Who is the manufacturer of SYNGO TRUED SOFTWARE?

Siemens Medical Solutions filed the 510(k) submission for SYNGO TRUED SOFTWARE (K101749).

What is the FDA product code for SYNGO TRUED SOFTWARE?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for SYNGO TRUED SOFTWARE?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SYNGO TRUED SOFTWARE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SYNGO TRUED SOFTWARE

K101749 · Siemens Medical Solutions · LLZ · Aug 16, 2010 · Radiology

Device Facts

Record ID	K101749
Device Name	SYNGO TRUED SOFTWARE
Applicant	Siemens Medical Solutions
Product Code	LLZ · Radiology
Decision Date	Aug 16, 2010
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device, 3rd-Party Reviewed

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. 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.

Device Story

Software-only diagnostic application for multi-modality medical imaging (PET, SPECT, CT, MR). Inputs include anatomical and functional datasets; supports respiratory gated studies and dynamic PET data. Transforms inputs via visualization tools (MIP, volume rendering) and analytical quantification (SUV, PERCIST criteria, VOI structures). Used in clinical settings by trained professionals (physicians/technicians) to support oncological workflows. Outputs include visualized images, quantification metrics, and DICOM RT-formatted VOIs for radiation therapy planning. Clinicians use outputs to assess morphological/functional changes, confirm lesions, and plan therapy. Benefits include improved visualization of disjointed data and standardized quantification for follow-up.

Clinical Evidence

Bench testing only. Software design description, hazard analysis, and validation testing performed in compliance with ISO 14971:2007 and DICOM standards. No clinical data provided.

Technological Characteristics

Software-only solution; Windows XP OS. Supports DICOM 2003 standard. Features include 3D visualization (MIP, volume rendering), VOI quantification, and respiratory gating. No patient-contacting materials. Minor level of concern per FDA software guidance.

Indications for Use

Indicated for oncological workflow support, including lesion confirmation, evaluation, quantification, follow-up, and documentation. Used for viewing, manipulating, and comparing multi-modality (PET, SPECT, CT, MR) and multi-time-point medical images. Supports respiratory gated study analysis for radiation therapy planning. For use by trained professionals; clinician retains ultimate diagnostic responsibility.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

TrueD VC60A (K091373)

Reference Devices

TrueD (K071950)

Related Devices

K091373 — SYNGO TRUED · Siemens Medical Solutions USA, Inc. · May 20, 2009
K071950 — SYNGO TRUED · Siemens Medical Solutions USA, Inc. · Jul 27, 2007
K173897 — syngo.via MI Workflows · Siemens Medical Solutions USA, Inc. · Apr 5, 2018
K133644 — SYNGO.VIA MI WORKFLOWS · Siemens Medical Solutions USA, Inc. · Feb 25, 2014
K163421 — syngo.via MI Workflows · Siemens Medical Solutions USA, Inc. · Jan 3, 2017

Submission Summary (Full Text)

{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 {4}------------------------------------------------ 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 Page 1 of 1