SYNGO, CT DUAL ENERGY

K133648 · Siemens Medical Solutions USA, Inc. · JAK · Jul 7, 2014 · Radiology

Device Facts

• Record ID: K133648
• Device Name: SYNGO, CT DUAL ENERGY
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: JAK · Radiology
• Decision Date: Jul 7, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

syngo.CT Dual Energy is designed to operate with CT images which have been acquired with Siemens Dual Source scanners. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. Depending on the region of interest, contrast agents may be used. These differences provide information on the chemical composition of the scanned body materials. syngo.CT Dual Energy combines images acquired with low and high energy spectra to visualize this information. The functionality of the syngo.CT Dual Energy applications is as follows: Monoenergetic, Brain Hemorrhage, Gout Evaluation, Lung Vessels, Heart PBV, Bone Removal, Lung Perfusion, Liver VNC, Monoenergetic Plus, Virtual Unenhanced, Bone Marrow, Kidney Stones. *) Kidney Stones is designed to support the visualization of the chemical composition of kidney stones and especially the differentiation between uric acid and non-uric acid stones. For full identification of the kidney stone additional clinical information should be considered such as patient history and urine testing. Only a well-trained radiologist can make the final diagnosis under consideration of all available information. The accuracy of identification is decreased in obese patients.

Device Story

Post-processing software package for Siemens Dual Source CT scanners; operates on syngo.via client-server platform. Inputs: CT datasets acquired at two different energy spectra (e.g., 80 kV and 140 kV). Processing: Combines low and high energy images to exploit material-specific attenuation differences; enables qualitative and quantitative evaluation of chemical composition. Outputs: Enhanced visualizations and reports for specific clinical applications (e.g., Monoenergetic Plus, Virtual Unenhanced, Bone Marrow, Kidney Stone analysis). Used by radiologists in clinical settings to improve tissue characterization and diagnostic confidence. Benefits: Enhanced visualization of energy-dependent materials; aids in differentiation of specific pathologies like kidney stone composition or bone marrow assessment. Final diagnosis remains the responsibility of the radiologist using all available clinical information.

Clinical Evidence

Bench testing only. Phantom bench tests conducted for Monoenergetic Plus application. Retrospective analysis of patient data from multiple hospitals performed for all three new application classes (Monoenergetic Plus, Virtual Unenhanced, Bone Marrow). Risk management and software verification/validation testing met acceptance criteria.

Technological Characteristics

Post-processing software application; operates on multi-user syngo.via client-server platform. Connectivity: DICOM 2008 compliant. Standards: IEC 60601-1-6 (usability), IEC 60601-1-4 (programmable electrical medical systems), IEC 62304 (software lifecycle), ISO 14971 (risk management).

Indications for Use

Indicated for use with CT images acquired via Siemens Dual Source scanners to visualize chemical composition of body materials. Applications include Monoenergetic, Brain Hemorrhage, Gout, Lung Vessels, Heart PBV, Bone Removal, Lung Perfusion, Liver VNC, Virtual Unenhanced, Bone Marrow, and Kidney Stone differentiation (uric vs. non-uric acid). Accuracy for kidney stones is reduced in obese patients; requires clinical correlation by a radiologist.

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 Software Package (K083524)
• SOMATOM DRI X-Ray Scanner CT System (K837107)

Submission Summary (Full Text)

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K133648
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## 510(K) Summary

JUL 07 2014

FOR

# syngo.CT Dual Energy Software Package

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

## Date Prepared: May 16, 2014

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. General Information Importer/Distributor: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway
Malvern, PA 19355

Establishment Registration Number: 2240869

Manufacturing Site: Siemens AG Medical Solutions Henkestraße 127 D-91052 Erlangen, Germany

Establishment Registration Number: 3002808157

### 2. Contact Person:

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

- 3. Device Name and Classification Product Name: syngo.CT Dual Energy Propriety Trade Name: syngo.CT Dual Energy Classification Name: Computed Tomography X-ray System

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Classification Panel: Radiology CFR Section: 21 CFR §892.1750 Device Class: Class II Product Code: 90JAK

Legally Marketed Predicate Devices

| Trade Name: | SOMATOM DRI X-Ray Scanner CT System |
|----------------------------|-------------------------------------|
| 510(k)#: | K837107 |
| Clearance Date: | March 09, 1983 |
| Classification Name: | System, X-Ray, Tomography, Computed |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR § 892.1750 |
| Device Class: | II |
| Product Code: | JAK |

syngo® Dual Energy with extended functionality Trade Name: 510(k)#: K083524 Clearance Date: April 01, 2009 Classification Name: System, X-Ray, Tomography, Computed Classification Panel: Radiology Classification Regulation:21 CFR § 892.1750 Device Class: = JAK Product Code:

### Substantial Equivalence: 4.

The subject device syngo. CT Dual Energy software package is substantially equivalent to following medical devices in commercial distribution:

| Predicate Device Name | FDA Clearance Number | FDA Clearance Date |
|----------------------------------------|----------------------|--------------------|
| syngo® Dual Energy Software<br>Package | K083524 | April 1, 2009 |
| SOMATOM DRI X-Ray Scanner<br>CT System | K837107 | March 09, 1983 |

### 5. Device Description:

Dual energy offers functions for qualitative and quantitative evaluations. Dual energy CT can be used to improve the visualization of the chemical composition of various energy dependent materials in the human body when compared to single energy CT.

Depending on the organ of interest, the user can select and modify different application classes or parameters and algorithms. syngo.CT Dual Energy Software Package is a post processing application package consisting of several post processing application classes that can be used to improve visualization of various energy dependent materials in the human body.

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syngo.CT Dual Energy is a post processing software package designed to operate on the most recent version syngo via client server platform, which supports preprocessing and loading of datasets by syngo.via depending on configurable rules. Similar to the predicate device (K083524, clearance date April 01, 2009), syngo.CT Dual Energy allows the evaluation of CT data acquired via spiral or sequence scans at two sufficiently different energy spectra (for example 80 kV and 140 kV) achieved with dual source CT scanners.

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

syngo.CT Dual Energy Software Package is a post processing application operating on the multi-user syngo.via client server platform. The subject syngo.CT Dual Energy provides similar evaluation, reporting and visualization tools, and functionality as the predicate device syngo® Dual Energy This includes image processing and visualization tools such as basic visualization of various energy dependent materials in the human body and VRT visualization. In addition to the previously cleared dual energy applications, syngo.CT Dual energy supports the following dual energy application classes:

- · Monoenergetic Plus
- Virtual Unenhanced
- · Bone Marrow

syngo.CT Dual Energy does not have significant changes in technological characteristics when compared to the predicate device syngo® Dual Energy. The Indication for Use, operating principle, and the scientific technology are similar; therefore, Siemens believes that syngo.CT Dual Energy Package is substantially equivalent to the predicate devices.

#### 7. Nonclinical Testing:

syngo.CT Dual Energy Software Package is designed to fulfill the requirements of following standards:

- IEC 60601-1-6 : 2007; Medical electrical equipment Part 1-6: General . requirements for basic safety and essential performance - Collateral Standard: Usability
- IEC 60601-1-4:2000; Consol. Ed. 1.1, Medical electrical equipment -● Part 1-4: General requirements for safety -- Collateral standard: Programmable electrical medical systems, edition 1.1
- IEC 62304 Ed. 1.0. "Medical Device Software Software Lifecvcle � Processes"
- ISO 14971:2007; Medical devices Application of risk management to . medical devices

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- . Digital Imaging and Communications in Medicine (DICOM) Set Standard: 2008 DICOM conformity is fully covered by syngo.via implementations.
Phantom bench tests have been conducted in the case of Monoenergetic Plus as well as a retrospective analysis of available patient data from several hospitals for all three new application classes.

The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all the software specifications have met the acceptance criteria. Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence.

Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission.

## 8. Indications for Use:

syngo.CT Dual Energy is designed to operate with CT images which have been acquired with Siemens Dual Source scanners. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. Depending on the region of interest, contrast agents may be used. These differences provide information on the chemical composition of the scanned body materials, syngo.CT Dual Energy combines images acquired with low and high energy spectra to visualize this information.

The functionality of the syngo. CT Dual Energy applications is as follows:

- Monoenergetic .
- Brain Hemorrhage ●
- Gout Evaluation .
- . Lung Vessels
- Heart PBV ●
- Bone Removal .
- Lung Perfusion .
- Liver VNC
- Monoenergetic Plus .
- Virtual Unenhanced
- Bone Marrow .
- Kidney Stones" .

*) Kidney Stones is designed to support the visualization of the chemical composition of kidney stones and especially the differentiation between uric acid and non-uric acid stones. For full identification of the kidney stone additional clinical information should be considered such as patient history and urine testing. Only a well-trained radiologist can make the final diagnosis under consideration of all available information. The accuracy of identification is decreased in obese patients.

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K133648
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### General Safety and Effectiveness Concerns: 9.

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. -

### 10. Conclusion as to Substantial Equivalence

In summary, Siemens is of the opinion that the syngo.CT Dual Energy Software Package does not introduce any new potential safety risk and is substantially equivalent to and performs as well as the predicate devices

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol of an eagle with three wings.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 7, 2014

Siemens Medical Solutions USA, Inc. % Ms. Kimberly Mangum Technical Specialist. Regulatory Submissions 51 Valley Stream Parkway, D02 MALVERN PA 19355

Re: K133648

Trade/Device Name: syngo.CT Dual Energy Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: June 20, 2014 Received: June 23, 2014

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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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Page 2-Ms. Mangum

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.


for

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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SIEMENS Traditional 510(k) Submission: syngo.CT Dual Energy Software Package

510(k) Number (if known): K133648

Device Name: syngo.CT Dual Energy

Indications for Use:

syngo.CT Dual Energy is designed to operate with CT images which have been acquired with Siemens Dual Source scanners. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. Depending on the region of interest, contrast agents may be used. These differences provide information on the chemical composition of the scanned body materials. syngo.CT Dual Energy combines images acquired with low and high energy spectra to visualize this information.

The functionality of the syngo.CT Dual Energy applications is as follows:

- Monoenergetic ●
- Brain Hemorrhage ●
- Gout Evaluation .
- Lung Vessels .
- .Heart PBV .
- Bone Removal .
- Lung Perfusion .
- Liver VNC .
- Monoenergetic Plus ●
- Virtual Unenhanced .
- Bone Marrow .
- י Kidney Stones .

*) Kidney Stones is designed to support the visualization of the chemical composition of kidney stones and especially the differentiation between uric acid and non-uric acid stones. For full identification of the kidney stone additional clinical information should be considered such as patient history and urine testing. Only a well-trained radiologist can make the final diagnosis under consideration of all available information. The accuracy of identification is decreased in obese patients.

| 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)

(Division Sign Off)

Division of Radiological Health

Office of In Vitro Diagnostic and Radiological Health

K133648 510(k) -----------------------------------------------------------------------------------------------------------------------------------------------------------------------

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