SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power

K142955 · Siemens Medical Solutions USA, Inc. · JAK · Nov 24, 2015 · Radiology

Device Facts

• Record ID: K142955
• Device Name: SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: JAK · Radiology
• Decision Date: Nov 24, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

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. This CT system can be used for low dose lung cancer screening in high risk populations. * * As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

Device Story

Siemens SOMATOM CT scanners are whole-body X-ray systems using rotating tube-detector assemblies based on the fan-beam principle. Systems range from 6 to 192 slices. Input consists of X-ray transmission data; output is cross-sectional images reconstructed by computer. Used in clinical settings by trained physicians to aid diagnosis. The device supports low-dose lung cancer screening protocols consistent with the National Lung Screening Trial (NLST). The system software manages patient data, scan control, image reconstruction, and archiving. Physicians view reconstructed images to identify pulmonary nodules or other abnormalities. The device provides diagnostic information to support clinical decision-making, potentially benefiting patients through early detection of lung cancer.

Clinical Evidence

Bench testing only. Performance characteristics (CT number accuracy, uniformity, spatial resolution, slice thickness, noise, contrast-to-noise ratio, scan speed) were compared between subject devices and predicates used in the National Lung Screening Trial (NLST). Results demonstrate subject devices perform comparably or better than those used in the NLST, supporting suitability for low-dose lung cancer screening.

Technological Characteristics

Whole-body X-ray CT system; fan-beam principle; rotating tube-detector assembly. 6 to 192 slice configurations. Conforms to IEC 60601-2-44, IEC 60601-1-3, NEMA XR 25, and DICOM PS 3.1-3.18. Software life cycle per IEC 62304. Connectivity via DICOM. Energy source: X-ray.

Indications for Use

Indicated for cross-sectional imaging of patients via computer reconstruction of x-ray transmission data to aid physician diagnosis. Also indicated for low-dose lung cancer screening in high-risk populations as defined by professional medical societies.

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 Force (K133589)
• SOMATOM Definition Flash (K121072)
• SOMATOM Definition Edge (K120579)
• SOMATOM Definition AS/AS+ (K081022)
• SOMATOM Definition (K122471)
• SOMATOM Definition AS Open (K130901)
• SOMATOM Emotion 16 CT System (K133424)
• SOMATOM Perspective (32) (K133590)
• SOMATOM Perspective (64) (K113287)
• SOMATOM Scope/SOMATOM Scope Power (K140912)
• SOMATOM Plus 4WITH Volume Zoom CT Scanners (K982349)

Submission Summary (Full Text)

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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three human profiles facing to the right, with the profiles overlapping to create a sense of depth and unity.

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

November 24, 2015

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

Re: K142955

Trade/Device Name: Somatom Force, Somatom Definition Flash, Somatom Definition Edge, Somatom Definition AS/AS+, Somatom Definition AS Open, Somatom Definition, Somatom Emotion 16, Somatom Perspective 64/128, Somatom Perspective 64/32, Somatom Scope/Scope Power, SOMATOM Plus 4WITH Volume Zoom CT Scanners Regulation Number: 21 CFR 892.1750

Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: October 30, 2015 Received: November 3, 2015

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

{1}------------------------------------------------

forth in the quality systems (OS) 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/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,

Robert Oals

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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510(k) Number (if known) K142955

Device Name SOMATOM Force

#### Indications for Use (Describe)

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.

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.

This CT system can be used for low dose lung cancer screening in high risk populations *

* As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------|-----------------------------------------------------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{3}------------------------------------------------

510(k) Number (if known) K142955

Device Name SOMATOM Definition AS/AS+

#### Indications for Use (Describe)

The Siemens SOMATOM Definition AS/ AS+(Project P46) 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 resulting from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

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 a trained physician as an aid in diagnosis.

This CT system can be used for low dose lung cancer screening in high risk populations *

* As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

| 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) |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{4}------------------------------------------------

510(k) Number (if known) K142955

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 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 resulting from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

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 a trained physician as an aid in diagnosis.

This CT system can be used for low dose lung cancer screening in high risk populations *

*As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| <div> <span> X Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{5}------------------------------------------------

510(k) Number (if known) K142955

Device Name SOMATOM Definition Flash

Indications for Use (Describe)

The Siemens SOMATOM Definition Flash system is 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.

In addition the SOMATOM Definition Flash is able to produce additional image planes and analysis results by executing optional post processing features, which operate on DICOM images.

The images and results delivered by the system can be used by a trained physician as an aid in diagnosis. (*spiral planes: the axial planes resulting from the continuous rotation of detectors and the simultaneous translation of the patient.)

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 a trained physician as an aid in diagnosis.

This CT system can be used for low dose lung cancer screening in high risk populations *

* As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 10pt;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{6}------------------------------------------------

510(k) Number (if known) K142955

Device Name SOMATOM Definition Edge

#### Indications for Use (Describe)

The Siemens SOMATOM Definition Edge (Project P46F) 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 resulting from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

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 a trained physician as an aid in diagnosis.

This CT system can be used for low dose lung cancer screening in high risk populations *

* As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| <div> <span> X Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{7}------------------------------------------------

510(k) Number (if known) K142955

Device Name SOMATOM Definition

#### Indications for Use (Describe)

The SOMATOM P45 is 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 resulting from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

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 a trained physician as an aid in diagnosis.

This CT system can be used for low dose lung cancer screening in high risk populations *

* As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| <div> <span> <b> </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{8}------------------------------------------------

510(k) Number (if known) K142955

Device Name SOMATOM Emotion 16

#### Indications for Use (Describe)

The SOMATOM Emotion 16 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 resulting from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

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 a trained physician as an aid in diagnosis.

This CT system can be used for low dose lung cancer screening in high risk populations *

*As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{9}------------------------------------------------

510(k) Number (if known) K142955

Device Name SOMATOM Perspective 64/128

Indications for Use (Describe)

The Siemens SOMATOM Perspective 64/128 system is 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.

In addition the SOMATOM Perspective is able to produce additional image planes and analysis results by executing optional post-processing features, which operate on DICOM images. For cardiac imaging, which is an option on the system, a new reconstruction algorithm (iTRIM - Iterative Temporal Resolution Improvement Method) is used. iTRIM improves the temporal resolution of cardiac CT images compared to conventional cardiac CT image reconstruction. Actual results obtained with iTRIM can vary depending on the particular clinical situation.

The images and results delivered by the SOMATOM Perspective can be used by a trained physician as an aid in diagnosis. (*spiral planes: the axial planes resulting from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

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 a trained physician as an aid in diagnosis.

This CT system can be used for low dose lung cancer screening in high risk populations *

* As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

| 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.

{10}------------------------------------------------

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

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

{11}------------------------------------------------

510(k) Number (if known) K142955

Device Name SOMATOM Perspective 16/32

Indications for Use (Describe)

The Siemens SOMATOM Perspective 16/32 system is 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.

In addition the SOMATOM Perspective is able to produce additional image planes and analysis results by executing optional post-processing features, which operate on DICOM images. For cardiac imaging, which is an option on the system, a new reconstruction algorithm (iTRIM - Iterative Temporal Resolution Improvement Method) is used. iTRIM improves the temporal resolution of cardiac CT images compared to conventional cardiac CT image reconstruction. Actual results obtained with iTRIM can vary depending on the particular clinical situation.

The images and results delivered by the SOMATOM Perspective can be used by a trained physician as an aid in diagnosis. (*spiral planes: the axial planes resulting from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

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 a trained physician as an aid in diagnosis.

This CT system can be used for low dose lung cancer screening in high risk populations *

* As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

{12}------------------------------------------------

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

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

{13}------------------------------------------------

510(k) Number (if known) K142955

Device Name SOMATOM Scope/Scope Power

Indications for Use (Describe)

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 angels or spiral planes* taken at different angles.

The images and results delivered by the SOMATOM Scope and the SOMATOM Scope Power can be used by a trained physician as an aid in diagnosis.

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

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 a trained physician as an aid in diagnosis.

This CT system can be used for low dose lung cancer screening in high risk populations *

* As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

| 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) | |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{14}------------------------------------------------

510(k) Number (if known) K142955

Device Name

SOMATOM Plus 4WITH Volume Zoom CT Scanners

Indications for Use (Describe)

The Somatom Plus 4 with Volume Zoom package is 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 angels 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.)

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 a trained physician as an aid in diagnosis.

This CT system can be used for low dose lung cancer screening in high risk populations *

* As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
| <span style="font-family: sans-serif;"> </span> | |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{15}------------------------------------------------

Image /page/15/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are all capitalized and are a light blue color. The background is white, which makes the word stand out.

#### 510(K) SUMMARY FOR SOMATOM ( ) Computed Tomography System Family Scanners Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Mail code 65-1A Malvern, PA 19355 Date Prepared: October 28, 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: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Mail code: 65-1A 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:

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

#### 3. Device Name and Classification

| Product Name: | SOMATOM Force |
|----------------------------|-------------------------------------|
| Propriety Trade Name: | SOMATOM Force |
| Classification Name: | System, X-Ray, Tomography, Computed |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR § 892.1750 |
| Device Class: | II |
| Product Code: | 90 JAK |

{16}------------------------------------------------

Product Name: Propriety Trade Name: Classification Name: Classification Panel: Classification Requlation: Device Class: Product Code:

Product Name: Propriety Trade Name: Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:

Product Name: Proprietv Trade Name: Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:

Product Name: Propriety Trade Name: Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:

Product Name: Propriety Trade Name: Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:

Product Name: Propriety Trade Name: Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:

Product Name: Propriety Trade Name: Classification Name: Classification Panel:

SOMATOM Definition AS/AS+ SOMATOM Definition AS/AS+ System, X-Ray, Tomography, Computed Radiology 21 CFR § 892.1750 . 90 JAK

SOMATOM Definition AS Open SOMATOM Definition AS Open System, X-Ray, Tomography, Computed Radiology 21 CFR § 892.1750 .

90 JAK

SOMATOM Definition Flash SOMATOM Definition Flash System, X-Ray, Tomography, Computed Radiology 21 CFR § 892.1750

90 JAK

SOMATOM Definition Edge SOMATOM Definition Edge System, X-Ray, Tomography, Computed Radiology 21 CFR § 892.1750 90 JAK

SOMATOM Definition SOMATOM Definition System, X-Ray, Tomography, Computed Radiology 21 CFR § 892.1750 . 90 JAK

SOMATOM Emotion 16 SOMATOM Emotion 16 Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II 90JAK

SOMATOM Perspective 64/128 SOMATOM Perspective Computed Tomography X-ray System Radiology

{17}------------------------------------------------

Classification Requlation: Device Class: Product Code:

Product Name: Propriety Trade Name: Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:

Product Name: Propriety Trade Name: Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:

21 CFR §892.1750 Class II 90JAK

SOMATOM Perspective 16/32 SOMATOM Perspective Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II 90JAK

SOMATOM Scope/Scope Power SOMATOM Scope/Scope Power Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II 90JAK

Product Name:

Propriety Trade Name:

Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:

SOMATOM Plus 4WITH Volume Zoom CT Scanners SOMATOM Plus 4WITH Volume Zoom CT Scanners Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II 90JAK

Legally Marketed Predicate Devices

Trade Name: 510(k)#: Clearance Date: Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:

SOMATOM Definition Force K133589 April 17, 2014 System, X-Ray, Tomography, Computed Radiology 21 CFR § 892.1750 .

90 JAK

Trade Name: 510(k)#: K081022 Clearance Date: June 02, 2008 Classification Name: Classification Panel: Radiology Classification Regulation: Device Class: . Product Code: 90 JAK

SOMATOM Definition AS/AS+ System, X-Ray, Tomography, Computed 21 CFR § 892.1750

{18}------------------------------------------------

Trade Name: 510(k)#: Clearance Date: Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:

Trade Name: 510(k)#: Clearance Date: Classification Name: Classification Panel: Classification Requlation: Device Class: Product Code:

Trade Name: 510(k)#: Clearance Date: Classification Name: Classification Panel: Classification Requlation: Device Class: Product Code:

Trade Name: 510(k)#: Clearance Date: Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:

Trade Name: 510(k)#: Clearance Date: Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:

Trade Name: 510(k)#: Clearance Date: Classification Name: Classification Panel: Classification Regulation: Device Class:

SOMATOM Definition AS Open K130901 January 02, 2014 System, X-Ray, Tomography, Computed Radiologv 21 CFR § 892.1750 ll 90 JAK

SOMATOM Definition Flash K121072 May 08, 2012 System, X-Ray, Tomography, Computed Radiology 21 CFR § 892.1750

90 JAK

SOMATOM Definition Edge K120579 May 23, 2012 System, X-Ray, Tomography, Computed Radiology 21 CFR § 892.1750 .

90 JAK

SOMATOM Definition K122471 September 11, 2012 System, X-Ray, Tomography, Computed Radiology 21 CFR § 892.1750 . 90 JAK

SOMATOM Emotion 16 CT System K133424 January 17, 2014 Computed Tomography X-ray System Radiologv 21 CFR §892.1750 Class II 90JAK

SOMATOM Perspective (128/64) K113287 May 23, 2012 Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II

{19}------------------------------------------------

Image /page/19/Picture/0 description: The image contains the word "SIEMENS" in a large, sans-serif font. The text is a light teal color. The letters are evenly spaced and the word is horizontally oriented. The background is plain white.

Product Code:

Trade Name: 510(k)#: Clearance Date: Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:

90JAK

SOMATOM Perspective (16/32) K133590 April 30, 2014 Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II 90JAK

Trade Name: 510(k)#: Clearance Date: Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:

SOMATOM Scope/SOMATOM Scope Power K140912 September 15, 2014 Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II 90JAK

Trade Name:

510(k)#: Clearance Date: Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:

SOMATOM Plus 4WITH Volume Zoom CT Scanners K982349 September 30, 1998 Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II 90JAK

#### Substantial Equivalence: 4.

The subject devices are unmodified compared to their recent cleared versions. As such the cleared versions as listed in Table 1 below serve as the predicate devices:

| Predicate Devices | FDA Clearance<br>Number | FDA Clearance<br>Date |
|--------------------------------------|-------------------------|-----------------------|
| SOMATOM Force | K133589 | April 17, 2014 |
| SOMATOM Definition Flash | K121072 | May 08, 2012 |
| SOMATOM Definition Edge | K120579 | May 23, 2012 |
| SOMATOM Definition AS/AS+ | K081022 | June 02, 2008 |
| SOMATOM Definition | K122471 | September 11,<br>2012 |
| SOMATOM Definition AS Open | K130901 | January 02, 2014 |
| SOMATOM Emotion 16 CT System | K133424 | January 17, 2014 |
| SOMATOM Perspective (32) | K133590 | April 30, 2014 |
| SOMATOM Perspective (64) | K113287 | May 23, 2012 |
| SOMATOM Scope/SOMATOM<br>Scope Power | K140912 | September 15,<br>2014 |
| SOMATOM Plus 4WITH Volume | K982349 | September 30, 2014 |

#### Table 1: Predicate Device Comparable Properties

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| Predicate Devices | FDA Clearance<br>Number | FDA Clearance<br>Date |
|-------------------|-------------------------|-----------------------|
| Zoom CT Scanners | | 1998 |

The following performance characteristics and image quality metrics relevant for low dose lung cancer screening were compared for the subject devices and the predicate devices, including predicate devices used as part of the NLST study.

- CT Number Accuracy ●
- CT Number Uniformity ●
- Spatial Resolution (MTF in-plane resolution) ●
- Slice Thickness/Sensitivity Profile (minimum slice width) ●
- Noise Properties
- Contrast to Noise Ratio .
- . Maximum Scan Speed
- Minimum Reconstructed Slice Interval ●
- . Scan parameters for low dose lung cancer screening (as defined by publically available information including the NLST study)

#### 5. Device Description:

Siemens SOMATOM Computed Tomography System family scanners are whole body X-ray computed tomography systems which feature a continuously rotating tube-detector system and functions according to the fan beam principle. The SOMATOM Computed Tomography System family scanners vary in configurations from 6 to 192 slices, and 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.

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 systems described in this submission provide pre-defined low dose scan modes similar to the modes used for The National Lung Screening Trial (NLST), and the features as recommend by the study. This allows use of these systems for screening in the same way the CT systems were used for NLST.

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

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

The SOMATOM Computed Tomography System family scanners referenced in this submission are comparable in indications for use, and are substantially equivalent in design, material, functionality, technology, energy source and are substantially equivalent to the predicate devices. No technical modifications have taken place to the subject device, and there are no technical differences between the predicate device and the subject device. The reason for this submission is to support the following additional Indications for Use:

This computed tomography system is intended to generate and process crosssectional images of patients by computer reconstruction of x-ray transmission data.

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The images delivered by the system can be used by a trained physician as an aid in diagnosis.

This CT system can be used for low dose lung cancer screening in high risk populations.*

*As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

This additional Indication for Use is based on the currently available technical parameters and software versions cleared for the predicate devices. The low dose lung cancer screening indication will be applicable for the Siemens qualified CT systems, and will not require any device modifications. Siemens predicate device systems included in this submission that received clearance after the Siemens system utilized as part of the NLST study have undergone modifications to improve performance, including but not limited to iterative reconstruction methods that support improved image quality and reduced dose. This indication will also be applicable for future qualified Siemens CT systems.

The intended use remains unchanged and the Indications for Use are similar. The technical parameters for general use CT such as minimum slice width, noise, Uniformity and mean value of CT numbers, maximum in-plane resolution of a non-UHR spiral scan mode, the minimum interval between two reconstructed images in axial direction and maximum scan speed are also applicable for lung cancer screening. A discussion of the specific image quality metrics assessed for the addition of this indication is provided in the performance testing section of this summary. The material, energy source, and fundamental scientific technology remain unchanged from the predicate devices; therefore Siemens believes that they are substantially equivalent to the predicate devices.

#### 7. Nonclinical Testing:

The SOMATOM Computed Tomography System family scanners are designed to fulfill the requirements of following standards listed in Table 2 below:

| Recognition<br>Number | Product<br>Area | Title of Standard | Reference<br>Number and<br>Date | Publication<br>Date | Standards<br>Development<br>Organization |
|-----------------------|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|---------------------|------------------------------------------|
| 2-156 | Biocomp | Biological evaluation of medical<br>devices -- Part 1: Evaluation<br>and testing within a risk<br>management process | 10993-1:2009 | 01/15/2013 | AAMI ANSI ISO |
| 12-120 | Radiology | Medical electrical equipment -<br>Part 2-44: Particular<br>requirements for the safety of<br>X-ray equipment for computed<br>tomography - Ed. 2.1 | 60601-2-44<br>(2002-11): | 09/09/2008 | IEC |
| 12-126 | Radiology | Medical electrical equipment -<br>Part 2-28: Particular<br>requirements for the safety of<br>X-ray source assemblies and<br>X-ray tube assemblies for<br>medical diagnosis - Ed. 1.0 | 60601-2-28:<br>1993 | 10/31/2005 | IEC |
| Recognition<br>Number | Product<br>Area | Title of Standard | Reference<br>Number and<br>Date | Publication<br>Date | Standards<br>Development<br>Organization |
| 12-127 | Radiology | Medical electrical equipment -<br>Part 2-32: Particular<br>requirements for the safety of<br>associated equipment of X-ray<br>equipment - Ed. 1.0 | 60601-2-32:<br>1994 | 10/31/2005 | IEC |
| 12-199 | Radiology | Medical electrical equipment -<br>Part 1-3: General requirements<br>for basic safety 3. Collateral<br>Standard: General<br>requirements for radiation<br>protection in diagnostic X-ray<br>equipment | 60601-1-3 First<br>edition 1994-07 | 09/08/2009 | IEC |
| 12-204 | Radiology | Medical electrical equipment -<br>Part 2-28: Particular<br>requirements for the basic<br>safety and essential<br>performance of X-ray tube<br>assemblies for medical<br>diagnosis | 60601-2-28<br>Edition 2.0<br>2010-03 | 08/05/2013 | IEC |
| 12-210 | Radiology | Medical electrical equipment -<br>Part 1-3: General requirements<br>for basic safety and essential<br>performance - Collateral<br>Standard: Radiation protection<br>in diagnostic X-ray equipment | 60601-1-3<br>Edition 2.0<br>2008-01 | 08/05/2013 | IEC |
| 12-223 | Radiology | Evaluation and routine testing<br>in medical imaging<br>departments - Part 3-5:<br>Acceptance tests - Imaging<br>performance of computed<br>tomography X-ray equipment<br>CORRIGENDUM 1 | 61223-3-5<br>(First edition<br>2004) | 03/18/2011 | IEC |
| 12-225 | Radiology | Computed Tomography Dose<br>Check | XR 25 | 03/18/2011 | NEMA |
| 12-226 | Radiology | Evaluation and routine testing<br>in medical imaging<br>departments - Part 2-6:<br>Constancy tests - Imaging<br>performance of computed<br>tomography X-ray equipment | 61223-2-6<br>Second Edition<br>2006-11 | 02/28/2011 | IEC |
| 12-238 | Radiology | Digital Imaging and<br>Communications in Medicine<br>(DICOM) Set | PS 3.1 - 3.18 | 03/16/2012 | NEMA |
| 13-8 | Software | Medical device software -<br>Software life cycle processes | 62304 First<br>edition 2006-05 | 08/20/2012 | IEC |
| 5-27 | General | Medical electrical equipment --<br>Part 1-1: General requirements<br>for safety - Collateral standard:<br>Safety requirements for<br>medical electrical systems | 60601-1-<br>1:2000 | 09/08/2009 | IEC |
| 5-4 | General | Medical Electrical Equipment -<br>Part 1: General Requirements<br>for Safety, 1988; Amendment<br>1, 1991-11, Amendment 2,<br>1995 | 60601-1 | 10/31/2005 | IEC |
| 5-40 | General | Medical devices - Application<br>of risk management to medical<br>devices | 14971 Second<br>Edition 2007-<br>03-01 | 08/20/2012 | ISO |
| Recognition<br>Number | Product<br>Area | Title of Standard | Reference<br>Number and<br>Date | Publication<br>Date | Standards<br>Development<br>Organization |
| 5-41 | General | Medical electrical equipment -<br>Part 1-4: General requirements<br>for safety --<br>Collateral standard:<br>Programmable electrical<br>medical systems, edition 1.1 | 60601-1-<br>4:2000 Consol.<br>Ed. 1.1 | 09/08/2009 | IEC |
| 5-54 | General | Medical electrical equipment -<br>Part 1-2: General requirements<br>for basic safety and essential<br>performance - Collateral<br>standard: Electromagnetic<br>compatibility - Requirements<br>and tests (Edition 3) | 60601-1-<br>2:2007 | 08/05/2013 | AAMI ANSI IEC |

#### Table 2: Conformance Standards

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{23}------------------------------------------------

Non clinical tests (integration and functional) and phantom testing were conducted for the SOMATOM Computed Tomography System family 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. 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 was also provided for the systems referenced in 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.

#### Performance Testing

Technical parameters utilized to test general CT use are also applicable for lung cancer screening. The following technical parameters have been compared for the subject devices and the Siemens devices used in NLST:

- . CT number accuracy
- CT number uniformity ●
- Spatial resolution (MTF, maximum in-plane resolution) ●
- Slice thickness/sensitivity profile (minimum slice width) .
- . Noise properties
- . NPS
- Image noise (standard deviation)
- Contrast to Noise Ratio .
- . (Maximum) scan speed
- Minimum reconstructed slice interval .

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The test results demonstrate that the subject devices perform comparably or better than the older devices. Since the older devices have been identified as suitable for lung cancer screening within the NLST, the respective performance of the subject devices can be regarded as suitable for lung cancer screening as well.

#### Reference Criteria and Clinical Literature

The evaluation criteria for lung cancer screening using Computed Tomography is a subset of the evaluation criteria for general chest CT. Table 3 below provides a listing of criteria for chest CT for screening purposes and the applicable organizations assessed in support of Siemens Computed Scanners for low dose lung cancer screening:

| | General Chest CT | Chest CT for screening purpose | |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Topic | RSNA reporting<br>template(RSNA 2015) and<br>Fleischner criteria | Lung-RADs(Lung-<br>RADS 2014)<br>(criteria of ACR) | NCCN<br>guideline(NCCN 2015) |
| Lung and large<br>airways | e.g. pulmonary infiltrates,<br>emphysema, abnormalities<br>or the airways.<br>Evaluation of incidentally<br>found pulmonary nodules<br>explicitly outlined in the<br>Fleischner criteria<br>(MacMahon, Austin et al.<br>2005) :<br>Nodules >4mm requiring<br>follow-up, smaller nodules<br>only in a high-risk patient | Only focusing on<br>pulmonary nodules.<br>New nodules >4mm<br>require actions<br>(shortened follow-up<br>period) | Focusing on pulmonary<br>nodules, new ground-<br>glass nodules > 5mm<br>require action<br>(shortened follow up) |
| Pleura | e.g. effusion, thickening | Not addressed | Not specifically<br>addressed |
| Heart and<br>pericardium | e.g. Size, pericardial<br>effusion | Not addressed | Not specifically<br>addressed |
| Mediastinum and<br>hila | e.g. tumors, lymph nodes | Not addressed | Not specifically<br>addressed |
| Chest wall and<br>lower neck | e.g. thyroid, soft tissues | Not addressed | Not specifically<br>addressed |
| Vessels | e.g. Atherosclerotic changes<br>in aorta and coronaries | Not addressed | Not specifically<br>addressed |
| Bones | e.g. fractures | Not addressed | Not specifically<br>addressed |

#### Table 3: Chest CT Scanning Recommendations

Clinical literature, including the findings of the National Lung Screening Trial (NLST), and technical quidelines for general chest CT such as American College of Radiology (ACR) and National Comprehensive Cancer Network (NCCN) were also used to support the feasibility of the use of Siemens Computed Tomography scanners for low dose lung cancer screening.

#### 8. Intended Use Discussion:

In accordance with guidance document "Guidance for Industry. General/Specific Intended Use" issued November 4, 1998, and presentation "FDA/MITA Meeting on LDCT Lung Cancer Screening", the modified more specific indication for use does not alter the intended use for the legally marketed predicate devices with a general

{25}------------------------------------------------

indication for use, nor does it alter the intended diagnostic effect in comparison to the predicate devices.

The following decision making criteria included in document "Guidance for Industry. General/Specific Intended Use" issued November 4, 1998 were assessed as part of this submission:

- Risk
- Public Health Impact ●
- Knowledge Base
- Endpoints
- Tool or Treatment ●
- Adjunctive Therapy ●
- Design Changes .

Based on the results of the criteria above, Siemens computed tomography scanners are intended to produce cross sectional images of the body by computer reconstruction of x-ray transmission date. Lung cancer screening does not represent a new intended use

The more specific use of low dose lung cancer screening:

- Does not introduce new risk not normally associated with the general use of . the device
- . Does not impact public health to a significantly greater degree than the general diagnostic use of the device
- . There is an extensive body of publically available evidence that reflects understanding by the medical community that use of CT for lung cancer screening is a subset of the general use rather than a new intended use
- The performance or clinical endpoints used to evaluate general CT use can also be applied to the specific use of lung cancer screening
- . Does not perform any treatment functionality
- Does not require any other product not routinely needed for general CT to ● achieve the specific use safely or effectively
- Does not include any modifications to the general use CT device .

The more specific use of low dose lung cancer screening is a subset of the general use, rather than a new intended use. As such, Siemens is of the opinion that the Intended Use/Indications for use are substantially equivalent to the predicate devices.

#### 9. Indications for Use:

This computed tomography system is intended to generate and process crosssectional 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.

This CT system can be used for low dose lung cancer screening in high risk populations. *

{26}------------------------------------------------

*As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

#### (See Indications for Use Statement for full Indications for Use Statements)

#### 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 order to demonstrate substantial equivalence, the more specific indications for use low dose of lung cancer screening was assessed in accordance with guidance document "Guidance for Industry. General/Specific Intended Use" issued November 4, 1998, and presentation "FDA/MITA Meeting on LDCT Lung Cancer Screening", dated October 8, 2014. In accordance with these documents, it was determined that the modified more specific indication for use does not alter the intended use for the legally marketed predicate devices with a qeneral indication for use, nor does it alter the intended diagnostic effect in comparison to the predicate devices.

In accordance with guidance document "Guidance for Industry. General/Specific Intended Use" issued November 4, 1998, it was determined that:

- The more specific indications for use of low dose lung cancer screening does not ● introduce risks not normally associated with the general use of the CT device, as the nature of CT, functionality, and performance has not been changed.
Based on Siemens evaluation of publically available information regarding the risk/benefits associated with the use of Computed tomography for lung cancer screening, Siemens is of the belief that the use of Siemens CT scanners for low dose lung cancer screening does not impact public health to a significantly greater degree than the general diagnostic use of the device, and falls within the general use of CT, as the criteria for low dose lung cancer screening is a subset of the criteria for general use CT.

- There is an extensive body of publically available evidence that reflects existing understanding by the medical community that the more specific use of CT for low dose lung cancer screening is a subset of the general use of CT, rather than a new intended use.
- . Several general CT technical characteristics can also be used to define acceptable performance levels for use in lung cancer screening.
- . The use of CT for low dose lung cancer screening is not intended to perform any treatment functions.

{27}------------------------------------------------

- . There is no product not routinely needed for general CT required for use to safely or effectively perform the task of low dose lung cancer screening with CT.
- . The use of CT for low dose lung cancer screening does not render the device less applicable to the diagnostic X-ray system tasks of general CT. The more specific use of low dose lung cancer screening is a subset of the general use, rather than a new intended use.

A comparison of the available protocol information for the Siemens CT predicate device utilized as part of the NLST study was also conducted, and the resulting information was provided within this submission to support the finding of substantial equivalence.

The predicate devices were cleared based on non-clinical supportive information and clinical images. The results of these tests demonstrate that the predicate devices are adequate for the intended use. The comparison of technological characteristics, nonclinical 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.