SYNGOCIRCULATION DYNAMICPET, VERSION 1.0

K083327 · Siemens Medical Solutions USA, Inc. · LLZ · May 18, 2009 · Radiology

Device Facts

• Record ID: K083327
• Device Name: SYNGOCIRCULATION DYNAMICPET, VERSION 1.0
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LLZ · Radiology
• Decision Date: May 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Siemens syngoCirculation DynamicPET 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

Software application for visualization, assessment, and quantification of dynamic Rubidium-PET and Ammonia-PET images; inputs include PET image data; performs automatic and manual orientation and segmentation of myocardium; calculates myocardial perfusion measures over time; output consists of quantitative measurements and visualizations for clinician review; used in clinical settings by trained professionals; clinician retains ultimate responsibility for assessment; aids in interpretation of myocardial perfusion for coronary artery disease assessment; benefits include objective quantitative data to supplement traditional visual assessment.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use comparison to predicate devices.

Technological Characteristics

Software-based image processing system for PET data. Features automatic and manual tools for myocardial orientation and segmentation. Implements quantitative measurement algorithms for tracer uptake over time. Operates as a standalone software application within a PACS environment. Risk management conducted per IEC/ISO 14971.

Indications for Use

Indicated for trained professionals to perform visualization, assessment, and quantification of PET images, specifically dynamic Rubidium-PET and Ammonia-PET, to aid in the interpretation of myocardial perfusion for the 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

• ImagenMD™ with ImagenQ™ (K080770)
• Syngo® Circulation (K063762)
• Syngo® Circulation (K052029)

Submission Summary (Full Text)

{0}------------------------------------------------

KC83227

Template, Summary of Safety and Effectiveness (510(k)) Page 1 of 2

# 510(k) Summary

as required by 21 CFR Part 807.87(h)

# ldentification of the Submitter

18 2009 MAY

| Submitter: | Gunhild Paulsen |
|---------------------|-----------------|
| Telephone Number: | 847-304-7516 |
| Fax Number: | 847-304-6023 |
| Date of Submission: | 10-31-2008 |

## ldentification of the product

| Device Proprietary Name: | syngoCirculation DynamicPET |
|--------------------------|---------------------------------------------|
| Common Name: | Picture archiving and communications system |
| Classification Name: | System, Image Processing, Radiological |
| Product Code: | LLZ |
| Classification Panel: | Radiology |
| Device Class: | Class II |

# Marketed Devices to which Equivalence is claimed

| Device | Manufacturer | 510(k) Number |
|-------------------------|-------------------------------------|------------------|
| ImagenMD™ with ImagenQ™ | Cardiovascular Imaging Technologies | K080770 |
| Syngo® Circulation | Siemens AG Medical Solutions | K063762, K052029 |

\ : : :

{1}------------------------------------------------

KC83227

Template, Summary of Safety and Effectiveness (510(k)) Page 2 of 2

#### Device Description:

Siemens syngoCirculation DynamicPET is a software product intended for visualization, assessment and quantification of medical images. The application supports dynamic Rubidium - PET and 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 measures of myocardial perfusion over time, 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.

### Safety and Effectiveness:

Risk Management is ensured via a risk analysis in compliance with IEC/ISO 14971 to identify and provide mitigation to potential hazards beginning early in the design cycle and continuing throughout the development of the product.

Siemens 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 believes that the syngoCirculation DynamicPET software application is substantially equivalent to the predicate devices.

#### Indications for Use:

Siemens syngoCirculation DynamicPET 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.

QRMI0097-T-01

Reference: QRM10080-M

{2}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white.

## Public Health Service

18 2009 MAY

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Gunhild Paulson · Senior Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 2501 N. Barrington Road HOFFMAN ESTATES IL 60192

Re: K083327

Trade/Device Name: syngoCirculation DynamicPET Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: · II Product Code: LLZ Dated: April 17, 2009 Received: April 21, 2009

## Dear Mr. Paulson:

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 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;

{3}------------------------------------------------

Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR-884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

[signature]

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation. Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# INDICATIONS FOR USE

510(k) Number (if known): K083327

Device Name: syngoCirculation DynamicPET

Indications for Use:

Siemens syngoCirculation DynamicPET 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) Over the Counter Use_ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

tonie Mthan

---

(Division Sign-Off)

luctive, Abdominal, 510/k) Number

Page 1 of _1_