(141 days)
Not Found
No
The summary describes post-processing techniques based on the physical properties of materials at different energy levels, not AI/ML algorithms. There is no mention of AI, ML, or related concepts like training or inference.
No.
The device is a post-processing software for CT images used to improve visualization and differentiate materials based on energy dependence for diagnostic purposes, not for direct therapy.
Yes
The device aids in the visualization and differentiation of various body materials and conditions (e.g., brain hemorrhage, gout, kidney stones), which are crucial steps in reaching a clinical diagnosis. The "Kidney Stones" section explicitly states that the device 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" and mentions that "Only a well-trained radiologist can make the final diagnosis under consideration of all available information." This directly indicates its role in the diagnostic process.
Yes
The device is described as a "Software Package" and a "post processing application package" that operates on CT images. There is no mention of accompanying hardware being part of the device itself.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples (like blood, urine, tissue) outside the body. The text clearly states that syngo.CT Dual Energy operates with CT images acquired from a patient's body. It processes and visualizes information derived from these images, not from a biological sample.
- The device's function is image processing and visualization. It analyzes the attenuation coefficients of different materials within the body based on dual-energy CT scans. This is a form of medical imaging analysis, not in vitro testing.
- The intended use is for diagnostic imaging interpretation. The device aids radiologists in visualizing and differentiating materials within the body to support diagnosis, but it doesn't perform a test on a biological specimen.
Therefore, syngo.CT Dual Energy is a medical imaging software device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Syngo. Ct dual energy is designed to operate with ct images which siemens dual source scanners. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. Depending on the region of interest, contrast agents may be used. These differences provide information on the chemical composition of the scanned body materials. Syngo.Ct dual energy combines mages acquired with low and high energy spectra to visualize this information.
The functionality of the syngo. Ct dual energy applications is as follows:
- monoenergetic
- brain hemorrhage
- gout evaluation
- lung vessels
- heart pbv
- bone removal
- lung perfusion
- liver vnc
- monoenergetic plus
- virtual unenhanced
- bone marrow
- hard plaques
- Rho/Z
- kidney stones
*) 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
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
Dual energy offers functions for qualitative and quantitative evaluations. Dual energy CT 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. syngo.CT Dual Energy Software Package is a post processing application package consisting of several post processing application classes that can be used to improve visualization of various energy dependent materials in the human body.
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. A listing of device modifications is as follows:
-
- New software version syngo.via VB10 (SOMARIS/8 VB10A) for the syngo.CT Dual Energy post processing application package to support the following features:
- Addition of new application class Rho/Z .
- Support of application class Hard Plaque on synqo.via client . server platform
- Visualization of fat content (fat map) for application class Liver o VNC
-
- Modified Indication for Use to include features Rho/Z and Hard Plaques
The subject device syngo.CT Dual Energy also supports the following unmodified post-processing application classes:
- Monoenergetic ●
- Brain Hemorrhage
- Gout Evaluation ●
- Lung Vessels
- Heart PBV
- Bone Removal
- Luna Perfusion o
- Monoenergetic Plus ●
- Virtual Unenhanced
- Bone Marrow
- Kidney Stones ●
syngo.CT Dual Energy is designed to operate on the most recent version syngo.via client server platform which supports preprocessing and loading of datasets by synqo.via depending on confiqurable rules.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT images
Anatomical Site
Brain, Lung, Heart, Liver, Kidney (also generalized "anatomical region of interest" and "human body")
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Well-trained radiologist
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
Phantom bench testing and retrospective analysis of available patient data was conducted for application classes Rho/Z, Hardplaques, and feature Fat Map.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests (integration and functional) were conducted for syngo.CT Dual Energy during product development. The modifications described in this Premarket Notification were supported with verification/validation testing. 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 verification and validation of the device was found acceptable to support the claims of substantial equivalence. Performance tests were conducted to test the functionality of the syngo.CT Dual Energy. Phantom bench testing and retrospective analysis of available patient data was conducted for application classes Rho/Z, Hardplaques, and feature Fat Map. Supportive articles that demonstrate the usability of application class Rho/Z. Hardplaques and feature Fat Map for Liver VNC were provided to support device performance and functionality. In addition, these tests have been performed to test the ability of the included 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a silhouette effect. The graphic is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 11, 2015
Siemens Medical Solutions USA, Inc. % Ms. Kimberly Mangum Regulatory Affairs Specialist 51 Valley Stream Parkway, D02 MALVERN PA 19355
Re: K150757
Trade/Device Name: syngo.CT Dual Energy Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: July 6, 2015 Received: July 8, 2015
Dear Ms. Mangum:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150757
Device Name syngo.CT Dual Energy
Indications for Use (Describe)
Syngo. Ct dual energy is designed to operate with ct images which siemens dual source scanners. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. Depending on the region of interest, contrast agents may be used. These differences provide information on the chemical composition of the scanned body materials. Syngo.Ct dual energy combines mages acquired with low and high energy spectra to visualize this information.
The functionality of the syngo. Ct dual energy applications is as follows:
- monoenergetic
- brain hemorrhage
- gout evaluation
- lung vessels
- heart pbv
- bone removal
- lung perfusion
- liver vnc
- monoenergetic plus
- virtual unenhanced
- bone marrow
- hard plaques
- Rho/Z
- kidney stones
*) 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
| 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
510(k) Summary FOR syngo.CT Dual Energy Submitted by: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern. PA 19355 Date Prepared: June 19, 2015
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
1. General Information
Importer/Distributor Establishment: Registration No: 2240869 Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355
Manufacturing Facility:
Siemens AG Medical Solutions Siemens Str. 1 D-91301 Forchheim, Germany Establishment Registration Number: 3004977335
2. Contact Person:
Kimberly Manqum Regulatory Affairs Specialist Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway, Mail Code D02 Malvern, PA 19355 Phone: (610) 448-4912 Fax: (610) 448-1787 Email: kimberly.mangum@siemens.com
3. 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: 90JAK
5
4. Legally Marketed Primary Predicate Device:
| 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: | 90JAK |
Legally Marketed Secondary Predicate Device
| Product Name: | syngo® Dual Energy with extended functionality |
|---|---|
| Propriety Trade Name: | syngo® Dual Energy with extended functionality |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR § 892.1750 |
| Device Class: | Class II |
| Product Code: | 90JAK |
| Product Name: | SOMATOM DRI X-Ray CT Scanner |
|---|---|
| Propriety Trade Name: | SOMATOM DRI X-Ray CT Scanner |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR § 892.1750 |
| Device Class: | Class II |
| Product Code: | 90JAK |
5. Indications for Use
syngo.CT Dual Energy is designed to operate with CT images which have been acquired with Siemens Dual Source scanners. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. Depending on the region of interest, contrast agents may be used. 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.
The functionality of the syngo.CT Dual Energy applications is as follows:
- Monoenergetic ●
- Brain Hemorrhage ●
- Gout Evaluation ●
- Lung Vessels ●
- Heart PBV ●
- Bone Removal
- o Lung Perfusion
- Liver VNC ●
- Monoenergetic Plus ●
- Virtual Unenhanced ●
- Bone Marrow ●
- Hard Plaques ●
- o Rho/Z
- Kidney Stones"
*) Kidney Stones is designed to support the visualization of the chemical composition of kidney stones and especially the differentiation between uric
6
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.
6. Substantial Equivalence:
The subject device Siemens syngo.CT Dual Energy is substantially equivalent to following medical devices in commercial distribution as listed in Table 1:
| Manufacturer | Predicate Device | 510(k) | Clearance Date |
|---|---|---|---|
| Siemens | Primary Predicate Device: | ||
| syngo.CT Dual Energy | K133648 | July 7, 2014 | |
| Siemens | Secondary Predicate Device: | ||
| syngo® Dual Energy with extended | |||
| functionality | K083524 | April 1, 2009 | |
| Siemens | Secondary Predicate Device: | ||
| SOMATOM DRI X-ray Scanner | K837107 | March 9, 1983 |
| Table 1: Predicate Devices | ||
|---|---|---|
7. Device Description:
Dual energy offers functions for qualitative and quantitative evaluations. Dual energy CT 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. syngo.CT Dual Energy Software Package is a post processing application package consisting of several post processing application classes that can be used to improve visualization of various energy dependent materials in the human body.
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. A listing of device modifications is as follows:
-
- New software version syngo.via VB10 (SOMARIS/8 VB10A) for the syngo.CT Dual Energy post processing application package to support the following features:
- Addition of new application class Rho/Z .
- Support of application class Hard Plaque on synqo.via client . server platform
7
- Visualization of fat content (fat map) for application class Liver o VNC
-
- Modified Indication for Use to include features Rho/Z and Hard Plaques
The subject device syngo.CT Dual Energy also supports the following unmodified post-processing application classes:
- Monoenergetic ●
- Brain Hemorrhage
- Gout Evaluation ●
- Lung Vessels
- Heart PBV
- Bone Removal
- Luna Perfusion o
- Monoenergetic Plus ●
- Virtual Unenhanced
- Bone Marrow
- Kidney Stones ●
syngo.CT Dual Energy is designed to operate on the most recent version syngo.via client server platform which supports preprocessing and loading of datasets by synqo.via depending on confiqurable rules.
-
- Summary of Technical Characteristics of the Subject Device as Compared with the Predicate Device:
syngo.CT Dual Energy Software Package is a post processing application operating on the most recent version of the syngo.via client server platform. The subject device syngo.CT Dual Energy provides similar evaluation, reporting and visualization tools, and functionality as the primary predicate device syngo.CT Dual Energy, and secondary 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. Table 2 below provides a comparison of the primary features of the subject device in comparison to the predicate devices.
- Summary of Technical Characteristics of the Subject Device as Compared with the Predicate Device:
| Property | Subject Device | Primary Predicate Device K133648 | Secondary Predicate Device K083524 | Secondary Predicate Device K837107 |
|---|---|---|---|---|
| Software | ||||
| Features/ | ||||
| Functionality | Rho/Z - | |||
| Measurement of electron density as well as effective atomic number | Base material decomposition into tissue and iodine | Not Applicable | Visualization - Electron Density Visualization Features | |
| Hard Plaques- | ||||
| Support on syngo.via client server platform | Not Applicable | Hard Plaques and Vessels - Support on syngo classic platform | Not Applicable |
Table 2: Predicate and Subject Device Comparable Technological Characteristics
8
| Property | Subject Device | Primary
Predicate
Device
K133648 | Secondary
Predicate
Device
K083524 | Secondary
Predicate
Device
K837107 |
|----------|------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|---------------------------------------------|
| | Liver VNC -
Visualization of
fat content | Fat content
result in the
calculation of
Virtual Non
Contrast (VNC)
images | Fat content
result in the
calculation of
Virtual Non
Contrast (VNC)
images | Not Applicable |
syngo.CT Dual Energy does not have significant changes in technological characteristics when compared to the primary predicate device syngo.CT Dual Energy. The Indication for Use, operating principle, and the scientific technology are similar; therefore, Siemens believes that syngo.CT Dual Energy Package is substantially equivalent to the predicate devices.
9. Nonclinical Testing:
syngo.CT Dual Energy is designed to fulfill the requirements of the following safety and performance standards listed in Table 5 below:
| Recognition
Number | Product
Area | Title of Standard | Reference
Number and
Date | Publication
Date | Standards
Development
Organization |
|-----------------------|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|---------------------|------------------------------------------|
| 12-238 | Radiology | Digital Imaging and
Communications in
Medicine (DICOM) Set | PS 3.1 -
3.20 | 03/16/2012 | NEMA |
| 13-8 | Software | Medical device software -
Software life cycle
processes | 62304 First
edition 2006-
05 | 08/20/2012 | IEC |
| 5-40 | General | Medical devices -
Application of risk
management to medical
devices | 14971
Second
Edition 2007-
03-01 | 08/20/2012 | ISO |
| 5-85 | General | Medical electrical
equipment -- Part 1-6:
General requirements for
basic safety and essential
performance -- Collateral
Standard: Usability | 60601-1-6
Edition 3.0
2010-01 | 07/09/2014 | IEC |
| 5-41 | General | Medical electrical
equipment - Part 1-4:
General requirements for
safety -- Collateral
standard: Programmable
electrical medical
systems, edition 1.1 | 60601-1-
4:2000,
Consol. Ed.
1.1 | 09/08/2009 | IEC |
Table 5: Conformance Standards:
This submission contains performance data to demonstrate continued conformance with special controls for medical devices containing software. Non clinical tests (integration and functional) were conducted for syngo.CT
9
Dual Energy during product development. The modifications described in this Premarket Notification were supported with verification/validation testing.
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 verification and validation of the device was found acceptable to support the claims of substantial equivalence.
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 is also included as part of this submission.
Non-Clinical Testing Summary
Performance tests were conducted to test the functionality of the syngo.CT Dual Energy. Phantom bench testing and retrospective analysis of available patient data was conducted for application classes Rho/Z, Hardplaques, and feature Fat Map. Supportive articles that demonstrate the usability of application class Rho/Z. Hardplaques and feature Fat Map for Liver VNC were provided to support device performance and functionality.
In addition, these tests have been performed to test the ability of the included 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.
10. 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.
11. Conclusion as to Substantial Equivalence
syngo.CT Dual Energy has the same intended use and comparable indication for use as the predicate devices. The technological characteristics such as image visualization, operating platform, and image manipulation are similar to the predicate devices. Any differences in technological characteristics between the subject device and the predicate devices do not raise different questions of safety or effectiveness. The result of all conducted testing was found acceptable to support the claim of substantial equivalence.
10
The predicate devices were cleared based on non-clinical supportive information including phantom bench test, retrospective review of available patient data, and supportive clinical articles. The results of these tests demonstrate that the predicate devices are adequate for the intended use. The same testing and workflows were used to test the subject device modifications. 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. Since both devices were tested using the same methods, Siemens believes that the data generated from the syngo.CT Dual Energy testing supports a finding of substantial equivalence.