SYNGO BODY PERFUSION-CT

K050867 · Siemens AG · JAK · Apr 14, 2005 · Radiology

Device Facts

• Record ID: K050867
• Device Name: SYNGO BODY PERFUSION-CT
• Applicant: Siemens AG
• Product Code: JAK · Radiology
• Decision Date: Apr 14, 2005
• 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 Body Perfusion-CT software package has been designed to evaluate perfusion of organs and tumors. The software can calculate blood flow, blood volume 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

Syngo Body Perfusion-CT is post-processing software running on Intel-based PCs; processes dynamic CT image sets acquired from SOMATOM scanners post-contrast injection. Calculates blood flow, blood volume, and permeability; enables separate arterial/portal venous hepatic perfusion analysis. Supports region-of-interest (ROI) evaluation and time-density curve visualization. Used by clinicians to characterize tumors via perfusion parameter comparison against normal tissue and to monitor therapy response. Output assists clinical decision-making regarding tumor status and treatment efficacy.

Clinical Evidence

No clinical data provided. Safety and effectiveness established via 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 parameters (blood flow, blood volume, permeability), time-density curves. Connectivity: integrates with SOMATOM CT scanner data. Software-based analysis.

Indications for Use

Indicated for the evaluation of organ and tumor perfusion using dynamic CT image data acquired post-contrast media injection. Applicable for tumor characterization and therapy monitoring by analyzing perfusion parameter changes.

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 Perfusion-CT (K033832)
• CT Perfusion 2 (K010042)

Submission Summary (Full Text)

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K050867

Summary

# APR 1 4 2005

# Attachment 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.

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

## Importer/Distributor Establishment: 2. 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

### Contact Person: 4.

Mr. Rüdiger Körner Manager Regulatory Submissions Siemensstr.1; D-91301 Forchheim [phone] Phone: [phone] Fax:

## Date of Preparation of Summary: Feb 20" 2005 5.

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## SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL 川. 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.

### Substantial Equivalence: 7.

The syngo Body Perfusion-CT software package that is addressed in this premarket notification, is substantially equivalent to the following commercially available software package

| Manufacturer | Product | 510(k) | Clearance date |
|---------------------|--------------------|---------|----------------|
| 1. Siemens | syngo Perfusion-CT | K033832 | Dec. 23, 2003 |
| 2. General Electric | CT Perfusion 2 | K010042 | Jan. 30, 2001 |

### Device Description and Intended Use: 8.

Syngo Body Perfusion-CT is a post-processing software package, which runs on an Intel-based PC platform designed to post-process images acquired with SOMATOM CT scanners,

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

The software can calculate blood flow, blood volume 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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 4 2005

Siemens Medical Solutions, Inc. % Mr. Stefan Preiss Responsible Third Party Official TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891 Re: K050867

Trade/Device Name: syngo Body Perfusion-CT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography Regulatory Class: II Product Code: JAK Dated: April 4, 2005 Received: April 6, 2005

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 (Premarket Approval), it may be subject to such 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); 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in yourse and inding of substantial equivalence of your device to a legally prematice notification: "Thesalts 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 Part 801), please rr you dome of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the 001:57). I Camal 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,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for use

## Attachment 2

## Indication for use

510(k) Number (if known):

K050867

Device Name:

syngo Body Perfusion-CT

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

The software can calculate blood flow, blood volume 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.

Nancy Brozdon

(Division Sign Off)()

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K050867

(Please do not write below this line - continue on another page if needed)

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Concurrence of the CDRH, Office of Device Evaluation (ODE)

×

Prescription Use

Over-The-Counter Use OR

(Per 21 CFR §801.109)