SYNGO MBF

K110494 · Siemens Medical Solutions USA, Inc. · LLZ · Apr 6, 2011 · Radiology

Device Facts

• Record ID: K110494
• Device Name: SYNGO MBF
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Apr 6, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Siemens syngo MBF is a software product intended for visualization, assessment and quantification of PET images. The application performs quantitative measurements of tracer uptake over time to aid in the interpretation of myocardial perfusion PET images. The product is intended for use by trained professionals. The Clinician retains the ultimate responsibility for making the pertinent assessment based on their standard practices and visual comparison of the information.

Device Story

syngo MBF is a software-only application for visualization, assessment, and quantification of dynamic Rubidium-PET and Ammonia-PET images. Input data consists of PET image sets; software provides tools for automatic and manual myocardial orientation and segmentation. It calculates myocardial blood flow (MBF) measurements by quantifying tracer uptake over time. Used in clinical settings by trained professionals; output is presented to clinicians for review. Clinicians integrate these quantitative results with traditional visual assessment of myocardial perfusion to aid in the diagnosis and assessment of coronary artery disease. The device facilitates clinical decision-making by providing objective blood flow metrics compared against a database.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use compared to the predicate device.

Technological Characteristics

Software-only application for PET image processing. Features automatic and manual segmentation and orientation tools for myocardial analysis. Implements quantitative measurement algorithms for tracer uptake. Operates on standard clinical workstations. Risk management performed per ISO 14971:2007.

Indications for Use

Indicated for trained professionals to visualize, assess, and quantify PET images, specifically dynamic Rubidium-PET and Ammonia-PET, to aid in the interpretation of myocardial perfusion and assessment of coronary artery disease.

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

• SyngoCirculation Dynamic PET 1.0 (K083327)

Submission Summary (Full Text)

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syngo MBF Special 510(k) Premarket Notification Strictly Confidential

APR - 6 2011

# 510(k) Summary

as required by 21 CFR Part 807.87(h)

Elaine Chang Submitter: Regulatory Technical Specialist Siemens Medical Solutions USA, Inc. 2501 N. Barrington Road Hoffman Estates, IL 60192 USA [phone] Telephone Number: [phone] . Fax Number: Siemens Medical Solutions USA, Inc. Name / Address of Molecular Imaging Manufacturer 2501 N. Barrington Road Hoffman Estates, IL 60192 USA 02/18/2011 Date of Submission: Identification of the product Device Proprietary Name: syngo MBF Picture Archiving and Communication System Common Name: Picture Archiving and Communication System per 21 Classification Name: CFR 892.2050 LLZ Product Code: Radiology Classification Panel: Class II Device Class:

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#### Marketed Devices to which Equivalence is claimed

| Device | Manufacturer | 510(k) Number |
|-------------------------------------|-------------------------------------|---------------|
| SyngoCirculation<br>Dynamic PET 1.0 | Siemens Medical Solutions USA, Inc. | K083327 |

#### Device Description:

syngo MBF is a software only product intended for visualization, assessment and quantification of medical images: specifically providing quantitative blood flow measurements of PET images. The application supports dynamic Rubidium – PET and dynamic Ammonia - PET images.

The application provides visualization and measurement tools, for qualitative and quantitative visualization and assessment of the input data. It provides automatic and manual tools to orient and segment the myocardium. The software calculates measurements of myocardial blood flow, and provides tools, for the Clinician to assess these results. The user may save the results.

The application is intended for use by trained professionals. The Clinician retains the ultimate responsibility for making the pertinent assessment based on their standard practices and visual assessment of the myocardial perfusion PET images. The quantitative assessment is to be used in conjunction with traditional visual assessment of myocardial perfusion PET images for the assessment of coronary artery disease, and quantitatively by comparing to a database.

#### Safety and Effectiveness:

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.

Siemens Medical Solutions USA, Inc considers that the proposed device does not introduce new safety concerns, and is substantially the same in indications for use, design, materials, energy sources and technology as the predicate devices. Siemens Medical Solutions USA, Inc believes that the syngo MBF software application is substantially equivalent to the predicate devices.

#### Indications for Use:

Siemens syngo MBF is a software product intended for visualization, assessment and quantification of PET images.

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The application performs quantitative measurements of tracer uptake over time to aid in the interpretation of myocardial perfusion PET images.

The product is intended for use by trained professionals. The Clinician retains the ultimate responsibility for making the pertinent assessment based on their standard practices and visual comparison of the information.

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## Indications for Use

14110494 510(k) Number (if known):

Device Name: syngo MBF

Indications for Use:

Siemens syngo MBF is a software product intended for visualization, assessment and quantification of PET images.

The application performs quantitative measurements of tracer uptake over time to aid in the interpretation of myocardial perfusion PET images.

The product is intended for use by trained professionals. The Clinician retains the ultimate responsibility for making the pertinent assessment based on their standard practices and visual comparison of the information.

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 Devices (OIVD)

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract emblem resembling an eagle or bird in flight, composed of three curved lines that suggest wings and a head.

### 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

Ms. Elaine Chang Regulatory Technical Specialist Siemens Medical Solutions USA, Inc. Molecular Imaging Group 2501 North Barrington Road HOFFMAN ESTATES IL 60192

APR -- 6 2011

Re: K110494

Trade/Device Name: syngo MBF Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 29, 2011 Received: March 30, 2011

#### Dear Ms. Chang:

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 5 00%) premarket notification. The FDA finding of substantial equivalence of your device to a logal y 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

510(k) Number (if known):

Device Name: syngo MBF

Indications for Use:

Siemens syngo MBF is a software product intended for visualization, assessment and quantification of PET images.

The application performs quantitative measurements of tracer uptake over time to aid in the interpretation of myocardial perfusion PET images.

The product is intended for use by trained professionals. The Clinician retains the ultimate responsibility for making the pertinent assessment based on their standard practices and visual comparison of the information.

Prescription Use X (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 Devices (OIVD)

Mary Scott

(Division Sign-Off)
Division of Radiological Device
Office of In Vitro Diagnostic Device Evaluat.

510K K110494

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