SYNGO.MR NEUROLOGY

K121459 · Siemens Medical Solutions USA, Inc. · LLZ · Jun 22, 2012 · Radiology

Device Facts

• Record ID: K121459
• Device Name: SYNGO.MR NEUROLOGY
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jun 22, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

syngo.MR Neurology is a software solution to be used for viewing and evaluation of Neuroperfusion MR images for the routine use in MR image viewing. It is a syngo via based software option with dedicated MR specific workflows and basic MR specific evaluation tools and thus supports interpretation and evaluation of examinations within healthcare institutions, for example in Radiology, Neuroradiology and Neurosurgery environments.

Device Story

syngo.MR Neurology is a post-processing software application for neurological MR images; operates on the syngo.via platform. Inputs include brain perfusion datasets (DSC imaging) and BOLD fMRI data. The device processes these inputs to generate perfusion maps (relMTT, relCBV, relCBF) using Arterial Input Function (AIF) calculations and performs perfusion-diffusion mismatch evaluations. Used in clinical settings (radiology, neuroradiology, neurosurgery) by healthcare professionals. Output is visualized via color displays and structured evaluation tools, assisting clinicians in interpreting neurological examinations. Benefits include standardized workflow for complex neuro-imaging analysis.

Clinical Evidence

No clinical data. Safety and effectiveness supported by risk management in compliance with ISO 14971:2007, software verification, and validation testing. Device conforms to applicable FDA-recognized IEC, ISO, and NEMA standards.

Technological Characteristics

Software-based post-processing application; syngo.via platform. Features include perfusion map calculation (relMTT, relCBV, relCBF) and perfusion-diffusion mismatch evaluation. Conforms to IEC, ISO, and NEMA standards for MR safety and performance. Risk management per ISO 14971:2007.

Indications for Use

Indicated for healthcare professionals in radiology, neuroradiology, and neurosurgery environments for the viewing and evaluation of neurological MR images, including perfusion and functional MRI data.

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 D11D for MAGNETOM Aera & MAGNETOM Skyra (K111242)
• syngo.x (K092519)

Submission Summary (Full Text)

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SIEMENS

Traditional 510(k) Submission: syngo.MR Neurolo

JUN 2 2 2012

### 510(k) Summary: syngo.MR Neuroloqy

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: May 15, 2012

l. General Information

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

Manufacturer

Siemens AG Sector Healthcare Medical Solutions Henkestrasse 127 D-91052 Erlangen, Germany 8010024

Registration Number:

Contact Person

Michelle Byrne Regulatory Affairs Technical Specialist Siemens Medical Solutions USA, Inc. 51 Valley Stream Pkwv Mail Code D02 Malvern, PA 19355, USA Phone: [phone] Fax: [phone] Email: [e-mail]

#### Device Name and Classification

| Data | Details |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade name /<br>Device<br>Proprietary<br>Name: | syngo.MR Neurology |
| | syngo.MR Neurology includes syngo.MR Neuro Perfusion<br>Engine and syngo.MR Neuro fMRI. syngo.MR Neuro<br>Perfusion Engine bundles the applications syngo.MR<br>Neuro Perfusion and syngo.MR Neuro Perfusion Mismatch. |
| | Each application is also sold separately. |

Traditional 510(k) for syngo.MR Neurology

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Traditional 510(k) Submission: syngo.MR Neurology

| Data | Details |
|------------------------|--------------------------------------------------------------------------------|
| Classification Name: | Regulation Description:<br>- Picture Archiving and Communication System (PACS) |
| Classification Panel: | Radiology |
| Device Classification: | Class II devices |
| Regulation number: | 21 CFR 892.2050 |
| Product Code: | LLZ, LNH |

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

#### Intended Use

SIEMENS

syngo.MR Neurology is a software solution to be used for viewing and evaluation of Neuroperfusion MR images for the routine use in MR image viewing.

It is a syngo via based software option with dedicated MR specific workflows and basic MR specific evaluation tools and thus supports interpretation and evaluation of examinations within healthcare institutions, for example in Radiology, Neuroradiology and Neurosurgery environments.

#### Device Description

syngo.MR Neurology is a post-processing software/application to be used for viewing and evaluating neurological MR images provided by a magnetic resonance diagnostic device. syngo.MR Neurology is a syngo.via-based software that enables structured evaluation of MR neurological images.

The medical device syngo.MR Neurology comprises syngo.MR Neuro fMRI (Neuro functional evaluation) and syngo.MR Neuro Perfusion Engine. syngo.MR Neuro Perfusion Engine comprises syngo.MR Neuro Perfusion (Perfusion

and Local as well as Global AIF (Arterial Input Function)) and syngo.MR Neuro Perfusion Mismatch (Perfusion-Diffusion Mismatch Evaluation). This bundling is done for purchase purposes. Each application can also be purchased separately.

- syngo.MR Neuro Perfusion enables: processing of brain perfusion datasets acquired with DSC imaging. It provides color display and calculation of perfusion maps based on Arterial Input Function (AIF) (relative Mean Transit Time (relMTT), relative Cerebral Blood Volume (relCBV), and relative Cerebral Blood Flow (relCBF)).
- syngo.MR Neuro Perfusion Mismatch performs a calculation of the area differences between perfusion-diffusion datasets.

Traditional 510(k) for syngo.MR Neurology

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SIEMENS

Traditional 510(k) Submission: syngo.MR Neurology

#### syngo.MR Neuro fMRI is a workflow-oriented visualization package for BOLD fMRI.

#### 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.

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 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 Neurology 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.MR Neurology is substantially equivalent to the following predicate devices (see Table 1):

| Predicate Device Name | FDA Clearance Number | FDA Clearance Date |
|-----------------------------------------------------|----------------------|--------------------|
| syngo MR D11D for MAGNETOM<br>Aera & MAGNETOM Skyra | K111242 | November 23, 2011 |
| syngo.x®3 | K092519 | August 27, 2009 |

Predicate devices for syngo.MR Neurology Table 1:

#### Conclusion as to Substantial Equivalence

syngo.MR Neurology has a similar intended use and the same basic technical characteristics as the predecessor devices syngo MR D11D (on MAGNETOM Aera and MAGNETOM Skyra) and syngo.x, in regards to the specific neurological functionalities. syngo.MR Neurology will be used for post-processing neurological images (viewing, processing and reading). The predicate device, MAGNETOM Aera and MAGNETOM Skyra with software syngo MR D11D, is also capable of postprocessing neurological images (viewing, processing and reading), in addition to acquiring the MR images. syngo.x is used as the basic software platform and is intended for post-processing, for example, viewing, manipulating, communicating and

3 syngo.x is a registered trademark of Siemens AG. Traditional 510(k) for syngo.MR Neurology

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# SIEMENS

Traditional 510(k) Submission: syngo.MR Neurology

storing medical images. The differences between the subject device and the predicate devices, which include the aforementioned new software applications, give the subject device greater capabilities than the predicate devices, but have the same technological characteristics as the predicate devices, are similar to the functionalities of the predicate devices, and do not introduce any new issues of safety or effectiveness.

#### Traditional 510(k) for syngo.MR Neurology

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## 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

JUN 2 2 2012

Ms. Michelle L. Byrne Regulatory Affairs Technical Specialist Siemens Medical Solutions USA. Inc. 51 Valley Stream Parkway, Mail Code D02 MALVERN PA 19355

Re: K121459

Trade/Device Name: syngo.MR Neurology Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 15. 2012 Received: May 17, 2012

#### Dear Mr. Ms. Byrne:

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 r 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 any I vith 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 pactice mourements 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,

Janine M. Morris

Acting 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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K121459

# SIEMENS

Traditional 510(k) Submission: syngo.MR Neurology

### Indications for Use Statement

510(k) Number (if known)

syngo.MR Neurology Device Name:

Indications for Use:

syngo.MR Neurology is a software solution to be used for viewing and evaluation of Neuroperfusion MR images for the routine use in MR image viewing.

It is a syngo via based software option with dedicated MR specific workflows and basic MR specific evaluation tools and thus supports interpretation and evaluation of examinations within healthcare institutions, for example in Radiology, Neuroradiology and Neurosurgery environments.

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 Diagnostic Devices (OIVD)

Aalund D. O'R

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

510(k) Kla1459

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Traditional 510(k) for syngo.MR Neurology