syngo® Dual Energy is designed to operate with Siemens Dual Source CT scanners. CT images taken at the same time, using two different kV levels, of the same anatomical region of a patient are used. Depending on the region of interest, contrast agents may be used. 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® Dual Energy applications are as follows:

Lung Nodules
Xenon (Lung Ventilation)
Monoenergetic
Brain Haemorrhage
Gout Evaluation
Lung Vessels
Heart PBV
Dual Energy Bone Removal
Cartilage, Tendon, Ligament
Lung Perfusion
Liver
Hard Plaques in Vessels
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 Description

syngo® Dual Energy Software Package is a post processing application package consisting of the following applications that can be used to improve visualization of various energy dependent materials in the human body:

. Lung Nodules
Lung Nodules
Xenon (Lung Ventilation) .
Monoenergetic .
Brain Haemorrhage .
Gout Evaluation .
Luna Vessels .
Heart PBV .
. Dual Energy Bone Removal
Cartilage, Tendon, Ligament .
Lung Perfusion .
Liver ●
Hard Plaques in Vessels .
Kidney Stones .

The output of the syngo® Dual Energy Software Package applications are shown within three orthogonal slices (sagittal, coronal, and axial) as overlay to anatomical grayscale information. Typically the anatomical information is built from a combination of the original dual energy scans (for example 80kV and 140kV or 100 kV and 140kV and/or by using different filters).

Window values, color look-up tables (LUTs) and masking operations for both datasets (anatomical and the material decomposition information) can be interactively defined and user modified. An additional side-by-side display of Dual Energy results is also supported, and navigation and rotation of datasets are provided.

After two series of dual energy images have been loaded from the patient browser (80kV and 140kV or 100 kV and 140kV), three orthogonal slices (sagittal, coronal, and axial) of both spectra are shown within the respective segments on the monitor in grayscale mode. The middle axial, sagittal and coronal view is used for the initial display.

The Kidney Stones application class is a post processing application that uses dual energy information to visualize the chemical composition in kidney stones. The basis for this approach is a material decomposition into tissue, uric acid, and oxalate stones. The result of material decomposition is shown as a color overlay to anatomical gray scale information.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the syngo® Dual Energy Software Package, specifically concerning the Kidney Stones application class, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes the syngo® Dual Energy Software Package as a post-processing application for CT images, with a specific application for Kidney Stones designed to visualize the chemical composition and differentiate between uric acid and non-uric acid stones.

Acceptance Criteria:

The document states that "The testing results supports that all the software specifications have met the acceptance criteria." However, it does not explicitly list quantitative acceptance criteria for the Kidney Stones application's performance (e.g., specific accuracy, sensitivity, or specificity thresholds). Instead, it describes the type of testing performed and the expected outcomes of the software.

Reported Device Performance:

No specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity) for the Kidney Stones application are reported in the provided text. The document focuses on establishing substantial equivalence to previously cleared devices rather than providing detailed performance data for the subject device.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Software Functionality and Specifications	All software specifications for the Kidney Stones application class are met.	"The testing results supports that all the software specifications have met the acceptance criteria." (No specific metrics provided)
Intended Use	Supports visualization of chemical composition of kidney stones and differentiation between uric acid and non-uric acid stones.	The device is designed to support this functionality.
Visualization and Processing Tools	Provides similar evaluation, reporting, and visualization tools, and functionality as predicate devices' Kidney Stones application classes (e.g., basic visualization of various energy-dependent materials, VRT visualization, interactive definition/modification of window values, color LUTs, masking, side-by-side display).	"The subject device Kidney Stones application class provides similar evaluation, reporting and visualization tools, and functionality as the predicate devices Kidney Stones application classes."
Substantial Equivalence	The device must be deemed substantially equivalent to predicate devices (K083524 and K062351) regarding indication for use, operating principle, and scientific technology.	Concluded to be substantially equivalent by Siemens and cleared by the FDA.
Safety and Risk Management	Fulfills requirements of IEC 60601-1-6, IEC 62304, ISO 14971. Risk analysis completed, and risk controls implemented.	"Risk analysis was completed and risk control implemented to mitigate identified hazards." (Compliance with standards implied by submission).
Performance Limitations (Implicit)	Performance limitations for small or multicomponent stones should be understood and identified.	"performance limitations for small or multicomponent stones are a result of the analysis." (No specific details on these limitations).
Guidance on Clinical Interpretation	A well-trained radiologist should make the final diagnosis considering all available information. Additional clinical information (patient history, urine testing) should be considered. Accuracy may be decreased in obese patients.	This is a cautionary statement provided in the Indications for Use, acknowledging potential limitations.

Study Details

The provided text describes non-clinical testing for the Kidney Stones application class during product development.

Sample Size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of phantoms or stones. It mentions "kidney stones of various chemical composition and sizes" were used.
- Data Provenance: Retrospective or Prospective is not specified. The data was generated through "Phantom based test" which were "conducted during product development." This implies a controlled, likely prospective, experimental setup using phantoms. No country of origin for data generation is specified beyond the general manufacturing site in Germany for Siemens AG Medical Solutions.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for this phantom-based test. The ground truth was inherent in the known chemical composition and size of the kidney stones placed in the phantoms.
Adjudication method for the test set:
- Not applicable. Ground truth was established by the known composition of the phantom stones, not by expert adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was mentioned. The study described is a non-clinical, phantom-based validation of the software's ability to classify stone composition. It does not involve human readers or assess improvement with AI assistance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the described "Phantom based test" appears to be a standalone test of the algorithm's performance in classifying stone composition given known samples. "Classification performance was measured as a function of CTDIval."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Known chemical composition and size of kidney stones within phantoms. This is a highly controlled, synthetic ground truth, not derived from clinical expert consensus, pathology, or outcomes data from patients.
The sample size for the training set:
- Not specified. The document only covers validation testing, not the specifics of the training data.
How the ground truth for the training set was established:
- Not specified. The document does not describe the training process or the ground truth establishment for any training data.

Summary

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SIEMENS

Traditional 510(k) Submission: syngo® Dual Energy Software Package

N32902
Page 1 of 5

510(K) Summary

APR 0 7 2014

FOR

syngo® Dual Energy Software Package

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

Date Prepared: August 9, 2013

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

lmporter/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:

Mrs. Kimberly Manqum Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Vallev Stream Parkway D02 Malvern, PA 19355-1406 Phone: (610) 448-1772 Fax: (610) 448-1778 Email: kimberly.mangum@siemens.com

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SIEMENS

Traditional 510(k) Submission: syngo® Dual Energy Software Package

3.	Device Name and Classification
	Product Name:	syngo® Dual Energy Software Package
	Propriety Trade Name:	syngo® Dual Energy Software Package
	Classification Name:	Computed Tomography X-ray System
	Classification Panel:	Radiology
	CFR Section:	21 CFR §892.1750
	Device Class:	Class II
	Product Code:	90JAK
	Legally Marketed Predicate Devices
	Trade Name:	syngo® Dual Energy
	510(k)#:	K062351
	Clearance Date:	October 5, 2006
	Classification Name:	System, X-Ray, Tomography, Computed
	Classification Panel:	Radiology
	Classification Regulation:21 CFR & 892.1750
	Device Class:
	Product Code:	JAK
	Trade Name:	syngo® Dual Energy with extended functionality
	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:
	Product Code:	JAK

4. Substantial Equivalence:

The subject device Kidney Stones application class included as part of Siemens syngo® Dual Energy software package is substantially equivalent to the Kidney Stone application classes included as part of the following medical devices in commercial distribution:

Predicate Device Name	FDA Clearance Number	FDA Clearance Date
syngo® Dual Energy SoftwarePackage	K083524	April 1, 2009
syngo® Dual Energy	K062351	October 5, 2006

ട്. Device Description:.

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SIEMENS

Traditional 510(k) Submission: syngo® Dual Energy Software Package

. Lung Nodules
Lung Nodules
Xenon (Lung Ventilation) .
Monoenergetic .
Brain Haemorrhage .
Gout Evaluation .
Luna Vessels .
Heart PBV .
. Dual Energy Bone Removal
Cartilage, Tendon, Ligament .
Lung Perfusion .
Liver ●
Hard Plaques in Vessels .
Kidney Stones .

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

The Kidney Stones application class is a post processing application included as part of syngo® Dual Energy Software Package. syngo® Dual Energy Software Package is a post processing application package embedded in the frame-work of a single user HW/SW architecture based on advanced workstations.

The predicate device Kidney Stones application class is a post processing application which was cleared as part of syngo® Dual Energy Software (K062351, clearance date October 5, 2006) and syngo® Dual Energy with extended functionality (K083524, clearance date April 1, 2009). The subject device Kidney Stones application class provides similar evaluation,

{3}------------------------------------------------

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

reporting and visualization tools, and functionality as the predicate devices Kidney Stones application classes.

This includes image processing and visualization tools such as basic visualization of various energy dependent materials in the human body and VRT visualization. The subject device Kidney Stones application class does not have significant changes in technological characteristics when compared to the predicate devices Kidney Stones application class. The Indication for Use, operating principle, and the scientific technology are similar; therefore, Siemens believes that Kidney Stones application class marketed as part of the syngo® Dual Energy Software Package is substantially equivalent to the predicate devices. No other post processing applications cleared as part of the predicate devices have been modified with this submission.

7. Nonclinical Testing:

SIEMENS

syngo® 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 62304 Ed. 1.0, "Medical Device Software - Software Lifecycle Processes"
t ISO 14971:2007; Medical devices - Application of risk management to medical devices
DICOM (Digital Imaging and Communications in Medicine) Standard: . 2009 DICOM conformity is fully covered by syngo.via implementations.

Non clinical tests were conducted for the Kidney Stones Application class during product development. Phantom based test were conducted using kidney stones of various chemical composition and sizes. The stones were put into cylindrical phantoms with varying diameters and scanned. Classification performance was measured as a function of CTDIval, and performance limitations for small or multicomponent stones are a result of the analysis.

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

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K132902
Page 5 of 5

SIEMENS

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

Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission.

8. Indications for Use:

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

Lung Nodules
Xenon (Lung Ventilation)
Monoenergetic .
Brain Haemorrhage ●
Gout Evaluation .
Lung Vessels
Heart PBV
Dual Energy Bone Removal
Cartilage, Tendon, Ligament
Lung Perfusion ●
Liver ●
Hard Plaques in Vessels .
Kidney Stones

9. 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, 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® 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three overlapping, curved lines that resemble a person with outstretched arms.

Public Health Service

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

April 7, 2014

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

Re: K132902

Trade/Device Name: syngo® Dual Energy Software Package Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 5, 2014 Received: March 7, 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 11 (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.

{6}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 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/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 (800) 638 2041 or (301) 796-7100 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below,

510(k) Number (if known) K132902

Device Name

syngow Dual Energy

Indications for Use (Describe)

syngo® Dual Energy is designed to operate with Siemens Dual Source CT images taken at the same time, using two different kV levels, of the same anatomical region of a patient are used. Depending on the region of interest, contrast agents may be used. 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 contined to visualize and analyze information about anatomical and pathological structures.

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

· Lung Nodules
· Dual Energy Bone Removal
· Monoenergetic · Cartilage, Tendon, Ligament · Lung Perfusion
. Brain Haemorrhage
· Gout Evaluation • Liver
- · Hard Plaques in Vessels
· Lung Vessels • Heart PBV
· Kidney Stones

Kidney Stones is designed to support the visualization of the chemical composition of kidney stones and especially the differentiation between 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.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

{8}------------------------------------------------

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Regulation Number and Section

N/A