SYNGO.MR GENERAL; SYNGO.MR CARDIOLOGY; SYNGO.MR VASCULAR

K130749 · Siemens Medical Solutions USA, Inc. · LLZ · Aug 20, 2013 · Radiology

Device Facts

• Record ID: K130749
• Device Name: SYNGO.MR GENERAL; SYNGO.MR CARDIOLOGY; SYNGO.MR VASCULAR
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Aug 20, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The software comprising the syngo.MR post-processing applications are post-processing software / applications to be used for viewing and evaluating the designated images provided by a magnetic resonance diagnostic device. All of the software applications comprising the syngo.MR post-processing applications have their own indications for use. syngo.MR General is a syngo based post-processing software for viewing, manipulating, and evaluating MR images. syngo.MR Cardiology is a syngo based post-processing software for viewing, manipulating, and evaluating MR cardiac images. syngo.MR Vascular is a syngo based post-processing software for viewing, manipulating, and evaluating MR vascular images.

Device Story

syngo.MR post-processing software (General, Cardiology, Vascular) functions as an add-on to the syngo.via platform; processes 2D, 3D, and 4D MR image data. Inputs include MR image datasets; outputs include structured evaluations, quantitative results (e.g., ventricular function, blood flow dynamics), and full-format images from overlapping volumes. Used in clinical settings by healthcare professionals (radiologists, cardiologists) for diagnostic support. Software automates loading and structuring of examination results into layouts to ensure data completeness. Benefits include standardized, efficient image evaluation and quantitative analysis for clinical decision-making.

Clinical Evidence

No clinical data. Safety and effectiveness supported by bench testing, software verification and validation, and adherence to recognized international standards for performance and safety of MR post-processing software.

Technological Characteristics

Software-based post-processing application; runs on syngo.via platform. Features include 2D/3D/4D image reading, composing of overlapping volumes, and automated workflow structuring. Conforms to IEC, ISO, and NEMA standards for MR performance and safety. Connectivity via DICOM/standard hospital networks.

Indications for Use

Indicated for healthcare professionals to view, manipulate, and evaluate MR images (general, cardiac, and vascular) provided by magnetic resonance diagnostic devices.

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

• MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Avanto and MAGNETOM Verio with syngo MR D13A (K121434)
• syngo.via (K123375)

Submission Summary (Full Text)

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K130749

SIEMENS

Traditional 510(k) Submission / Bundling 510(k) for: syngo.MR Post-Processing Software (Version SMRVA16A)

#### 510(k) Summary: syngo.MR General, syngo.MR Cardiology and syngo.MR Vascular

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92.

Date of Summary Preparation: March 15, 2013

- I. General Information
AUG 20 2013

Importer / Distributor Siemens Medical Solutions USA, Inc. 51 Valley Stream Pkwy Mail Code D02 Malvern, PA 19355, USA Registration Number: 2240869

Siemens AG Manufacturer Medical Solutions Henkestrasse 127 D-91052 Erlangen, Germany Registration Number: 3002808157

Contact Person Nadia Sookdeo Requlatory Affairs Technical Specialist Siemens Medical Solutions USA, Inc. 51 Valley Stream Pkwy Mail Code D02 Malvern, PA 19355, USA Phone: [phone] Fax: [phone] Email: [e-mail]

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SIEMENS

Data

Traditional 510(k) Submission / Bundling 510(k) for: 4)

| ﺍﺱ ﮐﮯ ﻟﯿﮯ ﺍ | | Syngo.MR Post-Processing Software (Version SMRVA16A | | |
|-------------|------------------|-----------------------------------------------------|--|--|
| | l Classification | | | |
| | Oetails | | | |
| | svngo.MR General | | | |

| Trade name /<br>Device<br>Proprietary<br>Name: | syngo.MR General<br>syngo.MR General includes syngo.MR Reading, syngo.MR<br>Composing and syngo.MR General Engine.<br>syngo.MR Composing and syngo.MR General Engine are<br>sold separately.<br>syngo.MR Cardiology<br>syngo.MR Cardiology includes syngo.MR Cardiac 4D<br>Ventricular Function and syngo.MR Cardiac Flow.<br>The applications can be sold together as syngo. MR Cardio<br>Engine.<br>syngo.MR Vascular<br>syngo.MR Vascular includes syngo.MR Vascular Analysis. |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification<br>Name: | Regulation Description:<br>Picture Archiving and Communication System (PACS) |
| Classification<br>Panel: | Radiology |
| Device<br>Classification: | Class II devices |
| Regulation<br>number: | 21 CFR § 892.2050 |
| Product<br>Code: | Primary: LLZ, Secondary: LNH |

# II. Safety and Effectiveness Information Supporting Substantial Equivalence

#### Intended Use

The software comprising the syngo.MR post-processing applications are postprocessing software / applications to be used for viewing and evaluating the designated images provided by a magnetic resonance diagnostic device. All of the software applications comprising the syngo.MR post-processing applications have their own indications for use.

syngo.MR General is a syngo based post-processing software for viewing, manipulating, and evaluating MR images.

syngo.MR Cardiology is a syngo based post-processing software for viewing, manipulating, and evaluating MR cardiac images.

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Image /page/2/Picture/0 description: The image shows the word "SIEMENS" in a stylized, outlined font. The letters are large and bold, with a distinct outline that gives them a three-dimensional appearance. The font is sans-serif, and the letters are evenly spaced.

#### Traditional 510(k) Submission / Bundling 510(k) for: syngo.MR Post-Processing Software (Version SMRVA16A)

syngo.MR Vascular is a syngo based post-processing software for viewing, manipulating, and evaluating MR vascular images.

## Device Description

syngo.MR General, syngo.MR Cardiology and syngo.MR Vascular are post-processing software / applications to be used for viewing and evaluating MR images provided by a magnetic resonance diagnostic device. syngo.MR General; syngo.MR Cardiology and syngo.MR Vascular is syngo.via-based software that enable structured evaluation of MR images.

syngo.MR General, syngo.MR Cardiology and syngo.MR Vascular comprise the following (please refer to Table 1).

| Medical device /<br>post-processing<br>application | content |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| syngo.MR General | covered single and engines applications<br>syngo.MR Reading<br>enables reading of 2D, 3D and 4D MR data. |
| | syngo.MR Composing (optional)<br>is an offline application for creation of full-format images from<br>overlapping MR volume data sets acquired at multiple stages. |
| | syngo.MR General Engine (optional)<br>extends syngo.via by adding software for professional and<br>routine MR radiology usage. It includes workflows for<br>dedicated MR examinations that load and structure<br>examination results automatically into layouts including user<br>support to make sure that no data is missed.<br>syngo.MR General Engine contains several MR Radiology<br>Workflows, MR Cardio-Vascular Workflows and MR Basic<br>Evaluation features. |
| syngo.MR<br>Cardiology | syngo.MR Cardiac 4D Ventricular Function<br>enables 4D ventricular function evaluation and processes MR<br>cine images of the heart and generates quantitative results for<br>physicians in the diagnostic process.<br>syngo.MR Cardiac Flow<br>enables cardiac flow evaluation and processes velocity-<br>encoded MR images to evaluate blood flow dynamics e.g. in<br>the heart and the great vessels. The application generates<br>quantitative results for physicians in the diagnostic process.<br>syngo.MR Cardio Engine |

syngo.MR General, syngo.MR Cardiology and syngo.MR Vascular and their Table 1:

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| Medical device /<br>post-processing<br>application | covered single and engines applications |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------|
| | contains:<br>- syngo.MR Cardiac 4D Ventricular Function;<br>- syngo.MR Cardiac Flow. |
| syngo.MR Vascular | syngo.MR Vascular Analysis<br>enables assessment / quantification of general vascular<br>pathologies |

## General Safety and Effectiveness Concerns

Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner.

Product risk management is accomplished through a process in compliance with ISO 14971:2009 to identify and provide mitigation to potential hazards in a risk analysis beginning early in the design phase and continuing throughout the development of the product. These risks are controlled via measures realized in software development, SW testing and product labeling. To minimize risks, Siemens adheres to recognized and established industry practices and standards. Furthermore, the operators are healthcare professionals familiar with and responsible for the evaluating and post-processing of magnetic resonance images.

syngo.MR General, syngo.MR Cardiology and syngo.MR Vascular conform to the applicable FDA recognized and international IEC, ISO and NEMA standards with reqards to performance and safety as recommended by the respective MR FDA Guidance Document.

## Substantial Equivalence

syngo.MR General, syngo.MR Cardiology and syngo.MR Vascular are substantially equivalent to the following current legally marketed devices (please refer to Table 2):

| Predicate Device Name | FDA Clearance Number | FDA Clearance Date | Product Code |
|--------------------------------------------------------------------------------------------------|----------------------|--------------------|--------------|
| MAGNETOM Aera,<br>MAGNETOM Skyra,<br>MAGNETOM Avanto and<br>MAGNETOM Verio with<br>syngo MR D13A | K121434 | November 05, 2012 | LNH |
| syngo.via | K123375 | November 20, 2012 | LLZ |

| Table 2: Predicate devices for syngo.MR General, syngo.MR Cardiology and syngo.MR |
|--------------------------------------------------------------------------------------|
| Vascular |

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Image /page/4/Picture/0 description: The image contains the word "SIEMENS" in all capital letters. The letters are outlined with a double border, giving them a three-dimensional appearance. The font is sans-serif and the letters are evenly spaced. The overall impression is clean and professional.

Traditional 510(k) Submission / Bundling 510(k) for: syngo.MR Post-Processing Software (Version SMRVA16A)

## Conclusion as to Substantial Equivalence

The syngo.MR post-processing applications are intended for similar indications as cleared in the predicate devices, as previously noted.

In summary. Siemens is of the opinion that the syngo.MR post-processing applications do not raise new questions of safety or effectiveness and are substantially equivalent to the currently marketed devices MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Avanto and MAGNETOM Verio with software syngo MR D13A (K121434 cleared on November 5, 2012) as well as syngo.via (K123375 cleared on November 20, 2012).

There are minor changes to the indications for use for the subject device, compared to that of the predicate devices MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Avanto and MAGNETOM Verio with software syngo MR D13A as well as syngo.via VA20A. The differences between the subject devices and the predicate devices include the aforementioned improved changes, adaption to the updated syngo.via basis platform and other enhancements. The differences give the devices greater capabilities than the predicate devices, but have same technological characteristics and functionalities as the predicate devices, and do not introduce any new issues of safety or effectiveness.

Therefore, Siemens believes that the subject devices, the syngo.MR post-processing applications, are substantially equivalent to the predicate devices listed above.

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Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Poblic Health Service

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

August 20, 2013

NADIA SOOKDEO REGULATORY AFFAIRS TECHNICAL SPECIALIST SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PARKWAY MALVERN PA 19355

Re: K130749

Trade/Device Name: syngo.MR General; syngo.MR Cardiology; syngo.MR Vascular Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ, LNH Dated: July 24, 2013 Received: July 25, 2013

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. 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.

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Page 2-Ms. Sookdeo

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D. O'Hara

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

for

Enclosure

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# Indications for Use

510(k) Number (if known): K130749

syngo.MR General, syngo.MR Cardiology and syngo.MR Vascular Device Name:

Indications for Use:

The software comprising the syngo.MR post-processing applications are post-processing software / applications to be used for viewing and evaluating the designated images provided by a magnetic resonance diagnostic device. All of the software applications comprising the syngo.MR post-processing applications have their own indications for use.

syngo.MR General is a syngo based post-processing software for viewing, manipulating, and evaluating MR images.

syngo.MR Cardiology is a syngo based post-processing software for viewing, manipulating, and evaluating MR cardiac images.

syngo.MR Vascular is a syngo based post-processing software for viewing, manipulating, and evaluating MR vascular images.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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 Diagnostics and Radiological Health (OIR)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) K130749

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