(141 days)
Not Found
No
The document describes post-processing software for CT images that uses dual-energy techniques to differentiate materials based on their attenuation properties. There is no mention of AI, ML, or related concepts like deep learning or neural networks in the intended use, device description, or performance studies sections. The functionality described is based on established physics principles of dual-energy CT.
No
The device is a post-processing software package that aids in visualizing medical images for diagnostic purposes, rather than directly treating or preventing disease.
Yes.
The device is a post-processing application that analyzes CT images to provide information on the chemical composition of scanned body materials, differentiate specific conditions (e.g., uric acid kidney stones), and aid radiologists in making a final diagnosis. This directly supports the diagnostic process.
Yes
The device is described as a "Software Package" and a "post processing application package" that operates on a client-server platform. While it processes images from a CT scanner, the device itself is presented as software for post-processing and visualization, without mention of accompanying hardware components being part of the submitted device.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description of syngo.CT Single Source Dual Energy clearly states it operates on CT images acquired from a scanner. It processes and visualizes information from these images, which are representations of the internal structure of the body, not biological specimens like blood, urine, or tissue.
- The intended use is for post-processing and visualization of CT images. The device helps radiologists interpret the images by highlighting different materials based on their energy attenuation properties. While this information can be used to support a diagnosis, it is not a test performed on a biological sample.
- The device description focuses on software for image processing and visualization. It details application classes for analyzing CT data, not for analyzing biological samples.
Therefore, syngo.CT Single Source Dual Energy is a medical device, specifically a radiological image processing software, but it does not fit the definition of an In Vitro Diagnostic.
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 Dual Spiral 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 is as follows:
- · Monoenergetic
- · Monoenergetic Plus
- · Brain Hemorrhage
- · Liver VNC
- · Gout Evaluation
- Bone Marrow
- Rho/Z
- · Kidney Stones*)
*) Kidney Stones is designed to support 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 Single Source 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 for the correct evaluation of data sets. syngo.CT Single Source 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 Single Source Dual Energy post processing application package to support the following features:
- Addition of new application class Rho/Z .
- Visualization of fat content (fat map) for application class Liver . VNC
-
- Modified Indication for Use to include features Rho/Z
-
- Modified Indication for Use to include reference to Dual Spiral Single Source Scanners
The subject device syngo.CT Single Source Dual Energy also supports the following unmodified post-processing application classes:
- . Monoenergetic
- Brain Hemorrhage ●
- o Gout Evaluation
- . Monoenergetic Plus
- o Bone Marrow
- o Kidney Stones
syngo.CT Single Source Dual Energy 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT images
Anatomical Site
anatomical region of interest, human body, Brain, Liver, Kidney
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
Non clinical tests (integration and functional) were conducted for syngo.CT Single Source Dual Energy during product development. Performance tests were conducted to test the functionality of the syngo.CT Single Source Dual Energy. Phantom bench testing and retrospective analysis of available patient data was conducted for application classes Rho/Z 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 Single Source Dual Energy during product development. Performance tests were conducted to test the functionality of the syngo.CT Single Source Dual Energy. Phantom bench testing and retrospective analysis of available patient data was conducted for application classes Rho/Z and feature Fat Map. Supportive articles that demonstrate the usability of application class Rho/Z and feature Fat Map for Liver VNC 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
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 MALVERN PA 19355
Re: K150745
Trade/Device Name: syngo.CT Single Source Dual Energy Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: June 24, 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 O'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) K150745
Device Name syngo.CT Single Source Dual Energy
Indications for Use (Describe)
Syngo.CT Single Source Dual Energy is designed to operate with CT images which have been acquired with Siemens Dual Spiral 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 is as follows:
- · Monoenergetic
- · Monoenergetic Plus
- · Brain Hemorrhage
- · Liver VNC
- · Gout Evaluation
- Bone Marrow
- Rho/Z
- · Kidney Stones*)
*) Kidney Stones is designed to support 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) |
|---|
| 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."
3
510(k) Summary FOR syngo.CT Single Source Dual Energy Submitted by: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern. PA 19355 Date Prepared: June 24, 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 Reqistration 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 Single Source Dual Energy Propriety Trade Name: syngo.CT Single Source Dual Energy (dual spiral) Classification Name: Computed Tomography X-ray System Classification Panel: Radiology CFR Section: 21 CFR §892.1750 Device Class: Class II Product Code: 90JAK
4
4. Legally Marketed Primary Predicate Device:
| Product Name: | syngo.CT Single Source Dual Energy |
|---|---|
| Propriety Trade Name: | syngo.CT Single Source 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.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 |
| 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 Single Source Dual Energy is designed to operate with CT images which have been acquired with Siemens Dual Spiral 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 Dual Energy applications is as follows:
- Monoenergetic ●
- Monoenergetic Plus ●
- Brain Hemorrhage ●
- Liver VNC
- Gout Evaluation .
- Bone Marrow .
- 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
5
consideration of all available information. The accuracy of identification is decreased in obese patients.
6. Substantial Equivalence:
The subject device Siemens syngo.CT Single Source 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 | K133677 | October 16, 2014 | |
| Siemens | Secondary Predicate Device: | ||
| syngo.CT Dual Energy | K133648 | July 07, 2014 | |
| 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 Single Source 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 for the correct evaluation of data sets. syngo.CT Single Source 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 Single Source Dual Energy post processing application package to support the following features:
- Addition of new application class Rho/Z .
- Visualization of fat content (fat map) for application class Liver . VNC
-
- Modified Indication for Use to include features Rho/Z
-
- Modified Indication for Use to include reference to Dual Spiral Single Source Scanners
6
The subject device syngo.CT Single Source Dual Energy also supports the following unmodified post-processing application classes:
- . Monoenergetic
- Brain Hemorrhage ●
- o Gout Evaluation
- . Monoenergetic Plus
- o Bone Marrow
- o Kidney Stones
syngo.CT Single Source Dual Energy 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.
-
- Summary of Technical Characteristics of the Subject Device as Compared with the Predicate Device:
syngo.CT Single Source 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 Single Source Dual Energy provides similar evaluation, reporting and visualization tools, and functionality as the primary predicate device synqo.CT Single Source 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:
| Table 2: Predicate and Subject Device Comparable Technological | ||||
|---|---|---|---|---|
| Characteristics | ||||
| Property | Subject Device | Primary | ||
| Predicate Device | ||||
| K133677 | Secondary | |||
| Predicate Device | ||||
| K133648 | Secondary | |||
| Predicate | ||||
| Device | ||||
| K837107 | ||||
| Software | ||||
| Features/ | ||||
| Functionality | Rho/Z - | |||
| Measurement of | ||||
| electron density | ||||
| as well as | ||||
| effective atomic | ||||
| number | Not Applicable | Base material | ||
| decomposition | ||||
| into tissue and | ||||
| iodine | Visualization - | |||
| Electron Density | ||||
| Visualization | ||||
| Features | ||||
| 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 Single Source Dual Energy does not have significant changes in technological characteristics when compared to the primary predicate device syngo.CT Single Source Dual Energy. The Indication for Use, operating principle, and the scientific technology are similar: therefore, Siemens believes that syngo.CT Single Source Dual Energy Package is substantially equivalent to the predicate devices.
7
9. Nonclinical Testing:
syngo.CT Single Source 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 Single Source 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.
8
Non-Clinical Testing Summary
Performance tests were conducted to test the functionality of the syngo.CT Single Source Dual Energy. Phantom bench testing and retrospective analysis of available patient data was conducted for application classes Rho/Z and feature Fat Map. Supportive articles that demonstrate the usability of application class Rho/Z and feature Fat Map for Liver VNC 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.
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 Single Source 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.
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 Single Source Dual Energy testing supports a finding of substantial equivalence.