SYNGO.MR NEUROLOGY, SYNGO.MMR GENERAL

K140897 · Siemens Medical Solutions USA, Inc. · LLZ · Jul 18, 2014 · Radiology

Device Facts

• Record ID: K140897
• Device Name: SYNGO.MR NEUROLOGY, SYNGO.MMR GENERAL
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jul 18, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.mMR General is a syngo based post-processing software for viewing, and evaluating MR, PET, and CT images as well as MR-PET and CT-PET images.

Device Story

syngo.mMR General is a syngo.via-based post-processing software application; functions as a tool for viewing, manipulating, and evaluating medical images (MR, PET, CT, MR-PET, CT-PET). Input data consists of images provided by diagnostic imaging devices; processing involves structured evaluation and visualization of these datasets. Used in clinical environments by healthcare professionals (physicians, radiologists, technologists) to assist in diagnostic assessment. Output is displayed on a workstation for clinical review; supports clinical decision-making by enabling image analysis and structured evaluation. Benefits include enhanced visualization and workflow efficiency for multi-modality image review.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, software verification and validation, and adherence to recognized international standards (IEC, ISO, NEMA) for performance and safety.

Technological Characteristics

Software-based post-processing application; syngo.via platform. Operates on standard workstation hardware. Connectivity via DICOM (private tags may limit cross-vendor processing). Conforms to IEC, ISO, and NEMA standards. Risk management per ISO 14971:2009.

Indications for Use

Indicated for viewing, manipulating, and evaluating MR, PET, and CT images, including MR-PET and CT-PET hybrid images, in a clinical setting by healthcare professionals.

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

• syngo.MR Post-Processing Software Version SMRVA16B (K133401)

Submission Summary (Full Text)

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SIEMENS

Traditional 510(k) Submission for: syngo.MR Post-Processing Softwar

#### syngo.mMR General 510(k) Summary:

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: April 7, 2014

l. General Information

| Importer / Distributor | Siemens Medical Solutions USA, Inc |
|------------------------|------------------------------------|
| | 51 Valley Stream Parkway |
| | Mail Code D02 |
| | Malvern, PA 19355, USA |

2240869 Registration Number:

Siemens AG Manufacturer Medical Solutions Henkestrasse 127 D-91052 Erlangen, Germany

3002808157 Registration Number:

Contact Person:

Cordell L. Fields, Esq Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 51 Valley Stream Pkwy Mail Code D02 Malvern, PA 19355, USA Phone: [phone] Fax: [phone] Email: [e-mail]

JUL 1 8 2014

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| Data | Details |
|---------------------------------------------|------------------------------------------------------------------------------------------------------|
| Trade name /<br>Device Proprietary<br>Name: | syngo.mMR General (NEW Indications for Use)<br>syngo.mMR General is available as single application. |
| Classification<br>Name: | Regulation Description:<br>- Picture Archiving and Communication System (PACS) |
| Classification<br>Panel: | Radiology |
| Device<br>Classification: | Class II devices |
| Regulation number: | 21 CFR § 892.2050 |
| Product Code: | Primary: LLZ, Secondary: LNH |

## Device Name and Classification

## 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.mMR General is a syngo based post-processing software for viewing, manipulating, and evaluating MR, PET, and CT images as well as MR-PET and CT-PET images.

#### Device Description

syngo.mMR General is a syngo.via-based post-processing software / application to be used for viewing and evaluating MR images provided by a magnetic resonance diagnostic device and enabling structured evaluation of MR images. syngo.mMR General comprises the following:

While viewing (i.e. assessing) of images from other vendors is always possible; for advanced postprocessing applications, some of the post-processing steps may depend on information contained in private DICOM tags ,therefore evaluation and processing of images can't be guaranteed for other vendors.

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11

Table 1: syngo.mMR General and its content; new applications for this submission are denoted (New); all other applications are currently cleared.

| Medical device /<br>post-processing<br>application | covered single and engines applications |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| syngo.mMR<br>General | syngo.mMR General (NEW Indications for USE)<br>syngo.mMR General is a syngo based post-processing<br>software for viewing, manipulating, and evaluating MR, PET,<br>and CT images as well as MR-PET and CT-PET images. |

# General Safety and Effectiveness Concerns

Instructions for use are included within the device labeling which enables 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 MR images.

syngo.mMR General conforms to the applicable FDA recognized and international IEC, ISO and NEMA standards with regards to performance and safety as recommended by the respective MR FDA Guidance Document.

# Substantial Equivalence

syngo.mMR General is substantially equivalent to the following current legally marketed device:

| Predicate Device Name | FDA<br>Clearance<br>Number | FDA Clearance<br>Date | Product Code |
|-------------------------------------------------------|----------------------------|-----------------------|--------------|
| syngo.MR Post-Processing<br>Software Version SMRVA16B | K133401 | March 11, 2014 | LLZ<br>LNH |

Table 2: Predicate device for syngo.mMR General

# Conclusion as to Substantial Equivalence ·

The syngo.MR post-processing application is intended for similar indications as cleared in the predicate device.

In summary, Siemens is of the opinion that the syngo.MR post-processing application does not raise new questions of safety or effectiveness and are substantially equivalent

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K140897
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to the currently marketed device syngo.MR Post-Processing Software Version SMRVA16B (K133401 cleared on March 11, 2014)

There are minor changes to the indications for use for the subject device with regards to syngo.mMR General. The differences give the device greater capabilities than the predicate, but the technological characteristics and functionalities are similar.

Therefore, Siemens believes that the subject device, the syngo.MR post-processing application, is substantially equivalent to the predicate device listed above in Table 2.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. 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 Center - WO66-Goly Silver Spring, MD 20993-0002

July 18, 2014

SIEMENS MEDICAL SOLUTIONS USA, INC. CORDELL FIELDS, ESQ. 51 VALLEY STREAM PARKWAY MALVERN PA 19355

Re: K140897

Trade/Device Name: syngo.mMR General Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ, LNH Dated: June 18, 2014 Received: June 19, 2014

Dear Mr. Fields:

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 cither 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone]

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Page 2—Mr. Fields

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" (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 Industry and Consumer Education 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

for

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K140897

Device Name syngo.mMR General

Indications for Use (Describe)

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.

syneo.mMR General is a syngo based post-processing software for viewing, and evaluating MR, PET, and CT images as well as MR-PET and CT-PET images.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Michael D. O'Hara

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