(79 days)
Not Found
No
The description focuses on post-processing algorithms based on dual-energy CT data and material attenuation properties. There is no mention of AI, ML, or related concepts like training data, models, or performance metrics typically associated with AI/ML devices.
No
Explanation: This device is a post-processing software application for CT images, designed to improve visualization and analysis of various materials in the human body. It is used to aid diagnosis by providing additional information from CT scans, but it does not directly treat or alleviate a disease, injury, or disability.
Yes
The device aids in making a diagnosis by providing information on the chemical composition of scanned body materials, visualizing urate depositions for gout, and differentiating between uric acid and non-uric acid kidney stones. It states that "Only a well-trained radiologist can make the final diagnosis under consideration of all available information," indicating its role in supporting the diagnostic process.
Yes
The device is explicitly described as a "Software Package" and a "post processing application package" that operates on existing CT images. It does not mention any associated hardware components that are part of the device itself.
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 of the human body acquired through Computed Tomography (CT).
- The intended use and device description clearly state that it operates on CT images. It's a post-processing application for medical imaging data.
- The applications listed are focused on visualizing and analyzing anatomical structures and materials within the body based on their attenuation properties in CT scans. Examples include bone removal, liver analysis, gout evaluation (visualizing urate depositions), and kidney stone analysis.
While the device provides information that can be used in conjunction with other clinical information (like urine testing for kidney stones), its primary function is the processing and analysis of medical images, not the analysis of biological samples.
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 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
- Lung Analysis
- Gout Evaluation
- 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 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 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
- Lung Analysis
- Gout Evaluation
- Monoenergetic Plus
- Virtual Unenhanced
- Rho/Z
- Hard Plaques
- Kidney 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 major device modifications within the scope of the new software version SOMARIS 8/VB20 is as follows:
- The Use of Twin Beam Images for additional Dual Energy post-processing Applications (Lung Analysis and Gout)
- Modified Indications for Use Statement
An additional modification is the support of Offline Ranges for Dual Energy which allows the user to select the required post-processing for reconstructed Dual Energy image series at the scanner.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Various materials in the human body, anatomical region of interest, organ of interest, kidney, lung, pulmonary vessels, lung parenchyma.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Well-trained radiologist.
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance tests were conducted to test the functionality of the syngo.CT Single Source Dual Energy (twin beam) post-processing application. A clinical validation has been conducted to show that both application classes "Gout" and "Lung Analysis" operate as intended. We have shown that this software application based on Twin Beam Dual Energy data successfully visualizes urate depositions as a consequence of gout. The second validation shows that the application class Lung Analysis for Twin Beam data successfully calculates Lung PBV and Lung Vessels images from contrast enhanced Dual Energy CT-scans of the lung. Both application classes do not offer additional or new application features compared to the secondary predicate device.
Furthermore, phantom bench testing and clinical validation in a retrospective study was conducted to test the functionality of the remaining application classes Rho/Z and Kidney Stones. Retrospective clinically validated studies were conducted to test the performance for applications classes Monoenergetic Plus, Bone Removal, Liver VNC, and Hard Plaques, as well as the predicate device application classes. These studies demonstrate that the subject device 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 circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of three human profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 9, 2017
Siemens Medical Solutions USA, Inc., % Ms. Kimberly Mangum Regulatory Affairs Specialist 40 Liberty Blvd., Mail Code 65-1A MALVERN PA 19355
Re: K163289
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: November 22, 2016 Received: November 23, 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/ResourcesforYou/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. O'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
Image /page/2/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The word is displayed in a light blue color. The letters are evenly spaced and appear to be bolded.
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 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
- · Lung Analysis
- · Gout Evaluation
- · 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 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(0fda.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
PSC Pablabling Services (101) 443-5740 EFF
3
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 09, 2016
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.
I. Submitter
Importer/Distributor
Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355
Establishment Registration Number 2240869
Manufacturing Site Siemens Healthcare GmbH Siemensstr. 1 D-91301 Forchheim, Germany
Establishment Registration Number 3004977335
Contact Person
Kimberly Mangum Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Phone: (610) 448 - 6477 Fax: (610) 640 - 4481 Email: kimberly.mangum@siemens.com
II. Device Name and Classification
Product Name: Propriety Trade Name: Classification Name: Classification Panel: CFR Section: Device Class: Product Code:
syngo.CT Single Source Dual Energy (twin beam) syngo.CT Single Source Dual Energy (twin beam) Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II 90JAK
III. Predicate Device
Primary Predicate Device:
| Trade Name: | |
|---|---|
| 510(k) Number: | |
| Clearance Date: |
syngo.CT Single Source Dual Energy (twin beam) K153220 02/19/2016
4
| Classification Name: | Computed Tomography X-ray System |
|---|---|
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | 90JAK |
| Recall: | There have been no recalls for this device |
Secondary Predicate Device:
| Trade Name: | syngo.CT Dual Energy |
|---|---|
| 510(k) Number: | K150757 |
| Clearance Date: | 08/11/2015 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR § 892.1750 |
| Device Class: | Class II |
| Product Code: | 90JAK |
| Recall: | There have been no recalls for this device |
IV. 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
- Lung Analysis
- Gout Evaluation ●
- Monoenergetic Plus ●
- Virtual Unenhanced .
- Rho/Z ●
- Hard Plaques .
- Kidney 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 major device modifications within the scope of the new software version SOMARIS 8/VB20 is as follows:
- . The Use of Twin Beam Images for additional Dual Energy post-processing Applications (Lung Analysis and Gout)
- Modified Indications for Use Statement ●
An additional modification is the support of Offline Ranges for Dual Energy which allows the user to select the required post-processing for reconstructed Dual Energy image series at the scanner.
5
V. 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 ●
- Lung Analysis ●
- Gout Evaluation ●
- 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.
VI. Comparison of Technological Characteristics 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. 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 aforementioned evaluation reporting and visualization tools and functionality as well as the post-processing algorithms remain unchanged.
| Feature | Subject Device | Primary Predicate Device
(K153220) | Secondary Predicate Device
(K150757) |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Data
Acquisition
Mode | The subject device uses
DICOM images acquired
using Twin Beam (split
filtration) Single Source
scanners. | The primary predicate device
uses DICOM images acquired
using Twin Beam (split
filtration) Single Source
scanners. | This device uses DICOM
images acquired with Dual
Source scanners. |
| Image
Processing | The software processes Twin
Beam Dual Energy images. | The software processes Twin
Beam Dual Energy images. | The software processes Dual
Source Dual Energy images. |
| Functionality | Post-processing application
supports the use of Twin
Beam datasets with various
post-processing applications.
Here, two additional (Gout
Evaluation and Lung
Analysis) post-processing
applications are able to
process twin beam images. | Post-processing application
supports the use of Twin
Beam datasets with various
post-processing applications. | Post processing application
supports the use of Dual
Source datasets with various
post processing applications |
6
| Feature | Subject Device | Primary Predicate Device (K153220) | Secondary Predicate Device (K150757) |
|---|---|---|---|
| Application Class | |||
| "Gout Evaluation" | The Dual Energy information | ||
| can be used to visualize urate, | |||
| calcifications and contrast | |||
| agent in the case of gout. The | |||
| basis for this approach is a | |||
| material decomposition into | |||
| tissue and uric acid deposits. | |||
| The results of this calculation | |||
| are shown as color overlay to | |||
| anatomical, grayscale | |||
| information. |
This application class
evaluates images acquired
with Siemens Twin Beam
Scanners. The post-
processing functionality has
not been changed compared
to the secondary predicate
device. | N/A | The Dual Energy information
can be used to visualize urate,
calcifications and contrast
agent in the case of gout. The
basis for this approach is a
material decomposition into
tissue and uric acid deposits.
The results of this calculation
are shown as color overlay to
anatomical, grayscale
information.
This application class
evaluates images acquired
with Siemens Dual Source
Scanners. |
| Application Class
"Lung Analysis | This application class is
designed to visualize the
iodine enhancement in
pulmonary vessels and
visualize and quantify the
iodine uptake in the lung
parenchyma.
This application class
evaluates images acquired
with Siemens Twin Beam
Scanners. The post-
processing functionality has
not been changed compared
to the secondary predicate
device. | N/A | This application class is
designed to visualize the
iodine enhancement in
pulmonary vessels and
visualize and quantify the
iodine uptake in the lung
parenchyma.
This application class
evaluates images acquired
with Siemens Dual Source
Scanners. |
The subject device syngo.CT Single Source Dual Energy (twin beam) does not have changes in technological characteristics when compared to the predicate devices. The post-processing software functionality remains unchanged from the subject device and the predicate devices. The operating principle and the scientific technology are same; therefore, Siemens believes that syngo.CT Single Source Dual Energy (twin beam) application is substantially equivalent to the predicate devices.
VII. Performance Data
Software Verification and Validation Testing
Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission.
Non-Clinical / Clinical Testing Summary
syngo.CT Single Source Dual Energy (twin beam) is designed to fulfill the requirements of the following safety and performance standards:
| Recognition
Number | Product
Area | Title of Standard | Publication
Date | Standards
Development
Organization |
|-----------------------|-----------------|-------------------------------------------------------------------------------------|---------------------|------------------------------------------|
| 12-300 | Radiology | Digital Imaging and Communications in
Medicine (DICOM) Set; PS 3.1 – 3.20 | 06/27/2016 | NEMA |
| 13-32 | Software | Medical Device Software –Software Life
Cycle Processes; 62304:2006 (1st Edition) | 08/20/2012 | AAMI, ANSI,
IEC |
7
| Recognition
Number | Product
Area | Title of Standard | Publication
Date | Standards
Development
Organization |
|-----------------------|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|------------------------------------------|
| 5-40 | Software/
Informatics | Medical devices – Application of risk
management to medical devices; 14971
Second Edition 2007-03-01 | 08/20/2012 | ISO |
| 5-95 | General I
(QS/RM) | Medical devices - Part 1: Application of
usability engineering to medical devices
IEC 62366-1:2015 | 06/27/2016 | IEC |
| 19-4 | General II
(ES/EMC) | AAMI / ANSI ES60601-1:2005/(R)2012 and
A1:2012, Medical electrical equipment - part
1: general requirements for basic safety and
essential performance (IEC 60601-1:2005,
mod) | 07/09/2014 | AAMI, ANSI |
Performance tests were conducted to test the functionality of the syngo.CT Single Source Dual Energy (twin beam) post-processing application. A clinical validation has been conducted to show that both application classes "Gout" and "Lung Analysis" operate as intended. We have shown that this software application based on Twin Beam Dual Energy data successfully visualizes urate depositions as a consequence of gout. The second validation shows that the application class Lung Analysis for Twin Beam data successfully calculates Lung PBV and Lung Vessels images from contrast enhanced Dual Energy CT-scans of the lung. Both application classes do not offer additional or new application features compared to the secondary predicate device.
Furthermore, phantom bench testing and clinical validation in a retrospective study was conducted to test the functionality of the remaining application classes Rho/Z and Kidney Stones. Retrospective clinically validated studies were conducted to test the performance for applications classes Monoenergetic Plus, Bone Removal, Liver VNC, and Hard Plaques, as well as the predicate device application classes. These studies demonstrate that the subject device 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.
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, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.
VIII. Conclusions
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 same as the predicate devices. 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 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.