SYNGO VOLUME PERFUSION-CT BODY

K092013 · Siemens AG Medical Solutions · JAK · Jul 17, 2009 · Radiology

Device Facts

• Record ID: K092013
• Device Name: SYNGO VOLUME PERFUSION-CT BODY
• Applicant: Siemens AG Medical Solutions
• Product Code: JAK · Radiology
• Decision Date: Jul 17, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

The Siemens syngo Volume Perfusion-CT Body software package with extended functionality has been designed to evaluate perfusion of organs and tumors. The software can calculate blood flow, blood volume, mean transit time and permeability from sets of images reconstructed from dynamic CT data acquired after the injection of contrast media. The package also allows the separate calculation of the arterial and portal venous component of hepatic perfusion. It supports evaluation of regions of interest and the visual inspection of time density curves. A potential application is the characterization of tumors by analysing the differences of perfusion parameters to normal tissue. Determination of the change of perfusion parameters during the course of treatment may be helpful in therapy monitoring.

Device Story

Post-processing software for Intel-based PCs; processes dynamic CT image data acquired from Siemens SOMATOM scanners (e.g., Definition, Sensation 64) following contrast media injection. Software calculates blood flow, blood volume, mean transit time, and permeability; enables separate calculation of arterial and portal venous hepatic perfusion components. Supports region-of-interest (ROI) evaluation and time-density curve visualization. Used by clinicians to characterize tumors via perfusion parameter analysis vs. normal tissue and to monitor treatment response. Benefits include quantitative assessment of tissue perfusion to aid clinical decision-making in oncology and therapy management.

Clinical Evidence

No clinical data provided. Safety and effectiveness supported by hazard analysis, software verification, and validation testing.

Technological Characteristics

Post-processing software package; runs on Intel-based PC platform. Inputs: dynamic CT image data. Outputs: perfusion maps (blood flow, blood volume, mean transit time, permeability), time-density curves. Connectivity: integrates with SOMATOM CT scanner data. Software-based evaluation of contrast-enhanced dynamic CT.

Indications for Use

Indicated for the evaluation of organ and tumor perfusion in patients undergoing dynamic CT imaging with contrast media. Used for characterization of tumors and therapy monitoring by analyzing perfusion parameters.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• syngo Volume Perfusion CT Body (K073373)
• syngo Volume Perfusion CT Neuro (K073238)

Submission Summary (Full Text)

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# SIEMENS

## JUL 1 7 2009

510(k)

1092013

Section 8

## 510(k) - Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

#### GENERAL INFORMATION l.

- Device Name and Classification 1,
syngo® Volume Perfusion-CT Body Product Name: Classification Name: Accessory to Computed Tomography System Classification Panel: Radiology 21 CFR §892.1750 CFR Section: Device Class: Class II Product Code: 90 JAK

## 2. Importer/Distributor Establishment: Registration Number: 2240869

Siemens Medical Solutions, Inc. 51 Valley Stream Pkwy Malvern, PA 19355

#### Manufacturing Facility: 3.

Siemens AG Medical Solutions Henkestrasse 127

D-91052 Erlangen, Germany

#### 4. Contact Person:

Mr. Ralf Hofmann Regulatory Affairs Specialist Siemensstr.1; D-91301 Forchheim Phone: [phone] Fax: [phone]

#### Date of Preparation of Summary: Jun. 19th 2009 5.

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# SIEMENS

## SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL ll. EQUIVALENCE DETERMINATION

### General Safety and Effectiveness Concerns: 6.

The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device.

Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.

#### 7. Substantial Equivalence:

The syngo® Volume Perfusion-CT Body software package with extended functionality that is addressed in this premarket notification, is substantially equivalent to the following commercially available software packages

| Manufacturer | Product | 510(k) | Clearance date |
|---------------|---------------------------------|---------|----------------|
| 1. Siemens AG | syngo Volume Perfusion CT Body | K073373 | Dec 18, 2007 |
| 2. Siemens AG | syngo Volume Perfusion CT Neuro | K073238 | Jan 03, 2008 |

### Device Description and Intended Use: 8.

syngo® Volume Perfusion-CT Body software package with extended functionality is a post-processing software package, which runs on an Intel-based PC platform designed to post-process images acquired with SOMATOM CT scanners, which meet certain minimal requirements (i.e. Siemens Definition, Sensation 64, ....). It is a package containing evaluation software that supports the evaluation of Dynamic CT data gathered after the injection of a compact bolus of contrast media, where the contrast media acts as a pure intravascular tracer.

The Siemens syngo Volume Perfusion-CT Body software package with extended functionality has been designed to evaluate perfusion of organs and tumors.

The software can calculate blood flow, blood volume, mean transit time and permeability from sets of images reconstructed from dynamic CT data acquired after the injection of contrast media.

The package also allows the separate calculation of the arterial and portal venous component of hepatic perfusion. It supports evaluation of regions of interest and the visual inspection of time density curves.

A potential application is the characterization of tumors by analysing the differences of perfusion parameters to normal tissue. Determination of the change of perfusion parameters during the course of treatment may be helpful in therapy monitoring.

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Image /page/2/Picture/0 description: The image contains a logo for the U.S. Department of Health and Human Services. The logo features the department's seal, which includes an abstract caduceus symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the seal. The seal and text are in black and white.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 1 7 2009

Siemens AG Medical Solutions % Mr. Stefan Preiss TÜV SÜD America 1775 Old Hwy 8 NW, Ste 104 NEW BRIGHTON MN 55112-1891

Re: K092013

Trade/Device Name: syngo® Volume Perfusion-CT Body Regulation Number: 21 CFR 892,1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: July 3, 2009 Received: July 6, 2009

## Dear Mr. Preiss:

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 either 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

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to http://www.fda.gov/cdrl/mdr/ 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 Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for use

510(k) Number (if known):

K092013

Device Name:

## syngo® Volume Perfusion-CT Body

The Siemens syngo Volume Perfusion-CT Body software package with extended functionality has been designed to evaluate perfusion of organs and tumors.

The software can calculate blood flow, blood volume, mean transit time and permeability from sets of images reconstructed from dynamic CT data acquired after the injection of contrast media.

The package also allows the separate calculation of the arterial and portal venous component of hepatic perfusion. It supports evaluation of regions of interest and the visual inspection of time density curves.

A potential application is the characterization of tumors by analysing the differences of perfusion parameters to normal tissue. Determination of the change of perfusion parameters during the course of treatment may be helpful in therapy monitoring.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|--------|
| | AND/OR |
| Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

rrence of CDRH, Office of Device Evaluation (ODE)

Reproductive, Abdominal

Section 2