SYNGO.MR ONCO, SYNGO.MR 3D LESION SEGMENTATION, SYNGO.MR ONCO ENGINE

K111861 · Siemens Medical Systems USA · LLZ · Jan 6, 2012 · Radiology

Device Facts

• Record ID: K111861
• Device Name: SYNGO.MR ONCO, SYNGO.MR 3D LESION SEGMENTATION, SYNGO.MR ONCO ENGINE
• Applicant: Siemens Medical Systems USA
• Product Code: LLZ · Radiology
• Decision Date: Jan 6, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

syngo.MR Oncology is a syngo.via-based image viewing, processing and reading software. This software allows for oncological MR image evaluation in a structured way. It is a reading application primarily for convenient reading of MR scans of single or multiple body regions up to the entire body which have been acquired for clinical purposes such as oncological screening, staging and grading. The reading application does not block the display of data from other modalities that syngo.via supports. syngo.MR Oncology is designed to support the oncological workflow including interpretation and evaluation of examinations, and follow-up documentation of findings. 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.MR Oncology is a tool to support the standard practices and visual comparisons. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.

Device Story

syngo.MR Oncology is a syngo.via-based software application for oncological MR image evaluation. It processes MR scans of single or multiple body regions to support clinical workflows, including screening, staging, and grading. The device includes specific workflow configurations (MR Onco Multi-Region, Liver, Brain, TimCT) and a 3D Lesion Segmentation tool. The segmentation tool utilizes Random walker or Level Set algorithms to provide volumetric evaluation of tumors, lymph nodes, and metastases. Clinicians use the software to interpret examinations and document findings. The device acts as a support tool for standard clinical practices; the clinician retains ultimate diagnostic responsibility. It is used in clinical settings where MR imaging is performed. The software facilitates structured reading and follow-up documentation, potentially improving the efficiency and consistency of oncological assessments.

Clinical Evidence

No clinical data provided. Safety and effectiveness are supported by software verification and validation testing, and adherence to recognized industry standards.

Technological Characteristics

Software-based image viewing and processing application. Operates on the syngo.via platform. Includes specific workflow modules and a 3D lesion segmentation tool. Segmentation algorithms include Random walker and Level Set. Software development follows ISO 14971:2007 risk management standards.

Indications for Use

Indicated for oncological MR image evaluation, including screening, staging, and grading of single or multiple body regions. Intended for use by clinicians to support interpretation, evaluation, and follow-up documentation of oncological examinations. Not intended for digital mammography diagnosis.

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

• Software syngo MR B17 (K082427)
• Software syngo.x (syngo.via) (K092519)
• Software syngo PET&CT Oncology (K093621)
• Syngo Dosimetrist Workspace v2.7 (K101119)

Submission Summary (Full Text)

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SIEMENS

KIII 861

# 510(k) Summary: syngo.MR Oncology

This summary of 510(k) safety and effectiveness information is being submitted in This burnmary of STO(1) Caroly at Safe Medical Device Act 1990 and 21 CFR § 807.92.

#### General Information l.

| Establishment | Siemens Medical Solutions USA, Inc.<br>51 Valley Stream Parkway<br>Mail Code D02<br>Malvern, PA 19355, USA |
|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration Number | 2240869 |
| Manufacturer | Siemens AG<br>Henkestrasse 127<br>D-91052 Erlangen, Germany |
| Registration Number | 8010024 |
| Contact Person | Ms. Nadia Sookdeo<br>Technical Specialist<br>Regulatory Affairs/Clinical Affairs<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Device Name<br>Classification Name:<br>Classification Panel:<br>Regulation number:<br>Device Class:<br>Product Code: | syngo.MR Oncology<br>Picture Archiving and Communications System<br>(PACS)<br>Radiology<br>21 CFR § 892.2050<br>II<br>LLZ, LNH |

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#### Safety and Effectiveness Information Supporting Substantial Equivalence II.

## Indications for Use:

manations for oncology is a syngo.via-based image viewing, processing and reading offware. This software allows for oncological MR image evaluation in a structured way. It is a reading application primarily for convenient reading of MR scans of way. It is a lually and regions up to the entire body which have been acquired for clinical purposes such as oncological screening, staging and grading. The reading application does not block the display of data from other modalities that syngo.via supports.

syngo.MR Oncology is designed to support the oncological workflow including interpretation and evaluation of examinations, and follow-up documentation of findings.

The clinician retains the ultimate responsibility for making the pertinent Note: diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo.MR Oncology is a tool to support the standard practices and visual comparisons.

The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.

#### Device Description

In addition to the reading and reporting functions/tools that are available in the predicate syngo.via basic software configuration, Siemens Healthcare intends to offer MR specific workflow configurations that are adapted for MR Oncology (syngo.MR Oncology).

syngo.MR Oncology is a syngo-based image viewing, processing and reading software. This software allows for oncological MR image evaluation in a structured way. It is a reading application supporting convenient reading of MR scans of single or multiple body regions, up to the entire body which have been acquired for clinical purposes such as oncological screening, diagnosis and staging.

The medical device software syngo.MR Oncology consists of the following two applications: syngo.MR Onco Workflows and the syngo.MR 3D Lesion Segmentation Tool.

The syngo.MR Onco Workflow application consists of the following tools: MR Onco Multi-Region, MR Onco Liver, MR Onco Brain, MR Onco TimCT and an Onco report.

The syngo.MR 3D Lesion Segmentation Tool also known as MR Segmentation tool, is a tool using the Random walker algorithm (default algorithm) or the Level Set algorithm. 3D Lesion Segmentation provides convenient volumetric evaluation of lesions and/or other structure of interest as well as a particularly useful tool for oncology applications (for example volumetric evaluation of tumors, lymph nodes and metastases), and nononcology lesions or other structures of interest with sufficient contrast to surrounding tissue.

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syngo.MR Oncology 510(k)

## General Safety and Effectiveness Concerns:

General Oalery and Enternetions for use and any necessary cautions and warnings to provide for safe and effective use of the device.

Risk management is ensured via a risk analysis in compliance with ISO 14971:2007 to identify and provide mitigation to potential hazards beginning early in the design cycle and continuing throughout the development of the product.

These potential hazards are controlled via software development, verification and validation testing. To minimize hazards, Siemens adheres to recognized and established industry practice and standards.

### Substantial Equivalence

The syngo.MR Oncology is substantially equivalent to the following devices:

| Predicate<br>Software Name | 510(K) Clearance<br>Number | 510(k) Clearance Date |
|-------------------------------------|----------------------------|-----------------------|
| Software<br>syngo MR B17 | K082427 | November 7, 2008 |
| Software<br>syngo.x (syngo.via) | K092519 | August 27, 2009 |
| Software<br>syngo PET&CT Oncology | K093621 | February 23, 2010 |
| Syngo Dosimetrist Workspace<br>v2.7 | K101119 | June 6, 2010 |

In summary, modifications made to the predicate device software do not affect the intended use of the device nor alter its fundamental scientific technology. Siemens believes that the subject software (syngo.MR Oncology) is substantially equivalent to the above listed predicate devices.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

JAN - 6 2012

Ms. Nadia Sookdeo Technical Specialist Regulatory & Clinical Affairs Siemens Medical Solutions USA, Inc. Customer Solutions Group 51 Valley Stream Parkway, Mail Code D02 MALVERN PA 19355

Re: K111861

Trade/Device Name: syngo. MR Oncology Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 7, 2011 Received: December 8, 2011

Dear Ms. Sookdeo:

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 comply with 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

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

Sincerely Yours.

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

510(k) Number (if known): K111861

Device Name: syngo MR Oncology

Indications for Use:

syngo.MR Oncology is a syngo.via-based image viewing, processing and reading software. syngo.MR Oncology is a syngo.via Babea image evaluation in a structured way. It is a This soltware allows for orloological will image even of single or multiple body
reading application primarily for convenient reading of MR scans of single or reading application primanly for corrective en acquired for clinical purposes such as regions up to the entire body which have been application does not block the display of data from other modalities that syngo.via supports.

syngo.MR Oncology provides analytical tools to help the user assess and document syngo.MR Oneonogy provides andryther to the diagnostic and therapy follow-up examinations.

syngo.MR Oncology is designed to support the oncological workflow including interpretation Syngolian Shoology is examinations, and follow-up documentation of findings.

Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis Note. The Citilician relains the untinute respensibility to of the separate unregistered images. syngo.MR Oncology is a tool to support the standard practices and visual comparisons.

The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.

Prescription Use _X_ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _ AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary Storts

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K111861/3
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