SOMATOM SCOPE/SOMATOM SCOPE POWER

K140912 · Siemens Medical Solutions USA, Inc. · JAK · Sep 15, 2014 · Radiology

Device Facts

• Record ID: K140912
• Device Name: SOMATOM SCOPE/SOMATOM SCOPE POWER
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: JAK · Radiology
• Decision Date: Sep 15, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

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

Device Story

Whole-body X-ray computed tomography (CT) scanner; inputs X-ray transmission data; transforms data via SOMARIS/5 software (syngo CT VC28) using iterative reconstruction (IRIS) and adaptive signal processing; produces cross-sectional images. Used in clinical settings by trained operators. Features include eCockpit (eMode for tube power reduction, eStart for tube pre-warming, eSleep for energy saving), table footswitch, and gantry tilt speed-up. Adaptive Signal Boost reduces noise/streaks in obese patients or those with metal implants. Output viewed by clinicians for diagnostic evaluation; supports clinical decision-making through high-quality cross-sectional imaging. Benefits include improved tube longevity, energy efficiency, and optimized image quality for challenging patient anatomies.

Clinical Evidence

Bench testing only. Performance verified through phantom testing and non-clinical verification/validation of software specifications. Risk analysis and hazard mitigation conducted per ISO 14971. Conformance to electrical/mechanical safety standards (IEC 60601 series) and NEMA XR-25 (Dose Check) confirmed.

Technological Characteristics

Whole-body CT scanner; 16-slice capacity; generator outputs 26kW (Scope) or 50kW (Scope Power); DURA 202/422 MV tubes. Connectivity via DICOM standard. Software: syngo CT VC28 (SOMARIS/5). Iterative reconstruction (IRIS). Compliance with IEC 60601-1, 60601-1-4, 60601-1-6, 60601-2-44, and IEC 61223 standards.

Indications for Use

Indicated for producing cross-sectional body images via computer reconstruction of x-ray transmission data in patients requiring CT imaging.

Regulatory Classification

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.

Predicate Devices

• SOMATOM Emotion 16 (K050297)
• SOMATOM Spirit (K042328)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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)

#### 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)

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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: [phone] Fax: [phone] Email: [e-mail]

#### 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 Clearance<br>Number | FDA Clearance<br>Date | Product<br>Code |
|--------------------|-------------------------|-----------------------|-----------------|
| SOMATOM Emotion 16 | K050297 | 03/01/2005 | JAK |
| SOMATOM Spirit | K042328 | 09/14/2004 | JAK |

### 5. 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.

#### 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 | SOMATOM<br>Scope | SOMATOM<br>Scope Power | SOMATOM<br>Emotion 16 | SOMATOM<br>Spirit |
|------------------------------------------|---------------------------------------------|-------------------------------------------------|----------------------------------|------------------------------|
| Generator<br>Output// Tube<br>Name | 26kW/DURA<br>202 MV | 50kW/DURA<br>422 MV | 50kW/DURA<br>422 MV | 26kW/DURA<br>202 MV |
| Maximum.<br>number of<br>slices/rotation | 16 | 16 | 16 | 2 |
| # Elements//<br>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-<br>Range | 80, 110, 130<br>kV/ 20-180MV<br>DURA 202 MV | 80, 110, 130<br>kV/ 20-345<br>mA DURA<br>422-MV | 80, 110, 130<br>kV/ 20-345<br>mA | 80, 110, 130<br>kV/ 20-180Ma |

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

| Anode Heat<br>Storage | 2MHU //DURA<br>20 | 5 MHU //<br>DURA 422 MV<br>2 MV | 5 MHU<br>//DURA 422<br>MV | 2MHU //DURA<br>202 MV |
|--------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Tube Focal Spot /<br>mm | 0.8 x 0.4 / 0.8<br>x 0.7// DURA<br>202 MV | 0.8 x 0.5 / 0.8<br>x 0.7// DURA<br>422 MV | 0.8 x 0.5 / 0.8<br>x 0.7 | 0.8 x 0.4 / 0.8<br>x 0.7// DURA<br>202 MV |
| Scan Times<br>(partial) // Subsec<br>(partial) | 0.8(optional);<br>1.0; 1.5 sec | 0.5 (optional);<br>0.6; 1.0; 1.5<br>sec | 0,5 (optional);<br>0.6; 1.0; 1.5<br>sec | 0.8, 1.0, 1.5 s |
| Topogram<br>(Length x Scan<br>Field) | 128 —1530 x<br>500 mm | 128 —1530 x<br>500 mm | 128 —1530 x<br>500 mm | 128 —1500 x<br>500 mm |
| Recon Time:<br>Stand. // HiRes //<br>Topo | Up to 6<br>images/s// 12<br>images<br>(optional) | Up to 8<br>images/s// 16<br>images/s<br>(optional) | Up to 8<br>images/s// 16<br>images/s<br>(optional) | Up to 5<br>images/s |
| LC Resolution<br>(20cm Catph. /<br>CTDIvol 32cm) | 5 mm/ 3HU/<br>12.54 mGy | 5 mm/ 3HU/<br>12.88 mGy | 5 mm/ 3HU/<br>12.88 mGy | 5mm/3HU/13.7<br>mGy (Dose at<br>surface) |
| CTDI (Dose/100<br>mAs) /<br>16cm Phant.<br>(typical head)<br>32cm Phant.<br>(typical body) | Typical<br>head:130kV A:<br>18.6 mGy B:<br>19.5 mGy<br>Typical<br>body:130kVA:<br>5.7 mGy B:<br>10.5 mGy | Typical<br>head:130kV A:<br>18.7mGy B:<br>19.6mGy<br>Typical<br>body:130kVA:<br>5.8mGy B:<br>10.9mGy | Typical<br>head:130kV<br>A: 18.7mGy B:<br>19.6mGy<br>Typical<br>body:130kV<br>A: 5.8mGy B:<br>10.9mGy | Typical<br>head:130kV<br>A: 19.0mGy<br>B: 21.3mGy<br>Typical<br>body:130kV<br>A: 5.8mGy B:<br>10.8mGy |
| Max. HC<br>Resolution (2%<br>MTF wire in<br>plastic) | 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

| Recognition<br>Number | Product<br>Area | Title of Standard | Reference<br>Number and<br>Date | Standards<br>Development<br>Organization |
|-----------------------|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|------------------------------------------|
| 5-40 | General | Medical devices - Application of risk<br>management to medical devices | 14971 Second<br>Edition 2007-<br>03-01 | ISO |
| 5-41 | General | Medical electrical equipment - Part<br>1-4: General requirements for safety<br>-- Collateral standard:<br>Programmable electrical medical<br>systems, edition 1.1 | 60601-1-4:<br>2000 Consol.<br>Ed. 1.1 | IEC |
| 5-85 | General | Medical electrical equipment -- Part<br>1-6: General requirements for basic<br>safety and essential performance --<br>Collateral Standard: Usability | 60601-1-6<br>Edition 3.0<br>2010-01 | IEC |
| 13-8 | Software | Medical device software - Software<br>life cycle processes | 62304 First<br>edition 2006-05 | IEC |
| 12-218 | Radiology | Digital Imaging and Communications<br>in Medicine (DICOM) Set | PS 3.1-3.18<br>(2009) | NEMA |
| 12-222 | Radiology | Evaluation and routine testing in<br>medical imaging departments - Part<br>3-5: Acceptance tests - Imaging<br>performance of computed<br>tomography X-ray equipment | 61223-3-5 First<br>Edition 2004-<br>08 | IEC |
| 12-226 | Radiology | Evaluation and routine testing in<br>medical imaging departments - Part<br>2-6: Constancy tests - Imaging<br>performance of computed<br>tomography X-ray equipment | 61223-2-6<br>Second Edition<br>2006-11 | IEC |
| 12-225 | Radiology | Computed Tomography Dose Check | XR-25 | NEMA |
| 12-250 | Radiology | Medical electrical equipment - Part<br>2-44: Particular requirements for the<br>basic safety and essential<br>performance of X-ray equipment for<br>computed tomography | 60601-2-44<br>Edition 3.0<br>2012-08<br>Amendment 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.