Scan&GO

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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. 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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) | <div style="display:flex; align-items:center;"> <span> <svg height="16" width="16"> <rect fill="none" height="16" stroke="black" stroke-width="1" width="16"></rect> <line stroke="black" stroke-width="2" x1="2" x2="14" y1="2" y2="14"></line> <line stroke="black" stroke-width="2" x1="14" x2="2" y1="2" y2="14"></line> </svg> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"> <span> <svg height="16" width="16"> <rect fill="none" height="16" stroke="black" stroke-width="1" width="16"></rect> </svg> </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The background is white, which makes the word stand out. ## 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}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "SIEMENS" in a large, sans-serif font. The color of the text is a light teal. The text is horizontally oriented and centered in the image. 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 - 5) 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<br>Characteristic | Siemens CT Scanner<br>Frontend:<br>Subject Device<br>Mobile Medical Application<br>Software Function | Predicate Device<br>SOMATOM Drive<br>(K161196)<br>Frontend:<br>Human Machine<br>Interface | Comparison | |---------------------------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Supported Hardware | Detached commercially<br>available tablet that meets<br>certain minimum requirements | Affixed Siemens<br>proprietary tablet | The tablet hardware<br>supported for the subject<br>device is comparable to the<br>hardware supported for the<br>predicate device, as both are<br>required to meet similar<br>minimum technical<br>requirements based on the<br>windows operating platform. | | Operating Software<br>Platform | Windows 10 and .Net is<br>required as operating platform | Software for Human<br>Machine Interface is<br>included in the<br>SOMARIS/7 based<br>operating platform | Scan&GO connects to the<br>CT scanner via a mobile<br>interface to software platform<br>SOMARIS/10. For the<br>predicate device software the<br>Human Machine Interface is<br>included in the SOMARIS/7<br>based operating platform.<br>There is no impact on safety<br>and effectiveness. | Table 1 Differences and Similarities in Technical Characteristics {6}------------------------------------------------ | Technological<br>Characteristic | Siemens CT Scanner<br>Frontend:<br>Subject Device<br>Mobile Medical Application<br>Software Function | Predicate Device<br>SOMATOM Drive<br>(K161196)<br>Frontend:<br>Human Machine<br>Interface | Comparison | |---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Connection to the<br>scanner | Wi-Fi connection | Hardware connection to<br>the scanner for the HMI<br>tablet. Wireless<br>connection to the scanner<br>for the i-Control<br>interventional module. | Same function with no<br>impact on safety and<br>effectiveness. Always<br>connected. The system<br>starts with the scanner and<br>stop working by shut down<br>the scanner. | | User Interface | Siemens delivers a tablet<br>provided by external supplier<br>as part of the respective CT<br>system. Alternatively, the<br>application supports a<br>commercially available tablet<br>that meets certain minimum<br>requirements. This has no<br>specific modification compared<br>to other commercial available<br>tablet. | Siemens Human Machine<br>Interface (HMI) that<br>included a proprietary<br>touch panel | The touch panel of the<br>subject device is a mobile<br>tablet. The touch panel of<br>predicate device the GDP is<br>affixed on the gantry. In<br>contrast to the predicate<br>device, the hardware<br>supported for the subject<br>device is detached from the<br>gantry has no hardware<br>buttons. | | Software Function | The mobile workflow<br>application allows to:<br>Scan parameter display<br>Patient table position display<br>Tools and instruction message<br>area<br>Patient table position planning<br>area<br>Physiological data display<br>Patient data display<br>Information icons display<br>display of acquired topogram<br>and tomogram images<br>planning of tomogram scan<br>finalization of exam<br>Selection of patients<br>Selection of pre-defined | The fixed touch panel<br>allows to:<br>Scan parameter display<br>Patient table position<br>display<br>Tools and instruction<br>message area<br>Patient table position<br>planning area<br>Physiological data display<br>Patient data display<br>Information icons display<br>display of acquired<br>topogram and tomogram<br>images<br>N/A<br>N/A<br>N/A<br>N/A | The interface functionality for<br>the subject device is<br>comparable to that of the<br>predicate device. Both allow<br>display of scan related<br>information and support<br>functions provided by<br>Siemens CT Scanner<br>software with the SOMARIS<br>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.