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.

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.

AI/ML Overview

The provided text describes Siemens' Scan&GO device and its performance, primarily focusing on its substantial equivalence to a predicate device (SOMATOM Drive, K161196) rather than presenting a standalone study with detailed acceptance criteria and performance metrics.

Based on the information, here's a breakdown of the requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format for Scan&GO's performance as a diagnostic or outcome-related device (which is expected given its function as a planning and information system for CT scanners). Instead, the acceptance criteria are generally qualitative and refer to meeting software specifications, safety standards, and demonstrating substantial equivalence to the predicate device.

Acceptance Criteria Category	Reported Device Performance (Scan&GO)
Software Specifications	All software specifications have met the acceptance criteria based on verification and validation testing.
Safety and Effectiveness	Demonstrated continued conformance with special controls for medical devices containing software. Risk analysis completed, risk controls implemented to mitigate identified hazards. Testing supports claims of substantial equivalence. Device labeling contains necessary cautions and warnings for safe and effective use.
Non-Clinical Performance	Non-clinical tests (integration and functional) were conducted. Performance data demonstrates continued conformance with special controls. Comparable to predicate device using the same test methods.
Conformance to Standards	Conforms to ISO 14791, IEC 62304, IEC60601, NEMA XR-25, NEMA XR-26, NEMA XR-29, 21 CFR 1020.30, and 21 CFR 1020.33 (for SW functionality only). Electrical safety (60601-2-44) conducted (e.g., SCAN&GO initializes READY STATE).
Cybersecurity	Conforms to Cybersecurity requirements (preventing unauthorized access, modifications, misuse, or unauthorized use of information).
Wireless Coexistence	Measures taken to address wireless coexistence. Testing included Co-Channel, Adjacent Channel, RF Interference, and Separation Distance/Location. Designed with dynamic frequency selection and transmission power control (802.11h). Ensured wireless communications actively transmitting without interference.
Clinical Use (Simulated/External)	Internal Clinical Use Test (CT scanner customer environment simulated in Siemens Test Cabins, with customers/clinical expertise). External Clinical Use Test (CT scanner tested in clinic/hospital with selected customers). All tests met pre-determined acceptance criteria.
Functional Equivalence to Predicate	Provides simplified view of workstation; synchronous view of CT scanner. Controls/displays similar software interactions (patient selection, protocols, scan parameters, table position, physiological data, acquired images, exam finalization). Workflow comparable to predicate device.
Hardware Technical Requirements	Supports detached commercially available tablets meeting certain minimum technical requirements (Windows operating platform) comparable to the predicate's affixed proprietary tablet.
Software Interface Compatibility	Connects to CT scanner via a mobile interface to software platform SOMARIS/10, comparable to the predicate's SOMARIS/7. No impact on safety and effectiveness due to software platform difference.
Connection to Scanner	Wi-Fi connection (same function, no impact on safety/effectiveness as predicate's hardware connection/wireless for interventional module; always connected, starts/stops with scanner).
User Interface (Mobile vs. Affixed)	Mobile tablet (subject device) comparable to predicate's affixed touch panel. No hardware buttons on subject device's tablet.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify a quantitative "sample size" in terms of number of patient cases or studies for the non-clinical or clinical use tests.

Test Set Description: The "test set" for performance evaluation consisted of:
- Verification and validation testing of software.
- Non-clinical tests (integration and functional).
- Dosimetry and imaging performance analysis of phantom images.
- Wireless coexistence testing (Co-Channel, Adjacent Channel, RF Interference, Separation Distance/Location).
- Clinical use testing: "Internal Clinical Use Test" (simulated customer environment, typically with customers with clinical expertise) and "External Clinical Use Test" (in clinic/hospital with selected customers before rollout).
Data Provenance:
- The non-clinical and internal clinical use tests were conducted internally by Siemens.
- External clinical use tests were conducted in actual clinic/hospital environments.
- The data is prospective in the sense that it was generated specifically for the verification and validation of the Scan&GO device during its development and pre-market submission. The country of origin for the internal tests would be Germany (where Siemens Healthcare GmbH is located) and potentially the US for Siemens Medical Solutions USA, Inc. The external tests would be at selected customer sites (countries not specified).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document does not specify a "ground truth" established by experts in the traditional sense of diagnostic accuracy. Scan&GO is a control/planning application, not a diagnostic one.

For the "Internal Clinical Use Test," it mentions inviting "customers with clinical expertise which perform tests." The exact number and specific qualifications (e.g., radiologist with X years of experience) are not provided.
For the "External Clinical Use Test," it mentions performing tests with "selected customer" in a clinic/hospital environment. Again, specific numbers or qualifications are not provided.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set, as this typically applies to studies where multiple readers interpret images against a ground truth. Given that Scan&GO is a CT scanner control/planning application, such a method would not be directly applicable to its core function. The acceptance criteria for the clinical use tests were "pre-determined" and met, suggesting an evaluation of functionality and workflow rather than diagnostic agreement.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was mentioned. Scan&GO is not an AI-powered diagnostic assistance tool for human readers; it's a mobile interface for controlling a CT scanner and managing its workflow. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" is not relevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the primary evaluation of Scan&GO's performance appears to be analogous to a standalone evaluation of its software functionality and system integration. The software itself, running on a tablet, performs its designated tasks (patient selection, protocol display, scan parameter display, etc.). The "non-clinical testing" and "verification and validation" would largely fall under this category, assessing if the algorithm (software) performs according to its specifications and established standards without human interpretation of its outputs in a diagnostic context. The "customer use testing" then assesses its usability and functional performance in a simulated/real clinical environment with human operators.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For Scan&GO, the "ground truth" is not in terms of disease presence or absence. Instead, the ground truth relates to:

Functional correctness: Does the application accurately display information from the CT scanner? Does it correctly execute commands like patient and protocol selection?
Adherence to specifications: Does the software meet its documented requirements?
Compliance with standards: Does the device conform to relevant safety, electrical, and cybersecurity standards?
Workflow efficiency and usability: Is the mobile workflow effective and convenient for operators in a clinical setting?

This "ground truth" was established through internal engineering verification and validation, adherence to regulatory standards, and feedback from clinical "customers/experts" during simulated and external use tests.

8. The Sample Size for the Training Set

Scan&GO is described as a "planning and information system" and "optional software interaction and control component." It is not presented as a machine learning or AI-driven diagnostic device that would require a "training set" of data in the typical sense for model development. Therefore, a training set was not applicable or specified in the document. Its development likely followed traditional software engineering practices.

9. How the Ground Truth for the Training Set Was Established

As no training set was specified for an AI/ML model, this question is not applicable.

Summary

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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.

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.

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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

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Indications for Use

510(k) Number (if known) K163297

Device Name Scan&GO

Indications for Use (Describe)

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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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

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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

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.

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
1. 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

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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.

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:

TechnologicalCharacteristic	Siemens CT ScannerFrontend:Subject DeviceMobile Medical ApplicationSoftware Function	Predicate DeviceSOMATOM Drive(K161196)Frontend:Human MachineInterface	Comparison
Supported Hardware	Detached commerciallyavailable tablet that meetscertain minimum requirements	Affixed Siemensproprietary tablet	The tablet hardwaresupported for the subjectdevice is comparable to thehardware supported for thepredicate device, as both arerequired to meet similarminimum technicalrequirements based on thewindows operating platform.
Operating SoftwarePlatform	Windows 10 and .Net isrequired as operating platform	Software for HumanMachine Interface isincluded in theSOMARIS/7 basedoperating platform	Scan&GO connects to theCT scanner via a mobileinterface to software platformSOMARIS/10. For thepredicate device software theHuman Machine Interface isincluded in the SOMARIS/7based operating platform.There is no impact on safetyand effectiveness.

Table 1 Differences and Similarities in Technical Characteristics

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TechnologicalCharacteristic	Siemens CT ScannerFrontend:Subject DeviceMobile Medical ApplicationSoftware Function	Predicate DeviceSOMATOM Drive(K161196)Frontend:Human MachineInterface	Comparison
Connection to thescanner	Wi-Fi connection	Hardware connection tothe scanner for the HMItablet. Wirelessconnection to the scannerfor the i-Controlinterventional module.	Same function with noimpact on safety andeffectiveness. Alwaysconnected. The systemstarts with the scanner andstop working by shut downthe scanner.
User Interface	Siemens delivers a tabletprovided by external supplieras part of the respective CTsystem. Alternatively, theapplication supports acommercially available tabletthat meets certain minimumrequirements. This has nospecific modification comparedto other commercial availabletablet.	Siemens Human MachineInterface (HMI) thatincluded a proprietarytouch panel	The touch panel of thesubject device is a mobiletablet. The touch panel ofpredicate device the GDP isaffixed on the gantry. Incontrast to the predicatedevice, the hardwaresupported for the subjectdevice is detached from thegantry has no hardwarebuttons.
Software Function	The mobile workflowapplication allows to:Scan parameter displayPatient table position displayTools and instruction messageareaPatient table position planningareaPhysiological data displayPatient data displayInformation icons displaydisplay of acquired topogramand tomogram imagesplanning of tomogram scanfinalization of examSelection of patientsSelection of pre-defined	The fixed touch panelallows to:Scan parameter displayPatient table positiondisplayTools and instructionmessage areaPatient table positionplanning areaPhysiological data displayPatient data displayInformation icons displaydisplay of acquiredtopogram and tomogramimagesN/AN/AN/AN/A	The interface functionality forthe subject device iscomparable to that of thepredicate device. Both allowdisplay of scan relatedinformation and supportfunctions provided bySiemens CT Scannersoftware with the SOMARISoperating 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.

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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.

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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.

Regulation Number and Section

§ 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.