(119 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard CT technology and image processing, without mentioning any AI/ML components.
No
This device is a diagnostic imaging system (CT scanner) used for generating images to aid in diagnosis and screening, not for providing direct therapy or treatment.
Yes
The device is a Computed Tomography (CT) system intended to generate images that "can be used by a trained physician as an aid in diagnosis." It also states that the images "can be used by trained staff for post-processing applications commercially distributed by Siemens and other vendors as an aid in diagnosis and treatment preparation." Both uses explicitly align with the definition of a diagnostic device.
No
The device description explicitly states it is comprised of CT Scanner Systems (hardware) and the software is a component of these systems used for control, reconstruction, and processing.
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 description clearly states that this is a computed tomography (CT) system that generates and processes images of patients using x-ray transmission data. This is an in vivo imaging technique, meaning it is performed on a living organism (the patient) rather than on a sample taken from the patient.
- Intended Use: The intended use is to generate images to aid in diagnosis and for low dose lung cancer screening. This is consistent with an imaging device, not an IVD.
Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for 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. High risk populations are 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
JAK, LLZ
Device Description
The Siemens SOMATOM go. Platform is comprised of 2 Computed Tomography (CT) Scanner Systems, SOMATOM go.Now and SOMATOM go.Up. These CT scanners feature one continuously rotating tube-detector system and function according to the fan beam principle. The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The SOMATOM go.Now and SOMATOM go.Up scanners produce CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Siemens and other vendors as an aid in diagnosis and treatment preparation. The computer system delivered with the CT scanner is able to run optional post processing applications.
The software version for the SOMATOM go.Now and SOMATOM go.Up scanners, syngo CT VA10A (SOMARIS/10 syngo CT VA10A), is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The software platform SOMARIS/10 syngo CT VA10A is designed to provide a plugin interface to integrate potential advanced post processing tasks, tools, or extendable functionalities.
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
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 go.Now and SOMATOM go.Up during product development. The modifications described in this Premarket Notification were supported with verification 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 go.Now and SOMATOM go.Up in accordance with the following standards: IEC 60601-1, 60601-2-44, and 60601-1-2. Completed Form 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 support the claim of substantial equivalence.
Siemens Healthcare conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse 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. Additionally, Siemens conforms to the requirements for Radio Frequency Wireless Technology as defined in FDA guidance document "Radio Frequency Wireless Technology in Medical Devices, Guidance for Industry and Food and Drug Administration Staff, issued on August 14, 2013" by adhering to the EMC and risk based verification and validation requirements in design, testing, and labeling of the wireless remote control components of the subject devices.
The Radio Frequency Wireless Technology of Remote Scan Control and Control Device (Scan&GO) which are options for SOMATOM go.Now and SOMATOM go.Up CT Systems complies to 47 CFR part 15 subpart c – Intentional Radiators. All Radio device labels will show an FCC ID code to show the compliance.
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 go.Now and SOMATOM go.Up during product development. The modifications described in this Premarket Notification were supported with verification 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.
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 support the claim of substantial equivalence.
The National Lung Screening Trial (NLST), sponsored by the National Cancer Institute, is used to support the additional lung cancer screening Indications for Use. The study was a randomized trial of screening with the use of low-dose CT compared to chest radiography to determine whether screening with low-dose CT could reduce mortality from lung cancer. The study start date was August, 2002 and the completion date was October, 2010. The interpretation task with CT for this study was to detect lung nodules of 4mm diameter or greater.
Summary of results: 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 and validation testing of the device was found acceptable to support the claim of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 21, 2017
Siemens Medical Solutions USA, Inc. % Ms. Kimberly Mangum Regulatory Affairs Specialist 40 Liberty Blvd., Mail Code 65-1A MALVERN PA 19355
Re: K163296
Trade/Device Name: Somatom Go.up, Somatom Go.now Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: February 21, 2017 Received: February 23, 2017
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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael O'Hara
For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K163296
Device Name Somatom Go.up, Somatom Go.now
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 CT system can be used for low dose lung cancer screening in high risk populations. High risk populations are 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)
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3
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510(K) SUMMARY FOR SOMATOM GO. PLATFORM SCANNERS Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Date Prepared: January 26, 2017
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 Siemensstr. 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:
Kimberly Mangum Requlatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Phone: (610) 448-6477 Fax: (610) 640-4481 Email: kimberly.mangum@siemens.com
II. Device Name and Classification
| Product Name: | SOMATOM go.Now |
|---|---|
| Propriety Trade Name: | SOMATOM go.Now |
| Classification Name: | Computed Tomography X-Ray System |
| Secondary Classification Name: | Picture Archiving and Communications System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Secondary CFR Section: | 21 CFR 892.2050 |
| Device Class: | Class II |
| Primary Product Code: | JAK |
| Secondary Product Code: | LLZ |
4
lll.
| Product Name: | SOMATOM go.Up |
|---|---|
| Propriety Trade Name: | SOMATOM go.Up |
| Classification Name: | Computed Tomography X-Ray System |
| Secondary Classification Name: | Picture Archiving and Communications System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Secondary CFR Section: | 21 CFR 892.2050 |
| Device Class: | Class II |
| Primary Product Code: | JAK |
| Secondary Product Code: | LLZ |
| Predicate Device | |
| Primary Predicate Device: | |
| Trade Name: | SOMATOM Perspective |
| 510(k) Number: | K142955 |
| Clearance Date: | November 24, 2015 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 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 |
| Secondary Predicate Devices: | |
| Trade Name: | SOMATOM Drive |
| 510(k) Number: | K161196 |
| 510(k) Number: | K161196 |
|---|---|
| Clearance Date: | August 24, 2016 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 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 |
Trade Name: SOMATOM Scope
| 510(k) Number: | K142955 |
|---|---|
| Clearance Date: | November 24, 2015 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 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
The Siemens SOMATOM go. Platform is comprised of 2 Computed Tomography (CT) Scanner Systems, SOMATOM go.Now and SOMATOM go.Up. These CT scanners feature one continuously rotating tube-detector system and function according to the fan beam principle. The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The SOMATOM go.Now and SOMATOM go.Up scanners produce CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Siemens and other vendors as an aid in diagnosis and treatment preparation. The computer system delivered with the CT scanner is able to run optional post processing applications.
5
The software version for the SOMATOM go.Now and SOMATOM go.Up scanners, syngo CT VA10A (SOMARIS/10 syngo CT VA10A), is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The software platform SOMARIS/10 syngo CT VA10A is designed to provide a plugin interface to integrate potential advanced post processing tasks, tools, or extendable functionalities.
The SOMATOM go.Now and SOMATOM go.Up will support the following modifications in comparison to the predicate devices:
- New Marketing Name: SOMATOM go.Now or SOMATOM go.Up ●
- New/Modified Hardware ●
- Gantry Mechanics (modified) ●
- Generator (modified) ●
- Patient Table (modified)
- . Stellar Detector Technology (modified)
- Remote Scan Control (wired/wireless) (new) ●
- Control Box (modified)
- X-Ray Tube (modified)
- . Software version SOMARIS/10 syngo CT VA10A
- Basic Post Processing Viewer (modified) ●
- Acquisition Application (modified) ●
- Image Reconstruction (modified)
- Interface for Advanced Post Processing Application (new) .
- Interface for Plugin (for future advanced visualization tools and extended functionalities) ● (new)
- . Interface to support an optional mobile workflow control application software (new)
- . Update 510(k) Information
A comparison of these modifications with respect to the predicate devices is provided the "Comparison of Technological Characteristics with the Predicate Device" section below. As with the primary predicate device, the SOMATOM go.Now will be available in a 16 row 32 slice configuration. The SOMATOM go.Up will be available in a 32 row 64 slice configuration. Both the SOMATOM qo.Now and the SOMATOM go.Up will include a UFC stellar-technology based detector system, with the SOMATOM go.Now supporting an 11.2 mm detector coverage in comparison to the SOMATOM go.Up which supports a 22.4 mm detector coverage. A summary of the differences between the SOMATOM go.Now and the SOMATOM go.Up is provided as Table 1 below:
| Key specifications | go.Now | go.Up |
|---|---|---|
| Physical Rows | 16 | 32 |
| Slice width (mm) | 0.7 | 0.7 |
| z coverage (mm) | 11.2 | 22.4 |
| Rotation time (s) | 0.8, 1.0, 1.5 | 0.8, 1.0, 1.5 |
| FoV (cm) | 50 | 50 |
| Max scan range (cm) | 125 | |
| 160 | 160 | |
| Bore size (cm) | 70 | 70 |
| Gantry tilt | NO | YES |
| Table Vertical Movement | Standard: No | |
| Optional: YES | YES | |
| Table Load (kg) | Table Load: 160 | |
| Optional: 227 | 227 | |
| Power (kW) | 32 | 32 |
| XTA X-ray Tube | Chronon | Chronon |
| Tube heat capacity (MHU) | 3.5 | 3.5 |
Table 1: Subject Device Comparable Properties
6
| Key specifications | go.Now | go.Up |
|---|---|---|
| Recon speed (images/s) | 9 (optional 13) | 13 |
| CaScoring | N/A | optional |
| Detector width | 11.2 mm | 22.4 mm |
| Iterative Reconstruction Methods | SAFIRE, iMAR | SAFIRE, iMAR |
| Spiral Scan | yes | yes |
V. Indications for 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. High risk populations are 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 go.Now and SOMATOM go.Up scanners provide the same technological characteristics in terms of materials, energy source, and control mechanisms when compared to the predicate devices. The software and hardware components of these scanners have been modified or improved in comparison to the predicate devices to support enhanced device functionality compared to the predicate devices. The hardware components of the subject device have been modified to include a Remote Scan Control (RSC) and a Control Device (Scan&GO) user interface (e.g. user interface via mobile tablet software application), modified gantry mechanics and patient tables, and a Stellar Technology detector.
Software version SOMARIS/10 syngo CT VA10A supports software features that are designed to enhance the user workflow such as, extended functionalities and GO technologies which provide interfaces to directly access optional post processing applications. The intended use and fundamental scientific technology for the SOMATOM go.Now and SOMATOM go.Up remains unchanged from the predicate devices.
At a high level, the subject and predicate devices are based on the following same technological 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 ●
- Tin filtration technology ●
- o Stellar detector technology
- . High Power 80 (High mA @low kV)
The following technological differences exist between the subject device and predicate devices:
- Software version SOMARIS/10 syngo CT VA10A ●
- Chronon X-ray Tube ●
- 32 kW maximum power Generator ●
- . Modified gantry that supports the integration of the ICS and IRS computers
- Support of additional cybersecurity features ●
- Support of workflow improvement features GO technologies ●
- Support of optional wired/wireless remote scan control module .
7
- . Support of interfaces to access optional post-processing applications
A tabular summary of the differences between the predicate and subject devices is provided as Table 2 below:
| Property | Subject
Device
SOMATOM
go.Up,
SOMATOM
go.Now | Primary
Predicate Device
SOMATOM
Perspective
(K142955) | Secondary
Predicate Device
SOMATOM Drive
(K161196) | Secondary
Predicate
Device
SOMATOM Scope
(K142955) | |
|--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|----------------|
| Type of CT
Scanner | whole body X-
ray computed
tomography
scanner | whole body X-ray
computed
tomography
scanner | whole body X-ray
computed
tomography scanner | whole body X-ray
computed
tomography scanner | |
| Sytem
Hardware | continuously
rotating tube
detector system | continuously
rotating tube
detector system | two continuously
rotating tube detector
systems | continuously rotating
tube detector system | |
| | high voltage
generator with
max power
32kW | high voltage
generator with max
power 55kW | high voltage
generator with max
power 2x100kW | high voltage
generator with max
power 26kW | |
| X-Ray Tube | Chronon | DURA 688/422 | STRATON MX
Sigma | DURA 352/202 | |
| kV Steps | 80kV,
110kV,130kV | 80kV, 110kV,130kV | 70 kV, 80kV, 90kV,
100kV,
110kV, 120kV,
130kV,
140kV | 80kV, 110kV,130kV | |
| Selective
Photon Shield | Tin Filter
Technology | N/A | Tin Filter Technology | N/A | |
| HMI & Gantry
Display | realized as
wireless tablet
mobile medical
application
software,
remote scan
control
(wired/wireless) | realized as buttons
on both side of the
gantry;
touch display panel
on gantry | realized as touch
screen and buttons
on both sides of the
gantry | realized as buttons
on both side of the
gantry; one LCD
display on gantry
front | |
| Operating
System | Windows based
SOMARIS/10
syngo CT
VA10A | Windows based
SOMARIS/5 syngo
CT VC40 | Windows based
SOMARIS/7 syngo
CT VA62A | Windows based
SOMARIS/5 syngo
CT VC40 | |
| Software | Basic Post
Processing
Viewer
CT View&GO | Basic Post
Processing
provided by :
syngo Viewing
syngo Filming | Basic Post
Processing provided
by:
syngo Viewing
syngo Filming | Basic Post
Processing provided
by :
syngo Viewing
syngo Filming | |
| Property | Subject
Device
SOMATOM
go.Up,
SOMATOM
go.Now | Primary
Predicate Device
SOMATOM
Perspective
(K142955) | Secondary
Predicate Device
SOMATOM Drive
(K161196) | Secondary
Predicate
Device
SOMATOM Scope
(K142955) | |
| Interface for
Advanced Post
Processing
Application | Interface for
Advanced Post
Processing
Application | Optional post
processing and
visualization
applications
accessed via a
supported
workstation | Optional post
processing and
visualization
applications
accessed via a
supported
workstation | Optional post
processing and
visualization
applications
accessed via a
supported
workstation | |
| Interface for
Plugin (for
future advanced
visualization
tools and
extended
functionalities) | Interface for
Plugin (for
future advanced
visualization
tools and
extended
functionalities) | Optional post
processing and
visualization
applications
accessed via a
supported
workstation | Optional post
processing and
visualization
applications
accessed via a
supported
workstation | Optional post
processing and
visualization
applications
accessed via a
supported
workstation | |
| Interface to
support an
optional mobile
workflow control
application
software | Interface to
support an
optional mobile
workflow control
application
software | Support of optional
i-control
interventional
module that can be
operated as a wired
or Bluetooth
connection based
wireless table and
gantry control
module | Support of optional i-
control interventional
module that can be
operated as a wired
or Bluetooth
connection based
wireless table and
gantry control
module | N/A | |
| Image
Reconstruction | Image
Reconstruction | Image
Reconstruction | Image
Reconstruction | Image
Reconstruction | |
| IT Hardening | IT Hardening | IT features
supported that
protect against
cybersecurity
attacks | IT Hardening | IT features
supported that
protect against
cybersecurity attacks | |
| Data Exchange
with external
SW client
(Teamplay) -
allows to copy
scan protocols
from other
systems | Data Exchange
with external
SW client
(Teamplay) -
allows to copy
scan protocols
from other
systems | support of
availability of scan
protocols form
other systems | Data Exchange with
external SW client
(Teamplay) - allows
to copy scan
protocols from other
systems | support of availability
of scan protocols
form other systems | |
| Iterative
Reconstruction
Methods | Iterative
Reconstruction
Methods | SAFIRE
iMAR | SAFIRE
iMAR | ADMIRE
SAFIRE
iMAR | SAFIRE
iMAR |
Table 2: Comparison of Technological Characteristics
8
Any differences in technological characteristics do not raise different questions of safety and effectiveness. Siemens believes that the subject device is substantially equivalent to the predicate devices. Testing and validation is completed. Test results show that the subject devices, the SOMATOM go.Now and SOMATOM go.Up, are comparable to the predicate devices
9
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 go.Now and SOMATOM go.Up during product development. The modifications described in this Premarket Notification were supported with verification testing. Siemens claims conformance to the following performance standards: ISO 14791, NEMA XR-29, IEC 61223-2-6, IEC 61223-3-5, IEC 62304, NÈMA XR-25, and DICOM 3.1-3.20.
Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted on the SOMATOM go.Now and SOMATOM go.Up in accordance with the following standards: IEC 60601-1, 60601-2-44, and 60601-1-2. Completed Form FDA 3654 are provided within this submission.
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 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 support the claim of substantial equivalence.
Siemens Healthcare conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse 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. Additionally, Siemens conforms to the requirements for Radio Frequency Wireless Technology as defined in FDA guidance document "Radio Frequency Wireless Technology in Medical Devices, Guidance for Industry and Food and Drug Administration Staff, issued on August 14, 2013" by adhering to the EMC and risk based verification and validation requirements in design, testing, and labeling of the wireless remote control components of the subject devices.
The Radio Frequency Wireless Technology of Remote Scan Control and Control Device (Scan&GO) which are options for SOMATOM go.Now and SOMATOM go.Up CT Systems complies to 47 CFR part 15 subpart c – Intentional Radiators. All Radio device labels will show an FCC ID code to show the compliance.
Additional Supportive Data
The National Lung Screening Trial (NLST), sponsored by the National Cancer Institute, is used to support the additional lung cancer screening Indications for Use. The study was a randomized trial of screening with the use of low-dose CT compared to chest radiography to determine whether screening with low-dose CT could reduce mortality from lung cancer. The study start date was August, 2002 and the completion date was October, 2010. The interpretation task with CT for this study was to detect lung nodules of 4mm diameter or greater.
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 and validation testing of the device was found acceptable to support the claim of substantial equivalence.
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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 hardware and software verification and validation demonstrates that the SOMATOM go.Now and SOMATOM go.Up should perform as intended in the specified use conditions. The data included in this submission demonstrates that the SOMATOM go.Now and SOMATOM go.Up scanners 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 go.Now and SOMATOM go.Up testing supports a finding of substantial equivalence.