The SOMATOM Scope and SOMATOM Scope Power 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 SOMATOM Scope and SOMATOM Scope Power configured with software version syngo® CT VC28 (SOMARIS/5 VC28) are whole body X-ray computed tomography scanners which operate with SOMARIS/5 software. SOMARIS/5 is a windows based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.

The SOMATOM Scope and SOMATOM Scope Power configured with software version syngo® CT VC28 (SOMARIS/5 VC28) are able to transfer the acquired CT image data for image evaluation, using the DICOM standard.

New software version syngo® CT VC28 supports the addition of eCockpit, eStart, eMode, eSleep, a Table Footswitch, Adaptive Signal Boost, and Gantry tilt Speed up.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Siemens SOMATOM Scope and SOMATOM Scope Power computed tomography (CT) x-ray systems. The document focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant standards.

However, the document does not contain any information about acceptance criteria, reported device performance in relation to those criteria, or the details of a study that would prove the device meets specific performance acceptance criteria related to a diagnostic task or algorithm performance.

The document details:

Substantial Equivalence: It claims the device is substantially equivalent to predicate devices (SOMATOM Emotion 16 and SOMATOM Spirit) based on similar intended use and fundamental scientific technology.
Device Description: It describes the CT systems and new software features (eCockpit, eStart, eMode, eSleep, Table Footswitch, Gantry tilt Speed up, IRIS, Adaptive Signal Boost) which primarily focus on operational efficiency, tube life extension, and image reconstruction techniques.
Technical Characteristics Comparison: A table compares technical specifications between the subject devices and predicate devices, showing some differences in generator output, anode heat storage, and scan times, among others.
Nonclinical Testing: It lists various international standards (ISO, IEC, NEMA) that the device is designed to fulfill, covering risk management, electrical safety, software life cycle processes, DICOM, and evaluation/testing of CT equipment performance. It states that non-clinical and phantom testing were conducted, and a risk analysis was completed. It mentions that testing results support "all the software specifications have met the acceptance criteria," and "verification/validation testing" was done.

Below is a breakdown of the requested information based on the provided text, highlighting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of acceptance criteria for a diagnostic task or a detailed report of device performance against such criteria. It mentions compliance with various technical standards and states that "all the software specifications have met the acceptance criteria" from non-clinical and phantom testing, but these specific criteria and their quantitative results are not detailed. The technical characteristics comparison table serves to show equivalence in hardware specifications rather than performance against a clinical acceptance criterion.

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

This information is not provided. The document refers to "non-clinical tests and phantom testing" but does not specify the sample size of cases/images used in a test set, nor the provenance (e.g., country of origin, retrospective/prospective) of any clinical data that might have been used for testing a diagnostic algorithm's performance. Since the device described is a CT scanner, rather than an AI-powered diagnostic algorithm, such clinical test sets for specific diagnostic tasks are typically not part of the initial 510(k) for the hardware itself.

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

This information is not provided. As no clinical test set for a diagnostic algorithm is detailed, there's no mention of experts establishing ground truth.

4. Adjudication Method for the Test Set

This information is not provided.

5. 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

This information is not provided. The document describes a CT system and its software features, some of which relate to image reconstruction (IRIS) or signal enhancement (Adaptive Signal Boost), but it does not mention any AI assistance or MRMC studies evaluating clinical reader performance with or without such assistance.

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

This information is not provided. The device is a CT scanner, not a standalone diagnostic algorithm. While some software features (like IRIS) process data, the document does not present them as a standalone diagnostic algorithm with performance metrics.

7. The Type of Ground Truth Used

This information is not provided. For non-clinical and phantom testing, the "ground truth" would typically refer to known physical properties of the phantoms or calibrated measurements, but details are absent.

8. The Sample Size for the Training Set

This information is not provided. The document does not describe the development or training of any specific AI algorithm that would require a training set. The software updates mentioned primarily enhance the scanner's operational efficiency and basic image processing.

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

This information is not provided. (See point 8).

Summary

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Image /page/0/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" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure in profile, composed of three curved lines.

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

September 15, 2014

Siemens Medical Solutions USA, Inc. % Ms. Eve Davis Regulatory Affairs Specialist Enter consultant name here, or erase this if there is none 51 Valley Stream Parkway MALVERN PA 19355

Re: K140912

Trade/Device Name: Somatom Scope/Somatom Scope Power Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-Ray system Regulatory Class: II Product Code: JAK Dated: July 23, 2014 Received: July 24, 2014

Dear Ms. Davis:

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.

Sm.7)

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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Indications for Use

510(k) Number (if known) K140912

Device Name SOMATOM Scope/Scope Power

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)

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

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510(k) Summary

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

Date Prepared: July 23, 2014

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 SHANGHAI, MEDICAL EQUIPMENT LTD. 278 Zhou Zhu Rd Shanghai, CHINA 201318

Establishment Registration Number: 3003202425

2. Contact Person:

Eve Davis Regulatory Affairs Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway D02 Malvern, PA 19355-1406 Phone: (610) 219-7133 Fax: (610) 448-1778 Email: eve.davis@siemens.com

3. Device Name and Classification

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

Propriety Trade Name: Classification Name: Classification Panel:

SOMATOM Scope Power Computed Tomography X-ray System Radiology

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CFR Section: Device Class: Product Code: 21 CFR §892.1750 Class II JAK

4. Substantial Equivalence:

Siemens SOMATOM Scope and SOMATOM Scope Power configured with software version syngo® CT VC28 (Somaris/5 VC28) are substantially equivalent to the following medical devices in commercial distribution:

Predicate Devices	FDA ClearanceNumber	FDA ClearanceDate	ProductCode
SOMATOM Emotion 16	K050297	03/01/2005	JAK
SOMATOM Spirit	K042328	09/14/2004	JAK

5. Device Description:

New software version syngo® CT VC28 supports the addition of eCockpit, eStart, eMode, eSleep, a Table Footswitch, Adaptive Signal Boost, and Gantry tilt Speed up.

eCockpit

The SOMATOM Scope and SOMATOM Scope Power will support a marketed bundle of features designed to support more efficient usage of system tube power. These features will be marketed under the name, "eCockpit," and comprised of the following:

· eMode

ECO Mode (eMode) is a software feature, which uses pre-set values to reduce tube power (mA) and increase scan time, while keeping the dose unchanged. With this reduction in tube power, tube life can be increased. There is a click button (eAdjust) to upload eMode. The usage of the ECO Mode (eMode) is recorded in the tube usage history.

· eStart

eStart is a software option that extends the tube lifetime by pre-warming the tube before a scan. The system provides a recommendation to the user to perform eStart to warm up the tube each time the scanner has not been used for scanning in the last 30 minutes. This functionality helps to protect the tube and extend the tube lifetime.

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· eSleep

eSleep is a software option designed to save energy by stopping gantry rotation during scan breaks.

Table Footswitch

Foot Switch located on the bottom edge of the patient table allowing table lifting and lowering. Speeds up patient preparation and keeps the operator hands sterilized.

Gantry tilt Speed up

Faster gantry tilt speed helps in dealing with higher patient throughput.

IRIS

IRIS is an approach to iterative reconstruction that works to intelligently solve the trade-off between reconstruction times and image quality. In an iterative reconstruction, a correction loop is introduced into the Image generation process. To avoid long reconstruction times, IRIS is applied to raw data reconstruction only once. During this initial raw data reconstruction, a master volume is generated that contains the full amount of raw data information, but at the expense of significant image noise. The following iterative corrections are then consecutively performed in the image space, removing image noise without degrading image sharpness.

Adaptive Signal Boost

Adaptive Signal Boost amplifies low signals when high attenuation is present - such as when imaging obese patients or patients with metal implants - and further reduces streaks and noise.

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

The SOMATOM Scope and SOMATOM Scope Power, both configured with software version syngo® CT VC28 (SOMARIS/5 VC28), do not have significant changes in materials, energy source, or technological characteristics when compared to the predicate devices.

The differences between the legally marketed predicate devices and the SOMATOM Scope and SOMATOM Scope Power are as follows:

Property	SOMATOMScope	SOMATOMScope Power	SOMATOMEmotion 16	SOMATOMSpirit
GeneratorOutput// TubeName	26kW/DURA202 MV	50kW/DURA422 MV	50kW/DURA422 MV	26kW/DURA202 MV
Maximum.number ofslices/rotation	16	16	16	2
# Elements//Channels	24x1472	24x1472	24x1472	2x1344
Slice Thickness	0.6-19.2 mm	0.6-19.2 mm	0.6-19.2 mm	1-10 mm
kV-Range // mA-Range	80, 110, 130kV/ 20-180MVDURA 202 MV	80, 110, 130kV/ 20-345mA DURA422-MV	80, 110, 130kV/ 20-345mA	80, 110, 130kV/ 20-180Ma

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Special 510(k) Submission: SOMATOM Scope and Scope Power

Anode HeatStorage	2MHU //DURA20	5 MHU //DURA 422 MV2 MV	5 MHU//DURA 422MV	2MHU //DURA202 MV
Tube Focal Spot /mm	0.8 x 0.4 / 0.8x 0.7// DURA202 MV	0.8 x 0.5 / 0.8x 0.7// DURA422 MV	0.8 x 0.5 / 0.8x 0.7	0.8 x 0.4 / 0.8x 0.7// DURA202 MV
Scan Times(partial) // Subsec(partial)	0.8(optional);1.0; 1.5 sec	0.5 (optional);0.6; 1.0; 1.5sec	0,5 (optional);0.6; 1.0; 1.5sec	0.8, 1.0, 1.5 s
Topogram(Length x ScanField)	128 —1530 x500 mm	128 —1530 x500 mm	128 —1530 x500 mm	128 —1500 x500 mm
Recon Time:Stand. // HiRes //Topo	Up to 6images/s// 12images(optional)	Up to 8images/s// 16images/s(optional)	Up to 8images/s// 16images/s(optional)	Up to 5images/s
LC Resolution(20cm Catph. /CTDIvol 32cm)	5 mm/ 3HU/12.54 mGy	5 mm/ 3HU/12.88 mGy	5 mm/ 3HU/12.88 mGy	5mm/3HU/13.7mGy (Dose atsurface)
CTDI (Dose/100mAs) /16cm Phant.(typical head)32cm Phant.(typical body)	Typicalhead:130kV A:18.6 mGy B:19.5 mGyTypicalbody:130kVA:5.7 mGy B:10.5 mGy	Typicalhead:130kV A:18.7mGy B:19.6mGyTypicalbody:130kVA:5.8mGy B:10.9mGy	Typicalhead:130kVA: 18.7mGy B:19.6mGyTypicalbody:130kVA: 5.8mGy B:10.9mGy	Typicalhead:130kVA: 19.0mGyB: 21.3mGyTypicalbody:130kVA: 5.8mGy B:10.8mGy
Max. HCResolution (2%MTF wire inplastic)	15.15 lp/cm	15.15 lp/cm	15.15 lp/cm	n.a.

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.

7. Nonclinical Testing:

The SOMATOM Scope and SOMATOM Scope Power configured with software version syngo® CT VC28 (SOMARIS/5 VC28) are designed to fulfill the requirements of the following standards:

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Special 510(k) Submission: SOMATOM Scope and Scope Power

RecognitionNumber	ProductArea	Title of Standard	ReferenceNumber andDate	StandardsDevelopmentOrganization
5-40	General	Medical devices - Application of riskmanagement to medical devices	14971 SecondEdition 2007-03-01	ISO
5-41	General	Medical electrical equipment - Part1-4: General requirements for safety-- Collateral standard:Programmable electrical medicalsystems, edition 1.1	60601-1-4:2000 Consol.Ed. 1.1	IEC
5-85	General	Medical electrical equipment -- Part1-6: General requirements for basicsafety and essential performance --Collateral Standard: Usability	60601-1-6Edition 3.02010-01	IEC
13-8	Software	Medical device software - Softwarelife cycle processes	62304 Firstedition 2006-05	IEC
12-218	Radiology	Digital Imaging and Communicationsin Medicine (DICOM) Set	PS 3.1-3.18(2009)	NEMA
12-222	Radiology	Evaluation and routine testing inmedical imaging departments - Part3-5: Acceptance tests - Imagingperformance of computedtomography X-ray equipment	61223-3-5 FirstEdition 2004-08	IEC
12-226	Radiology	Evaluation and routine testing inmedical imaging departments - Part2-6: Constancy tests - Imagingperformance of computedtomography X-ray equipment	61223-2-6Second Edition2006-11	IEC
12-225	Radiology	Computed Tomography Dose Check	XR-25	NEMA
12-250	Radiology	Medical electrical equipment - Part2-44: Particular requirements for thebasic safety and essentialperformance of X-ray equipment forcomputed tomography	60601-2-44Edition 3.02012-08Amendment 1	IEC

This submission contains performance data to demonstrate continued conformance with special controls for medical devices containing software. Non-clinical tests and phantom testing were conducted for the SOMATOM Scope and SOMATOM Scope Power configured with software version syngo® CT VC28 (SOMARIS/5 VC28) during product development.

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. The modifications described in this Premarket Notification were supported with verification/validation testing. Testing for verification and validation of the device was found acceptable to support the claim 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

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SIEMENS

equivalent to the predicate device in terms of safety and effectiveness. All testing and validation has been completed.

8. Indications for Use:

The SOMATOM Scope and the SOMATOM Scope Power 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 xray tube, and the simultaneous translation of the patient.)

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 Scope and the SOMATOM Scope Power configured with software version syngo® CT VC28 (SOMARIS/5 VC28) software package do not introduce any new potential safety risks and are substantially equivalent to and performs as well as the predicate devices.

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.