(129 days)
No
The document describes a new CT scanner system with photon counting technology and associated software for image reconstruction and workflow management. While it mentions image processing and algorithms, there is no explicit mention of AI, ML, or deep learning being used in the device's core functionality or image reconstruction. The focus is on the new detector technology and standard image processing techniques.
No
The device, NAEOTOM Alpha, is a computed tomography system used to generate and process cross-sectional images for diagnostic aid, treatment preparation, and radiation therapy planning. It is an imaging device, not a device that provides therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the images delivered by the system "can be used by a trained physician as an aid in diagnosis" and "can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning." It also mentions its use for "low dose lung cancer screening," which is a diagnostic application.
No
The device description clearly states that the NAEOTOM Alpha is a "dual-source Computed Tomography (CT) x-ray system" and includes hardware components like detectors and an x-ray system. While it includes software components like SOMARIS/10 syngo CT VA40 and the Scan&GO mobile application, the core device is a hardware system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The NAEOTOM Alpha is a Computed Tomography (CT) system. It generates images of the inside of the body using X-rays. It does not perform tests on biological samples.
- Intended Use: The intended use clearly states that the system generates and processes cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images are used as an aid in diagnosis, treatment preparation, and radiation therapy planning. This is consistent with the function of an imaging device, not an IVD.
- Device Description: The description details the hardware (CT scanner) and software for image acquisition, reconstruction, and management. It does not mention any components or processes related to analyzing biological samples.
While the device is used as an "aid in diagnosis," this is based on the interpretation of images of the patient's internal anatomy, not on the analysis of in vitro samples.
N/A
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 physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. 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.
Product codes
JAK, LLZ
Device Description
Siemens intends to market a new CT scanner system NAEOTOM Alpha supporting software version, SOMARIS/10 syngo CT VA40 with mobile workflow options. 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 VA40 is a dual-source Computed Tomography (CT) x-ray system featuring two detectors based on new 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 predicate devices, but support with improved technological characteristics.
The NAEOTOM Alpha with Software SOMARIS/10 synqo CT VA40 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, treatment preparation and therapy planning support (including, but not limited to, Brachytherapy, Particle including Proton Therapy, External Beam Radiation Therapy, Surgery). 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 NAEOTOM Alpha. Scan&GO can be operated on a Siemens provided various tablet hardware that meets certain minimum technical requirements.
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 VA40 (SOMARIS/10 syngo CT VA40), is a command-based program used for patient management, data manaqement, 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 VA40 (SOMARIS/10 syngo CT VA40) is a modified software version based on syngo CT VA30A (SOMARIS/10 syngo CT VA30) which was cleared for the secondary predicate device and supports the same plugin interfaces for the subject device Scan&GO mobile workflow and integration of post-processing tasks as the secondary predicate device Scan&GO cleared in (K200524).
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 physician, 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
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 tests is to verify and validate the functionality of the subject device modifications. Testing will cover 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 07 below.
Table 07: Non-Clinical Performance Testing outlines the following:
- Quantum Iterative Reconstruction: Performance testing was done to support all technological characteristics, that are associated with this new technology.
- Detector - QuantaMax: The performed tests include the measurement and analysis of raw data for single photon counting, the nonexistence of classical noise and the ability to measure multiple energies simultaneously. Furthermore, the performance evaluation provides an in-depth evaluation of NAETOM Alpha Image Quality for general CT imaging, based on phantom evaluation of Typical Modes, compared to the predicate device SOMATOM Force. It also includes parameters for supporting the suitability of the subject device for low dose lung cancer screening.
- Cardiac CT imaging - Motion artifact reduced ECG-gated imaging: The associated test evidence contains a basic test scenario and the results of measurements based on an andromorphic motion heart phantom to support the clinical approach based on technical phantom measurements, which are to some extend clinically realistic.
- CARE keV: The test procedure includes phantom measurements with clinically relevant phantom diameters and contrast materials to support the contrast, noise, and radiation dose related CARE keV information.
- Quantum Pure Lumen: Performance testing was done to support all technological characteristics, that are associated with this new technology.
- Always Dual Energy: Performance testing was done to assess the accuracy of these three image types on phantoms with iodine inserts.
- Motion artifact reduced non-gated imaging: Performance testing was done to confirm the characteristics to allow improvement of motion artifacts. It also contains a basic test scenario and the results of measurements based on an andromorphic motion heart and respiratory phantom to support the clinical approach based on technical phantom measurements, which are clinically realistic.
- Calcium Scoring with keV Images: The performance evaluation used monoenergetic images reconstructed at 70 keV with different QIR strength settings derived from a counting detector technology acquisition of the subject device NAEOTOM Alpha, which are suitable in the application of Agatston Score base Coronary Calcium scoring.
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. 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
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 tests is to verify and validate the functionality of the subject device modifications. Testing will cover 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.
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.
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.
Wireless Coexistence Testing:
Tested for 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 and validation testing of the device was found acceptable to support the claim of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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September 30, 2021
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Siemens Medical Solutions USA, Inc. % Tabitha Estes Regulatory Affairs Specialist 810 Innovation Drive KNOXVILLE TN 37932
Re: K211591
Trade/Device Name: NAEOTOM Alpha, Scan&GO Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: August 19, 2021 Received: August 20, 2021
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
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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,
, for
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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)
K211591
Device Name NAEOTOM Alpha Scan&GO
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 physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning.
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 done using special protocols.
Type of Use (Select one or both, as applicable)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------- |
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K211591
510(K) SUMMARY FOR NAEOTOM ALPHA CT SCANNER AND SCAN&GO Submitted by:
Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932 Date Prepared: February 21, 2021
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 (1)
Siemens Healthcare GmbH Siemensstr. 1 D-91301 Forchheim, Germany Establishment Registration Number 3004977335
Location of Manufacturing Site (2) SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD 278 Zhou Zhu Rd Shanghai, CHINA, 201318 Establishment Registration Number: 3003202425
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 Requlatory Affairs Siemens Medical Solutions USA, Inc. (865) 804-4553 (work cell) (865) 218-3019 FAX
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II. Device Name and Classification
| Product Name: | NAEOTOM Alpha |
|---|---|
| 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 |
| 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: SOMATOM Force Trade Name:
| 510(k) Number: | K190578 |
|---|---|
| Clearance Date: | June 27, 2019 |
| 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.cite, Scan&GO
| 510(k) Number: | K200524 |
|---|---|
| Clearance Date: | April 01, 2020 |
| 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: K200524 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 and Scan&GO software.
In this submission, the primary predicate device SOMATOM Force and the secondary predicate device SOMATOM X.cite including Scan&GO are being used, to demonstrate substantial equivalence of technological characteristics.
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IV. Device Description
Siemens intends to market a new CT scanner system NAEOTOM Alpha supporting software version, SOMARIS/10 syngo CT VA40 with mobile workflow options.
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 VA40 is a dual-source Computed Tomography (CT) x-ray system featuring two detectors based on new 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 predicate devices, but support with improved technological characteristics.
The NAEOTOM Alpha with Software SOMARIS/10 synqo CT VA40 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, treatment preparation and therapy planning support (including, but not limited to, Brachytherapy, Particle including Proton Therapy, External Beam Radiation Therapy, Surgery). 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 NAEOTOM Alpha. Scan&GO can be operated on a Siemens provided various tablet hardware that meets certain minimum technical requirements.
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 VA40 (SOMARIS/10 syngo CT VA40), is a command-based program used for patient management, data manaqement, 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 VA40 (SOMARIS/10 syngo CT VA40) is a modified software version based on syngo CT VA30A (SOMARIS/10 syngo CT VA30) which was cleared for the secondary predicate device and supports the same plugin interfaces for the subject device Scan&GO mobile workflow and integration of post-processing tasks as the secondary predicate device Scan&GO cleared in (K200524).
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 physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning.
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.
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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 comparable technological characteristics in terms of materials, energy source, and control mechanisms when compared to the primary predicate device SQMATOM Force. The software and hardware components of this scanner have been modified or improved in comparison to the predicate devices to support enhanced device functionality and a to introduce a new detector technology.
The subject device NAEOTOM Alpha is building on the dual-source CT system configuration of the primary predicate device SOMATOM Force.
NAEOTOM Alpha features comparable technological characteristics of a Siemens dual-source CT system, such as fast scan speed and temporal resolution down to 66ms. It uses the same general geometric dimensions of the measurement field (such as detector z coverage and scan-field-of-view) in comparison to the primary predicate device SOMATOM Force CT scanner system.
As a dual source CT scanner system, the primary predicate device SOMATOM Force features two conventional energy-integrating detectors made of scintillator ceramic (product marketing name "Ultra Fast Ceramic", abbreviated UFC, based on scintillator ceramic). The subject device NAEOTOM Alpha features two photon counting detectors built from Cadmium-Telluride (CdTe).
Supported by the subject device, SOMARIS/10 syngo CT VA40 software version is a further development of the SOMARIS/10 syngo CT VA30 software version which is cleared in K200524. It reuses all unmodified software features of the legacy software syngo CT VA30 as described below in the section "Unmodified Features used in the Subject Devices".
As with the secondary predicate device SOMATOM X.cite, the subject device NAEOTOM Alpha is supported by an optional mobile workflow, Scan&GO has been modified to add new iPad hardware and operating software that supports the application software installation.
Software version SOMARIS/10 synqo CT VA40 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 predicate devices.
At a high level, the subject device NAEOTOM Alpha and the primary predicate device SOMATOM Force or the secondary predicate device SOMATOM X.cite 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
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- 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 SOMATOM Force or the secondary predicate device SOMATOM X.cite:
- Software version SOMARIS/10 syngo CT VA40
- Support updated cybersecurity features
- Additional options for Inline and GO technologies ●
- Iterative Reconstruction Methods .
- . QuantaMax Detector based on Quantum Technology
The following technological differences exist between the subject device Scan&GO mobile application software and the secondary predicate device Scan&GO mobile application software cleared in K200524:
- Software version SOMARIS/10 syngo CT VA40
- iPad hardware to support mobile workflow options .
The NAEOTOM Alpha will support the following modifications/further developments in comparison to the predicate devices as listed in the tables below.
The configuration table and comparison table use the following terms to describe various technological characteristics in comparison to the predicate device information:
| Table 01: Overview 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 devices |
| Unmodified | This feature remains unchanged from the predicate device |
| 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 VA40 and is substantially equivalent | |
| compared to the cleared version. |
New/modified hardware features:
Table 02: Overview of hardware modifications of NAEOTOM Alpha
| Subject Device | ||
|---|---|---|
| Hardware properties supported by SOMARIS/10 syngo CT VA40 | NAEOTOM Alpha | |
| 01 | Detector - QuantaMax | new |
| 02 | Tablet hardware for Scan&GO - iPad | modified |
| 03 | Patient Table Configuration | modified |
New software version SOMARIS/10 syngo CT VA40 with enabled, modified and new software features:
Table 03: Overview of software modifications of NAEOTOM Alpha
| Subject Device | ||
|---|---|---|
| Software properties supported by SOMARIS/10 syngo CT VA40 | NAEOTOM Alpha | |
| 01 | Precision Matrix (10242) (large image matrices) | enabled |
| 02 | Quantum Iterative Reconstruction | new |
| 03 | Always Dual Energy | new |
| 04 | Calcium scoring with keV images | modified |
| 05 | Imaging - Cardio BestPhase | enabled |
| 06 | CARE keV | new |
| 07 | Quantum Pure Lumen | new |
| 08 | Cardiac CT imaging - Motion artifact reduced ECG-gated imaging | modified |
| 09 | Motion artifact reduced non-gated imaging | modified |
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| Subject Device | ||
|---|---|---|
| Software properties supported by SOMARIS/10 syngo CT VA40 | NAEOTOM Alpha | |
| 10 | myExam Console and myExam Satellite | modified |
| 11 | Recon&GO Inline Results - DE SPP | modified |
| 12 | Recon&GO Spectral Recon | modified |
A tabular summary of the comparable hardware and software properties between the subject device NAEOTOM Alpha with software version syngo CT VA40 and predicate devices are listed in Table 04 and Table 05 below (only the changes from the predicate devices are highlighted in gray in the sections below sections).
| Table 04: NAEOTOM Alpha comparable hardware properties (modified) | |||
|---|---|---|---|
| Hardware | |||
| properties | subject device | ||
| NAEOTOM Alpha | |||
| Dual Source | primary predicate device | ||
| SOMATOM Force | |||
| Dual Source | secondary predicate device | ||
| SOMATOM X.cite | |||
| Single Source | |||
| Scanner | whole body X-ray computed | ||
| tomography scanner | whole body X-ray computed | ||
| tomography scanner | whole body X-ray computed | ||
| tomography scanner | |||
| Generator | |||
| max. power | 2x 120 kW | 2x 120 kW | 105 kW |
| Detector | |||
| technology | Direct Conversion with | ||
| "Quantum Technology" | Energy-integrating | Energy-integrating | |
| Detector | |||
| volume coverage | 2 x 57.6 mm | 2 x 57.6 mm | 38.4 mm |
| Detector | |||
| physical rows | 2 x 288 | 2 x 96 | 64 |
| Detector | |||
| slice width | 0.2 mm | 0.6 mm | 0.6 mm |
| Detector | |||
| channel No. | 2752 (A system) | ||
| 1984 (B system) | 920 (A system) | ||
| 640 (B system) | 840 | ||
| X-ray Tube | Vectron | Vectron | Vectron |
| Tube | |||
| kV steps | 90 kV, 100 kV, | ||
| 120 kV, 140 kV | (in 10kV steps) | ||
| 70 kV to 150kV | (in 10kV steps) | ||
| 70 kV to 150kV | |||
| Tube | |||
| max. current | 2 x 1300 mA | 2 x 1300 mA | 1200 mA |
| Tube | |||
| tube focus | $0.4×0.5$ mm / $0.6x0.7$ mm / | ||
| $0.8x1.1$ mm | |||
| (for both tubes) | $0.4×0.5$ mm / $0.6×0.7$ mm / | ||
| $0.8x1.1$ mm | |||
| (for both tubes) | $0.6x0.7$ mm / $0.8x1.1$ mm | ||
| Tube | |||
| heat capacity | higher than 30 MHU | higher than 30 MHU | higher than 30 MHU |
| Tube | |||
| Collimator | adaptive dose shied | ||
| supported | adaptive dose shied | ||
| supported | adaptive dose shied | ||
| supported | |||
| Gantry | |||
| bore size | 82 cm | 78 cm | 82 cm |
| Gantry | |||
| Scan FoV | 50 cm | 50 cm | 50 cm |
| Gantry | |||
| rotation time (sec) | 0.25s; 0.5s; 1.0s; | 0.25s, 0.285s, 0.33s, 0.5s, | |
| 1.0s | 0.3s, 0.5s, 1.0s | ||
| Gantry | |||
| Tilt (degree) | N/A | N/A | +/- 25 |
| Patient Table | |||
| type | Vario 2.D: | ||
| 2000 mm, | |||
| Vitus: | |||
| 2000 mm | PHS5, MPT4: | ||
| 1600 mm or 2000 mm | Vario RT: 1600 mm, | ||
| Vario 2: 2000 mm | |||
| Max. Scan length | |||
| Topogram | Vario 2.D: | ||
| 2080 mm, | |||
| Vitus: | |||
| 2080 mm | 1600 mm, 2000 mm | 1680 mm, 2080 mm | |
| Max. Scan length | |||
| Image acquisition | Vario 2.D: | ||
| 2000 mm, | |||
| Vitus: | |||
| 2000 mm | 1600 mm, 2000 mm | 1600 mm, 2000 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 | |||
| Properties | |||
| software | subject device | ||
| NAEOTOM Alpha | |||
| (syngo CT VA40 ) | primary predicate device | ||
| SOMATOM Force | |||
| (K190578) (syngo CT VB20) | secondary predicate device | ||
| SOMATOM X.cite | |||
| (K200524) | |||
| Operating | |||
| System | Windows based | ||
| SOMARIS/10 | |||
| syngo CT VA40 | Windows based | ||
| SOMARIS/7 | |||
| syngo CT VB20 | Windows based | ||
| SOMARIS/10 | |||
| syngo CT VA30 A | |||
| Acquisition | |||
| Workplace | syngo Acquisition Workplace (AWP) | ||
| syngo Viewing, syngo Filming | |||
| and syngo Archiving & | |||
| Networking | |||
| 2nd Acquisition Workplace | |||
| supported with myExam | |||
| Satellite | syngo Acquisition Workplace (AWP) | ||
| syngo Viewing, syngo Filming | |||
| and syngo Archiving & | |||
| Networking | |||
| 2nd Acquisition Workplace: | |||
| RRWP | syngo Acquisition Workplace (AWP) | ||
| syngo Viewing, syngo Filming | |||
| and syngo Archiving & | |||
| Networking | |||
| No 2nd Acquisition Workplace | |||
| supported | |||
| IRS | Image Reconstruction from | ||
| photon counting data | Image Reconstruction from | ||
| classic Siemens dual source | |||
| CT scanner | Image Reconstruction from | ||
| classic Siemens single source | |||
| CT scanner | |||
| Detector | QuantaMax detector firmware | ||
| supported | Stellar detector firmware | ||
| supported | Stellar detector firmware | ||
| supported | |||
| Teamplay | Support teamplay Protocols | ||
| Support of: | Support teamplay Protocols | ||
| Support of: | Support teamplay Protocols | ||
| Support of: | |||
| Protocols | Protocol supporting | ||
| contrast bolus-triggered | |||
| data acquisition Contrast media protocols Pediatric Protocols Flex Dose Profile Turbo Flash Spiral Dual Energy acquisition | Protocols for Radiation | ||
| Therapy Planning Protocol supporting | |||
| contrast bolus-triggered | |||
| data acquisition Contrast protocols – CARE | |||
| Contrast III Pediatric Protocols Flex Dose Profile Turbo Flash Spiral Dual Energy acquisition Adaptive 4D Spiral Protocols that allow | |||
| scanning with support of | |||
| an 3rd party respiratory | |||
| gating system (ANZAI, | |||
| Varian RGSC) | Protocols for Radiation | ||
| Therapy Planning support | |||
| patient marking Protocol supporting | |||
| contrast bolus-triggered | |||
| data acquisition Contrast media protocols Pediatric Protocols Flex Dose Profile TwinBeam DE TwinSpiral DE Flex 4D Spiral Protocols that allow | |||
| scanning with support of | |||
| an 3rd party respiratory | |||
| gating system (ANZAI, | |||
| Varian RGSC) | |||
| 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) | Advanced reconstruction tools
supported:
The syngo acquisition
workplace provides, image
reconstruction, and routine
postprocessing. Various
advanced reconstruction
features supported by the CT
Scanner, e.g., FAST and CARE
applications. | Advanced reconstruction tools
supported via Recon&GO – - Spectral Recon (Dual Energy
Reconstruction) - Inline Results DE SPP
(Spectral Post-Processing) /
including
Virtual Unenhanced,
Monoenergetic plus - Inline Results DE Ranges
(Parallel/Radial) / Inline DE |
| Post-
Processing | Software Plugin functions
enabled via software interface
Recon&GO - Inline Results
various methods of cleared
software applications | syngo.via - Wide Range of
individual applications,
syngo.via is a software solution
intended to be used for
viewing, manipulation,
communication, and storage of
medical images. It can be used
as a standalone device or | Software Plugin functions
enabled via software interface
Recon&GO - Inline Results
various methods of cleared
software applications |
| | subject device | primary predicate device | secondary predicate device |
| Properties
software | NAEOTOM Alpha
(syngo CT VA40) | SOMATOM Force
(K190578) (syngo CT VB20) | SOMATOM X.cite
(K200524) |
| | | cleared and unmodified syngo based software options. | |
| Cybersecurity | IT Hardening | IT Hardening | IT Hardening |
| Standard
Technologies | FAST Features CARE Features GO technology CARE keV | FAST Features CARE Features CARE kV | FAST Features CARE Features GO technology CARE kV |
| Iterative
Reconstruction
Methods | Quantum Iterative
Reconstruction | iMAR, SAFIRE, ADMIRE | iMAR, ADMIRE |
| 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) | Matrix resolution 512x512
(auto mode not supported) |
| Ca Scoring | 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 Force
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. | Classic SOMATOM X.cite
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. |
Table 04: NAEOTOM Alpha comparable hardware properties (modified)
9
Table 05: NAEOTOM Alpha comparable software properties
10
Any differences in technological characteristics do not raise different questions of safety and effectiveness. Siemens believes that the subject device is substantially equivalent to the predicate devices. Testing and validation are completed. Test results show that the subject device, the NAEOTOM Alpha, is comparable to the predicate devices in terms of technological characteristics and safety and effectiveness and therefore is substantially equivalent to the primary predicate SOMATOM Force and secondary predicate device SOMATOM X.cite.
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.
The general purpose of each tests is to verify and validate the functionality of the subject device modifications.
Testing will cover 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 ●
11
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 07 below.
| # | Feature | Non-Clinical Performance Testing |
|---|---|---|
| 01 | Quantum Iterative Reconstruction | Quantum Iterative Reconstruction - QIR is routinely used in all reconstructions on the subject device NAEOTOM Alpha. |
| As with the primary predicate device SOMATOM Force supporting ADMIRE, the subject device supports iterative reconstruction principle. | ||
| NAEOTOM Alpha supports Quantum Iterative Reconstruction with image data generated with Quantum Technology (QuantaMax Detector) and optimized for photon counting data. | ||
| Iterative Beam Hardening Correction - IBHC is an iterative Beam Hardening Correction algorithm optimized for the subject device NAEOTOM Alpha. | ||
| Performance testing was done to support all technological characteristics, that are associated with this new technology. | ||
| 02 | Detector - QuantaMax | The subject device NAEOTOM Alpha supports two "QuantaMax" detectors for CT data acquisition. The QuantaMax detectors are built on the new "Quantum Technology" which is Siemens Healthineers' implementation of photon counting technology for CT detectors. |
| The performed tests include the measurement and analysis of raw data for single photon counting, the nonexistence of classical noise and the ability to measure multiple energies simultaneously. | ||
| Furthermore, the performance evaluation provides an in-depth evaluation of NAETOM Alpha Image Quality for general CT imaging, based on phantom evaluation of Typical Modes, compared to the predicate device SOMATOM Force. It also includes parameters for supporting the suitability of the subject device for low dose lung cancer screening. | ||
| 05 | Cardiac CT imaging - Motion artifact reduced ECG-gated imaging | As with the primary predicate device the subject device supports ECG-gated imaging based on ECG-controlled dose modulation and triggering derived from continuous monitoring of the ECG. With same technological principle as cleared with the primary predicate device, the subject device supports with an unmodified algorithm, the desired prediction of the target start- and stop phase in retrospective spiral and in sequence mode. The prediction of the start phase in ECG triggered high pitch scanning is modified to improve the prediction over a wider range of heart rates. |
| The associated test evidence contains a basic test scenario and the results of measurements based on an andromorphic motion heart phantom to support the clinical approach based on technical phantom measurements, which are to some extend clinically realistic. | ||
| 06 | CARE keV | CARE kV is supported by the primary predicate device SOMATOM Force. The subject device NAEOTOM Alpha based on Quantum Technology supports CARE keV. CARE keV takes the dose efficiency of Monoenergetic reconstructions into account, by automatically adjusting the appropriate kV and effective mAs settings to optimize the applied dose while the image quality is maintained. The test procedure includes phantom measurements with clinically relevant phantom diameters and contrast materials to support the contrast, noise, and radiation dose related CARE keV information. |
| 07 | Quantum Pure Lumen | The subject device NAEOTOM Alpha supports with its new feature "VCR - Pure Lumen" a modified algorithm, which allows to reconstruct with a virtual removal of calcium in spectral generated images with a possible application in heavily calcified vessels. |
| Algorithm, clinical references and example images derived from phantom based measurements. Performance testing was done to support all technological characteristics, that are associated with this new technology. | ||
| # | Feature | Non-Clinical Performance Testing |
| 08 | Always Dual Energy | The subject device NAEOTOM Alpha supports virtual monochromatic |
| images, virtual non-contrast images and iodine images for all | ||
| QuantumPlus scans, i.e., all scans with 120kV or 140kV without tin | ||
| filtration and not in UHR mode. | ||
| Performance testing was done to assess the accuracy of these three | ||
| image types on phantoms with iodine inserts. | ||
| 09 | Motion artifact reduced non- | |
| gated imaging | As with the primary predicate device SOMATOM Force the subject | |
| device supports spiral scanning at different pitch value of up to 3.2 in a | ||
| dual source acquisition and up to 1.5 in a single source acquisition. | ||
| These acquisitions at high pitch values and therefore table speeds | ||
| have the potential to minimize motion artifacts. This feature name and | ||
| detector hardware is modified. In comparison to the primary predicate | ||
| device SOMATOM Force, other technological characteristics to | ||
| support the feature remains unmodified. | ||
| Performance testing was done to confirm the characteristics to allow | ||
| improvement of motion artifacts. It also contains a basic test scenario | ||
| and the results of measurements based on an andromorphic motion | ||
| heart and respiratory phantom to support the clinical approach based | ||
| on technical phantom measurements, which are clinically realistic. | ||
| 10 | Calcium Scoring with keV Images | As with the primary predicate device SOMATOM Force, the subject |
| device support CaScoring. With its photon counting detector | ||
| technology, the subject device software is modified to use its | ||
| generated monoenergetic images as a base for calcium scoring. | ||
| The performance evaluation used monoenergetic images | ||
| reconstructed at 70 keV with different QIR strength settings derived | ||
| from a counting detector technology acquisition of the subject device | ||
| NAEOTOM Alpha, which are suitable in the application of Agatston | ||
| Score base Coronary Calcium scoring. |
Table 06: Non-Clinical Performance Testing
12
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 07 and Table 08 below.
| 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
performance (IEC 60601-1:2005,
MOD) |
| 09/17/2018 | 19-8 | ANSI AAMI
IEC | 60601-1-2:2014 | Medical electrical equipment - Part 1-
2: General requirements for basic |
| Date of
Recognition | Recognition
Number | Standard
Developing
Organization | Standard
Designation
Number and Date | Title of Standard |
| 12/23/2016 | 5-114 | ANSI AAMI
IEC | 62366-1:2015 | safety and essential performance -
Collateral Standard: Electromagnetic
disturbances - Requirements and
tests |
| 07/09/2014 | 12-273 | IEC | 60825-1 Edition 2.0
2007-03 | Medical devices - Part 1: Application
of usability engineering to medical
devices |
| 06/27/2016 | 12-302 | IEC | 60601-2-44 Edition
3.2: 2016 | 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. |
| 01/14/2014 | 12-269 | IEC | 60601-1-3 Edition
2.1 2013-04 | Medical electrical equipment - Part 2-
44: Particular requirements for the
basic safety and essential
performance of x-ray equipment for
computed tomography |
| 06/27/2016 | 5-89 | IEC | 60601-1-6 Edition
3.1 2013-10 | Medical electrical equipment - Part 1-
3: General requirements for basic
safety and essential performance -
Collateral Standard: Radiation
protection in diagnostic X-ray
equipment |
| 03/14/2011 | 12-226 | IEC | 61223-2-6 Second
Edition 2006-11 | Medical Electrical Equipment - Part
1-6: General Requirements For
Basic Safety And Essential
Performance - Collateral Standard:
Usability |
| 01/30/2014 | 12-270 | IEC | 61223-3-5 First
Edition 2004-08 | Evaluation and routine testing in
medical imaging departments - Part
2-6: Constancy tests - Imaging
performance of computed
tomography X-ray equipment |
| 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 | 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)] |
| 06/27/2016 | 12-299 | IEC | 62563-1 Edition 1.1 | Medical Electrical Equipment - Part
2-28: Particular Requirements For
The Basic Safety And Essential
Performance Of X-Ray Tube
Assemblies For Medical Diagnosis |
| | | | | Medical electrical equipment -
Medical image display systems - Part
1: Evaluation methods |
Table 07: Recognized Consensus Standards
13
14
Table 08: 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. |
| 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 09
below.
Table 09: 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. | |
| 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 |
15
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 quidance 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 quidance 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 with IEC60601-2-44.
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. According to FDA quidance '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 and validation testing of the device was found acceptable to support the claim of substantial equivalence.
16
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 predicate devices were cleared based on the results of non-clinical testing including verification and validation, phantom tests, and supportive literature. The subject device is also tested using the same test methods and workflows as used for the predicate devices. The non-clinical data supports the safety of the device and the hardware and software verification 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 predicate devices currently marketed for the same intended use. Since the subject and predicate devices were tested using the same methods, Siemens believes that the data generated from the NAEOTOM Alpha testing supports a finding of substantial equivalence.