SOMATOM FORCE by SIEMENS MEDICAL SOLUTIONS USA, INC.

This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis.

Device Description

The SOMATOM Force is a whole body X-ray Computed Tomography System which features two continuously rotating tube-detector systems and functions according to the fan beam principle. The SOMATOM Force produces CT images in DICOM format, which can be used by postprocessing 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 computer system delivered with the CT scanner is able to run the post processing applications optionally.

AI/ML Overview

The Siemens SOMATOM Force is a whole-body X-ray Computed Tomography System.

1. Acceptance Criteria and Device Performance:

The provided document does not contain a specific table of acceptance criteria with corresponding device performance metrics for diagnostic accuracy or clinical effectiveness. Instead, the submission focuses on demonstrating safety, technical equivalence, and compliance with recognized standards.

The acceptance criteria for the SOMATOM Force appear to be primarily based on conformance to established safety and performance standards and substantial equivalence to a legally marketed predicate device (SOMATOM Definition Flash). The performance is assessed through nonclinical testing (integration and functional), phantom testing, and verification/validation testing.

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance (Summary)
Safety	Adherence to IEC and other recognized safety standards (e.g., electrical, mechanical, radiation hazards).	Fulfilled requirements of listed safety standards (e.g., IEC 60601 series, ISO 14971 for risk management). Risk analysis completed and controls implemented. EMC/electrical safety evaluated.
Performance/Functionality	Generation and processing of cross-sectional images; computer reconstruction of X-ray transmission data. Image quality.	Nonclinical tests (integration and functional) and phantom testing conducted. IBHC feature designed to improve image quality.
Substantial Equivalence	Comparable indications for use, design, material, functionality, technology, and energy source to the predicate device.	Considered substantially equivalent to SOMATOM Definition Flash (K121072). Intended use, materials, energy source, and fundamental scientific technology are similar.
Software Integrity	Conformance with special controls for medical devices containing software; all software specifications meet acceptance criteria.	Performance data submitted for special controls. Software verification and validation found acceptable. Software documentation for a moderate level of concern included.
Risk Management	Identification and mitigation of potential hazards.	Risk analysis completed, and risk controls implemented. Testing results support mitigation of identified hazards.

2. Sample Size for Test Set and Data Provenance:

The document does not specify a "test set" in the context of clinical images or patient data for validating diagnostic performance. The testing described is primarily technical and phantom-based.

Sample Size for Test Set: Not applicable in the context of diagnostic accuracy assessment with patient data in this submission. The tests mentioned are "nonclinical tests (integration and functional) and phantom testing."
Data Provenance: Not applicable in the context of patient data. The nonclinical tests would have been performed by Siemens as part of product development.

3. Number of Experts for Ground Truth and Qualifications:

Not applicable. This submission focuses on the technical safety and performance of the CT scanner itself, not on the diagnostic performance of a software algorithm requiring expert ground truth for interpretation of patient images.

4. Adjudication Method:

Not applicable, as no external expert independent review of diagnostic performance with patient images is described.

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

No MRMC comparative effectiveness study is mentioned in the provided document. The submission focuses on the technical capabilities and safety of the CT scanner, not on comparing diagnostic accuracy with or without AI assistance.

6. Standalone (Algorithm Only) Performance:

Not applicable. The SOMATOM Force is a physical CT scanner, not a standalone algorithm. The "Iterative Beam Hardening Correction (IBHC)" is a feature within the system to improve image quality, not a separate diagnostic algorithm.

7. Type of Ground Truth Used:

For the evaluation described:

Technical Performance: Likely based on physical phantom measurements, engineering specifications, and established scientific principles for image quality metrics (e.g., resolution, noise, contrast).
Safety Compliance: Based on compliance with international and national safety standards (e.g., IEC standards for electrical safety, radiation protection, and medical device software).
Substantial Equivalence: Based on comparison of technical characteristics and intended use with a legally marketed predicate device.

8. Sample Size for the Training Set:

Not applicable. The SOMATOM Force is a hardware system with integrated software for image acquisition and reconstruction. It is not an AI/ML-based diagnostic algorithm that undergoes a distinct "training phase" on a dataset in the manner described for typical AI submissions. The IBHC feature is a predefined algorithm rather than a continuously learning system.

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

Not applicable, as there isn't a "training set" in the context of a machine learning model for diagnostic interpretation. The algorithms (like IBHC) are developed based on physics principles and engineering.

Summary

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SIEMENS

K133589

APR 1 7 2014

510(K) SUMMARY FOR . SOMATOM Force

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

Date Prepared: November 21, 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 91301 Forchheim, GERMANY

Establishment Registration Number: 3004977335

2. Contact Person:

Mrs. Kimberly Manqum 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

Device Name and Classification 3.

SOMATOM Force Product Name: SOMATOM Force Propriety Trade Name: Computed Tomography X-ray System Classification Name: Radiology Classification Panel: 21 CFR §892.1750 CFR Section:

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Device Class: Class II Product Code: 90JAK Legally Marketed Predicate Devices SOMATOM Definition Flash Trade Name: K21072 510(k)#: May 08, 2012 Clearance Date: System, X-Ray, Tomography, Computed Classification Name: Classification Panel: Radiology Classification Regulation:21 CFR § 892.1750 Device Class: 90 JAK Product Code:

4. Substantial Equivalence:

Siemens SOMATOM Force is substantially equivalent to the following medical devices in commercial distribution:

Predicate Device Name	FDA ClearanceNumber	FDA ClearanceDate
SOMATOM Definition Flash	K121072	May 08, 2012

Device Description: 5.

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 computer system delivered with the CT scanner is able to run the post processing applications optionally.

Summary of Technical Characteristics of the Subject Device as 6. Compared with the Predicate Device:
The SOMATOM Force is comparable in indications for use, design, material, functionality, technology, energy source and is considered substantially equivalent to the predicate device SOMATOM Definition Flash (K121072, clearance date May 08, 2012).

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The differences between the legally marketed predicate device and the SOMATOM Force are as follows:

Property	SOMATOM Force	SOMATOM Definition Flash
X-Ray Assembly Tube	2 × Vectron	2 × Straton MX P
Generator Power (max.)	120 kW/120 kW	100 kW/100 kW
Number of Detector Rows	96/96	64/64
Maximum Number ofslices/rotation	192/192	128/128
Number of measuringchannels in detector	1840/1280	1472/960
Beam HardeningCorrection	Iterative BeamHardening Correction(IBHC)	Posterior FossaOptimization(PFO)

The SOMATOM Force is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission.

The SOMATOM Force also supports Iterative Beam Hardening Correction (IBHC). The Iterative Beam Hardening Correction (IBHC) feature is an extension of the Posterior Fossa Optimization (PFO) feature. The PFO feature was cleared as part of the SOMATOM Definition Flash (K082220, clearance date October 10, 2008) and part of the predicate device SOMATOM Definition Flash (K121072, clearance date May 08, 2012).

IBHC is a raw data based beam hardening correction method designed to improve image quality. IBHC uses 3D forward projection, and an additional two-compartment iodine/water model to reduce beam hardening artifacts while maintaining anatomical structures.

The intended use, materials, energy source, and fundamental scientific technology are similar to the predicate device; therefore Siemens believes that they are substantially equivalent to the predicate device.

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7. Nonclinical Testing:

The SOMATOM Force is designed to fulfill the requirements of following safety and performance standards:

Recognition ProductNumber	Area	Title of Standard	ReferenceNumber andDate	PublicationDate	StandardsDevelopmentOrganization
2-156	Biocomp	Biological evaluation ofmedical devices - Part 1:Evaluation and testing withina risk management process	10993-1:2009	01/15/2013	AAMI ANSI ISO
12-120	Radiology	Medical electrical equipment- Part 2-44: Particularrequirements for the safety ofX-ray equipment forcomputed tomography - Ed.2.1	60601-2-44(2002-11):	09/09/2008	IEC
12-126	Radiology	Medical electrical equipment -Part 2-28: Particularrequirements for the safety of X-ray source assemblies and X-raytube assemblies for medicaldiagnosis - Ed. 1.0	60601-2-28:1993	10/31/2005	IEC
12-127	Radiology	Medical electrical equipment- Part 2-32: Particularrequirements for the safetyof associated equipment ofX-ray equipment - Ed. 1.0	60601-2-32:1994	10/31/2005	IEC
12-199	Radiology	Medical electrical equipment -Part 1-3: General requirementsfor basic safety 3. CollateralStandard: General reguirementsfor radiation protection indiagnostic X-ray equipment	60601-1-3 Firstedition 1994-07	09/08/2009	IEC
12-204	Radiology	Medical electrical equipment- Part 2-28: Particularrequirements for the basicsafety and essentialperformance of X-ray tubeassemblies for medicaldiagnosis	60601-2-28Edition 2.02010-03	08/05/2013	IEC
12-210	Radiology	Medical electrical equipment -Part 1-3: General requirementsfor basic safety and essentialperformance - CollateralStandard: Radiation protection indiagnostic X-ray equipment	60601-1-3Edition 2.02008-01	08/05/2013	IEC
RecognitionNumber	ProductArea	Title of Standard	ReferenceNumber andDate	PublicationDate	StandardsDevelopmentOrganization
12-223	Radiology	Evaluation and routinetesting in medical imagingdepartments - Part 3-5:Acceptance tests - Imagingperformance of computedtomography X-ray equipmentCORRIGENDUM 1	61223-3-5(First edition2004)	03/18/2011	IEC
12-225	Radiology	Computed Tomography DoseCheck	XR 25	03/18/2011	NEMA
12-226	Radiology	Evaluation and routine testing inmedical imaging departments -Part 2-6: Constancy tests -Imaging performance ofcomputed tomography X-rayequipment	61223-2-6Second Edition2006-11	02/28/2011	IEC
12-238	Radiology	Digital Imaging andCommunications in Medicine(DICOM) Set	PS 3.1 - 3.18	03/16/2012	NEMA
13-8	Software	Medical device software -Software life cycle processes	62304 Firstedition 2006-05	08/20/2012	IEC
5-27	General	Medical electrical equipment --Part 1-1: General requirementsfor safety - Collateral standard:Safety requirements for medicalelectrical systems	60601-1-1:2000	09/08/2009	IEC
5-4	General	Medical Electrical Equipment -Part 1: General Requirementsfor Safety, 1988; Amendment 1,1991-11, Amendment 2, 1995	60601-1	10/31/2005	IEC
5-40	General	Medical devices - Application ofrisk management to medicaldevices	14971 SecondEdition 2007-03-01	08/20/2012	ISO
5-41	General	Medical electrical equipment -Part 1-4: General requirementsfor safety --Collateral standard:Programmable electrical medicalsystems, edition 1.1	60601-1-4:2000 Consol.Ed. 1.1	09/08/2009	IEC
5-54	General	Medical electrical equipment -Part 1-2: General requirementsfor basic safety and essentialperformance - Collateral	60601-1-2:2007	08/05/2013	AAMI ANSI IEC

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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 testing were conducted for the SOMATOM Force during product development. The modifications described in this Premarket Notification were supported with verification/validation testing.

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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.

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.

8. Indications for Use:

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, 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 SOMATOM Force 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/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized symbol that resembles a person with outstretched arms, with three wavy lines extending from the person's arms.

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

April 17, 2014

Siemens Medical Solutions USA, Inc. % Kimberly Mangum 51 Valley Stream Pkwy. MALVERN PA 19355

Re: K133589/S002

Trade/Device Name: SOMATOM Force Regulation Number: 21 CFR 892.1750 Regulation Name: System, X-Ray, Tomography, Computed Regulatory Class: II Product Code: JAK Dated: March 14, 2014 Received: March 18, 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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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/ResourcesforYou/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/McdicalDevices/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,

Smh

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: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known)

K133589

Device Name SOMATOM Force

Indications for Use (Describe)

Type of Use (Select oner 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.

Image /page/8/Figure/12 description: The image shows a document with the heading "FOR FDA USE ONLY". Below the heading, there is a line that reads "Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)". An FDA logo is present, presumably indicating that the document is related to the Food and Drug Administration. The document appears to be an official form or record intended for internal use within the FDA.

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.