(90 days)
No
The summary describes a CT system with image processing and reconstruction capabilities, but there is no mention of AI or ML being used for these functions or any other purpose within the device.
No.
This device is a computed tomography system intended for generating and processing images to aid in diagnosis, treatment planning, and interventions, not for providing direct therapy. While it supports "radiation therapy planning," this is a diagnostic aid for therapy, not a therapeutic action itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The images delivered by the system can be used by a trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions." This clearly indicates its use in diagnosis.
No
The device is described as a Computed Tomography X-ray system, which is a hardware device that generates and processes images using x-ray transmission data. While it includes software components, it is fundamentally a hardware system.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: In Vitro Diagnostics are designed to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- This device generates images: The primary function of this computed tomography system is to generate and process cross-sectional images of patients using x-ray transmission data. It does not analyze biological samples.
- The intended use is image-based diagnosis and treatment planning: The intended use clearly states that the images are used as an aid in diagnosis, treatment, and radiation therapy planning, as well as for diagnostic and therapeutic interventions. This is consistent with an imaging device, not an IVD.
Therefore, this device falls under the category of a medical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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, treatment and radiation therapy planning 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.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
Siemens intends to market a new Single source CT system NAEOTOM Alpha.Prime and a new Dual Source CT system NAEOTOM Alpha.Pro based on the SOMARIS/10 software platform.
Siemens also intends to market updated software version, SOMARIS/10 syngo CT VB20, for the new NAEOTOM CT scanner systems and for the NAEOTOM Alpha cleared in K233657 (clearance date March 28th, 2024). The updated software version SOMARIS/10 syngo CT VB20 incorporates mainly features for radiotherapy planning support.
With the new software version SOMARIS/10 syngo CT VB20, the trade name of NAEOTOM Alpha cleared in K233657 has been changed to NAEOTOM Alpha.Peak for ex-factory systems. Systems already installed will receive the software update without change of the trade name. The system label keeps the product name NAEOTOM Alpha. System label information and UDI are not changed and remain the same as the original submitted.
For simplicity, the product name of NAEOTOM Alpha will be used throughout this submission instead of the trade name NAEOTOM Alpha.Peak.
The subject devices NAEOTOM Alpha (trade name ex-factory CT systems: NAEOTOM Alpha.Peak) and NAEOTOM Alpha.Pro with software version SOMARIS/10 syngo CT VB20 are Computed Tomography X-ray systems which feature two continuously rotating tube-detector systems, denominated as Aand B-systems respectively (dual source NAEOTOM CT scanner system).
The subject device NAEOTOM Alpha.Prime with software version SOMARIS/10 syngo CT VB20 is a Computed Tomography X-ray system which features one continuously rotating tube-detector systems, denominated as A-system (single source NAEOTOM Alpha CT scanner system).
The detectors' function is based on photon-counting technology.
In this submission, the above-mentioned CT scanner systems are jointly referred to as subject devices by "NAEOTOM CT scanner systems".
The NAEOTOM CT scanner systems with SOMARIS/10 syngo CT VB20 produce CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Siemens and other vendors. The CT images can be used by a trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions. The radiation therapy planning support includes, 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.
Only trained and qualified users, certified in accordance with country-specific regulations, are authorized to operate the system. For example, physicians, radiologists, or technologists. The user must have the necessary U.S. qualifications in order to diagnose or treat the patient with the use of the images delivered by the system.
The platform software for the NAEOTOM CT scanner systems is syngo CT VB20 (SOMARIS/10 syngo CT VB20). It 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 plugin software interfaces that allow for the use of specific commercially available post-processing software algorithms in an unmodified form from the cleared stand-alone post-processing version.
Software version syngo CT VB20 (SOMARIS/10 syngo CT VB20) is a modified software version of the primary predicate device NAEOTOM Alpha, syngo CT VB10 (SOMARIS/10 syngo CT VB10) cleared in K233657.
Software version SOMARIS/10 syngo CT VB20 will be offered ex-factory and as optional upgrade for the existing NAEOTOM Alpha systems.
The bundle approach is feasible for this submission since the subject devices have similar technological characteristics, software operating platform, and supported software characteristics. All subject devices will support previously cleared software and hardware features in addition to the applicable modifications as described within this submission. The intended use remains unchanged compared to the predicate devices.
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 (physicians, radiologists, or technologists) in a Professional Healthcare Facility.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
Non-clinical testing (integration and functional) including phantom tests were conducted for the subject devices NAEOTOM CT scanner systems 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 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 below:
- Direct i4D:
- Study Type: Bench test using a dynamic phantom.
- Objective: To compare a conventional respiratory 4DCT scan (spiral scan) with the breathing pattern of a thorax phantom and the result of Direct i4D with the same breathing pattern.
- Key Results: The test results show that with Direct i4D it is possible to acquire data for a full breathing cycle at every position of the patient even if the respiratory rate changes during the data acquisition. Compared to the conventional 4DCT scan mode interpolation artifacts (which occur because not for every position a complete breathing cycle could be acquired) can successfully be avoided with Direct i4D.
- DirectBreathhold:
- Study Type: Bench test.
- Key Results: The test results show that using the Direct Breathhold functionality, a spiral scan can automatically be triggered from an external respiratory gating device. The actual scan remains unchanged, and the object is correctly depicted in the resulting image.
- Recon&GO – RT planning:
- Study Type: Bench test.
- Key Results: The bench test underpins the possibility that with the introduction of the RTP scan protocols in the subject devices NAEOTOM CT scanner systems with syngo CT VB20, time and imaging dose can be saved, since each RTP scan range allows for spectral post-processing to provide task-specific images for an end-to-end radiotherapy workflow and thus no additional scan range with Single Energy is needed.
- FAST 3D Camera/FAST Integrated Workflow:
- Study Type: Bench test.
- Objective: To demonstrate that the FAST 3D camera achieves comparable or better results for both, adults and adolescents, as the predicate device for adults.
- Key Results: Overall, the subject devices with syngo CT VB20 delivers comparable or improved accuracy to the predicate devices with syngo CT VB10 predicate device for adults and extends the support to adolescents.
- Flex 4D Spiral:
- Study Type: Bench test.
- Objective: To demonstrate the proper function of Flex 4D Spiral and assess its image quality with NAEOTOM CT scanners.
- Key Results: The performed bench test report describes the technical background of Flex 4D Spiral and its functionalities with NAEOTOM CT scanners, demonstrate the proper function of those, and assess the image quality of Flex 4D Spiral.
- FAST Planning:
- Study Type: Bench test.
- Objective: To assess the fraction (percentage) of ranges calculated by the FAST Planning algorithm that are correct and can be applied without change. Additionally, calculation time was measured to check whether it meets interactive requirements.
- Key Results: The test results show that the editing actions for the scanner technician can be reduced to a minimum and that the calculation time is fast enough for interactive speed during scanning. For more than 90% of the ranges no editing action was necessary to cover standard ranges. For more than 95%, the speed of the algorithm was sufficient.
- Low-Dose Lung Cancer Screening – NAEOTOM Alpha.Pro:
- Study Type: Bench test.
- Objective: To compare technical parameters specific to Low-Dose Lung Cancer Screening of the predicate and subject devices.
- Key Results: It can be concluded that the subject and predicate devices are substantially equivalent for the task of Low-Dose Lung Cancer Screening since the bench test results showed comparable technical parameters.
- Low-Dose Lung Cancer Screening – NAEOTOM Alpha.Prime:
- Study Type: Bench test.
- Objective: To compare technical parameters specific to Low-Dose Lung Cancer Screening of the predicate and subject devices.
- Key Results: It can be concluded that the subject and predicate devices are substantially equivalent for the task of Low-Dose Lung Cancer Screening since the bench test results showed comparable technical parameters.
Verification and Validation:
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.
Cybersecurity:
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.
Wireless Coexistence Testing:
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 with IEC60601-2-44.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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February 12, 2025
Siemens Medical Solutions USA, Inc. % Tabitha Estes Regulatory Affairs Professional 810 Innovation Drive KNOXVILLE, TN 37932
Re: K243523
Trade/Device Name: NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: November 14, 2024 Received: November 14, 2024
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT8B: Division of Radiologic 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
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime
Indications for Use (Describe)
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, treatment and radiation therapy planning 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.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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K243523
510(k) Summary for
NAEOTOM CT Scanner Systems
with software version SOMARIS/10 syngo CT VB20
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 Healthineers AG Siemensstr. 1 -OR- Rittigfeld 1 D-91301 Forchheim, Germany Establishment Registration Number: 3004977335
Note: Descriptions in this submission use the short company name Siemens. Brand name on all products is Siemens Healthineers.
Submitter Contact Person: Tabitha Estes Regulatory Affairs Siemens Medical Solutions USA, Inc. (865) 804-4553 (work cell) tabitha.estes@Siemens-healthineers.com
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II. Device Name and Classification
| Product name | Trade name |
|---|---|
| NAEOTOM Alpha | NAEOTOM Alpha.Peak |
| NAEOTOM Alpha | |
| NAEOTOM Alpha.Pro | NAEOTOM Alpha.Pro |
| NAEOTOM Alpha.Prime | NAEOTOM Alpha.Prime |
| Classification Name: | Computed Tomography X-ray System |
|---|---|
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
III. Predicate Device
| Primary Predicate Device: | |
|---|---|
| Trade Name: | NAEOTOM Alpha |
| 510(k) Number: | K233657 |
| Clearance Date: | March 28, 2024 |
| 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 |
| 510(k) Number: | K233650 |
| Clearance Date: | March 26, 2024 |
| 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. |
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| Reference Predicate Device: | |
|---|---|
| Trade Name: | SOMATOM go. Platform |
| 510(k) Number: | K233650 |
| Clearance Date: | March 26, 2024 |
| 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: K233650 was a bundle 510(k) including the SOMATOM go. Platform (SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim and SOMATOM go.Open Pro) and the SOMATOM X. Platform (SOMATOM X.cite and SOMATOM X.ceed).
IV. Device Description
Siemens intends to market a new Single source CT system NAEOTOM Alpha.Prime and a new Dual Source CT system NAEOTOM Alpha.Pro based on the SOMARIS/10 software platform.
Siemens also intends to market updated software version, SOMARIS/10 syngo CT VB20, for the new NAEOTOM CT scanner systems and for the NAEOTOM Alpha cleared in K233657 (clearance date March 28th, 2024). The updated software version SOMARIS/10 syngo CT VB20 incorporates mainly features for radiotherapy planning support.
With the new software version SOMARIS/10 syngo CT VB20, the trade name of NAEOTOM Alpha cleared in K233657 has been changed to NAEOTOM Alpha.Peak for ex-factory systems. Systems already installed will receive the software update without change of the trade name. The system label keeps the product name NAEOTOM Alpha. System label information and UDI are not changed and remain the same as the original submitted.
For simplicity, the product name of NAEOTOM Alpha will be used throughout this submission instead of the trade name NAEOTOM Alpha.Peak.
The subject devices NAEOTOM Alpha (trade name ex-factory CT systems: NAEOTOM Alpha.Peak) and NAEOTOM Alpha.Pro with software version SOMARIS/10 syngo CT VB20 are Computed Tomography X-ray systems which feature two continuously rotating tube-detector systems, denominated as Aand B-systems respectively (dual source NAEOTOM CT scanner system).
The subject device NAEOTOM Alpha.Prime with software version SOMARIS/10 syngo CT VB20 is a Computed Tomography X-ray system which features one continuously rotating tube-detector systems, denominated as A-system (single source NAEOTOM Alpha CT scanner system).
The detectors' function is based on photon-counting technology.
In this submission, the above-mentioned CT scanner systems are jointly referred to as subject devices by "NAEOTOM CT scanner systems".
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Image /page/7/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern.
The NAEOTOM CT scanner systems with SOMARIS/10 syngo CT VB20 produce CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Siemens and other vendors. The CT images can be used by a trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions. The radiation therapy planning support includes, 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.
Only trained and qualified users, certified in accordance with country-specific regulations, are authorized to operate the system. For example, physicians, radiologists, or technologists. The user must have the necessary U.S. qualifications in order to diagnose or treat the patient with the use of the images delivered by the system.
The platform software for the NAEOTOM CT scanner systems is syngo CT VB20 (SOMARIS/10 syngo CT VB20). It 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 plugin software interfaces that allow for the use of specific commercially available post-processing software algorithms in an unmodified form from the cleared stand-alone post-processing version.
Software version syngo CT VB20 (SOMARIS/10 syngo CT VB20) is a modified software version of the primary predicate device NAEOTOM Alpha, syngo CT VB10 (SOMARIS/10 syngo CT VB10) cleared in K233657.
Software version SOMARIS/10 syngo CT VB20 will be offered ex-factory and as optional upgrade for the existing NAEOTOM Alpha systems.
The bundle approach is feasible for this submission since the subject devices have similar technological characteristics, software operating platform, and supported software characteristics. All subject devices will support previously cleared software and hardware features in addition to the applicable modifications as described within this submission. The intended use remains unchanged compared to the predicate devices.
V. Indications for Use
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, treatment and radiation therapy planning 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.
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Image /page/8/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a cluster of orange dots that are arranged in a circular pattern.
VI. Indications for Use Comparison
Subject Device Indications for Use:
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, treatment and radiation therapy planning 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.
Primary Predicate Device Indications for Use:
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.
Secondary Predicate Device Indications for Use:
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, treatment and radiation therapy planning 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.
Comparison:
The subject device Indications for Use is the exact same as the secondary predicate device Indications for Use (K233650).
Compared to the primary predicate device, the indications for Use of the subject devices have been extended with the phrase "radiation therapy planning" in the sentence "The images delivered by the system can be used by a trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions.". The extension of the indications for use reflects the support for radiotherapy planning introduced with the software version syngo CT VB20 of the subject devices.
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Image /page/9/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.
None of the intended uses include computed tomography as the principal means of guidance in invasive procedures (involving the introduction of a device, such as a needle or a catheter into the body of the patient).
The subject devices NAEOTOM CT scanner systems are not the principal means of guidance, because the CT Systems do not guide the invasive procedures, the needle orientation and the needle advance and handling are always done under the physician's control.
VII. Comparison of Technological Characteristics with the Predicate Device
Supported by the subject device, SOMARIS/10 syngo CT VB20 software version is a further development of the SOMARIS/10 syngo CT VB10 software version which is cleared in K233657.
The subject devices NAEOTOM CT scanner systems with SOMARIS/10 syngo CT VB20 software version provides the same technological characteristics in terms of materials, energy source, and control mechanisms when compared to the predicate devices. The software features of the NAEOTOM CT scanner systems have been modified or improved in comparison to the predicate devices to support enhanced device functionality compared to the predicate devices.
The new syngo CT VB20 software reuses all unmodified software features of the legacy software syngo CT VB10 cleared in K233657. Additionally, no features present in the predicate device are descoped.
Software version SOMARIS/10 syngo CT VB20 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 remain unchanged from the predicate devices.
At a high level, the subject and predicate devices 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
- QuantaMax Detector
- Tin filtration technology
- Vectron X-ray Tube
- Power Generator
- Scan&GO
- . Mobile workflow (Tablet)
- Optional injector arm
- Optional support of CT guided intervention workflow (myNeedle Guide)
- Optional support of FAST 3D Camera operation for fast patient positioning workflow
- Scanner display and control functionality
- Remote Scan Control
- Long scan range
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Image /page/10/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a cluster of orange dots of varying sizes.
The subject devices NAEOTOM CT scanner systems with SOMARIS/10 syngo CT VB20 will support hardware and software modifications/further developments in comparison to the predicate devices as listed in the Table 2. The column "HW/ SW change" in the table contains reference to a hardware (HW) or/and software (SW) change. The columns under "Predicate devices" of the Table 2 indicate the clearance of the technological properties in the corresponding predicate device.
The modification overview in Table 2 uses the terms "new, modified, or enabled" to describe various technological characteristics of the subject devices in comparison to the primary and secondary predicate devices. The definition of the above-mentioned terms is provided in the following Table 1.
| Term | Definition |
|---|---|
| New | The feature is newly supported for Siemens CT scanners and the subject device |
| Modified | This feature is a modified form of a feature cleared within the primary and/or |
| secondary predicate 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 | |
| VB20 and is substantially equivalent compared to the cleared version of the | |
| primary/secondary predicate device. | |
| n.a. | The feature is not supported by the subject device or by the primary and/or |
| secondary predicate device. |
Table 1: Overview of term definition.
The following Table 2 provides a modification overview of the subject devices at a high-level.
Table 2: High-level overview of key hardware (HW) and software (SW) modifications of the Dual source subject devices NAEOTOM Alpha (trade name ex-factory: NAEOTOM Alpha.Peak; trade name installed base: NAEOTOM Alpha) and
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Image /page/11/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of several orange dots arranged in a pattern.
NAEOTOM Alpha.Pro and the Single source subject device NAEOTOM Alpha.Prime with software version SOMARIS/10 syngo CT VB20 compared to the predicate devices.
| | Technological
property | HW/
SW
change | Subject devices | | | Predicate devices | |
|-----|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|--------------------------------------|------------------------------------------|--------------------------------------------|---------------------------------------------------|----------------------------------------------------|
| | | | Dual Source | | Single
source | Dual Source | Single
source |
| | | | NAEOTOM
Alpha | NAEOTOM
Alpha.Pro | NAEOTOM
Alpha.Prime | NAEOTOM
Alpha | SOMATOM
X.ceed |
| | | | syngo CT
VB20 | syngo CT
VB20 | syngo CT
VB20 | syngo CT
VB10 | syngo CT
VB10 |
| | | | | | | (K233657) | (K233650) |
| 1. | Respiratory Motion
Management -
Interfaces for
respiratory gating:
- Varian RGSC
- Anzai
- Open Interface
- Open Online
Interface | HW | modified¹ | modified¹ | modified¹ | n.a. | cleared |
| 2. | Respiratory Motion
Management -
FAST 4D | SW | enabled | enabled | enabled | n.a. | cleared |
| 3. | Respiratory Motion
Management -
Direct i4D | SW | enabled | enabled | enabled | n.a. | cleared |
| 4. | Respiratory Motion
Management -
DirectBreathhold | SW | enabled | enabled | enabled | n.a. | cleared |
| 5. | CT View&GO - Sim&GO | SW | modified² | modified² | modified² | cleared | cleared |
| 6. | Direct Laser
Steering | HW/
SW | enabled | enabled | enabled | n.a. | cleared |
| 7. | Recon&GO | SW | modified² | modified² | modified² | cleared | cleared |
| | Technological
property | HW/
SW
change | Subject devices | | | Predicate devices | |
| | | | NAEOTOM
Alpha
syngo CT
VB20 | NAEOTOM
Alpha.Pro
syngo CT
VB20 | NAEOTOM
Alpha.Prime
syngo CT
VB20 | NAEOTOM
Alpha
syngo CT
VB10
(K233657) | SOMATOM
X.ceed
syngo CT
VB10
(K233650) |
| | - RT planning | | | | | | |
| 8. | Oncology Exchange | SW | new | new | new | n.a. | n.a. |
| 9. | DirectSetupNotes | SW | enabled3 | enabled3 | enabled3 | n.a. | cleared |
| 10. | FAST 3D Camera/
FAST Integrated
Workflow | SW/
HW | modified4 | modified4 | modified4 | cleared | cleared |
| 11. | Flex 4D Spiral | SW | modified4 | modified4 | modified4 | cleared | cleared |
| 12. | FAST Planning | SW | modified4 | modified4 | modified4 | cleared | cleared |
| 13. | CARE Moodlight | HW | enabled5 | enabled5 | enabled5 | n.a. | n.a. |
| 14. | Eco Power Mode | HW/
SW | new | new | new | n.a. | n.a. |
| 15. | Power Shaver | SW/
HW | n.a. | n.a. | new | n.a. | n.a. |
| 16. | myExam
Companion –
myExam
Compass/
myExam Cockpit | SW | modified4 | modified4 | modified4 | cleared | cleared |
1 The listed interfaces for respiratory gating are implemented unchanged in the subject devices compared to the secondary predicate device SOMATOM X.ceed with exception of Open Online Interface is not available on the predicate devices and the interface is new for this submission.
2 In the subject devices NAEOTOM Alpha, NAEOTOM Alpha.Pro, and NAEOTOM Alpha.Prime with syngo CT VB20, the functionalities Recon&GO Inline Results and CT View&GO support the same functions as cleared in the secondary predicate device SOMATOM X.ceed but are modified compared to the primary predicate device NAEOTOM Alpha with software version syngo CT VB10.
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Image /page/12/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a cluster of orange dots arranged in a circular pattern.
A tabular summary of the comparable hardware and software properties between the subject devices NAEOTOM CT scanner systems with software version syngo CT VB20 and the
Siemens Healthineers AG
3 DirectSetupNotes is cleared in K233650 for the SOMATOM go.Open Pro. K233650 is a bundle 510(k) including the SOMATOM go. Platform (SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim and SOMATOM go.Open Pro) and the SOMATOM X.cite and SOMATOM X.cite and SOMATOM X.ceed).
4 These features are modified compared to the same feature cleared in the primary and secondary predicate device.
5 CARE Moodlight is cleared in K233650 for the SOMATOM go.Now, SOMATOM go.Top and SOMATOM go.All. K233650 is a bundle 510(k) including the SOMATOM go. Platform (SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim and SOMATOM go.Open Pro) and the SOMATOM X. Platform (SOMATOM X.cite and SOMATOM X.ceed).
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Image /page/13/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots.
primary/secondary predicate devices are listed in the following tables (modifications are in gray shaded sections).
Table 3 compares the hardware properties of the dual source subject devices NAEOTOM Alpha (trade name ex-factory: NAEOTOM Alpha.Peak; trade name installed base: NAEOTOM Alpha) and NAEOTOM Alpha.Pro with the primary/secondary predicate devices.
Table 4 provides a comparison of the hardware properties between the single source subject device NAEOTOM Alpha.Prime and the primary/secondary predicate devices.
Table 5 compares the software technological characteristics of the subject devices and the predicate devices.
Table 3: Hardware characteristics for the dual source subject devices NAEOTOM Alpha (trade name ex-factory: NAEOTOM Alpha.Peak; trade name installed base: NAEOTOM Alpha) and NAEOTOM Alpha.Pro with software version SOMARIS/10 syngo CT VB20 compared to the predicate devices.
| Hardware
property | Subject device
(Dual source NAEOTOM CT systems) | | Primary predicate
device | Secondary predicate
device |
|------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NAEOTOM Alpha
SOMARIS/10 syngo
CT VB20 | NAEOTOM
Alpha.Pro
SOMARIS/10 syngo
CT VB20 | NAEOTOM Alpha
SOMARIS/10 syngo
CT VB10
(K233657) | SOMATOM X.ceed
SOMARIS/10 syngo
CT VB10
(K233650) |
| Scanner | whole body X-ray
computed
tomography (CT)
scanner | whole body X-ray
computed
tomography (CT)
scanner | whole body X-ray
computed
tomography (CT)
scanner | whole body X-ray
computed
tomography (CT)
scanner |
| Product
name | NAEOTOM Alpha | NAEOTOM
Alpha.Pro | NAEOTOM Alpha | SOMATOM X.ceed |
| Trade name | • Ex-factory CT
systems:
NAEOTOM
Alpha.Peak
• Installed base CT
systems:
NAEOTOM Alpha | • Ex-factory CT
systems:
NAEOTOM
Alpha.Pro
• Installed base CT
systems:
n.a., new CT system | NAEOTOM Alpha | SOMATOM X.ceed |
| Design | without myNeedle
Laser:
Image: CT scanner | without myNeedle
Laser:
Image: CT scanner | without myNeedle
Laser:
Image: CT scanner | without myNeedle
Laser:
Image: CT scanner
with myNeedle Laser: |
| Hardware
property | Subject device
(Dual source NAEOTOM CT systems) | | Primary predicate
device | Secondary predicate
device |
| | NAEOTOM Alpha
SOMARIS/10 syngo
CT VB20 | NAEOTOM
Alpha.Pro
SOMARIS/10 syngo
CT VB20 | NAEOTOM Alpha
SOMARIS/10 syngo
CT VB10
(K233657) | SOMATOM X.ceed
SOMARIS/10 syngo
CT VB10
(K233650) |
| | with myNeedle
Laser:
Image: CT scanner | with myNeedle
Laser:
Image: CT scanner | with myNeedle
Laser:
Image: CT scanner | Image: CT scanner |
| System
configuration | Dual Source | Dual Source | Dual Source | Single Source |
| Environment
of Use | Professional
Healthcare Facility | Professional
Healthcare Facility | Professional
Healthcare Facility | Professional
Healthcare Facility |
| Generator
max. power
(kW) | 2x 120 | 2x 120 | 2x 120 | 105 or 120 |
| Detector
technology | QuantaMax
direct conversion
with "Quantum
Technology" | QuantaMax
direct conversion
with "Quantum
Technology" | QuantaMax
direct conversion
with "Quantum
Technology" | StellarInfinity
UFC (Ultra Fast
Ceramic) |
| Detector
volume
coverage
(mm) | 2x 57.6 | 2x 38.4 | 2x 57.6 | 38.4 |
| Detector
physical rows | 2x 288 | 2x 192 | 2x 288 | 64 |
| Detector
slice width
(mm) | 0.2 | 0.2 | 0.2 | 0.6 |
| Detector
DAS channel
no. | 2752 (A system)
1984 (B system) | 2752 (A system)
1984 (B system) | 2752 (A system)
1984 (B system) | 920 |
| Tube | VECTRON | VECTRON | VECTRON | VECTRON |
| Hardware
property | Subject device
(Dual source NAEOTOM CT systems) | | Primary predicate
device | Secondary predicate
device |
| | NAEOTOM Alpha
SOMARIS/10 syngo
CT VB20 | NAEOTOM
Alpha.Pro
SOMARIS/10 syngo
CT VB20 | NAEOTOM Alpha
SOMARIS/10 syngo
CT VB10
(K233657) | SOMATOM X.ceed
SOMARIS/10 syngo
CT VB10
(K233650) |
| technology | | | | |
| Tube
kV steps | 70, 90, 100, 120,
140, 150
(150 kV only
available on the
smaller tube-
detector system (B
system) and only in
combination with
the additional Sn
filter, 0.7 mm) | 70, 90, 100, 120,
140, 150
(150 kV only
available on the
smaller tube-
detector system (B
system) and only in
combination with
the additional Sn
filter, 0.7 mm) | 70, 90, 100, 120,
140, 150
(150 kV only
available on the
smaller tube-
detector system (B
system) and only in
combination with
the additional Sn
filter, 0.7 mm) | 70, 80, 90, 100, 110,
120, 130, 140, 150 |
| Tube
max. current
(mA) | 2x 1300 | 2x 1300 | 2x 1300 | 1200 mA (for 105
kW)
1300 mA (for 120
kW) |
| Tube
tube focus
(mm) | 0.4 x 0.5/8°
0.6 x 0.7/8°
0.8 x 1.1/8°
(for both tubes) | 0.4 x 0.5/8°
0.6 x 0.7/8°
0.8 x 1.1/8°
(for both tubes) | 0.4 x 0.5/8°
0.6 x 0.7/8°
0.8 x 1.1/8°
(for both tubes) | 0.4 x 0.5/8°
0.6 x 0.7/8°
0.8 x 1.1/8° |
| Tube
heat storage
capacity
(MHU) | higher than 30 | higher than 30 | higher than 30 | higher than 30 |
| Tube
cooling rate
(MHU/min) | 2.7 | 2.7 | 2.7 | 2.7 |
| Gantry
bore size
(cm) | 82 | 82 | 82 | 82 |
| Gantry
Scan FoV
(cm) | 50 | 50 | 50 | 50 |
| Gantry | 81.5 | 81.5 | 81.5 | 81.5 |
| Hardware
property | Subject device
(Dual source NAEOTOM CT systems) | | Primary predicate
device | Secondary predicate
device |
| | NAEOTOM Alpha
SOMARIS/10 syngo
CT VB20 | NAEOTOM
Alpha.Pro
SOMARIS/10 syngo
CT VB20 | NAEOTOM Alpha
SOMARIS/10 syngo
CT VB10
(K233657) | SOMATOM X.ceed
SOMARIS/10 syngo
CT VB10
(K233650) |
| Extended FoV
(cm) | | | | |
| Gantry
rotation time
(sec) | 0.25, 0.5, 1.0 | 0.25, 0.5, 1.0 | 0.25, 0.5, 1.0 | 0.25, 0.3, 0.5, 1.0 |
| Gantry
Tilt (degree) | N/A | N/A | N/A | +/- 25
+/-30 (only with
Vitus) |
| Maximum
temporal
resolution in
ECG gated or
triggered
examination
(ms) | mono- mono-
segment: 66
bi-segment: 33 | mono- mono-
segment: 66
bi-segment: 33 | mono-segment: 66
bi-segment: 33 | mono-segment: 125
bi-segment: 66 |
| Maximum
scan speed at
pitch
(mm/s at
pitch x) | 737 mm/s at pitch
3.2 | 492 mm/s at pitch
3.2 | 737 mm/s at pitch
3.2 | 261 at pitch 1.7 |
| Patient Table
Type | Vario 2.D
Vitus
Installation option
with extended
distance (Vitus) | Vario 2.D
Vitus
Installation option
with extended
distance (Vitus) | Vario 2.D
Vitus
Installation option
with extended
distance (Vitus) | Vario RT
Vitus
Vario 2.D |
| Max. Scan
length
Topogram
(mm) | Vario 2.D: 2080
Vitus: 2080 | Vario 2.D: 2080
Vitus: 2080 | Vario 2.D: 2080
Vitus: 2080 | Vario 2.D: 2080
Vitus: 2080
Vario RT: 1680 |
| Max. Scan
length
Image
acquisition
(mm) | Vario 2.D: 2000
Vitus: 2000 | Vario 2.D: 2000
Vitus: 2000 | Vario 2.D: 2000
Vitus: 2000 | Vario 2.D: 2000
Vitus: 2000
Vario RT: 1600 |
| Hardware
property | Subject device
(Dual source NAEOTOM CT systems) | | Primary predicate
device | Secondary predicate
device |
| | NAEOTOM Alpha
SOMARIS/10 syngo
CT VB20 | NAEOTOM
Alpha.Pro
SOMARIS/10 syngo
CT VB20 | NAEOTOM Alpha
SOMARIS/10 syngo
CT VB10
(K233657) | SOMATOM X.ceed
SOMARIS/10 syngo
CT VB10
(K233650) |
| Patient table
Max. weight
capacity (kg) | Vario 2.D: 307
Vitus: 307 or 340 | Vario 2.D: 307
Vitus: 340 | Vario 2.D: 307
Vitus: 307 or 340 | Vario 2.D: 307
Vitus: 307
Vario RT: 227 |
| Spectral
filtration | Tin Filter for both
tubes: 0.4 mm
additional Tin Filter
for the smaller
tube-detector
system (B-system)
only: 0.7 mm | Tin Filter for both
tubes: 0.4 mm
additional Tin Filter
for the smaller
tube-detector
system (B-system)
only: 0.7 mm | Tin Filter for both
tubes: 0.4 mm
additional Tin Filter
for the smaller tube-
detector system (B-
system) only: 0.7
mm | Combined Tin Filter /
Split Filter, and extra
Tin Filter |
| FAST 3D
Camera | option for patient
positioning with
FAST 3D Camera
installation options:
• ceiling mounted | option for patient
positioning with
FAST 3D Camera
installation options:
• ceiling mounted | option for patient
positioning with
FAST 3D Camera
installation options:
• ceiling mounted | option for patient
positioning with FAST
3D Camera
installation options:
• ceiling mounted |
| X-ray foot
switch | Option to trigger
hands-free scanning | Option to trigger
hands-free scanning | Option to trigger
hands-free scanning | Option to trigger
hands-free scanning |
| Table foot
switch | Option for table
patient movement | Option for table
patient movement | Option for table
patient movement | Option for table
patient movement |
| Tablet dock
for patient
table | Option for
mounting of the
tablet on the
patient table. | Option for
mounting of the
tablet on the
patient table. | Option for mounting
of the tablet on the
patient table. | Option for mounting
of the tablet on the
patient table. |
| Intervention
al Joystick
(IVJ) | Option to move the
table during
myNeedle Guide
procedures in the
examination room.
electrical
connection for the
tablet dock which
allows charging the
tablet when
mounted. | Option to move the
table during
myNeedle Guide
procedures in the
examination room.
electrical
connection for the
tablet dock which
allows charging the
tablet when
mounted. | Option to move the
table during
myNeedle Guide
procedures in the
examination room.
electrical connection
for the tablet dock
which allows
charging the tablet
when mounted. | Option to move the
table during
myNeedle Guide
procedures in the
examination room.
electrical connection
for the tablet dock
which allows
charging the tablet
when mounted. |
| Hardware
property | Subject device
(Dual source NAEOTOM CT systems) | | Primary predicate
device | Secondary predicate
device |
| | NAEOTOM Alpha
SOMARIS/10 syngo
CT VB20 | NAEOTOM
Alpha.Pro
SOMARIS/10 syngo
CT VB20 | NAEOTOM Alpha
SOMARIS/10 syngo
CT VB10
(K233657) | SOMATOM X.ceed
SOMARIS/10 syngo
CT VB10
(K233650) |
| Laser
supported
workflow | Laser in
combination with
FAST Isocentering
visualize
coordinates for
patient isocenter
position;
myNeedle Laser
visualizes a planned
needle path for
interventions | Laser in
combination with
FAST Isocentering
visualize
coordinates for
patient isocenter
position;
myNeedle Laser
visualizes a planned
needle path for
interventions | Laser in combination
with FAST
Isocentering visualize
coordinates for
patient isocenter
position;
myNeedle Laser
visualizes a planned
needle path for
interventions | Laser in combination
with FAST
Isocentering visualize
coordinates for
patient isocenter
position;
myNeedle Laser
visualizes a planned
needle path for
interventions |
| CARE
Moodlight | LED lights
integrated on the
gantry front to
indicate the system
status:
· System startup
• Scan countdown
• Radiation on | LED lights
integrated on the
gantry front to
indicate the system
status:
· System startup
• Scan countdown
· Radiation on | n.a.6 | n.a.6 |
| Respiratory
Motion
management
- Interfaces
for
respiratory
gating | acquisition of
respiration-
correlated scans
supported
Interface
connectors for:
• Anzai respiratory
gating system
• Varian RGSC
respiratory gating
system
• Open interface
compatible | acquisition of
respiration-
correlated scans
supported
Interface
connectors for:
• Anzai respiratory
gating system
• Varian RGSC
respiratory gating
system
· Open interface
compatible | n.a. | acquisition of
respiration-
correlated scans
supported
Interface connectors
for:
• Anzai respiratory
gating system
• Varian RGSC
respiratory gating
system
• Open interface
compatible |
| Hardware
property | Subject device
(Dual source NAEOTOM CT systems) | | Primary predicate
device | Secondary predicate
device |
| | NAEOTOM Alpha
SOMARIS/10 syngo
CT VB20 | NAEOTOM
Alpha.Pro
SOMARIS/10 syngo
CT VB20 | NAEOTOM Alpha
SOMARIS/10 syngo
CT VB10
(K233657) | SOMATOM X.ceed
SOMARIS/10 syngo
CT VB10
(K233650) |
| | respiratory gating
systems
• Open Online
Interface | respiratory gating
systems
• Open Online
Interface | | respiratory gating
systems |
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Image /page/14/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the word "Healthineers" is a graphic of orange dots that are arranged in a pattern.
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Image /page/15/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a series of orange dots that form an arrow shape.
16
Image /page/16/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a series of orange dots that are arranged in a pattern.
17
Image /page/17/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a series of orange dots that get progressively larger.
18
Image /page/18/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots.
რ CARE Moodlight is cleared in K233650 for the SOMATOM go.Now, SOMATOM go.Top and SOMATOM go.All. K233650 is a bundle 510(k) including the SOMATOM go. Platform (SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim and SOMATOM go.Open Pro) and the SOMATOM X. Platform (SOMATOM X.cite and SOMATOM X.ceed).
19
Image /page/19/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a series of orange dots that are arranged in a circular pattern. The logo is simple and modern.
Table 4: Hardware characteristics for the single source subject device NAEOTOM Alpha.Prime (software version SOMARIS/10 syngo CT VB20) compared to the predicate devices.
| Hardware
property | Subject device | Primary predicate
device | Secondary predicate
device |
|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NAEOTOM Alpha.Prime
SOMARIS/10 syngo CT
VB20 | NAEOTOM Alpha
SOMARIS/10 syngo CT
VB10
(K233657) | SOMATOM X.ceed
SOMARIS/10 syngo CT
VB10
(K233650) |
| Scanner | whole body X-ray
computed tomography
scanner | whole body X-ray
computed tomography
scanner | whole body X-ray
computed tomography
scanner |
| Design | without myNeedle
Laser:
Image: CT scanner without myNeedle Laser | without myNeedle
Laser:
Image: CT scanner without myNeedle Laser | without myNeedle
Laser:
Image: CT scanner without myNeedle Laser |
| | with myNeedle Laser:
Image: CT scanner with myNeedle Laser | with myNeedle Laser:
Image: CT scanner with myNeedle Laser | with myNeedle Laser:
Image: CT scanner with myNeedle Laser |
| Hardware
property | Subject device | Primary predicate
device | Secondary predicate
device |
| | NAEOTOM Alpha.Prime
SOMARIS/10 syngo CT VB20 | NAEOTOM Alpha
SOMARIS/10 syngo CT VB10
(K233657) | SOMATOM X.ceed
SOMARIS/10 syngo CT VB10
(K233650) |
| System
configuration | Single Source | Dual Source | Single Source |
| Environment of
Use | Professional Healthcare
Facility | Professional Healthcare
Facility | Professional Healthcare
Facility |
| Generator
max. power (kW) | 105 or 120 | 2x 120 | 105 or 120 |
| Detector
technology | QuantaMax
Direct Conversion with
"Quantum Technology" | QuantaMax
Direct Conversion with
"Quantum Technology" | UFC
(Ultra Fast Ceramic) |
| Detector
volume coverage
(mm) | 57.6 | 2x 57.6 | 38.4 |
| Detector
physical rows | 288 | 2x 288 | 64 |
| Detector
slice width (mm) | 0.2 | 0.2 | 0.6 |
| Detector
DAS channel no. | 2752 | 2752 (A system)
1984 (B system) | 920 |
| Tube
technology | VECTRON | VECTRON | VECTRON |
| Tube
kV steps | 70, 90, 100, 120, 140 | 70, 90, 100, 120, 140,
150
(150 kV only available
on the smaller tube-
detector system (B
system) and only in
combination with the | 70, 80, 90, 100, 110,
120, 130, 140, 150 |
| Hardware
property | Subject device | Primary predicate
device | Secondary predicate
device |
| | NAEOTOM Alpha.Prime | NAEOTOM Alpha | SOMATOM X.ceed |
| | SOMARIS/10 syngo CT
VB20 | SOMARIS/10 syngo CT
VB10
(K233657) | SOMARIS/10 syngo CT
VB10
(K233650) |
| | | additional Sn filter, 0.7
mm) | |
| Tube
max. current (mA) | 1200 (for 105 kW
Generator) | 2x 1300 | 1200 (for 105 kW
Generator) |
| | 1300 (for 120 kW
Generator) | | 1300 (for 120 kW
Generator) |
| Tube
tube focus (mm) | 0.4 x 0.5/8° | 0.4 x 0.5/8° | 0.4 x 0.5/8° |
| | 0.6 x 0.7/8° | 0.6 x 0.7/8° | 0.6 x 0.7/8° |
| | 0.8 x 1.1/8° | 0.8 x 1.1/8° | 0.8 x 1.1/8° |
| | | (for both tubes) | |
| Tube
heat capacity | higher than 30 MHU | higher than 30 MHU | higher than 30 MHU |
| | | | |
| Tube
cooling rate
(MHU/min) | 2.7 | 2.7 | 2.7 |
| | | | |
| Gantry
bore size (cm) | 82 | 82 | 82 |
| | | | |
| Gantry
Scan FoV (cm) | 50 | 50 | 50 |
| | | | |
| Gantry
Extended FoV
(cm) | 81.5 | 81.5 | 81.5 |
| | | | |
| Gantry
rotation time (sec) | 0.25, 0.5, 1.0 | 0.25, 0.5, 1.0 | 0.25, 0.3, 0.5, 1.0 |
| | | | |
| Gantry
Tilt (degree) | N/A | N/A | +/- 25
+/-30 (only with Vitus) |
| | | | |
| Hardware
property | Subject device | Primary predicate
device | Secondary predicate
device |
| | NAEOTOM Alpha.Prime
SOMARIS/10 syngo CT
VB20 | NAEOTOM Alpha
SOMARIS/10 syngo CT
VB10
(K233657) | SOMATOM X.ceed
SOMARIS/10 syngo CT
VB10
(K233650) |
| Maximum
temporal
resolution in ECG
gated or triggered
examination (ms) | mono-segment: 125
bi-segment: 66 | mono-segment: 66
bi-segment: 33 | mono-segment: 125
bi-segment: 66 |
| Maximum scan
speed at pitch
(mm/s at pitch x) | 345 mm/s at pitch 1.5 | 737 mm/s at pitch 3.2 | 261 mm/s at pitch 1.7 |
| Patient Table
Type | Vario 2.D
Vitus | Vario 2.D
Vitus
Installation option with
extended distance
(Vitus) | Vario RT
Vario 2.D
Vitus |
| Max. Scan length
Topogram (mm) | Vario 2.D: 2080
Vitus: 2080 | Vario 2.D: 2080
Vitus: 2080 | Vario RT: 1680
Vario 2.D: 2080
Vitus: 2080 |
| Max. Scan length
Image acquisition
(mm) | Vario 2.D: 2000
Vitus: 2000 | Vario 2.D: 2000
Vitus: 2000 | Vario RT: 1600
Vario 2.D: 2000
Vitus: 2000 |
| Patient table
Max. weight
capacity (kg) | Vario 2.D: 307
Vitus: 340 | Vario 2.D: 307
Vitus: 307 or 340 | Vario RT: 227
Vario 2.D: 307
Vitus: 307 or 340 |
| Spectral filtration | Tin Filter: 0.4 mm | Tin Filter for both tubes:
0.4 mm
additional Tin Filter for
the smaller tube-detector
system (B-system) only:
0.7 mm | Combined Tin Filter / Split
Filter, and extra
Tin Filter |
| Hardware
property | Subject device | Primary predicate
device | Secondary predicate
device |
| | NAEOTOM Alpha.Prime
SOMARIS/10 syngo CT
VB20 | NAEOTOM Alpha
SOMARIS/10 syngo CT
VB10
(K233657) | SOMATOM X.ceed
SOMARIS/10 syngo CT
VB10
(K233650) |
| FAST 3D Camera | option for patient
positioning with FAST
3D Camera
installation options:
• ceiling mounted | option for patient
positioning with FAST
3D Camera
installation options:
• ceiling mounted | option for patient
positioning with FAST
3D Camera
installation options:
• ceiling mounted |
| X-ray foot switch | Option to trigger hands-free scanning | Option to trigger hands-free scanning | Option to trigger hands-free scanning |
| Table foot switch | Option for table patient
movement | Option for table patient
movement | Option for table patient
movement |
| Tablet dock for
patient table | Option for mounting of
the tablet on the
patient table. | Option for mounting of
the tablet on the
patient table. | Option for mounting of
the tablet on the
patient table. |
| Interventional
Joystick (IVJ) | Option to move the
table during myNeedle
Guide procedures in the
examination room.
electrical connection for
the tablet dock which
allows charging the
tablet when mounted. | Option to move the
table during myNeedle
Guide procedures in the
examination room.
electrical connection for
the tablet dock which
allows charging the
tablet when mounted. | Option to move the
table during myNeedle
Guide procedures in the
examination room.
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 | Laser in combination
with FAST Isocentering
visualize coordinates
for patient isocenter
position;
myNeedle Laser
visualizes a planned
needle path for
interventions | Laser in combination
with FAST Isocentering
visualize coordinates
for patient isocenter
position;
myNeedle Laser
visualizes a planned
needle path for
interventions |
| Hardware
property | Subject device | Primary predicate
device | Secondary predicate
device |
| | NAEOTOM Alpha.Prime
SOMARIS/10 syngo CT
VB20 | NAEOTOM Alpha
SOMARIS/10 syngo CT
VB10
(K233657) | SOMATOM X.ceed
SOMARIS/10 syngo CT
VB10
(K233650) |
| CARE Moodlight | LED lights integrated on
the gantry front to
indicate the system
status:
• System startup
• Scan countdown
• Radiation on | n.a.7 | n.a.7 |
| Respiratory
Motion
management -
Interfaces for
respiratory gating | acquisition of
respiration-correlated
scans supported | n.a. | acquisition of
respiration-correlated
scans supported |
| | Interface connectors
for:
• Anzai respiratory
gating system
• Varian RGSC
respiratory gating
system
• Open interface
compatible
respiratory gating
systems
• Open Online Interface | | Interface connectors
for:
• Anzai respiratory
gating system
• Varian RGSC
respiratory gating
system
• Open interface
compatible
respiratory gating
systems |
| Power Shaver | energy storage
assembly to reduce
mains peak current
towards mains | n.a. | n.a. |
20
Image /page/20/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the word "Healthineers" is a series of orange dots that are arranged in a curved line.
21
Image /page/21/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the word "Healthineers" is a series of orange dots that are arranged in a curved line.
22
Image /page/22/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a cluster of orange dots.
23
Image /page/23/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the words is a graphic of orange dots.
24
Image /page/24/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots.
7 CARE Moodlight is cleared in K233650 for the SOMATOM go.Now, SOMATOM go.Top and SOMATOM go.All. K233650 is a bundle 510(k) including the SOMATOM go. Platform (SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim and SOMATOM go.Open Pro) and the SOMATOM X. Platform (SOMATOM X.cite and SOMATOM X.ceed).
25
Image /page/25/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the word "Healthineers" is a graphic of orange dots.
Table 5: Software characteristics for the dual source subject devices NAEOTOM Alpha and NAEOTOM Alpha.Pro and single source subject device NAEOTOM Alpha.Prime (software version SOMARIS/10 syngo CT VB20) compared to the predicate devices.
| Software
property | Subject device
(Dual Source) | Subject device
(Single Source) | Primary predicate
device | Secondary
predicate device | | |
|----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NAEOTOM Alpha
NAEOTOM
Alpha.Pro
SOMARIS/10 syngo
CT VB20 | NAEOTOM
Alpha.Prime
SOMARIS/10 syngo
CT VB20 | NAEOTOM Alpha
SOMARIS/10 syngo
CT VB10
(K233657) | SOMATOM X.ceed
SOMARIS/10 syngo
CT VB10
(K233650) | | |
| Operating
System | Windows based
SOMARIS/10 syngo
CT VB20
Note: the short
version syngo CT
VB20 is also used as
labeling
information | Windows based
SOMARIS/10 syngo
CT VB20
Note: the short
version syngo CT
VB20 is also used as
labeling
information | Windows based
SOMARIS/10 syngo
CT VB10
Note: the short
version syngo CT
VB10 is also used as
labeling
information | Windows based
SOMARIS/10 syngo
CT VB10
Note: the short
version syngo CT
VB10 is also used as
labeling
information | | |
| Workplace | syngo Acquisition
Workplace (ICS)
named as "myExam
Console"
Image
Reconstruction for
Quantum
Technology (IRS)
2nd workplace
option named as
"myExam Satellite"
with Remote Recon
function | syngo Acquisition
Workplace (ICS)
named as "myExam
Console"
Image
Reconstruction for
Quantum
Technology (IRS)
2nd workplace
option named as
"myExam Satellite"
with Remote Recon
function | syngo Acquisition
Workplace (ICS)
named as "myExam
Console"
Image
Reconstruction for
Quantum
Technology (IRS)
2nd workplace
option named as
"myExam Satellite"
with Remote Recon
function | syngo Acquisition
Workplace (ICS)
named as "myExam
Console"
Image
Reconstruction for
Quantum
Technology (IRS)
2nd workplace
option named as
"myExam Satellite"
with Remote Recon
function | | |
| Standard system
software | • syngo
Examination
• syngo Viewing
• syngo Filming
• syngo Archiving &
Network | • syngo
Examination
• syngo Viewing
• syngo Filming
• syngo Archiving &
Network | • syngo
Examination
• syngo Viewing
• syngo Filming
• syngo Archiving &
Network | • syngo
Examination
• syngo Viewing
• syngo Filming
• syngo Archiving &
Network | | |
| Detector
firmware | QuantaMax
detector firmware
supported | QuantaMax
detector firmware
supported | QuantaMax
detector firmware
supported | Stellar detector
firmware supported | | |
| Teamplay | Support of
teamplay Protocols | Support of
teamplay Protocols | Support of
teamplay Protocols | Support of
teamplay Protocols | | |
| Software
property | Subject device
(Dual Source) | Subject device
(Single Source) | Primary predicate
device | Secondary
predicate device | | |
| | NAEOTOM Alpha
NAEOTOM
Alpha.Pro
SOMARIS/10 syngo
CT VB20 | NAEOTOM
Alpha.Prime
SOMARIS/10 syngo
CT VB20 | NAEOTOM Alpha
SOMARIS/10 syngo
CT VB10
(K233657) | SOMATOM X.ceed
SOMARIS/10 syngo
CT VB10
(K233650) | | |
| Protocols | Support of:
• Protocol supporting
contrast bolus-
triggered data
acquisition
• Contrast media
protocols
(including
coronary CTA)
• Pediatric
Protocols
• Flex Dose Profile
• Turbo Flash
Spiral
• Dual Energy
acquisition
• Protocols
supporting CT
Intervention,
Cardiac
Scanning,
Spectral imaging
for child
examination,
Spectral imaging
with high
resolution
• Protocols for
Quantum
Imaging modes:
- Quantum
- Quantump
lus - Quantum
HD - Quantum
HD Cardiac - Quantump
eak
• Dynamic | Support of:
• Protocol
supporting
contrast bolus-
triggered data
acquisition
• Contrast media
protocols
(including
coronary CTA)
• Pediatric
Protocols
• Flex Dose Profile
• Turbo Flash
Spiral
• Dual Energy
acquisition
• Protocols
supporting CT
Intervention,
Cardiac
Scanning,
Spectral imaging
for child
examination,
Spectral imaging
with high
resolution
• Protocols for
Quantum
Imaging modes: - Quantum
- Quantump
lus - Quantum
HD - Quantum
HD Cardiac
• Dynamic | Support of:
• Protocol
supporting
contrast bolus-
triggered data
acquisition
• Contrast media
protocols
(including
coronary CTA)
• Pediatric
Protocols
• Flex Dose Profile
• Turbo Flash
Spiral
• Dual Energy
acquisition
• Protocols
supporting CT
Intervention,
Cardiac
Scanning,
Spectral imaging
for child
examination,
Spectral imaging
with high
resolution
• Protocols for
Quantum
Imaging modes: - Quantum
- Quantump
lus - Quantum
HD - Quantum
HD Cardiac - Quantump
eak
• Dynamic | Support of:
• Protocol
supporting
contrast bolus-
triggered data
acquisition
• Contrast media
protocols
(including
coronary CTA)
• Pediatric
Protocols
• Flex Dose Profile
• Turbo Flash
Spiral
• Dual Energy
acquisition
(TwinBeam DE
and TwinSpiral
DE)
• Protocols
supporting CT
Intervention,
Cardiac
Scanning | | |
| Software
property | Subject device
(Dual Source) | Subject device
(Single Source) | Primary predicate
device | Secondary
predicate device | | |
| | NAEOTOM Alpha
NAEOTOM
Alpha.Pro | NAEOTOM
Alpha.Prime | NAEOTOM Alpha | SOMATOM X.ceed | | |
| | SOMARIS/10 syngo
CT VB20 | SOMARIS/10 syngo
CT VB20 | SOMARIS/10 syngo
CT VB10
(K233657) | SOMARIS/10 syngo
CT VB10
(K233650) | | |
| | Spiral with
separation
factor driven
scan range)
• Protocols for
Radiation
Therapy
Planning
support patient
marking
• Protocols for
DirectBreathhold
• Protocols for
FAST 4D
• Protocols that
allow scanning
with support of
an external
respiratory
gating system
(Anzai, Varian
RGSC, Open
interface, Open
Online
Interface) | Spiral with
separation
factor driven
scan range)
• Protocols for
Radiation
Therapy
Planning
support patient
marking
• Protocols for
DirectBreathhold
• Protocols for
FAST 4D
• Protocols that
allow scanning
with support of
an external
respiratory
gating system
(Anzai, Varian
RGSC, Open
interface, Open
Online
Interface) | Spiral with cycle
time driven scan
range) | • Dynamic
imaging (Flex 4D
Spiral Flex 4D
Spiral with cycle
time driven scan
range)
• Protocols for
Radiation
Therapy
Planning
support patient
marking
• Protocols for
DirectBreathhold
• Protocols for
FAST 4D
• Protocols that
allow scanning
with support of
an external
respiratory
gating system
(ANZAI, Varian
RGSC, Open
interface) | | |
| Advanced
Reconstruction | Recon&GO: | Recon&GO: | Recon&GO: | Recon&GO: | | |
| | - Spectral Recon | - Spectral Recon | - Spectral Recon | - Spectral Recon | | |
| | - Inline Results - DE
SPP | - Inline Results – DE
SPP | - Inline Results - DE
SPP | - Inline Results - DE
SPP | | |
| | - Inline Results -
Anatomical ranges
(Parallel/Radial)
incl. Virtual
Unenhanced,
Monoenergetic plus | - Inline Results -
Anatomical ranges
(Parallel/Radial)
incl. Virtual
Unenhanced,
Monoenergetic plus | - Inline Results -
Anatomical ranges
(Parallel/Radial)
incl. Virtual
Unenhanced,
Monoenergetic plus | - Inline Results -
Anatomical ranges
(Parallel/Radial)
incl. Virtual
Unenhanced,
Monoenergetic plus | | |
| | - Inline Results -
Spine and Rib
Ranges | - Inline Results -
Spine and Rib
Ranges | - Inline Results -
Spine and Rib
Ranges | - Inline Results -
Spine and Rib
Ranges | | |
| Software
property | Subject device
(Dual Source) | Subject device
(Single Source) | Primary predicate
device | Secondary
predicate device | | |
| | NAEOTOM Alpha
NAEOTOM
Alpha.Pro
SOMARIS/10 syngo
CT VB20 | NAEOTOM
Alpha.Prime
SOMARIS/10 syngo
CT VB20 | NAEOTOM Alpha
SOMARIS/10 syngo
CT VB10
(K233657) | SOMATOM X.ceed
SOMARIS/10 syngo
CT VB10
(K233650) | | |
| | - Inline Results –
table and bone
removal | - Inline Results –
table and bone
removal | - Inline Results –
table and bone
removal | - Inline Results –
table and bone
removal | | |
| | Image viewing | CT View&GO: - basic post-
processing viewer
(CT View&GO) - 2D and 3D (MPR,
VRT, MIP and
minIP) - Evaluation tools,
Filming, Printing - Interactive
Spectral Imaging
(ISI) - Basic visualization
tools: Endo View - Basic
manipulation tools:
DE ROI, ROI HU
Threshold, Average - Automated table
and bone removal | CT View&GO: - basic post-
processing viewer
(CT View&GO) - 2D and 3D (MPR,
VRT, MIP and
minIP) - Evaluation tools,
Filming, Printing - Interactive
Spectral Imaging
(ISI) - Basic visualization
tools: Endo View - Basic
manipulation tools:
DE ROI, ROI HU
Threshold, Average - Automated table
and bone removal | CT View&GO: - basic post-
processing viewer
(CT View&GO) - 2D and 3D (MPR,
VRT, MIP and
minIP) - Evaluation tools,
Filming, Printing - Interactive
Spectral Imaging
(ISI) - Basic visualization
tools: Endo View - Basic
manipulation tools:
DE ROI, ROI HU
Threshold, Average - Automated table
and bone removal | | |
| | | Post-Processing
interface | • Recon&GO
Inline Results:
Software interface
to post-processing
algorithms which
are unmodified
when loaded onto
the CT scanners and
510(k) cleared as
medical devices,
Inline Results – RT-
Planning introduced | • Recon&GO
Inline Results:
Software interface
to post-processing
algorithms which
are unmodified
when loaded onto
the CT scanners and
510(k) cleared as
medical devices,
Inline Results – RT-
Planning introduced | • Recon&GO
Inline Results:
Software interface
to post-processing
algorithms which
are unmodified
when loaded onto
the CT scanners and
510(k) cleared as
medical devices | • Recon&GO
Inline Results:
Software interface
to post-processing
algorithms which
are unmodified
when loaded onto
the CT scanners and
510(k) cleared as
medical devices,
including the
interface Inline
Results – RT-
Planning |
| | | | Software
property | Subject device
(Dual Source) | Subject device
(Single Source) | Primary predicate
device |
| | | NAEOTOM Alpha
NAEOTOM
Alpha.Pro
SOMARIS/10 syngo
CT VB20 | NAEOTOM
Alpha.Prime
SOMARIS/10 syngo
CT VB20 | NAEOTOM Alpha
SOMARIS/10 syngo
CT VB10
(K233657) | SOMATOM X.ceed
SOMARIS/10 syngo
CT VB10
(K233650) | |
| | | • CT View&GO
plug-in
interface:
designed for
standalone plug-ins
which are
represented by the
cleared medical
device by its own
called syngo.CT
Extended
Functionality,
plug-in CT
View&GO –
Sim&GO introduced | • CT View&GO
plug-in
interface:
designed for
standalone plug-ins
which are
represented by the
cleared medical
device by its own
called syngo.CT
Extended
Functionality,
plug-in CT
View&GO –
Sim&GO introduced | • CT View&GO
plug-in
interface:
designed for
standalone plug-ins
which are
represented by the
cleared medical
device by its own
called syngo.CT
Extended
Functionality | • CT View&GO
plug-in
interface:
designed for
standalone plug-ins
which are
represented by the
cleared medical
device by its own
called syngo.CT
Extended
Functionality,
including the plug-
in CT View&GO –
Sim&GO | |
| | | • CT View&GO
software
interface for
Advanced
Visualization
Apps:
Software interfaces
for post-processing
functionalities to
provide advanced
visualization tools
to prepare and
process medical | • CT View&GO
software
interface for
Advanced
Visualization
Apps:
Software interfaces
for post-processing
functionalities to
provide advanced
visualization tools
to prepare and
process medical | • CT View&GO
software
interface for
Advanced
Visualization
Apps:
Software interfaces
for post-processing
functionalities to
provide advanced
visualization tools
to prepare and
process medical
images for | • CT View&GO
software
interface for
Advanced
Visualization
Apps:
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. | images for
diagnostic purpose.
Note: The clearance
of standalone
Advanced
Visualization
Application
software is
mandatory
precondition. | diagnostic purpose.
Note: The clearance
of standalone
Advanced
Visualization
Application
software is
mandatory
precondition.
These advanced
visualization tools | images for
diagnostic purpose.
Note: The clearance
of standalone
Advanced
Visualization
Application
software is
mandatory
precondition.
These advanced
visualization tools | |
| Software
property | | Subject device
(Dual Source) | Subject device
(Single Source) | Primary predicate
device | Secondary
predicate device | |
| | | NAEOTOM Alpha
NAEOTOM
Alpha.Pro
SOMARIS/10 syngo
CT VB20 | NAEOTOM
Alpha.Prime
SOMARIS/10 syngo
CT VB20 | NAEOTOM Alpha
SOMARIS/10 syngo
CT VB10
(K233657) | SOMATOM X.ceed
SOMARIS/10 syngo
CT VB10
(K233650) | |
| | 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. | 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. | are designed to
support the
technician &
physician in the
qualitative and
quantitative
measurement &
analysis of clinical
data acquired and
reconstructed by
Computed
Tomography
scanners. | are designed to
support the
technician &
physician in the
qualitative and
quantitative
measurement &
analysis of clinical
data acquired and
reconstructed by
Computed
Tomography
scanners. | | |
| Cybersecurity | IT Hardening | IT Hardening | IT Hardening | IT Hardening | | |
| HD FoV | supported | supported | supported | supported | | |
| Standard
technologies | • FAST
technologies
• CARE
technologies
• GO technologies
• CARE keV | • FAST
technologies
• CARE
technologies
• GO technologies
• CARE keV | • FAST
technologies
• CARE
technologies
• GO technologies
• CARE keV | • FAST
technologies
• CARE
technologies
• GO technologies
• CARE keV | | |
| Respiratory
Motion
management
(workflows) | Workflows for
respiration-
correlated scans for
radiation therapy
planning: - FAST 4D
- Direct i4D
- DirectBreathhold | Workflows for
respiration-
correlated scans for
radiation therapy
planning: - FAST 4D
- Direct i4D
- DirectBreathhold | n.a. | Workflows for
respiration-
correlated scans for
radiation therapy
planning: - FAST 4D
- Direct i4D
- DirectBreathhold | | |
| Direct Laser
Steering | software interface
to control 3rd party
lasers (LAP lasers)
to support a
markerless
workflow for
patient marking in | software interface
to control 3rd party
lasers (LAP lasers)
to support a
markerless
workflow for
patient marking in | n.a. | software interface
to control 3rd party
lasers (LAP lasers)
to support a
markerless
workflow for
patient marking in | | |
| Software
property | Subject device
(Dual Source) | Subject device
(Single Source) | Primary predicate
device | Secondary
predicate device | | |
| | NAEOTOM Alpha
NAEOTOM Alpha.Pro
SOMARIS/10 syngo
CT VB20 | NAEOTOM
Alpha.Prime
SOMARIS/10 syngo
CT VB20 | NAEOTOM Alpha
SOMARIS/10 syngo
CT VB10
(K233657) | SOMATOM X.ceed
SOMARIS/10 syngo
CT VB10
(K233650) | | |
| | radiation therapy
planning (RTP). | radiation therapy
planning (RTP). | radiation therapy
planning (RTP). | radiation therapy
planning (RTP). | | |
| FAST Integrated
Workflow (FAST
3D Camera) | FAST integrated
workflow:
• FAST Range
• FAST Isocentering
• FAST Direction
• Collision
Indication
• Centerline/Grid
Overlay | FAST integrated
workflow:
• FAST Range
• FAST Isocentering
• FAST Direction
• Collision
Indication
• Centerline/ Grid
Overlay | FAST integrated
workflow:
• FAST Range
• FAST Isocentering
• FAST Direction | FAST integrated
workflow:
• FAST Range
• FAST Isocentering
• FAST Direction | | |
| DirectSetup
Notes | patient and
accessory setup
documentation in
the Scan&GO
workflow | patient and
accessory setup
documentation in
the Scan&GO
workflow | n.a. | n.a. | | |
| Oncology
exchange | transfer of
prescription
information from
the ARIA Oncology
Information System
(OIS) to the CT
scanner | transfer of
prescription
information from
the ARIA Oncology
Information System
(OIS) to the CT
scanner | n.a. | n.a. | | |
| FAST Planning | detects globally
used scan and
recon ranges from
the topogram
image
additional body
regions: - Head/Neck
(Vascular),
Lateral/APPA - Vascular - Runoff
Knee | detects globally
used scan and
recon ranges from
the topogram
image
additional body
regions: - Head/Neck
(Vascular),
Lateral/APPA - Vascular - Runoff
Knee | detects globally
used scan and
recon ranges from
the topogram
image | detects globally
used scan and
recon ranges from
the topogram
image | | |
| Software
property | Subject device
(Dual Source) | Subject device
(Single Source) | Primary predicate
device | Secondary
predicate device | | |
| NAEOTOM Alpha
NAEOTOM
Alpha.Pro
SOMARIS/10 syngo
CT VB20 | NAEOTOM
Alpha.Prime | NAEOTOM Alpha | SOMATOM X.ceed | | | |
| | SOMARIS/10 syngo
CT VB20 | SOMARIS/10 syngo
CT VB10
(K233657) | SOMARIS/10 syngo
CT VB10
(K233650) | | | |
| | - Neck and chest - Neck and Lung
- Extremities -
Both knees | - Neck and chest - Neck and Lung
- Extremities -
Both knees | | | | |
| Eco Power Mode | reduce the energy
consumption during
idle times. | reduce the energy
consumption during
idle times. | n.a. | n.a. | | |
| Iterative
Reconstruction
Methods | Quantum Iterative
Reconstruction
iMAR | Quantum Iterative
Reconstruction
iMAR | Quantum Iterative
Reconstruction
iMAR | ADMIRE
SAFIRE
iMAR | | |
| Matrix sizes | 256 x 256 pixels
512 x 512 pixels
768 x 768 pixels
1024 x 1024 pixels
(Precision Matrix) | 256 x 256 pixels
512 x 512 pixels
768 x 768 pixels
1024 x 1024 pixels
(Precision Matrix) | 256 x 256 pixels
512 x 512 pixels
768 x 768 pixels
1024 x 1024 pixels
(Precision Matrix) | 256 x 256 pixels
512 x 512 pixels
768 x 768 pixels
1024 x 1024 pixels
(Precision Matrix) | | |
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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 devices, the NAEOTOM CT scanner systems with syngo CT VB20, is comparable to the predicate devices in terms of technological characteristics and safety and effectiveness and therefore are substantially equivalent to the predicate devices.
VIII. Performance Data
Non-Clinical Testing
Non-clinical testing (integration and functional) including phantom tests were conducted for the subject devices NAEOTOM CT scanner systems 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 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
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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 | Bench Testing performed for new and modified features |
|---|---|
| Direct i4D | The target of the bench test is to perform a respiratory sequence scan |
| using a dynamic phantom where at every planned position of the scan | |
| range at least one complete breathing cycle is acquired. | |
| Objective of the test is to compare a conventional respiratory 4DCT scan | |
| (spiral scan) with the breathing pattern of a thorax phantom and the | |
| result of Direct i4D with the same breathing pattern. | |
| The test results show that with Direct i4D it is possible to acquire data for | |
| a full breathing cycle at every position of the patient even if the | |
| respiratory rate changes during the data acquisition. Compared to the | |
| conventional 4DCT scan mode interpolation artifacts (which occur | |
| because not for every position a complete breathing cycle could be | |
| acquired) can successfully be avoided with Direct i4D. | |
| DirectBreathhold | The test results show that using the Direct Breathhold functionality, a |
| spiral scan can automatically be triggered from an external respiratory | |
| gating device. The actual scan remains unchanged, and the object is | |
| correctly depicted in the resulting image. | |
| Recon&GO – RT | |
| planning | The bench test underpins the possibility that with the introduction of the |
| RTP scan protocols in the subject devices NAEOTOM CT scanner systems | |
| with syngo CT VB20, time and imaging dose can be saved, since each RTP | |
| scan range allows for spectral post-processing to provide task-specific | |
| images for an end-to-end radiotherapy workflow and thus no additional | |
| scan range with Single Energy is needed. | |
| Feature/Non-clinical | |
| supportive testing | Bench Testing performed for new and modified features |
| FAST 3D Camera/ | |
| FAST Integrated | |
| Workflow | The FAST 3D camera sub-features FAST Isocentering, FAST Range, and |
| FAST Direction have been optimized using additional data from adults | |
| and adolescence patients. The bench test evaluates and compares the | |
| accuracy of the three sub-features in software version syngo CT VB20 to | |
| the accuracy of the predicate devices with syngo CT VB10. |
The objectives of the bench tests are to demonstrate that the FAST 3D
camera achieves comparable or better results for both, adults and
adolescents, as the predicate device for adults.
Overall, the subject devices with syngo CT VB20 delivers comparable or
improved accuracy to the predicate devices with syngo CT VB10
predicate device for adults and extends the support to adolescents. |
| Flex 4D Spiral | The performed bench test report describes the technical background of
Flex 4D Spiral and its functionalities with NAEOTOM CT scanners,
demonstrate the proper function of those, and assess the image quality
of Flex 4D Spiral. |
| FAST Planning | The purpose of the test is to provide a clear reporting on the applied
algorithm, its product development, validation, and verification on
patient data, which enable the claims.
Objective of the test is to assess the fraction (percentage) of ranges
calculated by the FAST Planning algorithm that are correct and can be
applied without change. Additionally, calculation time was measured to
check whether it meets interactive requirements.
The test results show that the editing actions for the scanner technician
can be reduced to a minimum and that the calculation time is fast
enough for interactive speed during scanning. For more than 90% of the
ranges no editing action was necessary to cover standard ranges. For
more than 95%, the speed of the algorithm was sufficient. |
| Low-Dose Lung Cancer
Screening –
NAEOTOM Alpha.Pro | The bench test provides a comparison of technical parameters specific to
Low-Dose Lung Cancer Screening of the predicate and subject devices,
following the established concept of our previous 510(k) submissions.
It can be concluded that the subject and predicate devices are
substantially equivalent for the task of Low-Dose Lung Cancer Screening
since the bench test results showed comparable technical parameters. |
| Low-Dose Lung Cancer
Screening –
NAEOTOM
Alpha.Prime | The bench test provides a comparison of technical parameters specific to
Low-Dose Lung Cancer Screening of the predicate and subject devices,
following the established concept of our previous 510(k) submissions.
It can be concluded that the subject and predicate devices are
substantially equivalent for the task of Low-Dose Lung Cancer Screening
since the bench test results showed comparable technical parameters. |
Table 6: Non-clinical performance testing (bench testing).
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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 Entry | Recognition
Number | Standard
Developing
Organization | Standard
Designation Number
and Date | Title of Standard |
|---------------|-----------------------|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 12/19/2022 | 12-349 | NEMA | PS 3.1 - 3.20 2022d | Digital Imaging and
Communications in
Medicine (DICOM) Set |
| 07/06/2020 | 12-325 | NEMA | XR 25-2019 | Computed
Tomography Dose
Check |
| 07/06/2020 | 12-330 | NEMA | XR 28-2018 | Supplemental
Requirements for User
Information and
System Function
Related to Dose in CT |
| 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 and constancy
tests - Imaging
performance of
computed tomography
X-ray equipment
[Including: Technical
Corrigendum 1 (2006)] |
| 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
performance of
computed tomography
X-ray equipment |
| 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 |
| Date of Entry | Recognition
Number | Standard
Developing
Organization | Standard
Designation Number
and Date | Title of Standard |
| 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 |
| 12/23/2019 | 5-125 | ANSI AAMI
ISO | 14971: 2019 | Medical devices -
Applications of risk
management to
medical devices |
| | | ISO | 14971 Third Edition
2019-12 | Medical devices -
Application of risk
management to
medical devices |
| 01/14/2019 | 13-79 | ANSI AAMI
IEC | 62304:2006/A1:2016 | Medical device
software - Software
life cycle processes
[Including Amendment
1 (2016)] |
| | | IEC | 62304 Edition 1.1
2015-06
CONSOLIDATED
VERSION | Medical device
software - Software
life cycle processes |
| 07/09/2014 | 19-46 | ANSI AAMI | ES60601-
1:2005/(R)2012 &
A1:2012,
C1:2009/(R)2012 &
A2:2010/(R)2012
(Cons. Text) [Incl.
AMD2:2021] | Medical electrical
equipment - Part 1:
General requirements
for basic safety and
essential performance
(IEC 60601-1:2005,
MOD) [Including
Amendment 2 (2021)] |
| 09/17/2018 | 19-36 | ANSI AAMI
IEC | 60601-1-2:2014
[Including AMD
1:2021] | Medical electrical
equipment - Part 1-2:
General requirements
for basic safety and
essential performance
- Collateral Standard:
Electromagnetic
disturbances -
Requirements and
tests |
| Date of Entry | Recognition
Number | Standard
Developing
Organization | Standard
Designation Number
and Date | Title of Standard |
| | | IEC | 60601-1-2 Edition 4.1
2020-09
CONSOLIDATED
VERSION | Medical electrical
equipment - Part 1-2:
General requirements
for basic safety and
essential performance - Collateral Standard:
Electromagnetic
disturbances -
Requirements and
tests |
| 12/23/2016 | 5-129 | ANSI AAMI
IEC | 62366-
1:2015+AMD1:2020
(Consolidated Text) | Medical devices Part 1:
Application of usability
engineering to medical
devices, including
Amendment 1 |
| | | IEC | 62366-1 Edition 1.1
2020-06
CONSOLIDATED
VERSION | 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 |
| 12/21/2020 | 5-132 | IEC | 60601-1-6 Edition 3.2
2020-07
CONSOLIDATED
VERSION | Medical electrical
equipment - Part 1-6:
General requirements
for basic safety and
essential performance - Collateral standard:
Usability |
| 12/23/2019 | 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 |
| 12/20/2021 | 12-341 | IEC | 62563-1 Edition 1.2
2021-07 | Medical electrical
equipment - Medical
image display systems |
| Date of Entry | Recognition
Number | Standard
Developing
Organization | Standard
Designation Number
and Date | Title of Standard |
| | | | CONSOLIDATED
VERSION | - Part 1: Evaluation
methods |
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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+A2:2020 | Medical electrical
equipment - part 1:
general requirements
for basic safety and
essential performance | ANSI AAMI ES60601-
1:2005/(R)2012 &
A1:2012,
C1:2009/(R)2012 &
A2:2010/(R)2012 (Cons.
Text) [Incl. AMD2:2021] |
| 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 9 below. Table 9: FDA Guidance Document and Effective Date
| FDA Guidance Document | Issue date |
|---|---|
| User Fees and Refunds for Premarket Notification Submissions (510(k)s | 10/05/2022 |
| Refuse to Accept Policy for 510(k)s | 04/21/2022 |
| Electronic Submission Template for Medical Device 510(k) Submissions | 10/2/2023 |
| Deciding When to Submit a 510(k) for a Change to an Existing Device | 10/25/2017 |
| The 510(k) Program: Evaluating Substantial Equivalence in Premarket | |
| Notifications [510(k)] | 07/28/2014 |
| Content of Premarket Submissions for Device Software Functions | 06/14/2023 |
| Off-The-Shelf Software Use in Medical Devices | 09/27/2019 |
| Applying Human Factors and Usability Engineering to Medical Devices | 02/03/2016 |
| Pediatric Information for X-ray Imaging Device Premarket Notifications | 11/28/2017 |
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| FDA Guidance Document | Issue date |
|---|---|
| Cybersecurity in Medical Devices: Quality System Considerations and Content | |
| of Premarket Submissions | 09/27/2023 |
| Electromagnetic Compatibility (EMC) of Medical Devices | 06/06/2022 |
| Design Considerations and Pre-market Submission Recommendations for | |
| Interoperable Medical Devices | 09/06/2017 |
| Appropriate Use of Voluntary Consensus Standards in Premarket Submissions | |
| for Medical Devices | 09/14/2018 |
Verification and Validation
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.
Cybersecurity
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.
Wireless Coexistence Testing
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 with IEC60601-2-44.
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:
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- 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.
IX. Conclusions
The non-clinical data supports the safety of the devices and the hardware and software verification and validation demonstrates that the NAEOTOM CT scanner systems perform as intended in the specified use conditions. Verification and validation, clinical/patient and phantom testing were performed. The data included in this submission demonstrates that the NAEOTOM CT scanner systems with described modifications performs comparably to the predicate devices currently marketed for the same intended use. The conclusions drawn from the nonclinical tests demonstrate that the subject devices are as safe, as effective, and perform as well as or better than the predicate devices.