SYNGO COLONOGRAPHY SOFTWARE PACKAGE

K030982 · Siemens Medical Solutions USA, Inc. · LLZ · Apr 8, 2003 · Radiology

Device Facts

• Record ID: K030982
• Device Name: SYNGO COLONOGRAPHY SOFTWARE PACKAGE
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Apr 8, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

syngo Colonography is a self-contained image analysis software package for evaluating CT volume data sets. This software package can also be utilized for evaluating suitable MR volume datasets. Combining enhanced commercially available digital image processing tools with optimized workflow and reporting tools, the software is designed to support the physician in studying the inside (intra-lumenal view), the wall and the outside (extra-lumenal view) of the colon. With the functionality to view datasets from both the prone and supine positions, it facilitates the detection of colonic lesions (eg. Polyps) in addition to the evaluation, documentation and follow-up of any such lesions using standard spiral CT or MR scanning. This evaluation tool allows for volumetric analysis of colonic polyps or lesion size over time, helping the Physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue unambiguously, with respect to their size, dimensions, shape and position. Due to all these capabilities the syngo Colonography software has the advantage of noninvasive evaluation of colonic lesions as compared to conventional colonoscopy.

Device Story

Syngo Colonography is a software package for analyzing CT and MR volume datasets; used by physicians to visualize colon intra-lumenal, wall, and extra-lumenal structures. Inputs include spiral CT or MR volume data; software processes these to provide 3D reconstructions, volumetric analysis, and lesion measurement. Workflow includes prone and supine position viewing to facilitate polyp detection and longitudinal growth assessment. Output is displayed on a workstation for physician review; assists in non-invasive lesion evaluation and clinical decision-making regarding colonic health. Operates as a self-contained analysis tool within the syngo platform.

Clinical Evidence

Bench testing only. Safety and effectiveness established via hazard analysis, software verification, and validation testing. No clinical study data provided.

Technological Characteristics

Software-based image analysis package; operates on syngo platform. Features include 3D volume rendering, volumetric analysis, and multi-planar reconstruction. Connectivity via standard DICOM-compatible CT/MR imaging systems. Software-only device; no hardware components.

Indications for Use

Indicated for physicians to evaluate CT or MR volume datasets for colonic lesions, including polyps. Supports intra-lumenal, wall, and extra-lumenal visualization, volumetric analysis, and longitudinal follow-up of lesion growth in patients undergoing spiral CT or MR scanning.

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

• GE CT Colonography/Navigator 2 Workstation (K012313)
• Siemens Fly Through (K971717)
• Siemens RealTime 3D Diagnostic Workstation (3D Virtuoso) (K973010)

Reference Devices

• Volume Rendering Technique option (K923524/S2)
• syngo Multimodality Workstation (K010938)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness

K030982

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.

### I. GENERAL INFORMATION

### Device Name and Classification

| Product Name: | Syngo Colonography software package |
|-----------------------|-----------------------------------------|
| Common Name | 3D Reconstruction Software |
| Classification Name: | Accessory to Computed Tomography System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 2050 |
| Device Class: | Class II |
| Product Code: | 90 JAK LLZ |

# Establishment:

### Importer/Distributor:

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

Registration Number: 2240869

# Manufacturing Facility:

Siemens AG Medical Solutions Henkestrasse 127 D-91052 Erlangen, Germany syngo is a registered trademark of Siemens AG

Contact Person: Mr. Jamie Yieh Senior Technical Specialist Telephone: [phone] Fax: [phone]

Date of Preparation of Summary: November 26th 2002

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

# Device Description and Intended Use:

This premarket notification covers Siemens Syngo Colonography software package. It is based on Siemens syngo software platform.

syngo Colonography is a self-contained image analysis software package for evaluating CT volume data sets. This software package can also be utilized for evaluating suitable MR volume datasets. Combining enhanced commercially available digital image processing tools

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with optimized workflow and reporting tools, the software is designed to support the physician in studying the inside (intra-lumenal view), the wall and the outside (extra-lumenal view) of the colon. With the functionality to view datasets from both the prone and supine positions, it facilitates the detection of colonic lesions (eg. Polyps) in addition to the evaluation, documentation and follow-up of any such lesions using standard spiral CT or MR scanning. This evaluation tool allows for volumetric analysis of colonic polyps or lesion size over time, helping the Physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue unambiguously, with respect to their size, dimensions, shape and position.

Due to all these capabilities the syngo Colonography software has the advantage of noninvasive evaluation of colonic lesions as compared to conventional colonoscopy.

# General Safety and Effectiveness Concerns:

The device labeling contains instructions for use and any necessary cautions and warning, 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:

The Syngo Colonography software package, addressed in this premarket notification, is substantially equivalent to the following commercially available software package:

| Predicate Device Name | FDA Clearance<br>Number | FDA Clearance<br>Date |
|-------------------------------------------------------------|-------------------------|-----------------------|
| GE CT Colonography/Navigator 2<br>Workstation | K012313 | 08/07/01 |
| Siemens Fly Through | K971717 | 09/03/97 |
| Siemens RealTime 3D Diagnostic<br>Workstation (3D Virtuoso) | K973010 | 11/10/97 |

The Syngo Colonography software package described in this 510(k) has the same intended use and similar technical characteristics as the commercially available software listed above.

In addition, many of the image processing, display and evaluation components of syngo Colonography are currently available on software options like the Volume Rendering Technique option, K923524/S2, cleared on May 17th 1994 and workstations like the syngo Multimodality Workstation, K010938 cleared on 26th June 2001 wherein the Fly Thorough software algorithms were transferred over to the syngo software platform. syngo Colonography packages these image processing and image display components in an optimized workflow palette.

In summary, Siemens is of the opinion that Syngo Colonography software package does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate software components and the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three parallel lines that curve upwards and resemble wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 0 8 2003

Siemens Medical Solutions, Inc. % Mr. Heinz Joerg Steneberg Division Manager, Medical Division TUV Rheinland of North America 12 Commerce Road NEWTON CT 06470

Re: K030982

Trade/Device Name: Syngo Colongraphy Software Package Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: March 26, 2003 Received: March 28, 2003

Dear Mr. Steneberg:

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); 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) 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 the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

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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### Indication for use

KO30982 510(k) Number (if known):

Device Name:

syngo Colonography Software Package

syngo Colonography is a self-contained image analysis software package for evaluating CT volume data sets. This software package can also be utilized for evaluating suitable MR volume datasets. Combining enhanced commercially available digital image processing tools with optimized workflow and reporting tools, the software is designed to support the physician in studying the inside (intra-lumenal view), the wall and the outside (extra-lumenal view) of the colon. With the functionality to view datasets from both the prone and supine positions, it facilitates the detection of colonic lesions (eg. Polyps) in addition to the evaluation, documentation and follow-up of any such lesions using standard spiral CT or MR scanning. This evaluation tool allows for volumetric analysis of colonic polyps or lesion size over time, helping the Physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue unambiguously, with respect to their size, dimensions. shape and position.

Due to all these capabilities the syngo Colonography software has the advantage of non-invasive evaluation of colonic lesions as compared to conventional colonoscopy.

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

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

(Division Sign-Off)

Division of Reproductive, Abdominal,

and Radiological Devices

| 510(k) Number | K030982 |
|---------------|---------|
|---------------|---------|

| Prescription Use (Per 21 CFR 801.109) | OR Over-The-Counter Use |
|---------------------------------------|-------------------------|
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