SYNGO.MR SPECTRO ENGINE, SYNGO.MR SPECTRO SVS, SYNGO.MR SPECTRO CSI, SYNGO.MR SPECTRO EXTENSION

K120315 · Siemens Medical Solutions USA, Inc. · LLZ · Apr 13, 2012 · Radiology

Device Facts

• Record ID: K120315
• Device Name: SYNGO.MR SPECTRO ENGINE, SYNGO.MR SPECTRO SVS, SYNGO.MR SPECTRO CSI, SYNGO.MR SPECTRO EXTENSION
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Apr 13, 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 Spectroscopy is a post-processing application to analyze and evaluate MR spectroscopy data. It provides evaluation of MR Single Voxel Spectroscopy (SVS) data and MR Chemical Shift Imaging (CSI) data with workflow guidance to support the diagnostic process. syngo.MR Spectroscopy includes the possibility of an integrated reading of MR images and spectroscopy data for spectroscopy exams and focuses on ease-of-use by reducing complexity. A novel fit-algorithm reduces the need for manual data processing and offers the user reproducible evaluation results. When interpreted by a trained physician, these results provide information that may assist in diagnosis. The post-processing tool fits and displays spectra and provides intuitive representations of the metabolic profile. The calculation and display of predefined results such as spectral maps, and metabolite images is provided. The evaluation can be adapted by the customer via protocol modification and task configurations. Interactive reading of spectroscopy exams is supported by side-by-side display of MR images and spectroscopy results, and synchronized display.

Device Story

syngo.MR Spectroscopy is a syngo.via-based software application for post-processing, viewing, and reporting of MR spectroscopy data. Input data consists of MR SVS and CSI datasets acquired during in-vivo examinations. The device transforms these inputs using a novel fit-algorithm to generate metabolic profiles, spectral maps, and metabolite images. It is used in clinical settings by healthcare professionals (physicians) to interpret metabolic information. The software provides workflow guidance, side-by-side synchronized display of MR images and spectroscopy results, and customizable task configurations. By automating data processing and reducing manual intervention, the device aims to provide reproducible results, assisting physicians in diagnostic decision-making and improving ease-of-use.

Clinical Evidence

No clinical data provided. Safety and effectiveness were established through software development, verification, and validation testing in compliance with ISO 14971:2007 and applicable FDA-recognized standards.

Technological Characteristics

Software-based post-processing application for MR spectroscopy. Features include SVS and CSI evaluation modules and an extension for advanced parameter configuration. Operates on the syngo.via platform. Conforms to IEC, ISO, and NEMA standards for MR safety and performance. Software-based algorithm for spectral fitting.

Indications for Use

Indicated for use by trained physicians to analyze and evaluate MR Single Voxel Spectroscopy (SVS) and MR Chemical Shift Imaging (CSI) data acquired for in-vivo examinations of cell metabolism in tissue and organs to assist in the diagnostic process.

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 with software syngo MR D11A (K101347)
• syngo.x (K092519)

Submission Summary (Full Text)

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# SIEMENS

#### Traditional 510(k) Submission: syngo.MR Spectroscopy

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

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: January 30, 2012

- 1. 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 Registration Number: 8010024

### 2. Contact Person

Nadia Sookdeo Regulatory 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]

#### 3. Device Name and Classification

| Data | Details |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade name / Device<br>Proprietary Name: | syngo.MR Spectroscopy.<br><br>Please note: syngo.MR Spectroscopy is also<br>known as syngo.MR Spectro Engine which is the<br>commonly used trade name for syngo.MR<br>Spectroscopy |
| Classification Name: | Regulation Description: |

Traditional 510(k) for syngo.MR Spectroscopy

Siemens Medical Solutions USA, Inc.

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Traditional 510(k) Submission: syngo.MR Spectroscopy

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

#### 4. Device Description

syngo.MR Spectroscopy is a syngo.via-based MR spectroscopy data viewing, processing and reading software. This software allows MR spectroscopic data evaluation in a structured way. It is a reading application supporting convenient reading of MR Single Voxel Spectroscopy (SVS) data and MR Chemical Shift Imaging (CSI) data of body regions which have been acquired for in-vivo examinations of the cell metabolism of tissue and organs.

The medical device syngo.MR Spectroscopy comprises syngo.MR Spectro SVS, svngo.MR Spectro CSI and syngo.MR Spectro Extension.

- syngo.MR Spectro SVS: provides evaluation of MR Single Voxel Spectroscopy -(SVS) data with comprehensive workflow guidance.
- syngo.MR Spectro CSI: provides evaluation of MR Chemical Shift Imaging (CSI) data with comprehensive workflow guidance. syngo.MR Spectro CSI includes the possibility of an integrated reading of MR images and CSI spectroscopy data for prostate exams.
- syngo.MR Spectro Extension: provides access to advanced parameters, which allow the advanced user to configure the post processing and display of spectro results according to his / her personal needs. Both Single Voxel Spectroscopy (SVS) and Chemical Shift Imaging (CSI) data are supported.

syngo.MR Spectro Engine bundles the above three packages for post-processing for purchase separately or as part of the syngo.MR Spectro Engine.

#### 5. Intended Use

syngo.MR Spectroscopy is a post-processing application to analyze and evaluate MR spectroscopy data. It provides evaluation of MR Single Voxel Spectroscopy (SVS) data and MR Chemical Shift Imaging (CSI) data with workflow guidance to support the diagnostic process.

syngo.MR Spectroscopy includes the possibility of an integrated reading of MR images and spectroscopy data for spectroscopy exams and focuses on ease-of-

Traditional 510(k) for syngo.MR Spectroscopy

Siemens Medical Solutions USA, Inc.

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# SIEMENS

#### Traditional 510(k) Submission: synqo.MR Spectroscopy

use by reducing complexity. A novel fit-algorithm reduces the need for manual data processing and offers the user reproducible evaluation results. When interpreted by a trained physician, these results provide information that may assist in diagnosis.

The post-processing tool fits and displays spectra and provides intuitive representations of the metabolic profile. The calculation and display of predefined results such as spectral maps, and metabolite images is provided. The evaluation can be adapted by the customer via protocol modification and task configurations. Interactive reading of spectroscopy exams is supported by side-byside display of MR images and spectroscopy results, and synchronized display.

#### 6. Substantial Equivalence

syngo.MR Spectroscopy offers reading / viewing and reporting functionality. These functionalities are based on the basic functionality already cleared for syngo.via and adapted for syngo.MR Spectroscopy. The syngo.MR Spectroscopy software has been found to be substantially equivalent to the following current legally marketed devices (please refer to Table 1):

| Predicate Device Name | FDA Clearance<br>Number | FDA Clearance<br>Date |
|-----------------------------------------------------------------|-------------------------|-----------------------|
| MAGNETOM Aera,<br>MAGNETOM Skyra<br>with software syngo MR D11A | K101347 | October 01, 2010 |
| syngo.x®3 | K092519 | August 27, 2009 |

Predicate devices for syngo.MR Spectroscopy Table 1:

#### 7. Summary of Technological Characteristics of the Principal Device as Compared With the Predicate Device

syngo.MR Spectroscopy is aimed at increasing ease of use by simplifying workflows and features and reduces complexity from the user's perspective through an improved algorithm and intuitive processing capabilities. It offers additional spectroscopy specific features based on the currently cleared syngo.x and improved features based on the currently cleared syngo MR D11A (on MAGNETOM Aera and MAGNETOM Skyra).

New features of syngo.MR Spectroscopy that are not part of the syngo MR D11A (on MAGNETOM Aera and MAGNETOM Skyra) are related to workflow support, data processing, quality assessment of the spectra, and configuration of MR spectroscopy parameters.

syngo.x® is a registered trademark of Siemens AG.

Traditional 510(k) for syngo.MR Spectroscopy

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SIEMENS

#### 8. 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 health care professionals familiar with and responsible for the evaluating and post processing of magnetic resonance images.

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

#### 9. Conclusion as to Substantial Equivalence

syngo.MR Spectroscopy is intended for similar indications as cleared in the predicate software noted. In summary, Siemens is of the opinion that syngo.MR Spectroscopy does not raise new questions of safety or effectiveness and is substantially equivalent to the currently marketed devices.

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Image /page/4/Picture/0 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

APR 1 3 2012

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

Ms. Nadia Sookdeo Regulatory Affairs Technical Specialist Siemens Medical Solutions USA. Inc. 51 Valley Stream Parkway MALVERN PA 19355

Re: K120315

Trade/Device Name: syngo.MR Spectroscopy Regulation Number: CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 30, 2012 Received: February 1, 2012

#### 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,

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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## SIEMENS

Traditional 510(k) Submission: syngo.MR Spectroscopy

### Indications for Use Statement

510(k) Number (if known)

syngo.MR Spectroscopy Device Name:

#### Indications for Use:

syngo.MR Spectroscopy is a post-processing application to analyze and evaluate MR spectroscopy data. It provides evaluation of MR Single Voxel Spectroscopy (SVS) data and MR Chemical Shift Imaging (CSI) data with workflow guidance to support the diagnostic process.

syngo.MR Spectroscopy includes the possibility of an integrated reading of MR images and spectroscopy data for spectroscopy exams and focuses on ease-of-use by reducing complexity. A novel fit-algorithm reduces the need for manual data processing and offers the user reproducible evaluation results. When interpreted by a trained physician, these results provide information that may assist in diagnosis.

post-processing tool fits and displays spectra and provides intuitive The representations of the metabolic profile. The calculation and display of predefined results such as spectral maps, and metabolite images is provided. The evaluation can be adapted by the customer via protocol modification and task configurations. Interactive reading of spectroscopy exams is supported by side-by-side display of MR images and spectroscopy results, and synchronized display.

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 ANOTHER PAGE IF NEEDED)

AND/OR

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

Daniel Renaud

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

510(k) K130315

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Traditional 510(k) for syngo.MR Spectroscopy