SYNGO TRUED, MODEL VC10A

K061671 · Siemens Medical Solutions · LLZ · Jun 29, 2006 · Radiology

Device Facts

• Record ID: K061671
• Device Name: SYNGO TRUED, MODEL VC10A
• Applicant: Siemens Medical Solutions
• Product Code: LLZ · Radiology
• Decision Date: Jun 29, 2006
• 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 target or treatment volume over a defined phase of the respiratory cycle and thus provide information for radiation therapy planning.

Device Story

syngo TrueD is a software-only diagnostic application for clinical workstations; processes multi-modal medical images (PET, SPECT, CT, MR) and respiratory-gated datasets. Transforms raw DICOM inputs into 3D visualizations (MIP, volume rendering) and quantitative outputs; enables side-by-side or fused comparison of anatomical and functional data. Used by physicians and clinicians in clinical settings to assess morphological/functional changes, confirm lesion presence/absence, and delineate target volumes for radiation therapy planning. Exports VOI structures in DICOM RT format. Clinicians use outputs to inform diagnostic decisions and therapy follow-up; device acts as a complement to standard visual comparison procedures. Benefits include improved visualization of disjointed data and streamlined oncological workflow.

Clinical Evidence

Bench testing only. No clinical data provided. Software design description, hazard analysis, and technical documentation provided to support safety and effectiveness.

Technological Characteristics

Software-only solution; Windows XP operating system; supports DICOM standard. Features 3D visualization (MIP, volume rendering), quantification tools, and DICOM RT export. Minor level of concern per FDA software guidance.

Indications for Use

Indicated for use by trained professionals for viewing, manipulation, 3D visualization, and comparison of medical images (PET, SPECT, CT, MR) across multiple modalities or time-points. Supports oncological workflows, including lesion evaluation, quantification, follow-up, documentation, and radiation therapy planning (including respiratory gated studies).

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

• Syntegra Gamma Camera System (K041182)
• GE Advantage Sim 6.0 (K021780)
• GE Advantage MD (K052345)

Submission Summary (Full Text)

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K06167i

JUN 2 9 2006

## 510(k) Summary

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; April 26th, 2006

#### General Information

Manufacturer Facility (Developer/manufacturer) Siemens Medical Solutions USA, Inc. 20 Valley Stream Pkwy Malvern, PA 19355 Establishment Registration Number: Active, Awaiting Assignment

(mm) |

[mm2]Contact Person James E. Kuhn Jr. Senior Regulatory Submissions Manager Phone: [phone] Fax: [phone]

#### Device Name and Classification

Trade Name: Classification Name: CFR Section: Device Class: Product Code:

syngo TM 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 (Revised)

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.

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K061671

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

A summary of the software design description, hazard analysis, and technical and safety information can be found in the attached submission. The results[mm3] of the hazard analysis, 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 devices[mm4]:

| Predicate Device Name | FDA Clearance Number |
|------------------------------|----------------------|
| Syntegra Gamma Camera System | K041182 |
| GE Advantage Sim 6.0 | K021780 |
| GE Advantage MD | K052345 |

In summary, Siemens is of the opinion that the indicated change 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 A

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUN 2 9 2006

Siemens Medical Solutions % Mr. Casey Conry Project Manager Underwriters Laboratories, Inc. 7 Stuart Road CHELMSFORD MA 01824

Re: K061671

Trade/Device Name: Syngo™ TrueD Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 13, 2006 Received: June 14, 2006

### 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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

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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); 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.

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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|----------------|---------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894 xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone]

or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Nancy C. Hogdon

Nancy C. Brogdon Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

| 510(k) Number (if known): | Not Known | K06 (67) |
|---------------------------|--------------|----------|
| Device Name: | Syngo™ TrueD | |

## Indications for Use:

syngo TrueD is a medical diagnostic application for viewing, manipulation, 3D- visualization and syngo Truce to a mountar strom multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, appliodion bopper 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.

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 (Part 21 CFR 801 Subpart D) AND / OR

Over-The-Counter-Use (Part 21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

David M. Symons

510(k) Number