(55 days)
No
The summary describes image viewing, manipulation, visualization, and analytical tools, but does not mention any AI or ML capabilities.
No
The device is described as a "medical diagnostic application" that helps in viewing, manipulating, and comparing medical images for assessment, documentation, and generating information for therapy planning; it does not directly administer therapy.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that syngo TrueD is a "medical diagnostic application" and provides "analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations." It supports confirming the absence or presence of lesions, which is a diagnostic activity.
Yes
The device description explicitly states, "TrueD will be marketed as a software only solution for the end-user (with recommended hardware requirements)." While it requires hardware to run, the device itself is the software application.
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). The intended use and device description clearly state that syngo TrueD processes and visualizes medical images obtained from imaging modalities like PET, SPECT, CT, and MR. These are external imaging techniques, not analyses of biological samples.
- The focus is on image processing and visualization. The description emphasizes viewing, manipulation, 3D-visualization, comparison, and analysis of images. This aligns with medical imaging software, not IVD testing.
Therefore, syngo TrueD falls under the category of medical imaging software, not an IVD.
N/A
Intended Use / Indications for Use
syngo TrueD is a medical diagnostic application for viewing, manipulation, 3D- visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering.
syngo TrueD enables visualization of information that would otherwise have to be visually compared disjointedly. syngo TrueD provides analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations.
syngo TrueD is designed to support the oncological workflow by helping the user to confirm the absence or presence of lesions, including evaluation, quantification, follow-up and documentation of any such lesions. The application allows to store and export volume of interest (VOI) structures in DICOM RT format for use in radiation therapy planning systems.
syngo TrueD allows visualization and analysis of respiratory gated studies to support accurate delineation of the farget or treatment volume over a defined phase of the respiratory cycle and thus provide information for radiation therapy planning.
Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo TrueD is a complement to these standard procedures.
Product codes
LLZ
Device Description
syngo TrueD is a medical diagnostic application for viewing, manipulation, 3D- visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering.
syngo TrueD enables visualization of information that would otherwise have to be visually compared disjointedly. syngo TrueD provides analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations.
syngo TrueD is designed to support the oncological workflow by helping the user to confirm the absence or presence of lesions, including evaluation, quantification, follow-up and documentation of any such lesions. The application allows to store and export volume of interest (VOI) structures in DICOM RT format for use in radiation therapy planning systems.
syngo TrueD allows visualization and analysis of respiratory gated studies to support accurate delineation of the target or treatment volume over a defined phase of the respiratory cycle and thus provide information for radiation therapy planning.
TrueD will be marketed as a software only solution for the end-user (with recommended hardware requirements) .It will be installed by Siemens service engineers. The TrueD described supports DICOM formatted images and information. It is based on the Windows XP operating system.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
PET, SPECT, CT, MR
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals, physician
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)
Nonclinical Testing:
- DICOM (Digital Imaging and Communications in Medicine) Standard:2003
- ISO 14971:2007 Medical Devices Application of risk management to medical devices
Summary of the software design description, hazard analysis, validation testing, and technical and safety information can be found in the attached submission. The results of the hazard analysis and validation, combined with the appropriate preventive measures taken indicate the device is of minor level of concern, as per Guidance for the Content of Premarket Submission for Software Contained in Medical Devices, May 2005.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
TrueD VC60A K091373
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
510(k) Summary
AUG 1 6 2010
This summary of 510(k) safety and effectiveness is provided in accordance with the requirements of SMDA 1990 and 21 CFR §807.92
Date Prepared; May 20th, 2010
General Information
Manufacturer Facility (Developer/manufacturer) Siemens Medical Solutions USA, Inc. 20 Valley Stream Pkwy Malvern, PA 19355 Establishment Registration Number: 3002329443
Contact Person
James E. Kuhn Jr. Senior Regulatory Submissions Manager Phone: (610) 448-3006 Fax: (610) 448-4274
Device Name and Classification
Trade Name: Classification Name: CFR Section: Device Class: Product Code:
syngo™ TrueD Software Picture Archiving and Communications System 21 CFR §892.2050 Class II LLZ
Safety and Effectiveness Information Supporting the Substantial Equivalence Determination
Device Description and Intended Use
syngo TrueD is a medical diagnostic application for viewing, manipulation, 3D- visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering.
syngo TrueD enables visualization of information that would otherwise have to be visually compared disjointedly. syngo TrueD provides analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations.
syngo TrueD is designed to support the oncological workflow by helping the user to confirm the absence or presence of lesions, including evaluation, quantification, follow-up and documentation of any such lesions. The application allows to store and export volume of interest (VOI) structures in DICOM RT format for use in radiation therapy planning systems.
1
syngo TrueD allows visualization and analysis of respiratory gated studies to support accurate delineation of the target or treatment volume over a defined phase of the respiratory cycle and thus provide information for radiation therapy planning.
Technological Characteristics
TrueD will be marketed as a software only solution for the end-user (with recommended hardware requirements) .It will be installed by Siemens service engineers. The TrueD described supports DICOM formatted images and information. It is based on the Windows XP operating system.
Safety Information / Nonclinical Testing
The following nonclinical testing has been completed in compliance to the following;
- · DICOM (Digital Imaging and Communications in Medicine) Standard:2003 Developed by the American College of Radiology and the National Electrical Manufacturers Association. Specifies the format for the communication of digital images between individual devices and over networks.
- · ISO 14971:2007 Medical Devices Application of risk management to medical devices
A summary of the software design description, hazard analysis, validation testing, and technical and safety information can be found in the attached submission. The results of the hazard analysis and validation, combined with the appropriate preventive measures taken indicate the device is of minor level of concern, as per Guidance for the Content of Premarket Submission for Software Contained in Medical Devices, May 2005
The device has no patient contacting materials and is utilized only by trained professionals. The output of the device is evaluated by trained professionals allowing sufficient review for identification and intervention in the event of a malfunction. Device output and analysis is used to indicate the appropriateness of a referral. The device does not impact the quality or status of the original acquired data.
Substantial Equivalence:
The syngo TrueD Software is substantially equivalent, both in intended use and technically, to the following device:
| # | New Feature | Comparison | Predicate |
|---|---|---|---|
| 1 | Support Dynamic PET data |
Features:
- Dynamic PET in one
of the three time-points - Rotating MIP of a
timeslice in dynamic
study | The new version is extending the
functionality of syngo TrueD from
loading static as well as respiratory
gated PET data to loading dynamic
PET data.
Dynamic PET data are technically
equivalent to static PET data with the
only difference that dynamic PET
datasets consist of multiple time-slices, | TrueD VC60A
K091373 |
| | Cine of dynamic PET
studies
Copy VOI to another
time-slice of the
same dynamic data
Display dynamic
data information
Time activity curve
for dynamic studies
Add time activity
table and table data
to report | which is similar to respiratory gated
PET studies which have been cleared
in TrueD (K071950)
Similar to static and respiratory-gated
PET, TrueD can perform a rotating MIP
for each time-slice.
Similar to respiratory-gated PET data,
TrueD can perform cine for dynamic
PET data.
Similar to creating VOIs in one
respiratory gate and copying VOIs
across respiratory gates, TrueD allows
creating VOIs in one time-slice and
copying to other time-slices.
This new feature has been fully
validated and adds no additional
unmitigated risk or functionality that
would affect the safe and effective use
of this device in comparison to its
predicate | |
| 2 | Respiratory gated data
with multiple bed
positions. | The VE10A version of TrueD is
extended to allow respiratory gated
studies with multiple bed positions to
be loaded into the application, rather
than single bed positions as in TrueD
VC60A (K091373).
The respiratory gating functionality
remains otherwise unchanged. | TrueD VC60A
K091373 |
| 3 | Enabling PERCIST
workflow:
Features:
- Peak sphere
- Peak sphere
diameter - Provide SUV peak
quantification - Peak value
- PERCIST Reference
VOI - PERCIST threshold
- Peak trending
- Highest peak
trending | TrueD VE10A is extending the volume
of interest (VOI) quantification
functionality previously cleared in
K091373 by enabling the user to apply
the PERCIST (PET Response Criteria
in Solid Tumors). The interpretation of
the quantification results according to
the PERCIST criteria remains the
responsibility of the physician.
The peak sphere is a 3D sphere VOI
which is placed inside a larger 3D VOI
at the location of the highest average
SUV value in the VOI which is called
the 'peak SUV value'. This is an
extension to previously cleared
technology where TrueD is searching
for the highest SUV value in a VOI. | TrueD VC60A
K091373 |
| | | | |
| | For each peak sphere, the application
displays a peak sphere diameter which
is technically the same as a sphere
diameter. | | |
| | The application is extended to allow
users to create PERCIST reference
VOIs in the liver or blood pool: a 3 cm
spherical ROI (VOI) should be
manually placed by the user in the
normal right lobe of the liver (if the liver
is abnormal a 1 cm diameter ROI
should be positioned in the descending
thoracic aorta extending 2 cm along z-
axis). The VOI technology used for
PERCIST reference VOIs is equivalent
to existing VOIs in TrueD. | | |
| | In addition to the usual quantification
parameters, the PERCIST Reference
VOIs provide a PERCIST threshold
value which is calculated based on a
defined mathematical formula which is
provided to the user in the user
documentation of the application. | | |
| | The application provides peak
quantification trending in the same
manner as for other quantification
parameters. | | |
| | The trending is extended to allow users
to see trending values between the
highest values for each time point for
Peak, which may not be the same
lesions in each time-point. | | |
| | | | |
2
3
Summary
In summary, Siemens is of the opinion that the indicated changes to the syngo TrueD software, as described within this submission does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device.
REV B
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars representing its wings. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA".
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Siemens Medical Solutions USA, Inc. % Mr. Casey Conry Senior Project Engineer Underwriters Laboratories, Inc. 1285 Walt Whitman Rd. MELVILLE NY 11747
AUG 1 6 2010
Re: K101749
Trade/Device Name: syngo™ TrueD Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LLZ Dated: July 29, 2010 Received: August 2, 2010
Dear Mr. Conry:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 or mry reith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
5
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Donald J. Trump
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use Form
510(k) Number (if known): K101749
Device Name: Syngo™ TrueD
Indications for Use:
syngo TrueD is a medical diagnostic application for viewing, manipulation, 3D- visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering.
syngo TrueD enables visualization of information that would otherwise have to be visually compared disjointedly. syngo TrueD provides analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations.
syngo TrueD is designed to support the oncological workflow by helping the user to confirm the absence or presence of lesions, including evaluation, quantification, follow-up and documentation of any such lesions. The application allows to store and export volume of interest (VOI) structures in DICOM RT format for use in radiation therapy planning systems.
syngo TrueD allows visualization and analysis of respiratory gated studies to support accurate delineation of the farget or treatment volume over a defined phase of the respiratory cycle and thus provide information for radiation therapy planning.
Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo TrueD is a complement to these standard procedures.
Prescription Use _ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K101749
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