The Siemens SOMATOM Definition AS Open 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

The Siemens SOMATOM Definition AS Open is a whole body X-ray Computed Tomography System. The SOMATOM Definition AS Open produces 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 new version of system software, syngo® CT 2013B (SOMARIS/7 VA46A), supports the following features:

MARIS (Metal Artifact Reduction in Image Space) A image . reconstruction mode designed to reduce image artifacts caused by metal
HD FoV Pro (HD FoV 2.0) Designed to enable a more reliable . visualization of the skin line of human body parts located outside of the standard field of view
t-MIP -- Image manipulation method for arithmetic operations which allows . the calculation of temporal Maximum or Minimum Intensity Projection (MIP) images from a set of series.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the SOMATOM Definition AS Open configured with software version syngo® CT 2013B (SOMARIS/7 VA46A), based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device which is largely about demonstrating "substantial equivalence" to a predicate device. This type of submission often focuses on verifying that new features don't introduce new safety or effectiveness concerns, rather than conducting a full-scale clinical trial to prove a specific level of diagnostic performance against a robust ground truth. As such, some of the requested information (especially about specific performance metrics tied to acceptance criteria, MRMC studies, and detailed ground truth establishment for clinical effect) might not be explicitly present or as detailed as in a typical in vitro diagnostic (IVD) or AI-only software submission.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria / Feature	Reported Device Performance (as described in the document)
MARIS (Metal Artifact Reduction in Image Space) Effectiveness	Validated through clinical tests in different clinical scenarios. Designed to reduce image artifacts caused by metal.
HD FoV Pro (HD FoV 2.0) Visualization Range	Designed to enable a more reliable visualization of the skin line of human body parts located outside of the standard field of view. Allows visualization of up to 80 cm.
t-MIP (Temporal Maximum or Minimum Intensity Projection) Capability	Allows the calculation of temporal Maximum or Minimum Intensity Projection (MIP) images from a set of series.
Software Specifications	All software specifications have met the acceptance criteria (general statement from risk analysis and V&V).
Substantial Equivalence (General)	No new potential safety risks; performs as well as the predicate devices.
Conformance to Standards (e.g., IEC 60601-1-4, IEC 62304, ISO 14971, DICOM, IEC 60601-2-44, IEC 61223-3-5, IEC 61223-2-6)	Designed to fulfill the requirements of these standards. Performance data demonstrates continued conformance with special controls for medical devices containing software.
EMC/Electrical Safety	Evaluated according to IEC Standards; Siemens certifies conformance to Voluntary Standards covering Electrical and Mechanical Safety.
Risk Mitigation	Risk analysis completed and risk control implemented to mitigate identified hazards.

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

Sample Size (Clinical Tests): Not specified. The document states "Clinical tests were performed... to validate the performance of the MARIS algorithm" and "These tests include testing of the metal artifact reduction capabilities of MARIS in different clinical scenarios." However, the number of patients, scans, or images is not provided.
Data Provenance: Not explicitly stated (e.g., country of origin). The tests were "clinical tests," implying real patient data. It is highly likely to be retrospective clinical data, as typical for 510(k) submissions focusing on software improvements, but this is not explicitly confirmed.

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

The document mentions "clinical tests" for MARIS validation, but it does not specify how ground truth was established for these tests, nor does it mention the number or qualifications of experts involved in any ground truth assessment. In the context of metal artifact reduction, "ground truth" might be subjective visual assessment by radiologists if not compared to a gold standard imaging modality.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method (e.g., 2+1, 3+1). Given the lack of detail on expert involvement, it's unlikely a formal adjudication process was described for the submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done (or at least not described in this summary). The studies mentioned focus on validating the performance of features (MARIS, HD FoV Pro) in the device itself, not on comparing human reader performance with and without AI assistance from this specific device.

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

The document describes "bench tests were performed to verify and validate the performance of the MARIS and HD FoV Pro (HD FoV 2.0) features," which are likely standalone algorithm evaluations using phantoms or controlled datasets.
"Clinical tests" were also performed for the MARIS algorithm, which would involve the algorithm processing clinical data. While these involve physicians interpreting the output of the CT system, the focus of the "clinical tests" was on validating the algorithm's performance (e.g., artifact reduction), rather than a human reading study. So, in terms of the algorithm itself, yes, standalone performance was assessed.

7. The Type of Ground Truth Used:

For the "bench tests" of MARIS and HD FoV Pro, the ground truth would likely be phantom-based measurements and technical specifications. Phantoms provide a known, controlled environment to assess image quality, artifact reduction, and field of view accuracy.
For the "clinical tests" of MARIS, the document does not explicitly state the type of ground truth used. In the context of artifact reduction, it could involve visual assessment by clinicians comparing images with and without MARIS, or a comparison to an established 'gold standard' image if available (e.g., a non-metallic scan of the same area if feasible). However, no specifics are provided.

8. The Sample Size for the Training Set:

The document does not specify the sample size for any training set. This is not uncommon for 510(k) submissions where the software updates are incremental and rely on established engineering practices, rather than a deep learning model requiring a distinct, large training dataset. The MARIS algorithm is described as an "image reconstruction mode," implying an algorithmic approach rather than a machine learning model that undergoes explicit "training" on a labeled dataset.

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

As the document does not mention a training set in the context of machine learning, there is no information on how its ground truth was established. For algorithmic development, the "training" (design and tuning) is based on engineering principles, image science, and potentially smaller, internally-derived datasets with known properties or simulated artifacts.

Summary

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K130901

SIEMENS

JAN - 2 2014

510(K) Summary FOR

SOMATOM DEFINITION AS OPEN

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

Date Prepared: December 4, 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:

Importer/Distributor:

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

Establishment Registration Number: 2240869

Manufacturing Site: Siemens AG, Medical Solutions Siemensstrasse 1

Forchheim, Germany 91301

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) 448-1772 Fax: (610) 448-1778 Email: kimberly mangum@siemens.com

3. Device Name and Classification

Product Name:	SOMATOM Definition AS Open
Propriety Trade Name:	SOMATOM Definition AS Open
Classification Name:	Computed Tomography X-ray System

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Classification Panel: CFR Section: Device Class: Product Code:

Radiology 21 CFR §892.1750 Class II 90JAK

Legally Marketed Predicate Device

Trade Name:	SOMATOM Definition AS Open
510(k)#:	K103127
Clearance Date:	March 04, 2011
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
Classification Regulation:	21 CFR §892.1750 .
Device Class:	II
Product Code:	JAK

4. Device Description:

MARIS (Metal Artifact Reduction in Image Space) A image . reconstruction mode designed to reduce image artifacts caused by metal
HD FoV Pro (HD FoV 2.0) Designed to enable a more reliable . visualization of the skin line of human body parts located outside of the standard field of view
t-MIP -- Image manipulation method for arithmetic operations which allows . the calculation of temporal Maximum or Minimum Intensity Projection (MIP) images from a set of series.

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.)

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SIEMENS

6. Substantial Equivalence:

Siemens SOMATOM Definition AS Open configured with software version syngo® CT 2013B (Somaris/7 VA46A) is substantially equivalent to the following medical devices in commercial distribution:

Predicate Device Name	FDA Clearance Number	FDA Clearance Date
Siemens Definition AS Open	K103127	03/04/2011
Siemens SOMATOM DefinitionEdge	K120579	05/23/2012

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

SOMATOM Definition AS Open configured with software version syngo® CT 2013B (SOMARIS/7 VA46A) is a further software development to the commercially available SOMATOM Definition AS Open CT system.

The SOMATOM Definition AS Open configured with software version syngo® CT 2013B (SOMARIS/7 VA46A) features the same indications for use, gantry, imaging and administrative functions as the predicate SOMATOM Definition AS Open. The image reconstruction and image manipulation are similar to the predicate device SOMATOM Definition AS Open.

The difference between the legally marketed predicate device SOMATOM Definition AS Open and the SOMATOM Definition AS Open configured with software version syngo® CT 2013B (SOMARIS/7 VA46A) is as follows:

Property	SOMATOM Definition ASOpen(configured with softwareversion syngo® CT 2013B(SOMARIS/7 VA46A)	SOMATOM DefinitionAS Open
Image reconstructionmethod for artifactreduction	MARIS - Reduces metalartifacts	Posterior FossaOptimization (PFO)reduces beamhardening artifacts
Reconstructed Fieldof View	HD FoV Pro (HD FoV 2.0) –Allows visualization of up to 80cm	HD FoV – Allowsvisualization of up to 78cm
3D display	tMIP – Allows calculation oftemporal maximum intensityprojection images	MIP - Allows calculationof maximum intensityprojection images

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SIEMENS

The SOMATOM Definition AS Open configured with software version syngo® CT 2013B (SOMARIS/7 VA46A) 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.

8. Nonclinical Testina:

SOMATOM Definition AS Open configured with software version syngo® CT 2013B (SOMARIS/7 VA46A) is designed to fulfill the requirements of following standards:

· IEC 60601-1-4 : 2000; Medical electrical equipment Part 1-4: General requirements for basic safety and essential performance - Collateral Standard: Usability
IEC 62304 Ed. 1.0, "Medical Device Software - Software Lifecycle Processes"
I ISO 14971:2007; Medical Devices - Application of risk management to medical devices
I DICOM (Digital Imaging and Communications in Medicine) Standard: NEMA PS 3.1 - 3.18 (2009)
. IEC 60601-2-44:2009; Medical Electrical Equipment Part 2: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography
I IEC 61223-3-5:2004: Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment CORRIGENDUM 1
I IEC 61223-2-6:2006; Evaluation and routine testing in medical imaging departments - Part 2 - 6: Constancy tests - Imaging performance of computed tomography X-ray equipment

This submission contains performance data to demonstrate continued conformance with special controls for medical devices containing software. Non clinical tests (integration and functional) and phantom were conducted on the SOMATOM Definition AS Open configured with software version syngo® CT 2013B (SOMARIS/7 VA46A) during software development. Additionally, bench tests were performed to verify and validate the performance of the MARIS and HD FoV Pro (HD FoV 2.0) features.

The risk analysis was completed and risk control implemented to mitiqate identified hazards. The testing supports that all 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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EMC/electrical safety was evaluated according to the IEC Standards. Siemens certify conformance to Voluntary Standards covering Electrical and Mechanical Safety. In conclusion, the identified risk of electrical hazards was mitigated and is substantially equivalent to the predicate device in terms of safety and effectiveness. All testing and validation has been completed.

9. Clinical Testing

Clinical test were performed using the SOMATOM Definition AS Open configured with software version syngo® CT 2013B (SOMARIS/7 VA46A) to validate the performance of the MARIS algorithm. These tests include testing of the metal artifact reduction capabilities of MARIS in different clinical scenarios.

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, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.

11. Conclusion as to Substantial Equivalence

In summary, Siemens is of the opinion that the SOMATOM Definition AS open configured with software version synqo® CT 2013B (SOMARIS/7 VA46A) 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 stylized human figure embracing a globe, symbolizing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

Public Health Service

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

January 2, 2014

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

Re: K130901

Trade/Device Name: SOMATOM Definition AS Open Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: December 13, 2013 Received: December 23, 2013

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 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/Resources/or You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 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/Industrv/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

510(k) Number (if known) K 1 3090 1

Device Name

SOMATOM Definition AS Open

Indications for Use (Describe)

The Siemens SOMATOM Definition AS Open systems are intended to produce cross-sectional images of the body by compuler 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 simulaneous translation of the patient.)

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

[X] 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)

Smh.p)

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

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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.