(105 days)
Not Found
No
The description focuses on post-processing algorithms based on dual-energy CT data and does not mention AI or ML.
No
The device is a post-processing software package for CT images, designed to improve visualization and aid in diagnosis. It does not directly treat a disease or condition.
Yes
This device is a post-processing application for CT images, designed to provide information on the chemical composition of scanned body materials and to support the visualization of various energy-dependent materials in the human body. Specifically, the "Kidney Stones" functionality is designed to support the visualization of their chemical composition and differentiation, clearly indicating its role in providing diagnostic information. The "Intended User / Care Setting" also mentions that "Only a well-trained radiologist can make the final diagnosis under consideration of all available information," further implying its use as a diagnostic aid.
Yes
The device is described as a "Software Package" that operates on a "client/server platform" and performs post-processing of CT images. While it requires CT images acquired from specific hardware (Siemens Twin Beam Single Source scanners), the device itself is the software application that processes these images. The description focuses entirely on the software's functionality and algorithms, with no mention of the device including or being integrated with any hardware components beyond the platform it runs on.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this software operates on CT images acquired from the human body, not on biological specimens like blood, urine, or tissue samples.
- The purpose of this device is image processing and visualization. It helps radiologists interpret CT scans by processing and displaying image data in different ways (e.g., monoenergetic, bone removal, virtual unenhanced). This is distinct from the function of an IVD, which is to provide information about a patient's health status through the analysis of biological samples.
- The "Kidney Stones" application, while supporting visualization of chemical composition, explicitly states that additional clinical information and urine testing are needed for full identification. This further reinforces that the device is an aid to diagnosis based on imaging, not a standalone diagnostic test based on a biological sample.
Therefore, syngo. CT Single Source Dual Energy is a medical imaging software application, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
syngo. CT Single Source Dual Energy is designed to operate with CT images which have been acquired with Siemens Twin Beam Single Source scanners. The various materials of an anatomical region of interest aremation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials. syngo. CT Single Source 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 functionality of the syngo. CT Single Source Dual Energy applications are as follows:
- · Monoenergetic
- · Bone Removal
· Liver VNC
- · Monoenergetic Plus
- · Virtual Unenhanced
- · Rho/Z
- · Hard Plaques
· Kidney Stones*
*) Kidney Stones is designed to support the visualization of the chemical composition of kidney stones and especially the differentiation between unc 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
syngo.CT Single Source Dual Energy (twin beam) 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. 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.
After loading the two reconstructed image datasets acquired with two different X-ray spectra into syngo.CT Single Source Dual Energy (twin beam), a correction algorithm is used in order to minimize motion effects. They are then displayed using linear blending with selectable mixing ratio and color scale. Multiplanar reformations (MPR) of the volume are shown in 3 image segments, which are initialized as sagittal, coronal and axial view. After arriving at an initial diagnosis on the basis of the CT-images, the user can choose one of the following application classes:
- Monoenergetic ●
- Bone Removal ●
- Liver VNC
- Monoenergetic Plus ●
- Virtual Unenhanced ●
- . Rho/Z
- Hard Plaques
- Kidnev Stones .
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 images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Only a well-trained radiologist can make the final diagnosis under 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
Not Found
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 Single Source Dual Energy (twin beam) during product development. The modifications described in this Premarket Notification were supported with verification/validation testing.
Performance tests were conducted to test the functionality of the syngo.CT Single Source Dual Energy (twin beam) application package. Phantom bench testing and clinical validation in a retrospective study was conducted to test the functionality of applications Rho/Z and Kidney Stones. Retrospective clinically validated studies were conducted to test the performance for applications Monoenergetic Plus, Bone Removal, Liver VNC, and Hard Plaques, as well as the predicate device applications. These studies demonstrate that the subject device using twin beam datasets 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 were provided to support device performance and functionality. 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 19, 2016
Siemens Medical Solutions USA, Inc. % Ms. Kimberly Mangum Regulatory Affairs Specialist 40 Liberty Boulevard, Mail Code 65-1A MALVERN PA 19355
Re: K153220
Trade/Device Name: syngo.CT Single Source Dual Energy (twin beam) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: January 19, 2016 Received: January 22, 2016
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. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Indications for Use
510(k) Number (if known)
Device Name syngo.CT Single Source Dual Energy (twin beam)
Indications for Use (Describe)
syngo. CT Single Source Dual Energy is designed to operate with CT images which have been acquired with Siemens Twin Beam Single Source scanners. The various materials of an anatomical region of interest aremation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials. syngo. CT Single Source 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 functionality of the syngo. CT Single Source Dual Energy applications are as follows:
- · Monoenergetic
- · Bone Removal
· Liver VNC
- · Monoenergetic Plus
- · Virtual Unenhanced
- · Rho/Z
- · Hard Plaques
· Kidney Stones*
*) Kidney Stones is designed to support the visualization of the chemical composition of kidney stones and especially the differentiation between unc 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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
Page 1 of 1
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510(K) Summary FOR syngo.CT Single Source Dual Energy (twin beam)
Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Date Prepared: November 03, 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: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number 2240869
Manufacturing Facility: Siemens AG Medical Solutions Siemensstraße 1 D-91301 Forchheim, Germany Establishment Registration Number: 3004977335
2. Contact Person
Kimberlv Mangum Regulatory Affairs Specialist Siemens Medical Solutions, Inc. USA 40 Liberty Boulevard Mail Code 65-1A Malvern, PA 19355 Phone: (610) 448-6477 Fax: (610) 640-4481 Email: kimberly.mangum@siemens.com
3. Device Name and Classification
syngo.CT Single Source Dual Energy (twin beam) Product Name: Propriety Trade Name: syngo.CT Single Source Dual Energy (twin beam) 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 Predicate Device: Primary Predicate Device: Trade Name: syngo.CT Dual Energy 510(k)#: K150757 Clearance Date: August 11, 2015 Classification Name: Computed Tomography X-ray System Classification Panel: Radiology Classification Requlation: 21 CFR § 892.1750
4
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| Device Class:
Product Code: | Class II
90JAK |
|--------------------------------|-----------------------------------------------------------|
| Secondary Predicate Device: | |
| Trade Name: | SOMATOM Definition AS/ AS+ and
SOMATOM Definition Edge |
| 510(k)#: | K152036 |
| Clearance Date: | October 9, 2015 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR § 892.1750 |
| Device Class: | Class II |
| Product Code: | 90JAK |
4. Substantial Equivalence:
The subject device syngo.CT Single Source Dual Energy (twin beam) is substantially equivalent to following medical devices in commercial distribution as listed in Table 1:
| Predicate Device | FDA Clearance
Number | FDA
Clearance
Date |
|------------------------------------------------------------------------------------------|-------------------------|--------------------------|
| Primary Predicate Device:
syngo.CT Dual Energy | K150757 | August 11,
2015 |
| Secondary Predicate Device:
SOMATOM Definition AS/ AS+ and
SOMATOM Definition Edge | K152036 | October 9,
2015 |
Table 1 Predicate Device
5. 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 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 Single Source Dual Energy (twin beam) 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. 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.
After loading the two reconstructed image datasets acquired with two different X-ray spectra into syngo.CT Single Source Dual Energy (twin beam), a correction algorithm is used in order to minimize motion effects. They are then displayed using linear blending with selectable mixing ratio and color scale. Multiplanar reformations (MPR) of the volume are shown in 3 image segments, which are initialized as sagittal, coronal and axial view. After arriving at an initial diagnosis on the basis of the CT-images, the user can choose one of the following application classes:
- Monoenergetic ●
- Bone Removal ●
- Liver VNC
- Monoenergetic Plus ●
- Virtual Unenhanced ●
- . Rho/Z
5
Image /page/5/Picture/0 description: The image shows the word "SIEMENS" in a bold, sans-serif font. The color of the text is a light blue or teal. The word is presented in all capital letters and is the central focus of the image.
- Hard Plaques
- Kidnev Stones .
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. A listing of device modifications is as follows:
-
- The Use of Twin Beam Images for Dual Energy post-processing Applications
-
- Modified Indications for Use Statement
-
- Modified Product Name
syngo.CT Single Source Dual Energy (twin beam) 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. Summary of Technical Characteristics of the Subject Device as compared with the Predicate Device:
syngo.CT Single Source Dual Energy (twin beam) Software Package is a post-processing application operating on the multi-user syngo.via client/server platform. The subject syngo.CT Single Source Dual Energy (twin beam) provides the same evaluation, reporting and visualization tools, and functionality as the primary predicate device syngo.CT Dual Energy. This includes image processing and visualization tools such as basic visualization of various energy dependent materials in the human body and VRT visualization. Compared to the secondary predicate device, the same type of input images is accepted and the same alqorithms as well as the same spectrum dependent parameters are used to generate the output images.
Table 2 below provides a comparison of the primary features of the subject device in comparison to the predicate devices.
| Property /
Feature | Subject Device | Primary Predicate Device
K150757 | Secondary Predicate
Device
K152036 |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Data Acquisition
Mode | The subject device uses
DICOM images acquired
using Twin Beam (split
filtration) Single Source
scanners. | This device uses DICOM
images acquired with Dual
Source scanners. | This device provides a
Single Source Twin Beam
(split filtration) data
acquisition mode. |
| Image
processing | The software processes
Twin Beam Dual Energy
images. | The software processes
Dual Source Dual Energy
images. | The software processes
Twin Beam (split filtration)
Single Source images. |
| Software
Features/
Functionality | Post-processing application
supports the use of
TwinBeam datasets with
various post-processing
applications | Post processing application
supports the use of Dual
Source datasets with various
post processing applications | Scanner supports the use
of TwinBeam datasets
with application FAST DE
Results for post-
processing Applications
Monoenegetic Plus and
Virtual Unenhanced |
Table 2 Predicate and Subject Device Comparable Technological Characteristics
The subject device synao.CT Single Source Dual Energy (twin beam) does not have significant changes in technological characteristics when compared to the predicate devices. The postprocessing software functionality remains unchanged from the subject device and the predicate The Indication for Use, operating principle, and the scientific technology are similar; devices. therefore, Siemens believes that syngo.CT Single Source Dual Energy (twin beam) application is substantially equivalent to the predicate devices.
6
7. Nonclinical Testing:
syngo.CT Single Source Dual Energy (twin beam) is designed to fulfill the requirements of the following safety and performance standards:
| Table 3 Conformance Standards |
|---|
| ------------------------------- |
| Recognition
Number | Product
Area | Title of Standard | Reference
Number and
Date | Publication
Date | Standards
Development
Organization |
|-----------------------|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|---------------------|------------------------------------------|
| N/A | Radiology | Digital Imaging and
Communications in Medicine
(DICOM) Set | PS 3.1 - 3.18 | 2008 | 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 | 07/09/2014 | IEC |
| N/A | 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 |
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 Single Source Dual Energy (twin beam) 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 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 Single Source Dual Energy (twin beam) application package. Phantom bench testing and clinical validation in a retrospective study was conducted to test the functionality of applications Rho/Z and Kidney Stones. Retrospective clinically validated studies were conducted to test the performance for applications Monoenergetic Plus, Bone Removal, Liver VNC, and Hard Plaques, as well as the predicate device applications. These studies demonstrate that the subject device using twin beam datasets performs as well as the predicate device applications that were tested using the same methods.
7
SIEMENS
Supportive articles that demonstrate the usability of the application classes were provided to support device performance and functionality. 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.
8. Indications for Use:
syngo.CT Single Source Dual Energy is designed to operate with CT images which have been acquired with Siemens Twin Beam Single Source scanners. 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 Single Source 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 functionality of the syngo.CT Single Source Dual Energy applications are as follows:
- · Monoenergetic
- Bone Removal
- · Liver VNC
- · Monoenergetic Plus
- Virtual Unenhanced
- Rho/Z
- Hard Plaques
- 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.
9. 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.
10. Conclusion as to Substantial Equivalence:
syngo.CT Single Source Dual Energy (twin beam) 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 primary predicate device. 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 testing conducted was found acceptable to support the claim of substantial equivalence.
The predicate devices were cleared based on non-clinical supportive information and clinical images. The results of these tests demonstrate that the predicate devices are adequate for the intended use. 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 Single Source Dual Energy (twin beam), Siemens used the same testing with the same workflows as used to clear the primary predicate device. Since both devices were tested
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using the same methods, Siemens believes that the data generated from the syngo.CT Single Source Dual Energy (twin beam) testing supports a finding of substantial equivalence.