SYNGO CT ONCOLOGY SOFTWARE PACKAGE

K071310 · Siemens AG · JAK · Jun 8, 2007 · Radiology

Device Facts

• Record ID: K071310
• Device Name: SYNGO CT ONCOLOGY SOFTWARE PACKAGE
• Applicant: Siemens AG
• Product Code: JAK · Radiology
• Decision Date: Jun 8, 2007
• 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

syngo CT Oncology is a self-contained, non invasive image analysis software package designed to support the physician in routine diagnostic oncology, staging and follow-up. Flexible layouts and automated image registration facilitate the synchronous display and navigation of multiple datasets for viewing multi-phase CT data and easy follow-up comparison. The application provides a range of interactive tools specifically designed for segmentation and volumetric analysis of lesions and includes dedicated tools to support the physician in lung, liver and lymph node assessment in CT data. Dedicated workflowsupport and integrated, accumulative reporting help to track lesions and their changes in e.g. size, shape and enhancement pattern over time. syngo CT Oncology also facilitates functional imaging offering fusion with other modalities such as PET data. It also features syngo LungCAD for detecting small lung nodules (PMA-approved).

Device Story

syngo CT Oncology is a non-invasive image analysis software package for diagnostic oncology, staging, and follow-up. Input: multi-phase CT datasets; PET data for fusion. Operation: software provides automated image registration, segmentation, and volumetric analysis tools for lung, liver, and lymph node lesions. Workflow support includes accumulative reporting to track lesion changes in size, shape, and enhancement patterns over time. Includes syngo LungCAD for lung nodule detection. Used in clinical settings by physicians to view, navigate, and compare datasets. Output: visual displays, volumetric measurements, and reports. Benefit: facilitates efficient lesion tracking and diagnostic assessment.

Clinical Evidence

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

Technological Characteristics

Software-based image analysis package. Features automated image registration, segmentation, and volumetric evaluation tools. Supports multi-modality fusion (e.g., PET/CT). Operates on standard workstation hardware. Software verification and validation performed per industry standards.

Indications for Use

Indicated for use by physicians for routine diagnostic oncology, staging, and follow-up of patients undergoing CT imaging. Supports assessment of lung, liver, and lymph node lesions. Contraindications not specified.

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

• LungCARE CT SW Package (K022013)
• IQQA-Liver (K061696)
• Advantage Windows Tissue Volume Option (K963345)
• syngo Multimodality Workstation (K010938)

Submission Summary (Full Text)

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Summary

K071310
JUN - 8 2007

# SECTION 9

# 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.

#### 1. Device Name and Classification

syngo CT Oncology - Software Package 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. lmporter/Distributor Establishment:

Registration Number: 2240869

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

#### Manufacturing Facility: 3.

Siemens AG Wittelsbacherplatz 2 D-80333 Muenchen, Germany

#### 4. Contact Person:

Dr. Kristin Frowein Regulatory Submissions Specialist Siemensstr.1; D-91301 Forchheim [phone] Phone: [phone] Fax:

#### 5. Date of Preparation of Summary: January 25, 2007

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# II. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL 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 CT Oncology 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 AG | LungCARE CT<br>SW Package | K022013 | 07/16/2002 |
| 2. Edda Technology, Inc. | IQQA-Liver | K061696 | 11/13/2006 |
| 3. GE Medical Systems | Advantage Windows | K963345 | |
| | Tissue Volume Option | | 10/18/1996 |
| 4. Siemens AG | syngo Multimodality | K010938 | 06/26/2001 |
| | Workstation | | |
| | (feature: Image Fusion) | | |

#### Device Description and Intended Use: 8.

syngo CT Oncology is a self-contained, non invasive image analysis software package designed to fast-track routine diagnostic oncology, staging and follow-up. Flexible layouts and automated image registration facilitate the synchronous display and navigation of multiple datasets for viewing multi-phase CT data and easy follow-up comparison. The application provides a range of automated tools specifically designed to support physicians in the segmentation and volumetric evaluation of suspicious lesions including dedicated tools for lung, liver and lymph node assessment in CT data. Dedicated workflow-support and integrated, accumulative reporting allow to track lesions and their changes in e.g. size, shape and enhancement pattern over time. syngo CT Oncology also facilitates functional imaging offering fusion with other modalities such as PET data. It also features syngo LungCAD for detecting small lung nodules (PMA-approved).

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Siemens AG Medical Solutions % Mr. Stefan Preiss Responsible Third Party Official TÜV SÜD America, Inc. 1775 Old Highway 8 N.W., Suite 104 NEW BRIGHTON MN 55112-1891

Re: K071310

Trade/Device Name: syngo CT Oncology - Software Package Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: May 22, 2007 Received: May 25, 2007

### 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.

Image /page/2/Picture/9 description: The image shows a circular logo with the text "1896-1996" at the top and "Centennial" at the bottom. In the center of the logo, there are the letters "PA" in a stylized font. Below the word "Centennial" are four stars arranged in a horizontal line. The logo appears to be a commemorative emblem for a centennial celebration.

noting Public Health

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Page 2 -

Enclosure

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.

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 Part 801), please contact the 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) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrlvindustry/support/index.html.

Sincerely yours,

Nancy Cbrogdon

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

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SIEMENS

Indication for Use

### SECTION 3

## INDICATION FOR USE

510(k) Number (if known):

Device Name:

syngo CT Oncology - Software Package

### Indications for Use:

syngo CT Oncology is a self-contained, non invasive image analysis software package designed to support the physician in routine diagnostic oncology, staging and follow-up. Flexible layouts and automated image registration facilitate the synchronous display and navigation of multiple datasets for viewing multi-phase CT data and easy follow-up comparison. The application provides a range of interactive tools specifically designed for segmentation and volumetric analysis of lesions and includes dedicated tools to support the physician in lung, liver and lymph node assessment in CT data. Dedicated workflowsupport and integrated, accumulative reporting help to track lesions and their changes in e.g. size, shape and enhancement pattern over time. syngo CT Oncology also facilitates functional imaging offering fusion with other modalities such as PET data. It also features syngo LungCAD for detecting small lung nodules (PMA-approved).

| Prescription Use | X |
|-----------------------------|----|
| (Part 21 CFR 801 Subpart D) | AN |

ND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

OF NEEDED)

concurrence of CDRH, Office of Device Evaluation (ODE)

Helstener

on Sign-Off Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number