(116 days)
Not Found
No
The document describes standard CT image reconstruction and processing techniques, including an iterative reconstruction method (iTRIM), but does not mention AI, ML, or related concepts.
No.
The device is described as a Computed Tomography (CT) system intended to generate and process cross-sectional images for diagnosis and treatment preparation, not for direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the images delivered by the system "can be used by a trained physician as an aid in diagnosis." This directly indicates its role as a diagnostic device.
No
The device description explicitly states it is a "Computed Tomography X-ray System" and describes hardware components like a "continuously rotating tube-detector system." While it includes software for image processing and control, it is fundamentally a hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The SOMATOM CT Scanner Systems are imaging devices that use X-rays to generate cross-sectional images of the patient's body. They do not analyze samples taken from the body.
- Intended Use: The intended use clearly states that the system generates and processes images of patients by computer reconstruction of x-ray transmission data. The images are used as an aid in diagnosis and treatment preparation. This is consistent with the function of a medical imaging device, not an IVD.
Therefore, the SOMATOM CT Scanner Systems described are medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
SOMATOM Perspective:
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.
The images delivered by the system can be used by trained staff as an aid in diagnosis and treatment preparation.
However, the images delivered by this system should not be used as an aid in radiation therapy planning.
For cardiac imaging, which is an option on the system, a reconstruction algorithm (iTRIM lterative 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.
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.
SOMATOM Scope/ Scope Power:
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.
The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning.
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.
SOMATOM Emotion 16:
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.
The images delivered by the system can be used by trained staff as an aid in diagnosis and treatment preparation.
However, the images delivered by this system should not be used as an aid in radiation therapy planning.
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.
Product codes (comma separated list FDA assigned to the subject device)
JAK, LLZ
Device Description
Siemens intends to market a new software version, SOMARIS/5 syngo CT VC50 for the following SOMATOM Computed Tomography (CT) Scanner Systems:
- SOMATOM Perspective
- SOMATOM Scope/Scope Power
- SOMATOM Emotion16
The subject devices SOMATOM CT Scanner Systems with SOMARIS/5 syngo CT VC50 are Computed Tomography X-ray Systems which support continuously rotating tube-detector system and function according to the fan beam principle. The SOMATOM CT Scanner Systems with software version SOMARIS/5 syngo CT VC50 produce CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Siemens Healthcare and other vendors as an aid in diagnosis, treatment preparation and therapy planning support (including, but not limited to, Brachytherapy, Particle including Proton Therapy, External Beam Radiation Therapy, Surgery). The computer system delivered with the CT scanners is able to run optional post processing applications.
The platform software for the SOMATOM CT Scanner Systems, SOMARIS/5 syngo CT VC50, is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The subject devices with software version SOMARIS/5 syngo CT VC50 will support the following modifications in comparison to the predicate devices: - Modified Indications for Use Statement 1)
-
- Software version SOMARIS/5 syngo CT VC50 (See Table 1.)
-
- Update 510(k) Information
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray transmission data (Computed Tomography)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician, trained staff
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
Non-clinical test (integration and functional) including phantom tests were conducted for the SOMATOM CT Scanner Systems during product development. The modifications described in this Premarket Notification were supported with verification and validation testing. Siemens claims conformance to the following performance standards: ISO 14791. NEMA XR-29. IEC 61223-2-6, IEC 61223-3-5, IEC 62304, NEMA XR-25, and DICOM 3.1-3.20.
Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted on the SOMATOM CT Scanner Systems in accordance with the following standards: IEC 60601-1, 60601-2-44, and 60601-1-2. Completed Forms FDA 3654 are provided within this submission.
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. The performance data demonstrates continued conformance with special controls for medical devices containing software. The Risk Analysis was completed and risk control implemented to mitigate identified hazards. The testing supports that all software specifications have met the acceptance criteria. Testing for verification and validation supports the claims of substantial equivalence.
The features described in this premarket notification are supported with verification and validation testing, dosimetry and imaging performance, and analysis of phantom images to assess device and feature performance during product development. The risk analysis was completed and risk control implemented to mitigate identified hazards. The test results show that all of the software specifications have met the acceptance criteria. Verification testing of the device was found acceptable to support the claim of substantial equivalence.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical test (integration and functional) including phantom tests were conducted for the SOMATOM CT Scanner Systems during product development. The modifications described in this Premarket Notification were supported with verification and validation testing. Siemens claims conformance to the following performance standards: ISO 14791. NEMA XR-29. IEC 61223-2-6, IEC 61223-3-5, IEC 62304, NEMA XR-25, and DICOM 3.1-3.20. Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted on the SOMATOM CT Scanner Systems in accordance with the following standards: IEC 60601-1, 60601-2-44, and 60601-1-2. The testing supports that all software specifications have met the acceptance criteria. Testing for verification and validation supports the claims of substantial equivalence. The features described in this premarket notification are supported with verification and validation testing, dosimetry and imaging performance, and analysis of phantom images to assess device and feature performance during product development. The test results show that all of the software specifications have met the acceptance criteria. Verification testing of the device was found acceptable to support the claim of substantial equivalence. The predicate devices were cleared based on the results of non-clinical testing including verification and validation, phantom tests, and supportive literature. The subject device is also tested using the same methods as used for the predicate devices. The non-clinical data supports the safety of the device and the software verification and validation demonstrates that the subject device SOMATOM CT Scanner Systems should perform as intended in the specified use conditions. The data included in this submission demonstrates that the SOMATOM CT Scanner Systems perform comparably to the predicate devices currently marketed for the same intended use. Since both devices were tested using the same methods, Siemens believes that the data generated from the SOMATOM CT Scanner Systems testing supports a finding of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
With the introduction of the next generation "HD FoV 3.0," phantom testing showed that the SOMATOM Perspective due to its differing system geometry cannot meet an HU accuracy of +/-20 HU as with the predicate device K173630. Therefore, the HU accuracy claim was modified to +/- 25 HU for the SOMATOM Perspective platform. This change is noted in the User Instruction documentation.
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.
K142955, K151765, K151749, K151752, K173630
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
§ 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.
0
Please wait...
If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document.
You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader_download.
For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader.
Windows is either a registered trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc., registered in the United States and other countries. Linux is the registered trademark of Linus Torvalds in the U.S. and other countries.
1
Please wait...
If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document.
You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader_download.
For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader.
Windows is either a registered trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc., registered in the United States and other countries. Linux is the registered trademark of Linus Torvalds in the U.S. and other countries.
2
Please wait...
If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document.
You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader_download.
For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader.
Windows is either a registered trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc., registered in the United States and other countries. Linux is the registered trademark of Linus Torvalds in the U.S. and other countries.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health & Human Services logo, which features an abstract image of a person. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Siemens Medical Solutions USA, Inc. % Ms. Kimberly Rendon Senior Manager Regulatory Affairs 40 Liberty Blvd. MALVERN PA 19355
April 15, 2019
Re: K183548
Trade/Device Name: SOMATOM Perspective, SOMATOM Scope/Scope Power, and SOMATOM Emotion 16 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK, LLZ Dated: March 19, 2019 Received: March 22, 2019
Dear Ms. Rendon:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
4
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Image /page/5/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of orange dots in a pattern.
K183548 510(K) SUMMARY
SOMATOM CT SCANNER SYSTEMS - SOFTWARE VERSION SOMARIS/5 syngo CT VC50
Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, Malvern, PA 19355 Date Prepared: February 19, 2019
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.
I. Submitter
Importer/Distributor Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number 2240869
Location of Manufacturing Site (1) Siemens Healthcare GmbH Siemensstrasse 1 D-91301 Forchheim, Germany Establishment Registration Number 3004977335
Location of Manufacturing Site (2) SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD 278 Zhou Zhu Rd Shanghai, CHINA, 201318 Establishment Registration Number: 3003202425
Contact Person: Kim Rendon Senior Manager Regulatory Affairs 610-448-6480
II. Device Name and Classification
Product Name: Trade Name: Classification Name: Classification Panel: Regulation Number: Device Class: Product Code: Secondary Product Code: LLZ
SOMATOM Perspective SOMATOM Perspective Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II JAK
6
Image /page/6/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern.
| Product Name: | SOMATOM Scope/Scope Power |
|---|---|
| Trade Name: | SOMATOM Scope/Scope Power |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| Secondary Product Code: | LLZ |
| Product Name: | SOMATOM Emotion 16 |
| Trade Name: | SOMATOM Emotion 16 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| Secondary Product Code: | LLZ |
III. Predicate Device Primary Predicate Device:
| Trade Name: |
|---|
| 510(k) Number: |
| Clearance Date: |
| Classification Name: |
| Classification Panel: |
| Regulation Number: |
| Device Class: |
| Product Code: |
| Recall Information: |
SOMATOM Computed Tomography System Family Scanners K142955 November 24, 2015 Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II JAK All applicable recalls are considered and addressed as part of the design control process
Predicate Device:
Trade Name: 510(k) Number: Clearance Date: Classification Name: Classification Panel: Regulation Number: Device Class: Product Code: Recall Information:
SOMATOM Perspective K151765 March. 25, 2016 Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II JAK All applicable recalls are considered and addressed as part of the design control process
Predicate Device:
- Trade Name: 510(k) Number: Clearance Date: Classification Name: Classification Panel: Requlation Number: Device Class: Product Code: Recall Information:
SOMATOM Scope/Scope Power K151749 March.18, 2016 Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II JAK All applicable recalls are considered and addressed as part of the design control process
7
Image /page/7/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a cluster of orange dots.
Predicate Device:
| Trade Name:
510(k) Number: | SOMATOM Emotion 6/16
K151752 |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clearance Date: | November.12, 2015 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| Requlation Number: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| Recall Information: | All applicable recalls are considered and addressed as part of the
design control process |
| Predicate Device | |
| Trade Name: | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive,
SOMATOM Definition Edge, SOMATOM Definition AS Open,
SOMATOM Definition AS/AS+, SOMATOM Confidence |
| 510(k) Number: | K173630 |
| Clearance Date: | March 30, 2018 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| Requlation Number: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| Recall Information: | All applicable recalls are considered and addressed as part of the
design control process |
IV. Device Description
Siemens intends to market a new software version, SOMARIS/5 syngo CT VC50 for the following SOMATOM Computed Tomography (CT) Scanner Systems:
- . SOMATOM Perspective
- SOMATOM Scope/Scope Power ●
- SOMATOM Emotion16 .
The subject devices SOMATOM CT Scanner Systems with SOMARIS/5 syngo CT VC50 are Computed Tomography X-ray Systems which support continuously rotating tube-detector system and function according to the fan beam principle. The SOMATOM CT Scanner Systems with software version SOMARIS/5 syngo CT VC50 produce CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Siemens Healthcare and other vendors as an aid in diagnosis, treatment preparation and therapy planning support (including, but not limited to, Brachytherapy, Particle including Proton Therapy, External Beam Radiation Therapy, Surgery). The computer system delivered with the CT scanners is able to run optional post processing applications.
The platform software for the SOMATOM CT Scanner Systems, SOMARIS/5 syngo CT VC50, is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The subject devices with software version SOMARIS/5 syngo CT VC50 will support the following modifications in comparison to the predicate devices:
- Modified Indications for Use Statement 1)
-
- Software version SOMARIS/5 syngo CT VC50 (See Table 1.)
-
- Update 510(k) Information
8
Image /page/8/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of orange dots.
Table 1: Overview of SW modifications to CT System Scanners with SOMARIS/5 syngo CT VC50 SW
| # | SOMATOM CT System Scanner | Subject Devices | ||
|---|---|---|---|---|
| with | ||||
| SOMARIS/5 syngo CT VC50 | ||||
| property | SOMATOM | |||
| Perspective | SOMATOM Scope/Scope | |||
| Power | SOMATOM | |||
| Emotion16 | ||||
| 1 | HD FoV 3.0 | Modified | Modified | N/A |
| 2 | IT Hardening | Enabled | Enabled | Enabled |
| 3 | Scan Protocol Management in | |||
| Teamplay | Unmodified | Unmodified | Enabled | |
| 4 | Team Viewer | Unmodified | Unmodified | Enabled |
| 5 | Dual Topo | Unmodified | Unmodified | Enabled |
A comparison of these modifications with respect to the predicate devices is provided in the "Comparison of Technological Characteristics with the Predicate Device" section below. Software version SOMARIS/5 syngo CT VC50 will be offered as an optional upgrade for the applicable existing SOMATOM CT Systems.
V. Indications for Use
SOMATOM Perspective
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.
The images delivered by the system can be used by trained staff as an aid in diagnosis and treatment preparation.
However, the images delivered by this system should not be used as an aid in radiation therapy planning.
For cardiac imaging, which is an option on the system, a reconstruction algorithm (iTRIM lterative 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.
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.
SOMATOM Scope/ Scope Power
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.
The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning.
9
Image /page/9/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern.
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.
SOMATOM Emotion 16
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.
The images delivered by the system can be used by trained staff as an aid in diagnosis and treatment preparation.
However, the images delivered by this system should not be used as an aid in radiation therapy planning.
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.
VI. Comparison of Technological Characteristics with the Predicate Device
The SOMATOM CT Scanner Systems with software version SOMARIS/5 syngo CT VC50 provides the same technological characteristics in terms of materials, energy source, and control mechanisms when compared to the predicate devices. The software of these scanners has been modified or improved in comparison to the predicate devices to support enhanced device functionality.
The device specific software features supported for software version SOMARIS/5 syngo CT VC50 depend on the SOMATOM CT Scanner Systems technological characteristics and are provided as optional features for updating the installed base: SOMATOM Perspective, SOMATOM Scope/Scope Power and SOMATOM Emotion 16 CT systems. A pre-condition for all newly supported subject device software modifications is that the technological characteristics of the hardware must support its intended software usage.
The intended use, fundamental scientific technology, and hardware for the SOMATOM Perspective, SOMATOM Scope/Scope Power and SOMATOM Emotion 16 remains unchanged from the predicate devices.
At a high level, the subject and predicate devices are based on the following same technoloqical elements:
- · Scanner Principle- Whole body X-Ray Computed Tomography Scanner
- · System Acquisition Continuously rotating tube detector system
- · Iterative Reconstruction Support of various iterative reconstruction methods
- · Workplaces Support of workplaces that include reconstruction and image evaluation software
- · Patient table
- · Patient table foot switch for movement
10
Image /page/10/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the word "Healthineers" is a graphic of orange dots.
The following technological differences exist between the subject device and predicate devices:
- . Software version SOMARIS/5 syngo CT VC50
- . Support of additional cybersecurity features
With the introduction of the next generation "HD FoV 3.0," phantom testing showed that the SOMATOM Perspective due to its differing system geometry cannot meet an HU accuracy of +/-20 HU as with the predicate device K173630. Therefore, the HU accuracy claim was modified to +/- 25 HU for the SOMATOM Perspective platform. This change is noted in the User Instruction documentation.
There are no hardware modifications for the subject devices in comparison to the predicate devices. All previously cleared predicate device hardware properties and components remain unchanged.
Additionally, low dose lung cancer screening was approved for the predicate device in K142955, the subject devices demonstrate substantial equivalence for the indication based on substantially equivalent image quality and dose metrics compared to that predicate.
A tabular summary of the comparable software properties for the subject devices with software version SOMARIS/5 syngo CT VC50 and the predicate devices are listed in Table 2.
| Subject Device | Predicate Devices | |||||
|---|---|---|---|---|---|---|
| Software | ||||||
| Property | SOMATOM | |||||
| Perspective | SOMATOM | |||||
| Emotion 16 | SOMATOM | |||||
| Perspective | SOMATOM | |||||
| Scope/Scope | ||||||
| Power | SOMATOM | |||||
| Emotion 6/16 | SOMATOM Force, | |||||
| SOMATOM | ||||||
| Definition Flash, | ||||||
| SOMATOM Drive, | ||||||
| SOMATOM | ||||||
| Definition Edge, | ||||||
| SOMATOM | ||||||
| Scope/Scope | ||||||
| Power | SOMATOM | |||||
| Definition AS | ||||||
| Open, SOMATOM | ||||||
| Definition AS/AS+. | ||||||
| SOMATOM | ||||||
| Confidence | ||||||
| syngo CT VC50 | K151765 | K151749 | K151752 | K173630 | ||
| Operating | ||||||
| System | Windows | |||||
| based | ||||||
| SOMARIS/5 | ||||||
| syngo CT | ||||||
| VC50 | Windows | |||||
| based | ||||||
| SOMARIS/5 | ||||||
| syngo CT | ||||||
| VC50 | Windows | |||||
| based | ||||||
| SOMARIS/5 | Windows based | |||||
| SOMARIS/5 | Windows based | |||||
| SOMARIS/5 | Windows based | |||||
| SOMARIS/7 | ||||||
| Software | IT Hardening | IT Hardening | IT features | |||
| supported that | ||||||
| protect | ||||||
| against | ||||||
| cybersecurity | ||||||
| attacks | IT features | |||||
| supported that | ||||||
| protect against | ||||||
| cybersecurity | ||||||
| attacks | IT features | |||||
| supported that | ||||||
| protect against | ||||||
| cybersecurity | ||||||
| attacks | IT | |||||
| Hardening | ||||||
| Scan protocol | ||||||
| management | ||||||
| in Teamplay | Scan | |||||
| protocol | ||||||
| management | ||||||
| in Teamplay | Same as | |||||
| subject device | Same as subject | |||||
| device | N/A | Scan protocol | ||||
| management in | ||||||
| Teamplay | ||||||
| HD FoV 3.0 | N/A | HD FoV | HD FoV | N/A | HD FoV 3.0 | |
| Team Viewer | Team Viewer | Same as | ||||
| subject device | Same as subject | |||||
| device | net viewer | N/A | ||||
| Dual Topo | Dual Topo | Dual Topo | Dual Topo | N/A | N/A |
Table 2: Device Software Comparison for Subject and Predicate Devices
Any differences in technological characteristics do not raise different questions of safety and effectiveness. Siemens believes that the subject devices are substantially equivalent to the
11
Image /page/11/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern.
Testing and validation is completed. Test results show that the subject predicate devices. devices, the SOMATOM CT Scanner Systems with software version SOMARIS/5 syngo CT VC50, are comparable to the predicate devices in terms of technological characteristics and safety and effectiveness and therefore are substantially equivalent to the predicate devices.
VII. Performance Data
Non Clinical Testing
Non-clinical test (integration and functional) including phantom tests were conducted for the SOMATOM CT Scanner Systems during product development. The modifications described in this Premarket Notification were supported with verification and validation testing. Siemens claims conformance to the following performance standards: ISO 14791. NEMA XR-29. IEC 61223-2-6, IEC 61223-3-5, IEC 62304, NEMA XR-25, and DICOM 3.1-3.20.
Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted on the SOMATOM CT Scanner Systems in accordance with the following standards: IEC 60601-1, 60601-2-44, and 60601-1-2. Completed Forms FDA 3654 are provided within this submission.
Table 3: FDA Guidance Documents
| FDA Guidance Document and Effective Date | |
|---|---|
| 1. | Guidance for Industry and FDA Staff – User Fees and Refunds for Premarket |
| Notification Submissions 510(k) - Document issued on October 2, 2017 | |
| 2. | Guidance for Industry and Food and Drug Administration Staff: Refuse to Accept |
| Policy for 510(k)s - Document issued on January 30, 2018 | |
| 3. | Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated |
| 510(k)s - Guidance for Industry and FDA Staff - Document issued on August 12, | |
| 2005 | |
| 4. | Guidance for Industry and FDA Staff: Deciding when to submit a 510(k) for a |
| change to an existing device - Document issued on October 25, 2017 | |
| 5. | Guidance for Industry and Food and Drug Administration Staff: The 510(k) |
| Program: Evaluating Substantial Equivalence in Premarket Notifications | |
| [510(k)] - Document Issued on July 28, 2014 | |
| 6. | Guidance for Industry and FDA Staff: Guidance for the Content of Premarket |
| Submission for Software in Medical Devices - Document issued on May 11, 2005 | |
| 7. | Guidance for Industry and FDA Staff: Guidance for Off-The-Shelf Software Use in |
| Medical Devices - Document issued on September 9, 1999 | |
| 8. | Guidance for Industry and FDA Staff: Applying Human Factors and Usability |
| Engineering to Medical Devices - Document issued February 3, 2016 | |
| 9. | Guidance for Industry and FDA Staff: Pediatric Information for X-ray Imaging |
| Device Premarket Notifications - Document issued on November 28, 2017 | |
| 10. | Guidance for Industry and FDA Staff: Content of Premarket Submissions for |
| Management of Cybersecurity in Medical devices - Document issued on October 2, | |
| 2014 | |
| 11. | Guidance for Industry and FDA Staff: Information to Support a Claim of |
| Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices - | |
| Document issued on July 11, 2016 | |
| 12. | Guidance for Industry and Food Drug Administration Staff: Design considerations |
| and Pre-Market Submission recommendations for Interoperable Medical devices - | |
| Document Issued on September 6, 2017 |
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. The performance data demonstrates continued conformance with special controls for medical devices
12
Image /page/12/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern.
containing software. The Risk Analysis was completed and risk control implemented to mitigate identified hazards. The testing supports that all software specifications have met the acceptance criteria. Testing for verification and validation supports the claims of substantial equivalence.
Siemens conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Cybersecurity information in accordance with guidance document "Content of Premarket Submissions for Management of Cybersecurity Medical Devices issues on October 2, 2014" is included within this submission.
Summary
The features described in this premarket notification are supported with verification and validation testing, dosimetry and imaging performance, and analysis of phantom images to assess device and feature performance during product development. The risk analysis was completed and risk control implemented to mitigate identified hazards. The test results show that all of the software specifications have met the acceptance criteria. Verification testing of the device was found acceptable to support the claim of substantial equivalence.
General Safety and Effectiveness Concerns
The device labeling contains instructions for use as well as necessary cautions and warnings to provide for safe and effective use of the device. Risk management is ensured via a system related risk analysis, which is used to identify potential hazards. These potential hazards are controlled during development, verification and validation testing according to the Risk Management process. In order to minimize electrical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.
VIII. Conclusions
The predicate devices were cleared based on the results of non-clinical testing including verification and validation, phantom tests, and supportive literature. The subject device is also tested using the same methods as used for the predicate devices. The non-clinical data supports the safety of the device and the software verification and validation demonstrates that the subject device SOMATOM CT Scanner Systems should perform as intended in the specified use conditions. The data included in this submission demonstrates that the SOMATOM CT Scanner Systems perform comparably to the predicate devices currently marketed for the same intended use. Since both devices were tested using the same methods, Siemens believes that the data generated from the SOMATOM CT Scanner Systems testing supports a finding of substantial equivalence.