SOMATOM Definition Edge, SOMATOM Definition AS/AS+ by SIEMENS MEDICAL SOLUTIONS USA, INC.

The Siemens SOMATOM Definition Edge, SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of xray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.

(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

Device Description

The Siemens SOMATOM Definition AS/AS* and SOMATOM Definition Edge equipped with syngo CT VA48 are Computed Tomography X- ray Systems. which feature a continuously rotating tube-detector system and functions according to the fan beam principle. The SOMATOM Definition AS/ AS* and SOMATOM Definition Edge produce CT images in DICOM format, which can be used by post-processing applications commercially distributed by Siemens and other vendors.

The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The version of system software, syngo CT VA48, supports functionality such as Twin Beam scanning, Fast 3D Align, TrueD 4D Viewer, Fast DE evaluation and improved functionality with extended Field of View. The computer system delivered with the CT scanner is able to run optional post processing applications.

In addition to the previously supported software functionality, which was cleared for the FAST DE Result evaluation of Dual Source and Single Source (dual spiral) data, the subject device will support the FAST DE Result evaluation of data acquired with TwinBeam technology. FAST DE Results evaluation allows to use the optional post-processing features Monoenergetic Plus and Virtual Enhanced.

AI/ML Overview

The Siemens SOMATOM Definition AS/AS+ and SOMATOM Definition Edge (with software version syngo CT VA48) is a Computed Tomography X-ray System. Its primary function is to produce cross-sectional images of the body by computer reconstruction of x-ray transmissions data. The device was evaluated to demonstrate continued conformance with special controls for medical devices containing software.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria / Performance Claim	Reported Device Performance
Conformance with safety and performance standards	The device is designed to fulfill the requirements of IEC 60601-2-44, IEC 61223-3-5, NEMA XR-25, IEC 61223-2-6, NEMA PS 3.1 3.20 (DICOM), IEC 62304 Ed. 1.0, IEC 60601-1, ISO 14971, NEMA XR-29, and IEC/ISO 10918.
Software specifications meet acceptance criteria	Testing results support that all software specifications have met the acceptance criteria.
Functionality of FAST DE Results for TwinBeam Data	Performance tests, including phantom bench testing and retrospective analysis of available patient data, were conducted for the Monoenergetic Plus and Virtual Unenhanced application classes within the FAST DE Results for TwinBeam Data software module. Supportive articles demonstrating usability were provided. The results of these tests demonstrate that the subject device performs as intended.
Substantial Equivalence with predicate devices	The device has the same intended use, comparable indications for use, and similar technological characteristics (image visualization, operating platform, image manipulation) as the predicate devices (Siemens SOMATOM Definition AS/AS+ K143400 and SOMATOM Definition Edge K143401 configured with software version SOMARIS/7 VA48). Any differences do not raise different questions of safety or effectiveness.
Verification/validation testing for modifications	Modifications described in the Premarket Notification were supported with verification/validation testing.
Risk analysis and control	Risk analysis was completed, and risk control was implemented to mitigate identified hazards.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not explicitly stated as a number of cases/patients. The document mentions "retrospective analysis of available patient data" and "supportive articles that demonstrate the usability," but does not provide a specific numerical sample size for this patient data.
Data Provenance: The document states "retrospective analysis of available patient data." The country of origin for the data is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not provided in the document. The document mentions "supportive articles that demonstrate the usability," which might imply expert review, but no details are given about the number or qualifications of experts for establishing ground truth on the test set.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done with human readers comparing performance with and without AI assistance. The study focuses on the device's technical performance and its equivalence to predicate devices, not on human reader improvement with AI.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

Yes, a standalone performance assessment was conducted for the device's software functionalities. The performance tests ("Phantom bench testing and retrospective analysis of available patient data was conducted for application classes Monoenergetic Plus and Virtual Unenhanced for the FAST DE Results for TwinBeam Data software module") evaluate the algorithm's output directly.

7. The Type of Ground Truth Used:

The document mentions "phantom bench testing" and "retrospective analysis of available patient data." For phantom testing, the ground truth would be the known properties of the phantom. For retrospective patient data, the type of ground truth is not explicitly stated (e.g., expert consensus on original scans, pathology). However, the context of "supportive articles that demonstrate the usability" suggests comparison against accepted clinical interpretation or existing diagnostic standards, rather than pathology or long-term outcomes data primarily.

8. The Sample Size for the Training Set:

The document does not specify a sample size for a training set. The descriptions focus on verification and validation testing, and on demonstrating functionality and equivalence. "Available patient data" is mentioned in the context of retrospective analysis for performance testing, not explicitly for training.

9. How the Ground Truth for the Training Set Was Established:

As a training set is not explicitly mentioned and described, information on how its ground truth was established is not provided. The device in this submission is an update to a CT system's software functionality (specifically "FAST DE Results for TwinBeam Data"), rather than a new AI/CADx algorithm that requires extensive new training data in the context of this 510(k) summary. The focus is on demonstrating that the new software version performs as intended and is substantially equivalent to previous versions.

Summary

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

October 9, 2015

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

Re: K152036

Trade/Device Name: SOMATOM Definition Edge, SOMATOM Definition AS/AS+ Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: September 11, 2015 Received: September 14, 2015

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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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 (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education 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,

Robert Oaks

Robert Ochs. Ph.D. 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) K152036

Device Name

SOMATOM Definition Edge, SOMATOM Definition AS/AS+

Indications for Use (Describe)

(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

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

Prescription Use (Part 21 CFR 801 Subpart D)

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)

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510(k) Summary FOR SOMATOM Definition AS/AS+ and SOMATOM Definition Edge Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Date Prepared: August 25, 2015

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. lmporter/Distributor Establishment:

Registration No: 2240869 Siemens Medical Solutions USA. Inc. 40 Liberty Boulevard Malvern, PA 19355

Manufacturing Facility:

Siemens AG Medical Solutions Siemensstrasse. 1 D-91301 Forchheim, Germany Establishment Registration Number: 3004977335

2. Contact Person:

Kimberly Mangum Regulatory Affairs Specialist Siemens Medical Solutions, Inc. USA 40 Liberty Boulevard Malvern, PA 19355 Phone: (610) 448-6477 Fax: (610) 640-4481 Email: kimberly.mangum@siemens.com

3. Device 1 Name and Classification

Product Name: SOMATOM Project P46 Propriety Trade Name: SOMATOM Definition AS/AS+ Classification Name: Computed Tomography X-ray System Classification Panel: Radiology CFR Section: 21 CFR §892.1750 Device Class: Class II Product Code: 90JAK

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Device 2 Name and Classification

Product Name: SOMATOM Project P46F Propriety Trade Name: SOMATOM Definition Edge Classification Name: Computed Tomography X-ray System Classification Panel: Radiologv 21 CFR §892.1750 CFR Section: Device Class: Class II 90JAK Product Code:

4. Legally Marketed Primary Predicate Device (for Device 1):

Product Name: SOMATOM Project P46 Propriety Trade Name: SOMATOM Definition AS/AS+ Classification Name: Computed Tomography X-ray System Classification Panel: Radiology CFR Section: 21 CFR § 892.1750 Device Class: Class II Product Code: 90JAK 510(k) Number: K143400

Legally Marketed Primary Predicate Device (for Device 2)

Product Name: SOMATOM P46F Propriety Trade Name: SOMATOM Definition Edge Classification Name: Computed Tomography X-ray System Classification Panel: Radiology 21 CFR § 892.1750 CFR Section: Device Class: Class II Product Code: 90JAK 510(k) Number: K143401

5. Indications for Use

SOMATOM Definition AS/AS+

The Siemens SOMATOM Definition AS/AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.

(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

SOMATOM Definition Edge

The Siemens SOMATOM Definition Edge (Project P46F) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.

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(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

6. Substantial Equivalence:

The subiect devices Siemens SOMATOM Definition AS/AS+ and Siemens SOMATOM Definition Edge, configured with software version syngo CT VA48 are substantially equivalent to following medical devices in commercial distribution as listed in Table 1:

Manufacturer	Predicate Device	510(k)	Clearance Date
Siemens	SOMATOM Definition AS/AS+ configuredwith software version SOMARIS/7 VA48	K143400	April 08, 2015
Siemens	SOMATOM Definition Edge configuredwith software version SOMARIS/7 VA48	K143401	April 6, 2015

Table 1: Predicate Devices

7. Device Description:

1. Summary of Technical Characteristics of the Subject Device as Compared with the Predicate Device:
  The subject device has been modified to support the use of TwinBeam datasets with FAST DE Results. For Twin Beam data, the evaluation with the available post-processing features can be preselected the same way as for Dual Source or Single Source data as realized/cleared with the predicate

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devices. Table 2 below provides a comparison of the primary features of the subject device in comparison to the predicate devices.

							Table 2: Predicate and Subject Device Comparable Technological
Characteristics

Property	Subject Device	Primary PredicateDeviceK143400	Predicate DeviceK143401
SoftwareFeatures/Functionality	FAST DE Results forTwinBeam Data–additionally supportthe use of TwinBeamdatasets with post-processingapplicationsMonoenegetic Plusand VirtualUnenhanced	Support of FAST DEresults for dual sourceand single source datasets	Support of FAST DEresults for dual sourceand single source datasets
		Support of TwinBeamscan mode	Support of TwinBeamscan mode

The subject devices SOMATOM Definition AS/AS+ and SOMATOM Definition Edge do not have significant changes in technological characteristics when compared to the primary predicate devices SOMATOM Definition AS/AS+ and SOMATOM Definition Edge configured with software version syngo CT VA48. The Indication for Use and fundamental scientific technology remains unchanged, and the operating principle is same; therefore, Siemens believes that the subject devices are is substantially equivalent to the predicate devices.

9. Nonclinical Testing:

SOMATOM Definition AS/AS+ and SOMATOM Definition Edge are designed to fulfill the requirements of the following safety and performance standards listed below:

IEC 60601-2-44: Medical electrical equipment Part 2: Particular requirements for the safety of X-ray equipment for CT
o IEC 61223-3-5: Evaluation and routine testing Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment CORRIGENDUM 1
NEMA XR-25: Computed Tomography Dose Check ●
IEC 61223-2-6: Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray equipment
NEMA PS 3.1 3.20: Digital Imaging and Communications in ● Medicine (DICOM) Set
IEC 62304 Ed. 1.0: Medical device software - software life cycle processes

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IEC 60601-1: Medical electrical equipment Part 1: General o requirements for Safety, 1988, Amendment 1, 1991-11, Amendment 2, 1995
ISO 14971: Medical devices - Application of risk management to medical devices
NEMA XR-29: Standard Attributes on CT Equipment Related to Dose ● Optimization and Management
o IEC/ISO 10918: Information Technology - Digital Compression and Coding of Continuous-Tone Still Images: Requirements and Guidelines [Including: Technical Corrigendum (2005)]

This submission contains performance data to demonstrate continued conformance with special controls for medical devices containing software. Non clinical tests (integration and functional) were conducted for SOMATOM Definition AS/AS+ and SOMATOM Definition Edge configured with software version syngo CT VA48 during product development. The modifications described in this Premarket Notification were supported with verification/validation testing.

The risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results support 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 Verification and Validation

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.

Non-Clinical Testing Summary

Performance tests were conducted to test the functionality of the FAST DE Results for TwinBeam Data. Phantom bench testing and retrospective analysis of available patient data was conducted for application classes Monoenergetic Plus and Virtual Unenhanced for the FAST DE Results for TwinBeam Data software module. Supportive articles that demonstrate the usability of Monoenergetic Plus and Virtual Unenhanced for the FAST DE Results for TwinBeam Data software module were provided to support device performance and functionality.

In addition, these tests have been performed to test the ability of the included features of the subject device. The results of these tests demonstrate that the subject device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence.

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10. 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.

11. Conclusion as to Substantial Equivalence

SOMATOM Definition AS/AS+ and SOMATOM Definition Edge with FAST DE Results for TwinBeam Data software module has the same intended use and comparable indication for use as the predicate devices. The technological characteristics such as image visualization, operating platform, and image manipulation are same as with the predicate devices. Anv differences in technological characteristics between the subject device and the predicate devices do not raise different questions of safety or effectiveness. The result of all conducted testing was found acceptable to support the claim of substantial equivalence.

The predicate devices were cleared based on non-clinical supportive information including phantom bench test, retrospective review of available patient data, and supportive clinical articles. The results of these tests demonstrate that the predicate devices are adequate for the intended use. The same testing and workflows were used to test the subject device modifications. The comparison of technological characteristics, non-clinical performance data, and software validation demonstrates that the subject device is as safe and effective when compared to the predicate devices that are currently marketed for the same intended use. Since both devices were tested using the same methods, Siemens believes that the data generated from the SOMATOM Definition AS/AS+ and SOMATOM Definition Edge with FAST DE Results for TwinBeam Data software module testing supports a finding of substantial equivalence.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
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.(b)
Classification. Class II.