Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the descriptions of the device and testing do not mention any AI/ML components or methodologies.

Therapeutic

No.
The device is a Computed Tomography (CT) system intended for generating and processing cross-sectional images for diagnosis and therapy planning. It does not directly provide therapy.

Diagnostic

Yes

The intended use explicitly states that the images delivered by the system "can be used by a trained staff as an aid in diagnosis and treatment" and also mentions "low dose lung cancer screening."

SaMD (Software as a Medical Device)

No

The device description clearly states that the NAEOTOM Alpha is a "dual source Computed Tomography (CT) x-ray system featuring two detectors based on photon counting technology," indicating it is a hardware device. While it includes software components (SOMARIS/10 syngo CT VA50 and Scan&GO), the core device is a physical CT scanner.

IVD (In Vitro Diagnostic)

Based on the provided information, the NAEOTOM Alpha computed tomography system is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly states that the system is used to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images are used as an aid in diagnosis and treatment, as well as for diagnostic and therapeutic interventions. This involves imaging the patient directly.
Device Description: The device is described as a dual source Computed Tomography (CT) x-ray system. This is an imaging modality that interacts directly with the patient using x-rays.
IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens, such as blood, urine, or tissue, that are taken from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. The NAEOTOM Alpha does not perform tests on specimens taken from the body.

The NAEOTOM Alpha is a medical imaging device used for in-vivo imaging of the patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

# Intended Use / Indications for Use
NAEOTOM Alpha
This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

The images delivered by the system can be used by a trained staff as an aid in diagnosis and treatment as well as for diagnostic and therapeutic interventions.

This CT system can be used for low dose lung cancer screening in high risk populations *

* As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011: 365:395-409) and subsequent literature, for further information.

Scan&GO
This 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 using special protocols.

# Product codes
JAK, LLZ

# Device Description
Siemens intends to update software version, SOMARIS/10 synqo CT VA50 for Siemens NAEOTOM Alpha Scanner Systems with unmodified mobile workflow options.

This update also includes optional hardware for CT guided intervention workflow.

Dual Source CT Scanner System:
- NAEOTOM Alpha
- . Scan&GO Mobile Medical Application (optional mobile workflow component)

The subject device NAEOTOM Alpha with SOMARIS/10 syngo CT VA50 is a dual source Computed Tomography (CT) x-ray system featuring two detectors based on photon counting technology.

The CT scanner system algorithm is designed to allow image reconstruction by using photon counting data generated by the subject device. The reconstruction results are comparable with the primary and secondary predicate devices, but support with improved technological characteristics as described in Section 10.

The NAEOTOM Alpha with Software SOMARIS/10 syngo CT VA50 produces CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Siemens and other vendors as an aid in diagnosis and treatment as well as for diagnostic and therapeutic interventions. The computer system delivered with the CT scanner is able to run optional post processing applications.

The Scan&GO mobile workflow is an optional planning and information software designed to perform the necessary functions required for planning and controlling of the workflow of the NAEOTOM Alpha. Scan&GO can be operated on a Siemens provided various tablet hardware 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 or personal computer with Wi-Fi connection 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)
- Mobile Organizer
- Patient Instruction Language ("API languages")
- . predefined workflow associated question/answer dialog
NOTE: Scan&GO does not support storage of images. Additionally, Scan&GO cannot trigger a scan or radiation release.

The software version for the NAEOTOM Alpha, syngo CT VA50 (SOMARIS/10 syngo CT VA50), is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.

The software platform provides a software plugin interface that allows for the use of specific commercially available post processing software algorithms in an unmodified form from the cleared stand-alone post processing version.

New software version syngo CT VA50 (SOMARIS/10 syngo CT VA50) is a modified software version based on syngo CT VA40 (SOMARIS/10 syngo CT VA40) which was cleared for the primary predicate device in [K211591](https://510k.innolitics.com/search/K211591) and supports the same plugin interfaces for the subject device Scan&GO mobile workflow and integration of post-processing tasks as the primary predicate device.

# Mentions image processing
Yes

# Mentions AI, DNN, or ML
Not Found

# Input Imaging Modality
Computed Tomography x-ray

# Anatomical Site
Not Found

# Indicated Patient Age Range
Not Found

# Intended User / Care Setting
trained staff

# Description of the training set, sample size, data source, and annotation protocol
Not Found

# Description of the test set, sample size, data source, and annotation protocol
Not Found

# Summary of Performance Studies
Non-clinical testing, (integration and functional) including phantom tests were conducted for the NAEOTOM Alpha during product development. The modifications described in this Premarket Notification were supported with verification and validation testing. The general purpose of each test is to verify and validate the functionality of the subject device modifications. Testing covered all related subsystems that contribute to the device modifications. Test levels are defined. For each test level several test activities are performed. The test specification and acceptance criteria are related to the corresponding requirements. Various test activities are performed to specific modifications on different test levels to ensure safe and effective integration in the system. Three test levels are defined:
- System Validation test:
  - Acceptance test (workflow and user manual test)
  - Legal and Regulatory test
- System Verification test:
  - System Integration Test (functional)
  - Functionality verification
  - Image Quality (IQ) Evaluation

Tests are conducted for all software components developed in product development and for the complete product itself. Several activities are considered for this process, including creation of test specifications that relate to software/hardware requirements including tests to address risk mitigations that are identified, documented, and traced by hazard keys.

Additional evaluation tests are performed as bench tests to support the new device or device modification on Non-Clinical Performance Testing for the following features:
- myNeedle Laser: The performed bench test covers the laser accuracy evaluation. The results of the accuracy test with a close to clinical workflow and test setup show that defined accuracy level can be achieved. The performed bench test report covers the workflow evaluation. A comparison to the essential workflow steps is performed.
- Flex 4D Spiral – Neuro & Body Perfusion/ Dynamic Angio: The performed bench test describes the technical background of Flex 4D Spiral and added functionalities with NAEOTOM Alpha (dynamic collimation and dose modulation), demonstrates the proper function of those and assesses the image quality of Flex 4D Spiral on NAEOTOM Alpha at all.
- QuantumPlus UHR: The performed bench test describes the reconstruction of spectral images from raw data acquired in ultra-high resolution (UHR) modes.
- PURE Calcium: The performed bench test describes the feature "PURE Calcium", which uses spectrally acquired input image data generated by the subject device NAEOTOM Alpha to obtain a modified image reconstruction that aims at removing the iodine contribution from the generated output images.
- Iterative Metal Artifact Reduction (iMAR): The performed bench test covers evaluation of phantom images to demonstrate the efficacy of iMAR to reduce metal arti-facts.
- High Resolution Dual Source Cardiac Modes: The performed bench test describes the basic image quality and the property of the ECG gated ultra-high resolution dual source cardiac acquisition mode introduced in NAEOTOM Alpha with software version syngo CT VA50.

Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted on the subject device NAEOTOM Alpha in accordance with standards 60601-2-44, and 60601-1-2.

Wireless Coexistence Testing: Siemens has considered several measures to address wireless coexistence by design to ensure the safe operation of the wireless components 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 has been considered. Testing for co-existence considered for following scenarios: Co-Channel Testing, Adjacent Channel Testing, RF Interference Testing, Separation Distance/Location Testing.

# Key Metrics
Not Found

# Predicate Device(s)
[K211591](https://510k.innolitics.com/search/K211591), [K211373](https://510k.innolitics.com/search/K211373)

# Reference Device(s)
Not Found

# Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found

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.

Summary

0

July 12, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Siemens Medical Solutions USA, Inc. % Tabitha Estes Regulatory Affairs Specialist 810 Innovation Drive KNOXVILLE TN 37932

Re: K220814

Trade/Device Name: NAEOTOM Alpha, Scan&GO Software Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: June 8, 2022 Received: June 9, 2022

Dear Tabitha Estes:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

1

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K220814

Device Name NAEOTOM Alpha Scan&GO Software

Indications for Use (Describe) NAEOTOM Alpha

This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

The images delivered by the system can be used by a trained staff as an aid in diagnosis and treatment as well as for diagnostic and therapeutic interventions.

This CT system can be used for low dose lung cancer screening in high risk populations *

As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011: 365:395-409) and subsequent literature, for further information.

Scan&GO

This 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 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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510(k) Summary

FOR

NAEOTOM Alpha CT Scanner System SOFTWARE VERSION SOMARIS/10 syngo CT VA50 (K220814) Submitted by: Siemens Medical Solutions USA, Inc. 810 Innovation Drive

Knoxville, TN 37932 Date Prepared: March 18, 2022

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

Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932 Establishment Registration Number 1034973

Importer/Distributor Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number 2240869

Location of Manufacturing Site Siemens Healthcare GmbH Siemensstr. 1 D-91301 Forchheim, Germany Establishment Registration Number 3004977335

Note: Description in this submission use the short company name Siemens. It covers both manufacturing locations and names as listed above. Brand name on all products is Siemens Healthineers.

Contact Person:

Tabitha Estes Regulatory Affairs Siemens Medical Solutions USA, Inc. (865) 804-4553 (work cell) (865) 218-3019 FAX tabitha.estes@Siemens-healthineers.com

II. Device Name and Classification

NAEOTOM Alpha Product Name:

Trade Name:	NAEOTOM Alpha
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
Regulation Number:	21 CFR §892.1750
Device Class:	Class II
Product Code:	JAK

4

Product Name:	Scan&GO
Propriety 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
Product Code:	JAK
Secondary Product Code:	LLZ

III. Predicate Device

Primary Predicate Device:
Trade Name:	NAEOTOM Alpha, Scan&GO
510(k) Number:	K211591
Clearance Date:	September 30, 2021
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
Regulation Number:	21 CFR §892.1750
Device Class:	Class II
Product Code:	JAK
Recall Information:	All predicate device recalls have been considered in the subject
device design.
Secondary Predicate Device:
Trade Name:	SOMATOM X.ceed, Scan&GO

510(k) Number:	K211373
Clearance Date:	August 27, 2021
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
Regulation Number:	21 CFR §892.1750
Device Class:	Class II
Product Code:	JAK
Recall Information:	All predicate device recalls have been considered in the subject
device design.

Note: K211373 was a bundle submission with various Siemens CT Scanner Systems, including SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro, SOMATOM X.cite, SOMATOM X.ceed and Scan&GO software.

In this submission, the primary predicate device NAEOTOM Alpha with software version SOMARIS/10 syngo CT VA40 and the secondary predicate device SOMATOM X.ceed, both including Scan&GO, are being used, to demonstrate substantial equivalence of technological characteristics.

5

IV. Device Description

Siemens intends to update software version, SOMARIS/10 synqo CT VA50 for Siemens NAEOTOM Alpha Scanner Systems with unmodified mobile workflow options.

This update also includes optional hardware for CT guided intervention workflow.

Dual Source CT Scanner System:

NAEOTOM Alpha
. Scan&GO Mobile Medical Application (optional mobile workflow component)

The subject device NAEOTOM Alpha with SOMARIS/10 syngo CT VA50 is a dual source Computed Tomography (CT) x-ray system featuring two detectors based on photon counting technology.

The CT scanner system algorithm is designed to allow image reconstruction by using photon counting data generated by the subject device. The reconstruction results are comparable with the primary and secondary predicate devices, but support with improved technological characteristics as described in Section 10.

The NAEOTOM Alpha with Software SOMARIS/10 syngo CT VA50 produces CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Siemens and other vendors as an aid in diagnosis and treatment as well as for diagnostic and therapeutic interventions. The computer system delivered with the CT scanner is able to run optional post processing applications.

The Scan&GO mobile workflow is an optional planning and information software designed to perform the necessary functions required for planning and controlling of the workflow of the NAEOTOM Alpha. Scan&GO can be operated on a Siemens provided various tablet hardware 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 or personal computer with Wi-Fi connection 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)
Mobile Organizer
Patient Instruction Language ("API languages")

6

. predefined workflow associated question/answer dialog
NOTE: Scan&GO does not support storage of images. Additionally, Scan&GO cannot trigger a scan or radiation release.

The software version for the NAEOTOM Alpha, syngo CT VA50 (SOMARIS/10 syngo CT VA50), is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.

The software platform provides a software plugin interface that allows for the use of specific commercially available post processing software algorithms in an unmodified form from the cleared stand-alone post processing version.

New software version syngo CT VA50 (SOMARIS/10 syngo CT VA50) is a modified software version based on syngo CT VA40 (SOMARIS/10 syngo CT VA40) which was cleared for the primary predicate device in K211591 and supports the same plugin interfaces for the subject device Scan&GO mobile workflow and integration of post-processing tasks as the primary predicate device.

V. Indications for Use

NAEOTOM Alpha:

This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

The images delivered by the system can be used by a trained staff as an aid in diagnosis and treatment as well as for diagnostic and therapeutic interventions.

This CT system can be used for low dose lung cancer screening in high risk populations*.

As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

Scan&GO:

This 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 NAEOTOM Alpha scanner provides the same technological characteristics in terms of materials, energy source, and control mechanisms when compared to the primary predicate device.

The subject device NAEOTOM Alpha is building on the dual-source CT system configuration of the primary predicate device NAEOTOM Alpha with software version SOMARIS/10 syngo CT VA40.

7

The predicate device and the subject device NAEOTOM Alpha features two photon counting detectors built from Cadmium-Telluride (CdTe).

Supported by the subject device, SOMARIS/10 syngo CT VA50 software version is a further development of the SOMARIS/10 syngo CT VA40 software version which is cleared in K211591.

lt reuses all unmodified software features of the legacy software syngo CT VA40 as described below in the section "Unmodified Features used in the Subject Devices".

The NAEOTOM Alpha with syngo CT VA50 also supports an optional laser component for a modified CT guided intervention workflow.

As with the primary device NAEOTOM Alpha with syngo CT VA40, the subject device NAEOTOM Alpha is supported by an optional mobile workflow, Scan&GO.

Software version SOMARIS/10 syngo CT VA50 is designed to reuse hardware independent extended functionalities and GO technologies provided by Siemens cleared software applications. The intended use and fundamental scientific technology for the NAEOTOM Alpha remains unchanged from the cleared primary predicate device.

At a high level, the subject device NAEOTOM Alpha and the primary/secondary predicate device are based on the same subset of technological elements:

Scanner Principle- Whole body X-Ray Computed Tomography Scanner
System Acquisition – Continuously rotating tube detector system
Iterative Reconstruction - Support of various iterative reconstruction principles
Workplaces – Support of workplaces that include reconstruction and image evaluation software
. Patient table
Patient table foot switch for movement
Tin filtration technology
Vectron X-ray Tube
Power Generator
Mobile Medical application Software functionality (Scan&GO)
Mobile workflow (Tablet)
. Support 3D Camera operation for fast patient positioning workflow
Scanner display and control functionality
Remote Scan Control
. Long scan range

The following technological differences exist between the subject device NAEOTOM Alpha and the primary predicate device NAEOTOM Alpha with syngo CT VA40 cleared in K211591:

Software version SOMARIS/10 syngo CT VA50 ●
. CT guided intervention – modified hardware and software application

8

The following technological differences exist between the subject device Scan&GO mobile application software and the predicate device Scan&GO mobile application software cleared in K211591:

Software version SOMARIS/10 syngo CT VA50 ●
. CT guided intervention – modified hardware and software application

The NAEOTOM Alpha will support the following modifications/further developments in comparison to the primary/secondary predicate devices as listed in the tables below.

1. New/Modified Hardware
- Table 1: Overview of hardware modifications .
1. Software version SOMARIS/10 syngo CT VA50
- Table 2: Overview of software modifications

The configuration table and comparison table use the following terms to describe various technological characteristics in comparison to the primary and secondary predicate devices information:

Table 1: Overview of term definition.

Term	Definition
N/A	The feature is not supported for the subject device
New	The feature is newly supported for Siemens CT Scanners and the subject
device
Modified	This feature is modified from the predicate / reference devices
Enabled	This feature is currently supported by other cleared Siemens CT systems or
cleared Siemens stand-alone software applications. This feature will be
supported for the subject device with software version SOMARIS/10 syngo CT
VA50 and is substantially equivalent compared to the cleared version.

New/modified hardware features:

Table 2: Overview of hardware modifications of NAEOTOM Alpha supported by software version SOMARIS/10 syngo CT VA50.

| | Hardware properties | Subject device
NAEOTOM Alpha
SOMARIS/10 syngo CT VA50 |
|----|-----------------------------------------|-------------------------------------------------------------|
| 1. | CT guided intervention – MyNeedle Laser | enabled |
| 2. | Tablet dock for patient table | enabled |
| 3. | Interventional Joystick (IVJ) | enabled |
| 4. | Integrated Injector Arm | enabled |
| 5. | Tablet hardware for Scan&GO | modified |

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New/modified software features:

Table 3: Overview of software modifications of NAEOTOM Alpha supported by software version SOMARIS/10 syngo CT VA50.

	Software properties	NAEOTOM Alpha
		SOMARIS/10 syngo CT VA50
		(subject device)
1.	CT guided intervention – MyNeedle Guide	enabled
2.	Flex 4D Spiral – Neuro & Body Perfusion/ Dynamic
Angio	modified
3.	Quantum 70 kV	modified
4.	QuantumPlus UHR	modified
5.	Flash Phase Spiral	modified
6.	PURE Calcium	new
7.	Iterative Metal Artifact Reduction (iMAR)	enabled
8.	Automated Patient Instructions	modified
9.	QuantumPlus Topo (Spectral Topo)	modified
10.	Multi-Threshold Acquisition	modified
11.	High Resolution Dual Source Cardiac Modes	modified
12.	Additional ex-factory exam protocols	modified

A tabular summary of the comparable hardware and software properties between the subject device NAEOTOM Alpha with software version syngo CT VA50 and primary/secondary predicate device are listed in Table 4 and Table 5 below (modifications are in gray shaded sections).

Table 4: Technical hardware characteristics for subject device NAEOTOM Alpha (software version SOMARIS/10 syngo CT VA50) compared to the predicate devices.

| Hardware
property | Subject device | Primary predicate
device | Secondary predicate
device |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NAEOTOM Alpha
SOMARIS/10 syngo CT
VA50 | NAEOTOM Alpha
SOMARIS/10 syngo CT
VA40
(K211591) | SOMATOM X.ceed
SOMARIS/10 syngo CT
VA40
(K211373) |
| Scanner | whole body X-ray
computed tomography
scanner | whole body X-ray
computed tomography
scanner | whole body X-ray
computed tomography
scanner |
| Scan Mode | Dual Source Dual Energy | Dual Source Dual Energy | Single Source Dual
Energy |
| Hardware
property | Subject device | Primary predicate
device | Secondary predicate
device |
| | NAEOTOM Alpha
SOMARIS/10 syngo CT
VA50 | NAEOTOM Alpha
SOMARIS/10 syngo CT
VA40
(K211591) | SOMATOM X.ceed
SOMARIS/10 syngo CT
VA40
(K211373) |
| Generator
max. power | 2x 120 kW | 2x 120 kW | 105 kW/ 120 kW |
| Detector
Technology | QuantaMax
Direct Conversion with
"Quantum Technology" | QuantaMax
Direct Conversion with
"Quantum Technology" | Stellarinfinity
Energy integrating |
| Detector
volume
coverage | 2 x 57.6 mm | 2 x 57.6 mm | 38.4 mm |
| Detector
physical rows | 2x 288 | 2x 288 | 64 |
| Detector slice
width | 0.2 mm | 0.2 mm | 0.6 mm |
| Detector
channel No. | 2752 (A system)
1984 (B system) | 2752 (A system)
1984 (B system) | 920 |
| X-ray Tube | VECTRON | VECTRON | VECTRON |
| Tube
kV steps | 70 kV, 90 kV, 100 kV,
120 kV, 140 kV | 90 kV, 100 kV, 120 kV,
140 kV | 70 kV to 150 kV
(in 10 kV steps) |
| Tube
max. current | 2 x 1300 mA | 2 x 1300 mA | 1200 mA; for 105 kW
1300 mA; for 120 kW |
| Tube
tube focus | 0.4 mm x 0.5 mm
0.6 mm x 0.7 mm
0.8 mm x 1.1 mm
(for both tubes) | 0.4 mm x 0.5 mm
0.6 mm x 0.7 mm
0.8 mm x 1.1 mm
(for both tubes) | min. 0.6 mm x 0,7 mm
(w/o comb)
min. 0.4 mm x 0.5 mm
(with comb) |
| Tube
heat capacity | higher than 30 MHU | higher than 30 MHU | higher than 30 MHU |
| Gantry
bore size | 82 cm | 82 cm | 82 cm |
| Gantry
Scan FoV | 50 cm | 50 cm | 50 cm |
| Gantry
rotation time [s] | 0.25 s, 0.5 s, 1.0 s | 0.25 s, 0.5 s, 1.0 s | 0.25 s, 0.3 s, 0.5 s, 1.0 s |
| Gantry
Tilt [degree] | N/A | N/A | +/- 25
+/- 30 (only with Vitus) |
| Hardware
property | Subject device | Primary predicate
device | Secondary predicate
device |
| | NAEOTOM Alpha
SOMARIS/10 syngo CT
VA50 | NAEOTOM Alpha
SOMARIS/10 syngo CT
VA40
(K211591) | SOMATOM X.ceed
SOMARIS/10 syngo CT
VA40
(K211373) |
| Patient Table
type | Vario 2.D
Vitus | Vario 2.D
Vitus | Vario 2.D
Vitus
Vario RT |
| Max. Scan
length
Topogram | Vario 2.D: 2080 mm
Vitus: 2080 mm | Vario 2.D: 2080 mm
Vitus: 2080 mm | Vario 2.D: 2080 mm
Vitus: 2080 mm
Vario RT: 1680 mm |
| Max. Scan
length
Image
acquisition | Vario 2.D: 2000 mm
Vitus: 2000 mm | Vario 2.D: 2000 mm
Vitus: 2000 mm | Vario 2.D: 2000 mm
Vitus: 2000 mm
Vario RT: 1600 mm |
| Spectral
filtration
Option* | Tin Filter for both tubes | Tin Filter for both tubes | Combined Split Filter /
Tin Filter supported, plus
extra Tin Filter |
| 3D Camera
for patient
positioning | option for patient
positioning with 3D
Camera | option for patient
positioning with 3D
Camera | option for patient
positioning with 3D
Camera |
| Tablet dock for
patient table | Option for mounting of
the tablet on the patient
table. | N/A | Option for mounting of
the tablet on the patient
table. |
| Interventional
Joystick (IVJ) | Option to support the
tablet mobile workflow
including an electrical
connection for the tablet
dock which allows
charging the tablet
when mounted. | N/A | Option to support the
tablet mobile workflow
including an electrical
connection for the tablet
dock which allows
charging the tablet
when mounted. |
| Laser supported
workflow | Laser in combination
with FAST Isocentering
visualize coordinates for
patient isocenter
position;
myNeedle Laser
visualizes a planned
needle path for
interventions | N/A | Laser in combination
with FAST Isocentering
visualize coordinates for
patient isocenter
position;
myNeedle Laser
visualizes a planned
needle path for
interventions |
| Software
property | Subject device | Primary predicate
device | Secondary predicate
device |
| | NAEOTOM Alpha
SOMARIS/10 syngo CT
VA50 | NAEOTOM Alpha
SOMARIS/10 syngo CT
VA40
(K211591) | SOMATOM X.ceed
SOMARIS/10 syngo CT
VA40
(K211373) |
| Operating
System | Windows based
SOMARIS/10 syngo CT
VA50 | Windows based
SOMARIS/10 syngo CT
VA40 | Windows based
SOMARIS/10 syngo CT
VA40 |
| Acquisition
Workplace | syngo Acquisition
Workplace named as
"myExam Console"

syngo Viewing, syngo
Filming and syngo
Archiving & Networking

2nd Acquisition
Workplace named as
"myExam Satellite" | syngo Acquisition
Workplace named as
"myExam Console"

syngo Viewing, syngo
Filming and syngo
Archiving & Networking

2nd Acquisition
Workplace named as
"myExam Satellite" | syngo Acquisition
Workplace named as
"myExam Console"

syngo Viewing, syngo
Filming and syngo
Archiving & Networking

2nd Acquisition
Workplace named as
"myExam Satellite" |
| IRS | Image Reconstruction
for Quantum
Technology | Image Reconstruction
for Quantum
Technology | Image Reconstruction
for classic Siemens
single source CT scanner |
| Detector | QuantaMax detector
firmware supported | QuantaMax detector
firmware supported | Stellar detector
firmware supported |
| Teamplay | Support teamplay
Protocols | Support teamplay
Protocols | Support teamplay
Protocols |
| Protocols | Support of:
Protocol supporting
contrast bolus-
triggered data
acquisitionContrast media
protocols (including
coronary CTA)Pediatric ProtocolsFlex Dose ProfileTurbo Flash SpiralDual Energy
acquisitionDynamic imaging
(Flex 4D Spiral) | Support of:
Protocol supporting
contrast bolus-
triggered data
acquisitionContrast media
protocols (including
coronary CTA)Pediatric ProtocolsFlex Dose ProfileTurbo Flash SpiralDual Energy
acquisitionProtocols supporting
Cardiac Scanning,
Spectral imaging for | Protocols for
Radiation Therapy
Planning support
patient markingProtocols that allow
scanning with
support of an
external respiratory
gating system
(ANZAI, Varian RGSC)Protocol supporting
contrast bolus-
triggered data
acquisition |
| Software
property | Subject device | Primary predicate device | Secondary predicate device |
| | NAEOTOM Alpha
SOMARIS/10 syngo CT
VA50 | NAEOTOM Alpha
SOMARIS/10 syngo CT
VA40
(K211591) | SOMATOM X.ceed
SOMARIS/10 syngo CT
VA40
(K211373) |
| | various i-spiral scan protocols and FAST i-sequence
(applying different scanning parameters such as different slice thicknesses, kV settings or reconstructions kernels to support different clinical scenarios) and using features like iMAR, CARE Dose4D and CARE kV Protocols supporting Intervention, Cardiac Scanning, Spectral imaging for child examination, Spectral imaging with high resolution | child examination, Spectral imaging with high resolution | Contrast media protocols (including coronary CTA) Pediatric Protocols Flex Dose Profile TwinBeam DE TwinSpiral DE Dynamic imaging (Flex 4D Spiral) various i-spiral scan protocols and FAST i-sequence
(applying different scanning parameters such as different slice thicknesses, kV settings or reconstructions kernels to support different clinical scenarios) and using features like iMAR, CARE Dose4D and CARE kV Protocols supporting Intervention |
| Advanced
Reconstruction | Recon&GO: Spectral Recon (Dual Energy Reconstruction from photon counting data) / including Virtual Unenhanced, Monoenergetic plus Inline Results DE SPP (Spectral Post-Processing with photon counting image data) | Recon&GO: Spectral Recon (Dual Energy Reconstruction from photon counting data) / including Virtual Unenhanced, Monoenergetic plus Inline Results DE SPP (Spectral Post-Processing with photon counting image data) | Recon&GO: Spectral Recon (Dual Energy Reconstruction) Inline Results DE SPP (Spectral Post-Processing) / including Virtual Unenhanced, Monoenergetic plus |
| Post- Processing
Interface | Recon&GO Inline Results: | Recon&GO Inline Results: | Recon&GO Inline Results: |
| Software
property | Subject device | Primary predicate
device | Secondary predicate
device |
| | NAEOTOM Alpha
SOMARIS/10 syngo CT
VA50 | NAEOTOM Alpha
SOMARIS/10 syngo CT
VA40
(K211591) | SOMATOM X.ceed
SOMARIS/10 syngo CT
VA40
(K211373) |
| | Software interface to
post-processing
algorithms which are
unmodified when
loaded onto the CT
scanners and 510(k)
cleared as medical
devices in their own
right. | Software interface to
post-processing
algorithms which are
unmodified when
loaded onto the CT
scanners and 510(k)
cleared as medical
devices in their own
right. | Software interface to
post-processing
algorithms which are
unmodified when
loaded onto the CT
scanners and 510(k)
cleared as medical
devices in their own
right. |
| | • software
interfaces for post-
processing
functionalities to
provide advanced
visualization tools to
prepare and process
medical images for
diagnostic purpose. | • software
interfaces for post-
processing
functionalities to
provide advanced
visualization tools to
prepare and process
medical images for
diagnostic purpose. | • software
interfaces for post-
processing
functionalities to
provide advanced
visualization tools to
prepare and process
medical images for
diagnostic purpose. |
| | Note: The clearance of
standalone Advanced
Visualization Application
software is mandatory
precondition. | Note: The clearance of
standalone Advanced
Visualization Application
software is mandatory
precondition. | Note: The clearance of
standalone Advanced
Visualization Application
software is mandatory
precondition. |
| | These advanced
visualization tools are
designed to support the
technician & physician
in the qualitative and
quantitative
measurement & analysis
of clinical data acquired
and reconstructed by
Computed Tomography
scanners. Additional
information regarding
the points of interface
and inputs for this
feature is provided in
Section 16. | These advanced
visualization tools are
designed to support the
technician & physician
in the qualitative and
quantitative
measurement & analysis
of clinical data acquired
and reconstructed by
Computed Tomography
scanners. Additional
information regarding
the points of interface
and inputs for this
feature is provided in
Section 16. | These advanced
visualization tools are
designed to support the
technician & physician
in the qualitative and
quantitative
measurement & analysis
of clinical data acquired
and reconstructed by
Computed Tomography
scanners. Additional
information regarding
the points of interface
and inputs for this
feature is provided in
Section 16. |
| Cybersecurity | IT Hardening | IT Hardening | IT Hardening |
| Software
property | Subject device | Primary predicate
device | Secondary predicate
device |
| | NAEOTOM Alpha
SOMARIS/10 syngo CT
VA50 | NAEOTOM Alpha
SOMARIS/10 syngo CT
VA40
(K211591) | SOMATOM X.ceed
SOMARIS/10 syngo CT
VA40
(K211373) |
| Standard
technologies | FAST Features CARE Features GO technology CARE keV | FAST Features CARE Features GO technology CARE keV | FAST Features CARE Features GO technology CARE kV |
| Iterative
Reconstruction
Methods | Quantum Iterative
Reconstruction
iMAR | Quantum Iterative
Reconstruction | ADMIRE
iMAR |
| Precision Matrix | Precision Matrix
resolution
support image matrix
sizes of 512x512,
768x768 pixels and
1024x1024 pixel (auto
mode supported) | Precision Matrix
resolution
support image matrix
sizes of 512x512,
768x768 pixels and
1024x1024 pixel (auto
mode supported) | image matrix sizes
256x256, 512x512 and
768x768 pixels |
| CaScoring | Photon counting
technology offers
monoenergetic images
which can be used as a
base for calcium scoring
independent from tube
voltage kV and beam
filtration settings. | Photon counting
technology offers
monoenergetic images
which can be used as a
base for calcium scoring
independent from tube
voltage kV and beam
filtration settings. | Classic SOMATOM
X.ceed technology offers
images which can be
used for calcium
scoring, independent
from tube voltage kV
and beam filtration
settings based on a
dedicated single energy
image reconstruction
method. |

10

11

12

Table 5: Software characteristics for subject device NAEOTOM Alpha (software version SOMARIS/10 syngo CT VA50) compared to the predicate devices.

13

14

15

Any differences in technological characteristics do not raise different questions of safety and effectiveness. Testing and validation is completed. Test results show that the subject device, the NAEOTOM Alpha with syngo CT VA50, is comparable to the predicate devices in terms of technological characteristics and safety and effectiveness and therefore are substantially equivalent to the predicate devices.

VII. Performance Data

Non-Clinical Testing

Non-clinical testing, (integration and functional) including phantom tests were conducted for the NAEOTOM Alpha during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.

16

The general purpose of each test is to verify and validate the functionality of the subject device modifications.

Testing covered all related subsystems that contribute to the device modifications. Test levels are defined. For each test level several test activities are performed. The test specification and acceptance criteria are related to the corresponding requirements. Various test activities are performed to specific modifications on different test levels to ensure safe and effective integration in the system. Three test levels are defined:

System Validation test:

Acceptance test (workflow and user manual test) ●
Legal and Regulatory test

System Verification test:

System Integration Test (functional) ●
. Functionality verification
. Image Quality (IQ) Evaluation

Tests are conducted for all software components developed in product development and for the complete product itself. Several activities are considered for this process, including creation of test specifications that relate to software/hardware requirements including tests to address risk mitigations that are identified, documented, and traced by hazard keys.

Additional evaluation tests are performed as bench tests to support the new device or device modification on Non-Clinical Performance Testing as listed in Table 6 below.

| Feature/Non-clinical

supportive testing	Testing performed
myNeedle Laser	The performed bench test covers the laser accuracy evaluation.
The results of the accuracy test with a close to clinical workflow
and test setup show that defined accuracy level can be achieved.
myNeedle Laser	The performed bench test report covers the workflow evaluation.
A comparison to the essential workflow steps is performed.
Flex 4D Spiral – Neuro &
Body Perfusion/ Dynamic
Angio	The performed bench test describes the technical background of
Flex 4D Spiral and added functionalities with NAEOTOM Alpha
(dynamic collimation and dose modulation), demonstrates the
proper function of those and assesses the image quality of Flex 4D
Spiral on NAEOTOM Alpha at all.
QuantumPlus UHR	The performed bench test describes the reconstruction of spectral
images from raw data acquired in ultra-high resolution (UHR)
modes.
PURE Calcium	The performed bench test describes the feature "PURE Calcium",
which uses spectrally acquired input image data generated by the
subject device NAEOTOM Alpha to obtain a modified image

Table 6: Non-clinical performance testing

17

| Feature/Non-clinical

supportive testing	Testing performed
	reconstruction that aims at removing the iodine contribution from
the generated output images.
Iterative Metal Artifact
Reduction (iMAR)	The performed bench test covers evaluation of phantom images to
demonstrate the efficacy of iMAR to reduce metal arti-facts.
High Resolution Dual Source
Cardiac Modes	The performed bench test describes the basic image quality and
the property of the ECG gated ultra-high resolution dual source
cardiac acquisition mode introduced in NAEOTOM Alpha with
software version syngo CT VA50.

Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted on the subject device NAEOTOM Alpha in accordance with the following standards: 60601-2-44, and 60601-1-2. A list of recognized and general consensus standards considered for the subject devices is provided as Table 7 and Table 8 below.

Table 7: Recognized Consensus Standards

| Date of
Recognition | Recognition
Number | Standard
Developing
Organization | Standard
Designation
Number and Date | Title of Standard |
|------------------------|-----------------------|----------------------------------------|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 06/27/2016 | 12-300 | NEMA | PS 3.1 - 3.20 (2016) | Digital Imaging and
Communications in Medicine
(DICOM) Set |
| 07/06/2020 | 12-325 | NEMA | XR 25-2019 | Computed Tomography Dose
Check |
| 01/27/2015 | 12-287 | NEMA | XR 28-2013 | Supplemental Requirements
for User Information and
System Function Related to
Dose in CT |
| 06/27/2016 | 5-40 | ANSI AAMI
ISO | 14971:2007/(R)2010
(Corrected 4
October 2007) | Medical Devices - Applications
Of Risk Management To
Medical Devices |
| | | ISO | 14971 Second
edition 2007-03-01 | Medical Devices - Applications
Of Risk Management To
Medical Devices |
| 01/14/2019 | 13-79 | IEC | 62304 Edition 1.1
2015-06
CONSOLIDATED
VERSION | Medical Device Software -
Software Life Cycle Processes |
| 07/09/2014 | 19-4 | ANSI AAMI | ES60601-
1:2005/(R)2012 And
A1:2012, | C1:2009/(R)2012 and
A2:2010/(R)2012
(Consolidated Text) Medical
electrical equipment - Part 1:
General requirements for basic
safety and essential |
| Date of
Recognition | Recognition
Number | Standard
Developing
Organization | Standard
Designation
Number and Date | Title of Standard |
| 09/17/2018 | 19-8 | ANSI AAMI
IEC | 60601-1-2:2014 | Medical electrical equipment -
Part 1-2: General
requirements for basic safety
and essential performance -
Collateral Standard:
Electromagnetic disturbances -
Requirements and tests |
| 12/23/2016 | 5-114 | ANSI AAMI
IEC | 62366-1:2015 | Medical devices - Part 1:
Application of usability
engineering to medical devices |
| 07/09/2014 | 12-273 | IEC | 60825-1 Edition 2.0
2007-03 | Safety Of Laser Products - Part
1: Equipment Classification,
And Requirements [Including:
Technical Corrigendum 1
(2008), Interpretation Sheet 1
(2007), Interpretation Sheet 2
(2007)]
Note: Requirements according
to IEC 60825-1:2014 (Ed.3.0)
are implemented. |
| 06/27/2016 | 12-302 | IEC | 60601-2-44 Edition
3.2: 2016 | Medical electrical equipment -
Part 2-44: Particular
requirements for the basic
safety and essential
performance of x-ray
equipment for computed
tomography |
| 01/14/2014 | 12-269 | IEC | 60601-1-3 Edition
2.1 2013-04 | Medical electrical equipment -
Part 1-3: General
requirements for basic safety
and essential performance -
Collateral Standard: Radiation
protection in diagnostic X-ray
equipment |
| 06/27/2016 | 5-89 | IEC | 60601-1-6 Edition
3.1 2013-10 | Medical Electrical Equipment -
Part 1-6: General
Requirements For Basic Safety
And Essential Performance -
Collateral Standard: Usability |
| 03/14/2011 | 12-226 | IEC | 61223-2-6 Second
Edition 2006-11 | Evaluation and routine testing
in medical imaging
departments - Part 2-6:
Constancy tests - Imaging |
| Date of
Recognition | Recognition
Number | Standard
Developing
Organization | Standard
Designation
Number and Date | Title of Standard |
| | | | | performance of computed
tomography X-ray equipment |
| 01/30/2014 | 12-270 | IEC | 61223-3-5 First
Edition 2004-08 | Evaluation and routine testing
in medical imaging
departments - Part 3-5:
Acceptance tests - Imaging
performance of computed
tomography X-ray equipment
[Including: Technical
Corrigendum 1 (2006)] |
| 12/23/2019 | 12-328 | IEC | 61223-3-5 Edition
2.0 2019-09 | Evaluation and routine testing
in medical imaging
departments - Part 3-5:
Acceptance tests - Imaging
performance of computed
tomography X-ray equipment
[Including: Technical
Corrigendum 1 (2006)] |
| 06/07/2018 | 12-309 | IEC | 60601-2-28 Edition
3.0 2017-06 | Medical Electrical Equipment -
Part 2-28: Particular
Requirements For The Basic
Safety And Essential
Performance Of X-Ray Tube
Assemblies For Medical
Diagnosis |
| 06/27/2016 | 12-299 | IEC | 62563-1 Edition 1.1 | Medical electrical equipment -
Medical image display systems

Part 1: Evaluation methods |

18

19

Table 8: General Use Consensus Standards

| Standard Developing
Organization | Standard Designation
Number and Date | Title of Standard | How was Standard
Used |
|-------------------------------------|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| IEC | 60601-
1:2005+A1:2012 | Medical electrical
equipment - part 1:
general requirements
for basic safety and
essential performance | Covered by ANSI AAMI
ES60601-
1:2005/(R)2012 and
A1:2012 as part of
EMC testing. |
| IEC/ISO | 17050-1 | Conformity
Assessment -
Supplier's declaration
of conformity - Part 1:
General requirements | Declaration of
conformance to FDA
recognized consensus
standards. |

20

| Standard Developing
Organization | Standard Designation
Number and Date | Title of Standard | How was Standard
Used |
|-------------------------------------|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| IEC/ISO | 17050-2 | Conformity
assessment –
Supplier's declaration
of conformity – Part 2:
Supporting
documentation. | General consensus
standards not
currently recognized
by FDA. |

A list of applicable guidance documents considered for this submission is provided as Table 9 below.

Table 9: FDA Guidance Document and Effective Date

	FDA Guidance Document and Effective Date
1.	Guidance for Industry and FDA Staff – User Fees and Refunds for Premarket Notification Submissions 510(k)
Document issued on October 2, 2017
2.	Guidance for Industry and Food and Drug Administration Staff: Refuse to Accept Policy for 510(k)s
Document issued on February 21, 2019
3.	Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s - Guidance for Industry and FDA Staff
Document issued on August 12, 2005
4.	Guidance for Industry and FDA Staff: Deciding when to submit a 510(k) for a change to an existing device.
Document issued on October 25, 2017
5.	Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]
Document Issued on July 28, 2014
6.	Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submission for Software in Medical Devices
Document issued on May 11, 2005
7.	Guidance for Industry and FDA Staff: Guidance for Off-The-Shelf Software Use in Medical Devices
Document issued on September 9, 1999
8.	Guidance for Industry and FDA Staff: Applying Human Factors and Usability Engineering to Medical Devices.
Document issued February 3, 2016
9.	Guidance for Industry and FDA Staff: Pediatric Information for X-ray Imaging Device Premarket Notifications.

21

	Document issued on November 28, 2017
10.	Guidance for Industry and FDA Staff: Content of Premarket Submissions for
Management of Cybersecurity in Medical devices.
Document issued on October 2, 2014
11.	Guidance for Industry and FDA Staff: Information to Support a Claim of
Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices
Document issued on July 11, 2016
12.	Guidance for Industry and Food Drug Administration Staff: Design considerations and Pre-
Market Submission recommendations for Interoperable Medical devices
Document Issued on September 6, 2017
13.	Guidance for Industry and Food Drug Administration Staff:
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical
Devices
Document issued on September 14, 2018

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 Risk Analysis was completed and risk control implemented to mitigate identified hazards. The testing supports that all software specifications have met the acceptance criteria. Testing for verification and validation support the claims of substantial equivalence.

Siemens conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Cybersecurity information in accordance with guidance document "Content of Premarket Submissions for Management of Cybersecurity Medical Devices issues on October 2, 2014″ is included within this submission.

Additionally, Siemens conforms to the requirements for Radio Frequency Wireless Technology as defined in FDA guidance document "Radio Frequency Wireless Technology in Medical Devices, Guidance for Industry and Food and Drug Administration Staff, issued on August 14, 2013" by adhering to the EMC and risk based verification and validation requirements in design, testing, and labeling of the wireless remote control components of the subject devices.

The Radio Frequency Wireless Technology of the optional Remote Scan Control and supporting Control Device iPad for Scan&GO complies to 47 CFR part 15 subpart c – Intentional Radiators. All Radio device labels will show an FCC ID code to show compliance. Shielding requirement applicable to the NAEOTOM Alpha 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

22

Siemens has considered several measures to address wireless coexistence by design to ensure the safe operation of the wireless components 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 has been considered. According to FDA guidance 'Radio Frequency Wireless Technology in Medical Devices" Siemens has addressed the safety, effectiveness, and high likelihood of 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 its 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-Channel Testing
. Adjacent Channel 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 IEEE 802.11h. Adjacent channel testing is addressed 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.

Summary

The features described in this premarket notification are supported with verification and validation testing, dosimetry and imaging performance, and analysis of phantom images to assess device and feature performance during product development. The risk analysis was completed, and risk control implemented to mitigate identified hazards. The test results show that all of the software specifications have met the acceptance criteria. Verification testing of the device was found acceptable to support the claim of substantial equivalence.

General Safety and Effectiveness Concerns

The device labeling contains instructions for use as well as necessary cautions and warnings to provide for safe and effective use of the device. Risk management is ensured via a system related risk analysis, which is used to identify potential hazards. These potential hazards are controlled during development, verification and validation testing according to the risk management process. In order to minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.

VIII. Conclusions

The primary and secondary predicate devices were cleared based on the results of non-clinical testing including verification and validation, phantom tests, and supportive literature. The nonclinical data supports the safety of the device and the hardware and software verification and validation demonstrates that the NAEOTOM Alpha should perform as intended in the specified use conditions. The data included in this submission demonstrates that the NAEOTOM Alpha with described modifications performs comparably to the primary predicate device currently marketed for

23

the same intended use. Siemens believes that the data generated from the NAEOTOM Alpha testing supports a finding of substantial equivalence.