1) | • Lung Perfusion |
| • Lung Mono 1) | • Liver VNC 1) |
| • Liver VNC 1) | • Monoenergetic Plus 1) |
| • Monoenergetic Plus 1) | • Virtual Unenhanced 1) |
| • Virtual Unenhanced 1) | • Bone Marrow |
| • Bone Marrow | • Hard Plaques |
| • Hard Plaques | • Rho/Z |
| • Rho/Z | • Kidney Stones 1) 2) |
| • Kidney Stones 1) 2) | • SPR (Stopping Power Ratio) |
| • SPR (Stopping Power Ratio) | • SPP (Spectral Post-Processing Format) 1) |
| • SPP (Spectral Post-Processing Format) 1) | • Optimum Contrast 1) |
| • Optimum Contrast 1) | The availability of each feature depends on the Dual Energy |
| The availability of each feature depends on the Dual Energy | scan mode. |
| scan mode. | 1) This functionality supports data from Photon-Counting |
| 1) This functionality supports data from Siemens | CT scanners. |
| Healthineers Photon-Counting CT scanners acquired in | 2) Kidney Stones is designed to support the visualization of |
| QuantumPlus modes. | the chemical composition of kidney stones and |
| 2) Kidney Stones is designed to support the visualization of | especially the differentiation between uric acid and non- |
| the chemical composition of kidney stones and | uric acid stones. For full identification of the kidney |
| especially the differentiation between uric acid and non- | stone, additional clinical information should be |
| uric acid stones. For full identification of the kidney | considered such as patient history and urine testing. |
| stone, additional clinical information should be | Only a well-trained radiologist can make the final |
| considered such as patient history and urine testing. | diagnosis upon consideration of all available |
6. Indications for Use Comparison to the Predicate Device
Only a well-trained radiologist can make the final
8
diagnosis upon consideration of all available information. The accuracy of identification is decreased in obese patients.
information. The accuracy of identific in obese patients.
The changes of the IFU-Statement as compared to the predicate device are depicted in bold font. For the changes conducted in SOMARIS/7 VB80, two application classes support Photon-Counting CT scanners: Brain Hemorrhage and Lung Analysis (represented by Lung Vessels and Lung Perfusion). The additional image type called Lung Mono has been included into the IFU statement as well, to reflect the entire functionality of syngo.CT Dual Energy. Furthermore, footnote 1 has been specified to reflect the possibility that some application classes are able to support data from Siemens Healthineers Photon-Counting CT scanners acquired in QuantumPlus modes. The intention of this change is to reflect the distinction between the photon-counter scan-mode "QuantumPlus" and the additional scan-mode called "QuantumPeak".
7. Comparison of Technological Characteristics with the Predicate Device
| Feature | Subject Device | Predicate Device |
|---|---|---|
| syngo.CT Dual Energy | ||
| (SOMARIS/8 VB80) | syngo.CT Dual Energy | |
| (SOMARIS/8 VB71) | ||
| Brain Hemorrhage | The application class visualizes the contrast agent | |
| concentration in the case of brain hemorrhage | ||
| without use of an additional non-contrast scan. | ||
| Basis for this approach is a material | ||
| decomposition into contrast agent and soft tissue. | ||
| The results of this calculation are shown as color | ||
| overlay to anatomical, grayscale information. This | ||
| output may be used for complimentary | ||
| visualization of iodine and overlay maps. | ||
| Modification: | ||
| Quantum Spectral Imaging (PCCT) scan-mode | ||
| support. | The application class visualizes the contrast agent | |
| concentration in the case of brain hemorrhage | ||
| without use of an additional non-contrast scan. | ||
| Basis for this approach is a material decomposition | ||
| into contrast agent and soft tissue. The results of | ||
| this calculation are shown as color overlay to | ||
| anatomical, grayscale information. | ||
| Lung Analysis |
- Lung Vessels | This application class visualizes the contrast
agent concentration in the lung without use of
an additional non-contrast scan. The basis for
this approach is a material decomposition into
contrast agent and soft tissue. The results of this
calculation are shown as color overlay to
anatomical, grayscale information.
Modification:
Quantum Spectral Imaging (PCCT) scan-mode
support. | This application class visualizes the contrast agent
concentration in the lung without use of an
additional non-contrast scan. The basis for this
approach is a material decomposition into contrast
agent and soft tissue. The results of this calculation
are shown as color overlay to anatomical, grayscale
information. |
| Feature | Subject Device | Predicate Device |
| | syngo.CT Dual Energy
(SOMARIS/8 VB80) | syngo.CT Dual Energy
(SOMARIS/8 VB71) |
| - Lung Perfusion | The application class visualizes the contrast
agent concentration in the lung without use of
an additional non-contrast scan. The basis for
this approach is a material decomposition into
contrast agent and soft tissue. The results of this
calculation are shown as color overlay to
anatomical, grayscale information. An optional
lung isolation is provided. Lung Mono series
should not be interpreted in isolation. | The application class visualizes the contrast agent
concentration in the lung without use of an
additional non-contrast scan. The basis for this
approach is a material decomposition into contrast
agent and soft tissue. The results of this calculation
are shown as color overlay to anatomical, grayscale
information. An optional lung isolation is provided. |
| | Modification:
Quantum Spectral Imaging (PCCT) scan-mode
support for Lung PBV.
Availability of an additional image type (Lung
Mono) for dual source dual energy and
Quantum Spectral Imaging (PCCT) scan modes. | |
| Monoenergetic Plus | This application class simulates images that are
equivalent to images scanned with a single
photon energy beam, depending on the energy
(keV). | This application class simulates images that are
equivalent to images scanned with a single photon
energy beam, depending on the energy (keV). |
| | Modification:
Dual Source Dual Energy (DSDE) data from PCCT
(QuantumPeak) can be loaded. | |
| Bone Marrow | This application class allows to visualize the
bone marrow composition based on
nonenhanced CT data. It generates virtual non-calcium (VNCa)
images by subtracting calcium from the Dual Energy data sets. | This application class allows to visualize the bone
marrow composition based on nonenhanced CT
data. It generates virtual non-calcium (VNCa)
images by subtracting calcium from the Dual Energy
data sets. |
| | Modification:
Dual Source Dual Energy (DSDE) data from PCCT
(QuantumPeak) can be loaded. | |
| Kidney Stones | This application class visualizes the chemical
differences between kidney stones by
decomposing the kidney stones into its
component parts: tissue, uric acid, and oxalate
(calcium stone). | This application class visualizes the chemical
differences between kidney stones by decomposing
the kidney stones into its component parts: tissue,
uric acid, and oxalate (calcium stone). |
| | Modification:
Dual Source Dual Energy (DSDE) data from PCCT
(QuantumPeak) can be loaded. | |
| Virtual Unenhanced | This application class visualizes the contrast
agent concentration in soft body tissue without
the need of an additional non-contrast scan. | This application class visualizes the contrast agent
concentration in soft body tissue without the need
of an additional non-contrast scan. |
| | Modification:
Dual Spiral/Twin Spiral scan-mode support for
Virtual Unenhanced. | |
The differences between the above referenced predicate device are listed at a high-level in the following table:
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The remaining applications classes/functions in syngo.CT Dual Energy rema the predicate version:
- SPR (Stopping Power Ratio)
- SPP (Spectral Post-Processing Format)
- Monoenergetic
- Gout Evaluation
- Bone Removal
- Hard Plaques
- Rho/Z
- Lung Lobe Segmentation
8. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Software Verification and Validation
Software Documentation for Enhanced documentation Level per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Device Software Functions" issued on June 14, 2023, is also included as part of this submission. The Risk Analysis was completed, and risk control implemented to mitigate identified hazards. The testing supports that all software specifications have met the acceptance criteria. Testing for verification and validation support the claim of substantial equivalence.
Summary of Performance Testing
DE Brain Hemorrhage for Photon-Counting CT
We performed a two-reader study to assess the clinical performance of the application class DE Brain Hemorrhage on photon-counting CT (PCCT) data, comparing the reading results on VNC and Iodine images with later follow-up data. The study demonstrated that DE Brain Hemorrhage can provide complementary visualization of iodine and overlay maps as demonstrated in a two reader study where 24 of 28 features were identified by both readers. Of all 28 features, 19 were assessed to be pure hemorrhage, 6 to be pure iodine staining, and 3 to be a mix of both, hemorrhage and iodine.
Lung Mono for Dual Source Dual Energy
A two-reader study on twenty cases of suspected pulmonary embolisms was performed. The test demonstrated adequate agreement between the position of obstructing clots and the location of perfusion defects in the Lung Mono maps. Thus, the Lung Mono maps can provide complementary visualization for the purposes of identifying and locating perfusion defects caused by obstructing clots. Lung Mono images should not be interpreted alone.
Lung Analysis (Lung PBV, Lung Mono, and Lung Vessels) for Photon-Counting CT
A two-reader study on 33 cases of suspected pulmonary embolisms was performed to assess the performance of Lung PBV, Lung Mono, and Lung Vessel maps.
The test demonstrated that the three image types visualize reduced local iodine content, either in the lung parenchyma or in the lung arteries. The test was based on obstructing clots, which are the cause of pulmonary embolism and can be identified in conventional CT images by trained radiologists.
Risk Analysis
The risk analysis was completed, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for
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verification and validation of the device was found acceptable to support equivalence.
Siemens hereby certifies that syngo.CT Dual Energy meets the following FDA Recognized Consensus standards listed below:
| Standard | Version | Content | FDA
Recognition
Number
(if applicable) |
|-----------------------------|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| ANSI AAMI IEC
62304 | :2006/A1:2016 | Medical device software - Software life cycle
processes [Including Amendment 1 (2016)] | 13-79 |
| NEMA PS 3.1 -
3.20 2022d | :2022 | Digital Imaging and Communications in
Medicine (DICOM) Set | 12-349 |
| ISO 14971 | :2019 | Application of Risk Management to Medical
Devices | 5-125 |
| IEC 62366-1 | Edition 1.1
2020-06
CONSOLIDATED
VERSION | Medical devices - Part 1: Application of
usability engineering to medical devices | 5-129 |
| ISO 15223-1 | Fourth edition
2021-07 | Medical devices - Symbols to be used with
information to be supplied by the
manufacturer - Part 1: General requirements | 5-134 |
| ISO 20417:2021 | First edition
2021-04
Corrected
version 2021-
12 | Medical devices - Information to be supplied
by the manufacturer | 5-135 |
9. Conclusion
syngo.CT Dual Energy has the same intended use and similar indication for use as the predicate device. The subject device syngo.CT Dual Energy does not have changes in fundamental scientific technology compared to the predicate devices. The technological characteristics such as image visualization, operating platform, and image measurement are the same as the predicate device. For the subject device, syngo.CT Dual Energy, Siemens used the same testing with the same workflows as used to clear the predicate device. Siemens considers syngo.CT Dual Energy to be as safe, as effective, and with performance substantially equivalent to the commercially available predicate device.