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.

(*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

Siemens intends to market a new software version, syngo® VA48 (SOMARIS/7 VA48) for its SOMATOM Definition Edge Computed Tomography X-ray systems. The subject device SOMATOM Definition Edge will be delivered with software version syngo® VA48 (SOMARIS/7 VA48). Additionally software version synqo® VA48 (SOMARIS/7 VA48 will be offered as an optional upgrade for existing SOMATOM Definition Edge systems. syngo® VA48 (SOMARIS/7 VA48) is a further development to the SOMARIS/7 operating software cleared as part of the predicate devices.

AI/ML Overview

This document is a 510(k) summary for the Siemens SOMATOM Definition Edge Computed Tomography Systems with software version syngo® VA48. It demonstrates substantial equivalence to previously cleared predicate devices.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific performance metrics for the SOMATOM Definition Edge with syngo® VA48. Instead, it states that the device is "designed to fulfill the requirements of the following standards" and that "The testing results supports that all the software specifications have met the acceptance criteria."

The listed standards include:

IEC 60601-2-44: Medical electrical equipment Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography - Ed. 2.1
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 3.18: Digital Imaging and Communications in Medicine (DICOM) Set
IEC 62304 Ed. 1.0: Medical device software software life cycle processes
IEC 60601-1: Medical electrical equipment - Part 1: General 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

The document generally states that "Performance tests were conducted to test the functionality of the SOMATOM Definition Edge configured with software version syngo® VA48. 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."

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

The document does not specify a sample size for a test set, nor does it detail the provenance (e.g., country of origin, retrospective/prospective) of any clinical data. The submission focuses on non-clinical testing and software validation. It mentions that "The predicate devices were cleared based on non-clinical supportive information and clinical images," but does not explicitly state that new clinical images were used for this particular submission's test set.

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

This information is not provided in the document. The testing described is non-clinical performance and software validation.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study is mentioned in this 510(k) summary. The document focuses on demonstrating substantial equivalence through non-clinical testing and software validation, not on comparative effectiveness with human readers.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

The document describes non-clinical technical performance tests and software verification/validation, indicating a standalone evaluation of the device's functionality. It states: "Non clinical tests were conducted for the SOMATOM Definition Edge configured with software version syngo® VA48 during product development. The modifications described in this Premarket Notification were supported with verification/validation testing." However, this is for the CT system itself, not an AI algorithm in the contemporary sense. The "AI" components listed (ADMIRE Iterative Reconstruction, iMAR Improved Metal Artifact Correction, MARIS) are features of the CT imaging chain rather than separate diagnostic AI algorithms requiring individual standalone performance evaluation in this context.

7. Type of Ground Truth Used

For the non-clinical testing and software validation, the ground truth would be defined by the technical specifications and expected performance characteristics of the CT system and its software features, as outlined in the referenced IEC and NEMA standards. There is no mention of ground truth established by expert consensus, pathology, or outcomes data, as this submission is for a CT system update, not a diagnostic AI algorithm.

8. Sample Size for the Training Set

This information is not applicable and therefore not provided. The document describes an update to a CT imaging system's software version, not a machine learning model that undergoes a distinct training phase with a specific training set. The "features" like ADMIRE, iMAR, and MARIS are advanced image reconstruction and processing techniques, not typically "trained" on a dataset in the way a deep learning model is.

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

This information is not applicable and therefore not provided.

Summary

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

April 6, 2015

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

Re: K143401

Trade/Device Name: SOMATOM Definition Edge Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: February 10, 2015 Received: February 13, 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 A Ochs

Robert Ochs. Ph.D. Acting 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) K143401

Device Name

SOMATOM Definition Edge

Indications for Use (Describe)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

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510(K) SUMMARY FOR

SOMATOM Definition Edge Computed Tomography Systems

Submitted by: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355 Date Prepared: January 29, 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. General Information: Importer/Distributor Establishment: Registration Number: 2240869 Siemens Medical Solutions, Inc. 51 Valley Stream Pkwy Malvern, PA 19355
  Manufacturing Facility: Siemens AG: Medical Solutions Siemensstrasse 1

91301 Forchheim, GERMANY Establishment Registration Number: 3004977335

2. Contact Person:

Ms. Kimberly Mangum Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway D02 Malvern, PA 19355-1406 Phone: (610) 448-4912 Fax: (610) 448-1787 Email: kimberly.mangum@siemens.com

3. Device Name and Classification

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

1. Legally Marketed Primary Predicate Device: Product Name: SOMATOM Definition Edge

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SIEMENS

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

Legally Marketed Secondary Predicate Device: Name: SOMATOM Definition AS Open Propriety Trade Name: SOMATOM Definition AS Open Classification Name: Computed Tomography X-ray System Classification Panel: Radiology CFR Section: 21 CFR §892.1750 Device Class: Class II Product Code: 90 JAK

5. Indications for Use

(*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:

Siemens SOMATOM Definition Edge Computed Tomography Systems with software version syngo® VA48 (SOMARIS/7 VA48) is substantially equivalent to the following medical devices in commercial distribution as listed in Table 1:

Manufacturer	Predicate Device	510(k) #	Clearance Date
Siemens	SOMATOM Definition Edge	K120579	May 23, 2012
Manufacturer	Secondary Device	510(k) #	Clearance Date
Siemens	SOMATOM Definition AS Open	K130901	January 2, 2014

Table 1: Predicate Devices

7. Device Description:

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SIEMENS

1. New software version syngo® VA48 (SOMARIS/7 VA48) to support the following additional features:
- TwinBeam Scanning ●
- Adaptive Spiral (zig-zag scan) for Sliding Gantry Configuration .
- Respiratory Analysis of Respiratory Rate & Pitch Adjustment ●
- FAST 3D Reconstruction (Auto 3D Recon FAST 3D Align) .
- Multiphase Reconstruction with extended Field of View ●
- FAST DE Results (Dual Energy PACS ready images) ●
- FAST Contact ●
- Iterative Reconstruction with Extended Field of View ●
- OEM Varian RGSc Online Mode
- Full 4D Lung Scan ●
- Applications at CT syngo.via client ●
- Temporal MIP (t-MIP) .
- TrueD 4D Viewer .
- . HD Field of View Pro (HD FoV 2.0)
1. ADMIRE Iterative Reconstruction (option)
1. iMAR Improved Metal Artifact Correction (option)
1. MARIS (Metal Artifact Reduction in Image Space) Option
1. HandCARE Quantitative Dose Reduction Option
1. CARE Dose4D Dose Reduction Option

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

SOMATOM Definition Edge configured with software version syngo® VA48 does not have significant changes in materials, energy source, or technological characteristics when compared to the predicate devices. Both the subject device and predicate devices are computed tomography scanners that support various visualization and evaluation tools. 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. Table 2 below provides a comparison of the primary features of the subject device in comparison to the predicate device.

Subject Device Feature	Predicate Device Comparable Feature
New software version syngo® VA48(SOMARIS/7 VA48) with supportedsoftware options	System scanner software syngo®VA44 (SOMARIS/7 VA44) withsupported software options
ADMIRE Iterative Reconstruction(option)	Optional Iterative Reconstruction(option)
iMAR Iterative Reconstruction (option)	Optional Iterative Reconstruction(option)
MARIS (option)	MARIS (option)
HandCARE with Quantitative Dose	HandCARE with Quantitative Dose

Table 2: Predicate Device Comparison

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Subject Device Feature	Predicate Device Comparable Feature
Reduction Option	Reduction Option
CARE Dose4D Quantitative DoseReduction Option	CARE Dose4D Quantitative DoseReduction Option

9. Nonclinical Testing:

SOMATOM Definition Edge configured with software version syngo® VA48 is designed to fulfill the requirements of the following standards:

IEC 60601-2-44: Medical electrical equipment Part 2-44: Particular . requirements for the safety of X-ray equipment for computed tomography - Ed. 2.1
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 3.18: Digital Imaging and Communications in Medicine ● (DICOM) Set
IEC 62304 Ed. 1.0: Medical device software software life cycle ● processes
. IEC 60601-1: Medical electrical equipment - Part 1: General 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

This submission contains performance data to demonstrate continued conformance with special controls for medical devices containing software. Non clinical tests were conducted for the SOMATOM Definition Edge configured with software version syngo® 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 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.

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SIEMENS

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.

Summary

Performance tests were conducted to test the functionality of the SOMATOM Definition Edge configured with software version syngo® VA48. 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.

General Safety and Effectiveness Concerns: 10.

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:

The SOMATOM Definition Edge configured with software version syngo® VA48 has the same intended use and comparable indication for use as the predicate devices. The technological characteristics such as image acquisition, operating platform, and image manipulation are similar to the predicate devices

The predicate devices were cleared based on non-clinical supportive information and clinical images. The results of these tests demonstrate that the SOMATOM Definition Edge (K120579) and SOMATOM Definition AS Open (K130901) are adequate for the intended use. 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.

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.