somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version)

• K Number: K151749
• Device Name: somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version)
• Manufacturer: Siemens Medical Solutions USA, Inc.
• Date Cleared: 2016-03-18 ( 263 days)
• Product Code: JAK
• Regulation Number: 892.1750

Intended Use

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.

Device Description

The Siemens SOMATOM Scope/Scope Power are Computed Tomography X- ray Systems which feature a continuously rotating tube-detector system and function according to the fan beam principle. 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, SOMARIS/5 VC30 supports 1) Localized language support of scan protocols, 2) Easy UI Improvement, 3) iMAR, 4) Study Split Improvement, 5) FAST kV, 6) e-Sleep Improvement, 7) syngo. via client, 8) Touch Panel (FAST Positioning), 9) online help based on knowledge gateway, 10) FAST Wizard, 11) new software field update concept, 12) Temporal-MIP, 13) TrueD-4D viewer, 14) RTP Enhancement 15) Adaptive Signal Boost Improvement, 16) FAST 3D Align, 17) Dual Spiral Dual Energy, 18) FAST DE Results (for Mono-energetic), 19) Tube Protection, 20) SAFIRE, 21) Modified Patient Table 22) Interleaved Volume Reconstruction (IVR)

Predicate Devices

K140912, K143401

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard CT imaging technology and software features without mentioning AI or ML. The listed software features are typical for CT systems and do not inherently indicate AI/ML use.

Therapeutic

No.
The device is used to produce cross-sectional images of the body, which aids in diagnosis rather than directly treating a condition.

Diagnostic

Yes

Explanation: The device creates "cross-sectional images of the body by computer reconstruction of x-ray transmission data," which are used by medical professionals to diagnose various conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Computed Tomography X-ray System" which is a hardware device. The software described is a component of this hardware system, not a standalone software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states that the device is used to "produce cross-sectional images of the body by computer reconstruction of x-ray transmission data." This describes an imaging device used for diagnostic purposes on the patient's body, not for testing samples in vitro (outside the body).
• Device Description: The description confirms it's a "Computed Tomography X-ray System," which is an imaging modality.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.

In summary, the SOMATOM Scope and SOMATOM Scope Power are medical imaging devices, not in vitro diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.)

Product codes (comma separated list FDA assigned to the subject device)

JAK

Device Description

The Siemens SOMATOM Scope/Scope Power are Computed Tomography X- ray Systems which feature a continuously rotating tube-detector system and function according to the fan beam principle. 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, SOMARIS/5 VC30 supports 1) Localized language support of scan protocols, 2) Easy UI Improvement, 3) iMAR, 4) Study Split Improvement, 5) FAST kV, 6) e-Sleep Improvement, 7) syngo. via client, 8) Touch Panel (FAST Positioning), 9) online help based on knowledge gateway, 10) FAST Wizard, 11) new software field update concept, 12) Temporal-MIP, 13) TrueD-4D viewer, 14) RTP Enhancement 15) Adaptive Signal Boost Improvement, 16) FAST 3D Align, 17) Dual Spiral Dual Energy, 18) FAST DE Results (for Mono-energetic), 19) Tube Protection, 20) SAFIRE, 21) Modified Patient Table 22) Interleaved Volume Reconstruction (IVR)

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

x-ray transmission data

Anatomical Site

body

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance tests were conducted to test the functionality of the SOMATOM Scope/Scope Power configured with software version SOMARIS/5 VC30 syngo® CT VC30-easyIQ version. 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K140912, K143401

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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

March 28, 2016

Siemens Medical Solutions USA, Inc. % Ms. Kimberly Mangum Technical Specialist, Regulatory Submissions 40 Liberty Boulevard, Mail Code 65-1A MALVERN PA 19355

Re: K151749

Trade/Device Name: SOMATOM Scope/Scope Power Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 7, 2016 Received: March 9, 2016

Dear Ms. Mangum:

This letter corrects our substantially equivalent letter of March 18, 2016.

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

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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.

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 [phone] or [phone] 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/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert Oels

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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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.

Indications for

Image /page/2/Picture/6 description: The image shows the 510(k) number, which is K151749. The text "510(k) Number (if known)" is above the number. The number is in a large, bold font.

Device Name SOMATOM Scope/Scope Power

Indications for Use (Describe)

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.)

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.

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FORM FDA 3881 (8/14)

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510(K) SUMMARY FOR SOMATOM SCOPE SYSTEMS

Submitted by: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355 Date Prepared: October 30, 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. 40 Liberty Boulevard Mail code: 65-1A Malvern, PA 19355

Manufacturing Facility (1):

SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD 278 Zhou Zhu Rd Shanghai, CHINA, 201318 Establishment Registration Number: 3003202425

Manufacturing Facility (2):

Siemens AG Medical Solutions Business Unit CR Siemensstrasse 1 DE-91301 Forchheim, Germany Establishment Registration Number: 3004977335

Contact Person: 2.

Kimberly Mangum Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 40 Liberty Boulevard, 65-1A Malvern, PA 19355-1406 Phone: [phone] Fax: [phone] Email: [e-mail]

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3. Device Name and Classification
Product Name:	SOMATOM Scope
Propriety Trade Name:	SOMATOM Scope (with syngo® CT VC30-
easyIQ version)
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.1750
Device Class:	Class II
Product Code:	JAK
Device Name and Classification
Product Name:	SOMATOM Scope Power
Propriety Trade Name:	SOMATOM Scope Power (with syngo® CT VC30-
easyIQ version)
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.1750
Device Class:	Class II
Product Code:	JAK

Legally Marketed Primary Predicate Device:

Product Name:	SOMATOM Scope/Scope Power
Propriety Trade Name:	SOMATOM Scope/Scope Power
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.1750
Device Class:	Class II
Product Code:	JAK
510(k) #:	K140912

Legally Marketed Secondary Predicate Device:

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:	JAK
510(k)#:	K143401

Substantial Equivalence: 4.

Siemens SOMATOM Scope/Scope Power with software version SOMARIS/5 VC30 syngo® CT VC30-easylQ version is substantially equivalent to the following medical devices in commercial distribution.

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Table 1 Predicate Devices

| Predicate Device Name and
Manufacturer | 510(k)
number | Clearance Date |
|---------------------------------------------------------------------------------------|------------------|----------------|
| Primary Predicate Device:
Siemens SOMATOM Scope/Scope Power
with SOMARIS/5 VC28 | K140912 | 09/15/2014 |
| Secondary Predicate Device:
Siemens SOMATOM Definition Edge with
SOMARIS/7 VA48 | K143401 | 04/06/2015 |

5. Device Description:

The Siemens SOMATOM Scope/Scope Power are Computed Tomography X- ray Systems which feature a continuously rotating tube-detector system and function according to the fan beam principle. 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, SOMARIS/5 VC30 supports 1) Localized language support of scan protocols, 2) Easy UI Improvement, 3) iMAR, 4) Study Split Improvement, 5) FAST kV, 6) e-Sleep Improvement, 7) syngo. via client, 8) Touch Panel (FAST Positioning), 9) online help based on knowledge gateway, 10) FAST Wizard, 11) new software field update concept, 12) Temporal-MIP, 13) TrueD-4D viewer, 14) RTP Enhancement 15) Adaptive Signal Boost Improvement, 16) FAST 3D Align, 17) Dual Spiral Dual Energy, 18) FAST DE Results (for Mono-energetic), 19) Tube Protection, 20) SAFIRE, 21) Modified Patient Table 22) Interleaved Volume Reconstruction (IVR)

6. Indications for Use

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

• 7. Summary of Technical Characteristics of the Subject Device as Compared with the Predicate Device:
     SOMATOM Scope/Scope Power configured with software version SOMARIS/5 VC30 syngo® CT VC30-easylQ version do 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

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scientific technology remain unchanged from 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.

		Predicate Device Comparable Feature
Subject Device
Feature	Subject Device
SOMATOM Scope/Scope
Power	Primary Predicate
Device
SOMATOM Scope/Scope
Power	SOMATOM
Definition Edge
(K143401)
Localized language
support of scan protocols	Localized language support of
scan protocols	N/A	N/A
Easy UI Improvement	Easy UI Improvement	Easy UI	Easy UI
iMAR	iMAR	N/A	iMAR
Study Split Improvement	Study Split Improvement	Study Split	Study Split
Improvement
FAST kV	FAST kV	N/A	N/A
e-Sleep Improvement	e-Sleep Improvement	e-Sleep	N/A
syngo.via client	syngo.via client	N/A	syngo.via client
FAST Positioning	FAST Positioning	N/A	N/A
Online help based on
knowledge gateway	Online help based on
knowledge gateway	Online help available	Online help
available
FAST Wizard	FAST Wizard	N/A	N/A
New software field
update concept	New software field update
concept	N/A	N/A
Temporal MIP (t-MIP)	Temporal MIP (t-MIP)	N/A	Temporal MIP (t-
MIP)
True-D-4D Viewer	True-D-4D Viewer	N/A	True-D-4D
Viewer
RTP Enhancement	RTP enhancement	RTP supported	RTP supported
Adaptive Signal Boost
Improvement (SDF
Improvement)	Adaptive Signal Boost
Improvement (SDF
Improvement)	Adaptive Signal Boost	N/A
FAST 3D Align	FAST 3D Align	N/A	FAST 3D Align
Dual Spiral Dual Energy	Dual Spiral Dual Energy	N/A	Dual Spiral Dual
Energy
FAST 3D Results for
Mono-Energetic	FAST 3D Results for Mono-
Energetic	N/A	FAST 3D Results
for Mono-
Energetic
SAFIRE	SAFIRE	N/A	SAFIRE
Modified Patient Table	Modified Patient Table	Normal table load	N/A
Tube Protection	Tube Protection	N/A	N/A
Interleaved Volume
Reconstruction (IVR)	Interleaved Volume
Reconstruction (IVR)	N/A	N/A

Table 2 Predicate Device Comparison

Nonclinical Testing: 8.

SOMATOM Scope/Scope Power configured with software version syngo® CT VC30-easylQ version is designed to fulfill the requirements of the following standards:

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• . IEC 60601-2-44: Medical electrical equipment – Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography - Ed. 3.1
• . 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 3.20 (2011): 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, 2005
• IEC 60601-1-6 : 2010; Medical electrical equipment Part 1-6: General ● requirements for basic safety and essential performance -- Collateral Standard: Usability
• 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
• NEMA XR-26: Access Controls for Computed Tomography-Identification, Interlocks, and Logs
• IEC/ISO 10918: Information Technology Digital Compression and ● Coding of Continuous-Tone Still Images: Requirements and Guidelines [Including: Technical Corrigendum (2005)]
• 60601-1-2 (2007): Medial Electrical Equipment Part 1-2: General ● requirements for basic safety and essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests

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 Scope/Scope Power configured with software version SOMARIS/5 VC30 syngo® CT VC30easylQ version during product development. The modifications described in this Premarket Notification were supported with verification/validation and performance 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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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 Scope/Scope Power configured with software version SOMARIS/5 VC30 syngo® CT VC30-easylQ version. 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.

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:

The SOMATOM Scope/Scope Power configured with software version SOMARIS/5 VC30 syngo® CT VC30-easylQ version 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 Scope/Scope Power (K140912) is 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.