SYNGO SINGLE SOURCE DUAL ENGERY

K122909 · Siemens Medical Systems, Inc. · JAK · Dec 27, 2012 · Radiology

Device Facts

• Record ID: K122909
• Device Name: SYNGO SINGLE SOURCE DUAL ENGERY
• Applicant: Siemens Medical Systems, Inc.
• Product Code: JAK · Radiology
• Decision Date: Dec 27, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

syngo® Single Source Dual Energy is designed to operate with CT images taken at the same anatomical region of a patient using two different kV levels. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. The images are combined to visualize and analyze information about anatomical and pathological structures. The functionality of the syngo® Single Source Dual Energy applications are as follows: - Gout Evaluation - Monoenergetic .

Device Story

Software application for post-processing CT images; inputs two subsequent CT scans of same anatomical region acquired at different kV levels; performs non-rigid image registration to compensate for motion; utilizes linear blending, color overlays, and multiplanar reformations (MPR) for visualization; provides specific application classes: Monoenergetic and Gout Evaluation. Gout Evaluation includes volume rendering (VRT) and manual/automated tools for table removal or punching. Used in clinical settings by radiologists/technicians to improve material visualization; output assists in diagnosis of pathological structures and chemical composition analysis; benefits include enhanced tissue characterization and motion-corrected dual-energy analysis.

Clinical Evidence

Bench testing only. Verification and validation performed for new components and software package per standards including DICOM, IEC 60601-1-4, IEC 60601-1-6, IEC 62304, and IEC/ISO 14971. No clinical data provided.

Technological Characteristics

Software-based post-processing application. Connectivity via DICOM (NEMA PS 3.1-3.18). Non-rigid registration algorithm for motion correction. Application classes: Monoenergetic and Gout Evaluation. Supports MPR, VRT, and linear blending. Software lifecycle managed per IEC 62304.

Indications for Use

Indicated for patients undergoing CT imaging at two different kV levels to visualize and analyze anatomical and pathological structures and chemical composition of body materials, specifically for Gout Evaluation and Monoenergetic analysis.

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® Dual Energy with extended functionality (K083524)
• syngo® Volume Perfusion - CT Body (K073373)

Submission Summary (Full Text)

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K122909

## SIEMENS

Special 510(k) Submission: syngo® Single Source Dual Energy

## DEC 2 7 2012

## 510(K) SUMMARY FOR syngo® Single Source Dual Energy

### Submitted by:

Siemens Medical Solutions USA, Inc.

51 Valley Stream Parkway

Malvern, PA 19355

September 14, 2012

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.

#### 1. Contact Person:

Mrs. Kimberly Mangum Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway D02 Malvern, PA 19355-1406 Phone: [phone] Fax: [phone] Email: [e-mail]

#### 2. Device Name and Classification

Product Name: Propriety Trade Name: Classification Name: Classification Panel: CFR Section: Device Class: Product Code:

syngo® Single Source Dual Energy syngo® Single Source Dual Energy Accessory to Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II 901AK

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#### Substantial Equivalence: 3.

Siemens syngo® Single Source Dual Energy is substantially equivalent to the following medical device in commercial distribution:

| Predicate Device Name | FDA Clearance<br>Number | FDA Clearance<br>Date |
|---------------------------------------------------|-------------------------|-----------------------|
| syngo® Dual Energy with<br>extended functionality | K083524 | 04/01/2009. |
| syngo® Volume Perfusion - CT<br>Body | K073373 | 12/18/2007 |

#### 4. Device Description:

Dual Energy CT can be used to obtain intensity measurements with two different spectra and thus provides additional information when compared to single energy.

This additional information is analyzed in the post processing application syngo Single Source Dual Energy and can be used to improve the visualization of various materials in the human body.

After loading the reconstructed images corresponding to the two subsequent scans with different X-ray spectra into syngo® Single Source Dual Energy, the images are first registered to compensate for motion effects. They are then displayed using linear blending with selectable mixing ratio and color scale ("General Viewing"). Multiplanar reformations (MPR) of the volume are shown in 3 image segments, which are initialized as sagittal, coronal and axial view.

After arriving at an initial diagnosis on the basis of the CT-images, the user can choose between application classes Monoenergetic or Gout Evaluation.

These application classes are designed for specific clinical tasks, so that algorithms, additional tool buttons, the use of colored overlay images and image representation (for example MPR or maximum intensity projection) are optimized correspondingly. For Gout Evaluation a fourth image segment is used for volume rendering techniques (VRT). If is possible to adjust Gout Evaluation by using a configuration dialog. Special tools are available to remove the table or perform manual punching.

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Special 510(k) Submission: syngo® Single Source Dual Energy

# SIEMENS

### Summary of Technical Characteristics of the Subject Device as 5. Compared with the Predicate Device:

syngo® Single Source Dual Energy software package provides the same and unmodified application classes as the predicate devices. The unmodified algorithm for motion correction as used in syngo® Volume Perfusion Body was added to allow the evaluation of images achieved with single source scanners and reduce motion effects in images from dual source scanners.

syngo® Single Source Dual Energy does not have significant changes in materials, energy source, or technological characteristics when compared to the predicate devices. The intended use and fundamental scientific technology are similar to the predicate devices; therefore Siemens believes that they are substantially equivalent to the predicate devices.

#### Nonclinical Testing: 6.

syngo Single Source Dual Energy software package uses the same algorithm for non rigid registration as syngo® Volume Perfusion - CT Body. This algorithm is unmodified since the release of syngo® Volume Perfusion-CT Body and in clinical use since that time without any known problems.

The verification and validation was performed for all newly developed components and the complete software package, according the following standards:

DICOM, NEMA PS 3.1 - 3.18 (2008),

IEC 60601-1-4: Ed. 1.1.2000 IEC 60601-1-6: 2004 IEC 62304 Ed. 1.0. 2006 IEC/ISO 14971 ( 2007 )

After completion of the test and comparison of the test results with the release acceptance criteria, Siemens is of the opinion, that syngo Single Source Dual Energy is substantially equivalent to the predicate devices.

#### 7. Indications for Use:

syngo® Single Source Dual Energy is designed to operate with CT images taken at the same anatomical region of a patient using two different kV levels. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. The images are combined to

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## SIEMENS

Special 510(k) Submission: syngo® Single Source Dual Energy

visualize and analyze information about anatomical and pathological structures.

The functionality of the syngo Single Source Dual Energy applications are as follows:

- Gout Evaluation .
- Monoenergetic .

### 8. General Safety and Effectiveness Concerns:

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 during development, verification and validation testing. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.

In summary Siemens is of the opinion, that syngo Single Source Dual Energy software package does not introduce any new potential safety risks and is substantially equivalent to the predicate devices.

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Image /page/4/Picture/0 description: The image shows the text 'DEPARTMENT OF HEALTH & HUMAN SERVICES'. The text is in bold and is in all caps. The text is centered in the image.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Siemens Medical Systems, Inc. Kimberly Magnum 51 Valley Stream Parkway MALVERN PA 19355-1406

December 27, 2012

Re: K122909

Trade/Device Name: syngo Single Source Dual Energy Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-ray System Regulatory Class: Class II Product Code: JAK Dated: Nov. 30, 2012 Received: Dec. 7, 2012

Dear Ms. Mangum:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 -- Ms. Mangum

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 Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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,

Michael D. O'Hara

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K122909

Device Name: syngo® Single Source Dual Energy

Indications For Use:

syngo® Single Source Dual Energy is designed to operate with CT images taken at the same anatomical region of a patient using two different kV levels. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. The images are combined to visualize and analyze information about anatomical and pathological structures.

The functionality of the syngo® Single Source Dual Energy applications are as follows:

- Gout Evaluation
- Monoenergetic .

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Michal D'Hara
(Division Sign Off)

Office of In Vitro Diagnostics and Radiological Health

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