(122 days)
Not Found
No
The description focuses on providing a mobile interface for existing CT scanner controls and information, with no mention of AI/ML algorithms for image processing, analysis, or decision support.
No.
The device is a planning and information system for CT scanners and does not directly provide therapy or affect a body structure or function.
No
This device is described as a "planning and information system" for controlling CT scanners and does not support image storage or trigger scans/radiation. Its primary function is to provide a simplified view of the workstation and synchronous view of the CT scanner, not to make a diagnosis.
Yes
The device is described as "stand-alone optional planning and information software" and can be operated on a commercially available tablet, indicating it is software designed to run on general-purpose hardware, not a dedicated hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the application is a "planning and information system" for controlling and planning scans of CT scanners. It focuses on the workflow and operation of the imaging equipment.
- Device Description: The description details the software's functions, which are primarily related to controlling and displaying information from the CT scanner, such as patient selection, protocol selection, scan parameters, table position, and displaying acquired images (topogram and tomogram). It explicitly states that it "does not support storage of images" and "cannot trigger a scan or radiation release."
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with biological specimens or perform any analysis on them. Its function is solely related to the operation and control of the CT imaging process.
The device is a software application designed to facilitate the operation of a CT scanner, which is an imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The in-room scan application is a planning and information system the necessary functions required for planning and controlling scans of supported SIEMENS CT scanners. It allows users to work in close proximity to the scanner.
The in-room scan application runs on standard information technology hardware and software, utilizing the standard information technology operating systems and user interface. Communication and data exchange are done using special protocols.
Product codes
JAK, LLZ
Device Description
Scan&GO is a stand-alone optional planning and information software designed to perform the necessary functions required for planning and controlling of the workflow of supported SIEMENS CT scanners. Scan&GO can be operated on a Siemens provided tablet or a commercially available tablet that meets certain minimum technical requirements. It allows users to work in close proximity to the scanner and the patient. Specifically Scan&GO allows control/display of the following software interactions via a wireless tablet that meets certain minimum requirements:
- Selection of patients
- Selection of pre-defined protocols
- Scan parameter display
- Patient table position display and gantry tilt parameter display
- Tools and instruction message area. Patient table position planning area
- Physiological data display
- Patient data display (e.g. date of birth, name)
- Display of acquired topogram and tomogram images
- Finalization of exam (close patient)
- NOTE: Scan&GO does not support storage of images. Additionally, Scan&GO cannot trigger a scan or radiation release.
The primary function of Scan&GO is to provide a simplified view of the workstation with a synchronous view of the CT scanner (i.e. functionality that occurs on the console can be viewed on the tablet and vice versa). The standard planning and information controls cleared for the respective CT scanners will also be available for those scanners. Scan&GO will support the following modifications in comparison to the predicate device:
- New Marketing Name: Scan&GO
- New Indications for Use
- Modified hardware interface
- New software interface for control of software interactions and display of scan related information via a wireless tablet
- New software version SOMARIS/10 syngo CT VA10A
Scan&GO works together with a supported SIEMENS CT Scanner system to allow mobile workflow via Wi-Fi connection. Scan&GO is designed to be compatible current and future Siemens CT systems that support software version SOMARIS/10 syngo CT VA10A or higher.
Note:
- Control is used for selecting the patient and display of patient information (e.g. Name, Sex, Date of Birth - control of the SOMARIS/10 syngo CT VA10A Software functions)
- Scan&GO function allows to apply a scan protocol and set patient orientation.
- Scan&GO function allows planning a tomogram scan.
- Scan&GO function initiates the READY STATE of the CT scanner. This includes all activities needed to prepare a scan before trigger a scan. (Trigger of a scan is not a feature of Scan&GO ).
Additionally, the Scan&GO application is designed to work as part of a mobile workflow which allows in room control of specific functions of a CT scanner. In combination with a supported tablet which is provided as part of the respective CT scan&GO is designed to provide a synchronous view of the workstation, and will allow the user direct visualization of the tasks performed at the workstation, and limited functionality of the scanner. Users of Scan&GO may experience the following benefits:
- Mobile workflow from where ever the user is in the scanner room or at the workstation
- Get closer to your patient by moving today's console into your scanner room" Scan&GO provide a visualization of the console into the scanner room"
- Gain flexibility by operating the scanner from wherever you are in the scanner room or in the control room and make use of existing room layouts
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Non Clinical Testing
Non clinical tests (integration and functional) were conducted for Scan&GO during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.
Wireless Coexistence Testing
Testing for co-existence considered for following scenarios:
- Co-Chanel Testing
- Adjacent Chanel Testing
- RF Interference Testing
- Separation Distance/Location Testing
Customer Use Testing
- Internal Clinical Use Test. CT scanner customer environment is simulated in Siemens Test Cabins. For such a test we typically invite customers with clinical expertise which perform tests.
- External Clinical Use Test: The CT scanner is tested in the environment of the clinic/hospital. Typically we perform such test with selected customer before rollout of the CT scanner.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data were provided in support of the substantial equivalence determination. This submission contains performance data to demonstrate continued conformance with special controls for medical devices containing software. Non clinical tests (integration and functional) were conducted for Scan&GO 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, IEC 62304, IEC60601 and in relation to required SW functionality only: NEMA XR-25, NEMA XR-26, NEMA XR-29, 21 CFR 1020.30, and. 21 CFR 1020.33.
Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography Electrical Safety were conducted for Scan&GO in accordance with the following standard: 60601-2-44 (e.g. SCAN&GO initialize the READY STATE of the corresponding CT Scanner). 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 supports the claims 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. The Radio Frequency Wireless Technology of the tablet as a supporting hardware device for Scan&GO which is an option for Siemens CT Scanners with SOMARIS/10 complies with 47 CFR part 15 subpart c – Intentional Radiators. All Radio device labels will show an FCC ID code to show the compliance.
Shielding requirement applicable to the CT Scanners and respective Scatter Radiation diagrams for typical room installations are provided in the User Documentation and Planning Guide of the intended Scanners in accordance to IEC60601-2-44.
Siemens has considered several measures to address wireless coexistence by design to ensure the safe operation of Scan&GO and in combination with the applicable system supported functionality wireless technology in the system setup to perform a task in a given shared environment where other systems have an ability to perform their tasks and may or may not be using the same set of rules. According the FDA quidance for 'Radio Frequency Wireless Technology in Medical Devices" we have addressed the safety and effectiveness and the high likely coexistence with other devices of this technology in our product design by our Risk Management Process, Failure Mode and Effects Analysis (FMEA) Process and Requirement Engineering Process. As part of the risk management process, hazardous situations associated with the Scan&GO and it's connection to the host system via Wi-Fi were addressed as part of the Risk Management process.
All test performed meet the pre-determined acceptance criteria and demonstrate that Scan&GO is safe and effective for the intended use.
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.
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 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
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" arranged 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 24, 2017
Siemens Medical Solutions USA, Inc. % Ms. Kimberly Mangum Regulatory Affairs Specialist 40 Liberty Blvd., 65-1A MALVERN PA 19355
Re: K163297
Trade/Device Name: Scan&GO Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: February 20, 2017 Received: February 22, 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) K163297
Device Name Scan&GO
Indications for Use (Describe)
The in-room scan application is a planning and information system the necessary functions required for planning and controlling scans of supported SIEMENS CT scanners. It allows users to work in close proximity to the scanner.
The in-room scan application runs on standard information technology hardware and software, utilizing the standard information technology operating systems and user interface. Communication and data exchange are done using special protocols.
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) |
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3
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510(K) SUMMARY FOR
Scan&GO
Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Date Prepared: March 22, 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
Contact Person:
Kimberly Mangum Regulatory 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
510(k) Number: K163297 Product Name: Scan&GO Proprietv Trade Name: Scan&GO 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
III. Predicate Device
Primary Predicate Device: Trade Name: 510(k) Number: Clearance Date:
SOMATOM Drive K161196 August 24, 2016
4
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Classification Name: Classification Panel: CFR Section: Device Class: Product Code: Recall Information:
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
IV. Device Description
Scan&GO is a stand-alone optional planning and information software designed to perform the necessary functions required for planning and controlling of the workflow of supported SIEMENS CT scanners. Scan&GO can be operated on a Siemens provided tablet or a commercially available tablet that meets certain minimum technical requirements. It allows users to work in close proximity to the scanner and the patient. Specifically Scan&GO allows control/display of the following software interactions via a wireless tablet that meets certain minimum requirements:
- Selection of patients ●
- Selection of pre-defined protocols ●
- Scan parameter display ●
- Patient table position display and gantry tilt parameter display ●
- Tools and instruction message area. Patient table position planning area ●
- . Physiological data display
- Patient data display (e.g. date of birth, name)
- . Display of acquired topogram and tomogram images
- Finalization of exam (close patient) ●
- NOTE: Scan&GO does not support storage of images. Additionally, Scan&GO cannot trigger a scan or radiation release.
The primary function of Scan&GO is to provide a simplified view of the workstation with a synchronous view of the CT scanner (i.e. functionality that occurs on the console can be viewed on the tablet and vice versa). The standard planning and information controls cleared for the respective CT scanners will also be available for those scanners. Scan&GO will support the following modifications in comparison to the predicate device:
- New Marketing Name: Scan&GO 1)
- New Indications for Use 2)
- Modified hardware interface 3)
- New software interface for control of software interactions and display of scan related 4) information via a wireless tablet
-
- New software version SOMARIS/10 syngo CT VA10A
Scan&GO works together with a supported SIEMENS CT Scanner system to allow mobile workflow via Wi-Fi connection. Scan&GO is designed to be compatible current and future Siemens CT systems that support software version SOMARIS/10 syngo CT VA10A or higher.
Note:
- Control is used for selecting the patient and display of patient information (e.g. Name, ● Sex, Date of Birth - control of the SOMARIS/10 syngo CT VA10A Software functions)
- . Scan&GO function allows to apply a scan protocol and set patient orientation.
- Scan&GO function allows planning a tomogram scan.
- Scan&GO function initiates the READY STATE of the CT scanner. This includes all ● activities needed to prepare a scan before trigger a scan. (Trigger of a scan is not a feature of Scan&GO ).
Additionally, the Scan&GO application is designed to work as part of a mobile workflow which allows in room control of specific functions of a CT scanner. In combination with a supported
5
SIEMENS
tablet which is provided as part of the respective CT scan&GO is designed to provide a synchronous view of the workstation, and will allow the user direct visualization of the tasks performed at the workstation, and limited functionality of the scanner. Users of Scan&GO may experience the following benefits:
- Mobile workflow from where ever the user is in the scanner room or at the workstation ●
- Get closer to your patient by moving today's console into your scanner room" Scan&GO ● provide a visualization of the console into the scanner room"
- Gain flexibility by operating the scanner from wherever you are in the scanner room or in the control room and make use of existing room layouts
V. Indications for Use
The in-room scan application is a planning and information system designed to perform the necessary functions required for planning and controlling scans of supported SIEMENS CT scanners. It allows users to work in close proximity to the scanner.
The in-room scan application runs on standard information technology hardware and software, utilizing the standard information technology operating systems and user interface. Communication and data exchange are done using special protocols.
VI. Comparison of Technological Characteristics with the Predicate Device
The use of Scan&GO as an optional software interaction and control component does not change the fundamental scientific technology, principle of operation, or intended use for the predicate device or the CT scanners that support it. - The CT scanner control function technological characteristics remain unchanged from the predicate devices. The basic workflow that was released for the predicate device SOMATOM Drive supported by software version syngo CT VA62A is comparable to the mobile workflow that is realized for the Scan&GO medical application software version VA10A. The table below shows the comparable characteristics for the connection to the scanner, user interface, software function.
A comparison between the technological characteristics of subject and predicate device is provided as below. Table 1 below:
| Technological
Characteristic | Siemens CT Scanner
Frontend:
Subject Device
Mobile Medical Application
Software Function | Predicate Device
SOMATOM Drive
(K161196)
Frontend:
Human Machine
Interface | Comparison |
|---------------------------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Supported Hardware | Detached commercially
available tablet that meets
certain minimum requirements | Affixed Siemens
proprietary tablet | The tablet hardware
supported for the subject
device is comparable to the
hardware supported for the
predicate device, as both are
required to meet similar
minimum technical
requirements based on the
windows operating platform. |
| Operating Software
Platform | Windows 10 and .Net is
required as operating platform | Software for Human
Machine Interface is
included in the
SOMARIS/7 based
operating platform | Scan&GO connects to the
CT scanner via a mobile
interface to software platform
SOMARIS/10. For the
predicate device software the
Human Machine Interface is
included in the SOMARIS/7
based operating platform.
There is no impact on safety
and effectiveness. |
Table 1 Differences and Similarities in Technical Characteristics
6
| Technological
Characteristic | Siemens CT Scanner
Frontend:
Subject Device
Mobile Medical Application
Software Function | Predicate Device
SOMATOM Drive
(K161196)
Frontend:
Human Machine
Interface | Comparison |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Connection to the
scanner | Wi-Fi connection | Hardware connection to
the scanner for the HMI
tablet. Wireless
connection to the scanner
for the i-Control
interventional module. | Same function with no
impact on safety and
effectiveness. Always
connected. The system
starts with the scanner and
stop working by shut down
the scanner. |
| User Interface | Siemens delivers a tablet
provided by external supplier
as part of the respective CT
system. Alternatively, the
application supports a
commercially available tablet
that meets certain minimum
requirements. This has no
specific modification compared
to other commercial available
tablet. | Siemens Human Machine
Interface (HMI) that
included a proprietary
touch panel | The touch panel of the
subject device is a mobile
tablet. The touch panel of
predicate device the GDP is
affixed on the gantry. In
contrast to the predicate
device, the hardware
supported for the subject
device is detached from the
gantry has no hardware
buttons. |
| Software Function | The mobile workflow
application allows to:
Scan parameter display
Patient table position display
Tools and instruction message
area
Patient table position planning
area
Physiological data display
Patient data display
Information icons display
display of acquired topogram
and tomogram images
planning of tomogram scan
finalization of exam
Selection of patients
Selection of pre-defined | The fixed touch panel
allows to:
Scan parameter display
Patient table position
display
Tools and instruction
message area
Patient table position
planning area
Physiological data display
Patient data display
Information icons display
display of acquired
topogram and tomogram
images
N/A
N/A
N/A
N/A | The interface functionality for
the subject device is
comparable to that of the
predicate device. Both allow
display of scan related
information and support
functions provided by
Siemens CT Scanner
software with the SOMARIS
operating system. |
VII. Performance Data
Non Clinical Testing
The following performance data were provided in support of the substantial equivalence determination. This submission contains performance data to demonstrate continued conformance with special controls for medical devices containing software. Non clinical tests (integration and functional) were conducted for Scan&GO 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, IEC 62304, IEC60601 and in relation to required SW functionality only: NEMA XR-25, NEMA XR-26, NEMA XR-29, 21 CFR 1020.30, and. 21 CFR 1020.33.
Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography Electrical Safety were conducted for Scan&GO in accordance with the following standard: 60601-2-44 (e.g. SCAN&GO initialize the READY STATE of the corresponding CT Scanner). Completed Form FDA 3654 are provided within this submission.
7
SIEMENS
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 supports the claims 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. The Radio Frequency Wireless Technology of the tablet as a supporting hardware device for Scan&GO which is an option for Siemens CT Scanners with SOMARIS/10 complies with 47 CFR part 15 subpart c – Intentional Radiators. All Radio device labels will show an FCC ID code to show the compliance.
Shielding requirement applicable to the CT Scanners and respective Scatter Radiation diagrams for typical room installations are provided in the User Documentation and Planning Guide of the intended Scanners in accordance to IEC60601-2-44.
Wireless Coexistence Testing
Siemens has considered several measures to address wireless coexistence by design to ensure the safe operation of Scan&GO and in combination with the applicable system supported functionality wireless technology in the system setup to perform a task in a given shared environment where other systems have an ability to perform their tasks and may or may not be using the same set of rules. According the FDA quidance for 'Radio Frequency Wireless Technology in Medical Devices" we have addressed the safety and effectiveness and the high likely coexistence with other devices of this technology in our product design by our Risk Management Process, Failure Mode and Effects Analysis (FMEA) Process and Requirement Engineering Process. As part of the risk management process, hazardous situations associated with the Scan&GO and it's connection to the host system via Wi-Fi were addressed as part of the Risk Management process.
Testing for co-existence considered for following scenarios:
- Co-Chanel Testing ●
- . Adjacent Chanel Testing
- RF Interference Testing
- Separation Distance/Location Testing .
Scan&GO is designed to allow dynamic frequency selection and transmission power control by default in accordance with 802.11h. Adjacent channel testing is address by the fact that SCAN&GO does not support shared medium access to Siemens Wi-Fi network. RF interference was tested by successfully ensuring that wireless communications were actively transmitting in situations where possible interference may exist. Recommended distance and router locations requirements are documented in the user documentation.
Customer Use Testing
The following clinical use testing was conducted to demonstrate Scan&GO's performance in the intended clinical environment:
- Internal Clinical Use Test. CT scanner customer environment is simulated in Siemens . Test Cabins. For such a test we tvpically invite customers with clinical expertise which perform tests.
8
SIEMENS
- External Clinical Use Test: The CT scanner is tested in the environment of the . clinic/hospital. Typically we perform such test with selected customer before rollout of the CT scanner.
All test performed meet the pre-determined acceptance criteria and demonstrate that Scan&GO is safe and effective for the intended use.
Summarv
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 non-clinical supportive information. The subject device was tested using the same non-clinical methods. The subject device non-clinical data supports the safety of the software with verification testing. Verification and Validation testing also demonstrates that Scan&GO performs as intended. The non-clinical test data demonstrates that Scan&GO device performance is comparable to the predicate devices that are currently marketed for the same intended use.
Furthermore, for the subject device, Scan&GO, Siemens used the same testing with the same workflows as was used to clear the predicate devices. Since both devices were tested using the same methods. Siemens believes that the data generated from the Scan&GO testing supports a finding of substantial equivalence. In summary, Siemens is of the opinion that the Scan&GO does not introduce any new potential safety risk and is substantially equivalent to and performs as well as the predicate devices.