(134 days)
Yes
The description of the "myNeedle Guide (with myNeedle Detection)" feature explicitly mentions an "automatic needle detection algorithm," which is a strong indicator of AI/ML being used for image analysis and feature detection.
No
Explanation: This device is a Computed Tomography (CT) system used for imaging and diagnosis. While the images can be used as an aid in treatment and radiation therapy planning, and for therapeutic interventions, the device itself is not directly therapeutic; it is a diagnostic imaging tool.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the images delivered by the system "can be used by trained staff as an aid in diagnosis" and "for diagnostic and therapeutic interventions." It also mentions its use for "low dose lung cancer screening," which is a diagnostic application.
No
The device is described as a "Computed Tomography X-ray system" which features hardware components like a "continuously rotating tube-detector system (dual source)". While it includes software for control, reconstruction, and processing, it is fundamentally a hardware-based imaging system.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: IVDs 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 is an imaging system: The description clearly states that this is a computed tomography (CT) system that generates and processes images of the patient's internal structures using X-rays. It does not analyze biological samples.
- Intended Use is for imaging and diagnosis based on images: The intended use describes the system's role in generating images for diagnosis, treatment planning, and interventions, all based on the visual information from the CT scans.
Therefore, while this device is a medical device used in diagnosis and treatment, it falls under the category of medical imaging systems, not In Vitro Diagnostics.
No
The letter does not affirmatively state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
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 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 Dual Source CT scanner system SOMATOM Pro.Pulse based on the SOMARIS/10 platform.
The subject device SOMATOM Pro.Pulse with software version SOMARIS/10 syngo CT VB10 is a Computed Tomography X-ray system which features two continuously rotating tube-detector system (dual source) and functions according to the fan beam principle. The SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB10 produces CT images in DICOM format. The images delivered by the system can be used by trained staff for post-processing applications commercially distributed by Siemens Healthcare and other vendors as an aid in diagnosis, treatment preparation, radiation therapy planning, and therapeutic interventions (including, but not limited to, Brachytherapy, Particle including Proton Therapy, External Beam Radiation Therapy, Surgery). The computer system delivered with the CT scanner is able to run optional post processing applications.
Only trained and qualified users, certified in accordance with country-specific regulations, are authorized to operate the system. For example, physicians, radiologists. 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 SOMATOM Pro.Pulse is SOMARIS/10 syngo CT VB10. 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 VB10 (SOMARIS/10 syngo CT VB10) is a modified software version of the predicate device, syngo CT VA40 (SOMARIS/10 syngo CT VA40) cleared in K211373.
The subject device SOMATOM Pro.Pulse 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 (e.g., physicians, radiologists) 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
Non-clinical testing, (integration and functional) including phantom tests were conducted for the SOMATOM Pro.Pulse during product development. Testing covered all related subsystems that contribute to the device modifications. Test levels are defined. For each test level several test activities are performed. The test specification and acceptance criteria are related to the corresponding requirements. Various test activities are performed to specific modifications on different test levels to ensure safe and effective integration in the system. Three test levels are defined:
System Validation test:
- Acceptance test (workflow and user manual test)
- Legal and Regulatory test
System Verification test:
- System Integration Test (functional)
- Functionality verification
- Image Quality (IQ) Evaluation
Tests are conducted for all software components 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 device modification on Non-Clinical Performance Testing as listed in Table 6.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Non-Clinical Testing (Integration and Functional), Bench Testing, Verification and Validation
ZeeFree Bench Test:
- Objectives: To demonstrate that the number of artifacts attributed to stack misalignment can be reduced and no new artifacts are introduced by a SAC reconstruction (marketing name: ZeeFree).
- Results: If misalignment artifacts are identified in non-corrected standard ECG-gated reconstructed sequence or spiral images, the "Cardiac Stack Artefact Correction" (SAC, marketing name: ZeeFree) enables optional stack artifact corrected images, which reduce the number of alignment artifacts. The SAC reconstruction does not introduce new artifacts. The SAC reconstruction realizes equivalent image quality in quantitative standard physics phantom-based measurements (ACR, Gammex phantom) in terms of noise, homogeneity, high-contrast resolution, slice thickness and CNR compared to a non-corrected standard reconstruction. The SAC reconstruction does realize equivalent image quality in quantitative and qualitative phantom-based measurements with respect to metal objects compared to a non-corrected standard reconstruction. The SAC algorithm can be successfully applied to phantom data if derived from a suitable motion phantom demonstrating its correct technical function on the tested device. The SAC algorithm is independent from the physical detector width of the acquired data.
Dual Source Dual Energy Bench Test:
- Objective: To verify the successful implementation of the Dual Source Dual Energy (DSDE) scan mode on the SOMATOM Pro.Pulse with two voltage combinations (80 kV / Sn140 kV and 100 kV / Sn140 kV).
- Results: Image quality and spectral properties were evaluated based on phantom studies using ex-factory scan protocols for head and abdomen. The spectral characteristics of the system in terms of iodine ratio are well comparable to the reference device SOMATOM Drive. All applied tests concerning image quality passed.
FAST 3D Camera/FAST Integrated Workflow Bench Test:
- Objective: To evaluate and compare the accuracy of FAST Isocentering, FAST Range, and FAST Direction to the predicate device.
- Results: The FAST Isocentering accuracy of the subject device is comparable to the predicate device, regardless of the camera mounting position. For the FAST Range feature, the detection accuracy of all body region boundaries is comparable. The FAST Direction pose detection results are of comparable accuracy for subject and predicate device. Overall, the SOMARIS/10 syngo CT VB10 delivers comparable accuracy to the SOMARIS/10 syngo CT VA40 predicate for the new FAST 3D Camera hardware, also in the new gantry position.
myNeedle Guide (with myNeedle Detection) Bench Test:
- Objective: To ensure clinical usability of the myNeedle Guide needle detection algorithm, specifically the accuracy of automatic needle detection and reduction of user interactions.
- Results: The algorithm was able to consistently detect needle-tips over a wide variety of scans in 90.76% of cases. The auto needle detection functionality reduces the number of interaction steps needed to generate a needle-aligned view in the CT Intervention Software. Zero user interactions are required and a needle-aligned view is displayed right away after a new scan if auto needle detection is switched on.
CARE kV Bench Test:
- Objective: To evaluate that the effective mAs settings of both low and high kV acquisitions of a TwinV scan (Dual Source Dual Energy scan mode) are adapted by CARE kV so that image quality (CNR) is maintained.
- Results: The image qualities (i.e. CNR values) of certain phantom under different kV settings in "Manual kV" mode are consistent. Using CARE kV for TwinV, contrast, noise, and CNR values in the mix images are consistent for all voltage combinations. In all cases, CNR values do not deviate by more than 10% from the average CNR over the available voltage combinations.
Flex 4D Spiral - Neuro/Body Bench Test:
- Objective: To evaluate the performance of F4DS mode on SOMATOM Pro.Pulse.
- Results: No artifacts were observed for any F4DS scan mode due to missing data, indicating that the trajectories work properly in hand. This also accounts for the scenario, where the user may change the pitch setting to get access to another range of scan coverages.
Low-Dose Lung Cancer Screening Bench Test:
- Objective: To compare technical parameters specific to Low-Dose Lung Cancer Screening of the predicate and subject devices.
- Results: 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: Software documentation at an Enhanced Documentation level per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on June 14, 2023 is included. The performance data demonstrates continued conformance with special controls for medical devices containing software. The Risk Analysis was completed, and risk control implemented to mitigate identified hazards. The testing supports that all software specifications have met the acceptance criteria. Testing for verification and validation support the claims of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- ZeeFree: Quantitative phantom-based measurements (ACR, Gammex phantom) in terms of noise, homogeneity, high-contrast resolution, slice thickness and CNR.
- Dual Source Dual Energy: Spectral characteristics in terms of iodine ratio.
- FAST 3D Camera/FAST Integrated Workflow: Accuracy of FAST Isocentering, FAST Range, and FAST Direction.
- myNeedle Guide (with myNeedle Detection): Algorithm was able to consistently detect needle-tips over a wide variety of scans in 90.76% of cases. Reduction of necessary user interactions to generate a needle-oriented view.
- CARE kV: CNR values. Deviation of CNR values not more than 10% from average CNR over available voltage combinations.
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
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 6, 2023
Siemens Medical Solutions USA, Inc. % Clayton Ginn Regulatory Affairs Specialist 810 Innovation Drive KNOXVILLE, TN 37932
Re: K232206
Trade/Device Name: SOMATOM Pro.Pulse Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: November 8, 2023 Received: November 8, 2023
Dear Clayton Ginn:
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.
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).
1
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.
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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
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
2
Indications for Use
510(k) Number (if known) K232206
Device Name SOMATOM Pro.Pulse
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 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)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
for
SOMATOM Pro.Pulse – Software Version SOMARIS/10 syngo CT VB10
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. Contact Details
Submitter Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932 Establishment Registration Number: 1034973
Importer/Distributor Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number: 2240869
Location of Manufacturing Site (1) Siemens Healthcare GmbH Siemensstr. 1 -OR- Rittigfeld 1 D-91301 Forchheim, Germany Establishment Registration Number: 3004977335
Location of Manufacturing Site (2) SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD 278 Zhou Zhu Rd Shanghai, CHINA, 201318 Establishment Registration Number: 3003202425
Note: Description in this submission use the short company name Siemens. It covers both manufacturing locations and names as listed above. Brand name on all products is Siemens Healthineers.
Submitter Contact Person:
Clayton Ginn Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. Molecular Imaging 810 Innovation Drive Knoxville, TN 37932 Phone: (865) 898-2692 clayton.ginn@siemens-healthineers.com Backup Contact
Alaine Medio Regulatory Affairs Manager Siemens Medical Solutions USA, Inc. Molecular Imaging 810 Innovation Drive Knoxville, TN 37932 Phone: (865) 206-0337 alaine.medio@siemens-healthineers.com
4
II. Device Name and Classification
| Product name: | SOMATOM Pro.Pulse |
|---|---|
| Trade name: | SOMATOM Pro.Pulse |
| 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: | SOMATOM go.Top |
|---|---|
| 510(k) Number: | K211373 |
| Clearance Date: | August 27, 2021 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| Recall Information: | All predicate device recalls have been considered in the subject device design. |
Reference device:
| Trade Name: | SOMATOM Drive |
|---|---|
| 510(k) Number: | K230421 |
| Clearance Date: | June 16, 2023 |
| 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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IV. Device Description Summary
Siemens intends to market a new Dual Source CT scanner system SOMATOM Pro.Pulse based on the SOMARIS/10 platform.
The subject device SOMATOM Pro.Pulse with software version SOMARIS/10 synqo CT VB10 is a Computed Tomography X-ray system which features two continuously rotating tube-detector system (dual source) and functions according to the fan beam principle. The SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB10 produces CT images in DICOM format. The images delivered by the system can be used by trained staff for post-processing applications commercially distributed by Siemens Healthcare and other vendors as an aid in diagnosis, treatment preparation, radiation therapy planning, and therapeutic interventions (including, but not limited to, Brachytherapy, Particle including Proton Therapy, External Beam Radiation Therapy, Surgery). The computer system delivered with the CT scanner is able to run optional post processing applications.
Only trained and qualified users, certified in accordance with country-specific regulations, are authorized to operate the system. For example, physicians, radiologists. 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 SOMATOM Pro.Pulse is SOMARIS/10 syngo CT VB10. 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 VB10 (SOMARIS/10 syngo CT VB10) is a modified software version of the predicate device, syngo CT VA40 (SOMARIS/10 syngo CT VA40) cleared in K211373.
The subject device SOMATOM Pro.Pulse 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 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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VI. Indications for Use Comparison
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 physician as an aid in diagnosis.
The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning.
This CT system can be used for low dose lung cancer screening in high risk populations *
*As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
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 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 reference predicate's Indications for Use (K230421), however it is slightly different than the primary predicate's Indications for Use.
-
The sentence "The images delivered by the system can be used by a trained physician as an aid in diagnosis" was removed, since the subsequent sentence restates the same, replacing 'trained physician' with 'trained staff'. It can be assumed a trained physician is part of the trained staff.
Only trained and qualified users, certified in accordance with country-specific regulations, are authorized to operate the system. For example, physicians, radiologists. 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 word 'preparation' has been removed from the phrase "treatment preparation and radiation therapy planning" since treatment planning better describes how the device is used.
-
The phrase "as well as for diagnostic and therapeutic interventions" was added to the second sentence. This was done to express use of the device in standard practice. The predicate device can and is commonly used as an aid in invasive procedures. The same is applicable to the subject device.
None of the intended use includes 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 SOMATOM CT System is not the principal means of guidance, because the CT System does not guide the invasive procedures, the needle orientation and the needle advance and handling is always done under the physicians control.
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VII. Comparison of Technological Characteristics with the Predicate Device
Supported by the subject device, SOMARIS/10 syngo CT VB10 software version is a further development of the SOMARIS/10 syngo CT VA40 software version which is cleared in K211373.
The SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB10 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 SOMATOM Pro.Pulse have been modified or improved in comparison to the predicate devices to support enhanced device functionality compared to the predicate devices.
The intended use and fundamental scientific technology for the SOMATOM Pro.Pulse remain unchanged from the predicate devices.
At a high level, the subject and predicate devices are based on the following same technological elements:
- Scanner Principle- Whole body X-Ray Computed Tomography Scanner
- System Acquisition – Continuously rotating tube detector system
- Workplaces Support of workplaces that include reconstruction and image evaluation software ●
- Patient table
- Patient table foot switch for movement
- Tin filtration technology
- Stellar detector technology
- Athlon type X-ray tube
- Power generator
- High Power 80/ High Power 70
- . Iterative reconstruction methods
- Scan&GO
- Mobile workflow (Tablets)
- Optional injector arm
- . Support of CT guided intervention workflow (myNeedle Guide)
- Precision matrix (large image matrices)
- DirectDensity™ Reconstruction ●
- Cardiac CT imaging
The subject device SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB10 will support the modifications/further developments in comparison to the predicate devices as listed in the tables under subsections 1) Modified Hardware and 2) Modified Software.
The configuration table and comparison table use the following terms to describe various technological characteristics in comparison to the primary and secondary predicate devices information:
Table 1: Overview of term definition
| Term | Definition |
|---|---|
| N/A | The feature is not supported for the subject device |
| 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 |
8
| Term | Definition |
|---|---|
| subject device with software version SOMARIS/10 syngo CT VB10 and is substantially | |
| equivalent compared to the cleared version of the predicate/reference device. | |
| modified | This feature is a modified form of a feature cleared within the predicate and/ or |
| reference devices | |
| new | The feature is newly supported for Siemens CT Scanners and the subject device |
1) Modified Hardware
Table 2: Overview of hardware modifications for the subject device SOMATOM Pro.Pulse with SOMARIS/10 syngo CTVB10 compared to the predicate/reference devices.
| # | Hardware properties | SOMATOM Pro.Pulse
SOMARIS/10 syngo CT VB10 |
|----|-----------------------------|-----------------------------------------------|
| 1. | CARE Breathe | enabled |
| 2. | FAST 3D Camera | modified |
| 3. | Full-range CARE 2D Camera | modified |
| 4. | Moodlight | modified |
| 5. | CARE Moodlight | modified |
| 6. | Patient table configuration | modified |
2) Modified Software (syngo CT VB10)
Table 3: Overview of software modifications for the subject device SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB10 compared to the predicate/reference devices.
| # | Software properties | SOMATOM Pro.Pulse
SOMARIS/10 syngo CT VB10 |
|----|-----------------------------------------------------|-----------------------------------------------|
| 1. | ZeeFree | new |
| 2. | Dual Source Dual Energy | enabled |
| 3. | FAST Integrated Workflow | modified |
| 4. | Automatic Patient Instruction | modified |
| 5. | myNeedle Guide (with MyNeedle Detection) | modified |
| 6. | CARE kV | modified |
| 7. | Recon&GO | modified |
| 8. | CT View&GO | modified |
| 9. | myExam Companion – myExam
Compass/myExam Cockpit | modified |
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| # | Software properties | SOMATOM Pro.Pulse
SOMARIS/10 syngo CT VB10 |
|-----|----------------------------|-----------------------------------------------|
| 10. | Scan&GO | enabled |
| 11. | Flex4D Spiral - Neuro/Body | modified |
A tabular summary of the comparable hardware properties between the subject and predicate/reference devices is provided in the following Table 4 and Table 5.
Table 4: Technical hardware characteristics for subject device SOMATOM Pro.Pulse (software version SOMARIS/10 syngo CT VB10) compared to the predicate/reference devices.
| Hardware
property | Subject device
SOMATOM Pro.Pulse
with SOMARIS/10 syngo
CT VB10 | Primary predicate device
SOMATOM go.Top
with SOMARIS/10 syngo
CT VA40
(K211373) | Reference device
SOMATOM Drive
with SOMARIS/7 syngo CT
VB30
(K230421) |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| scanner | Whole body Computed
Tomography (CT) Scanner
System | Whole body Computed
Tomography (CT) Scanner
System | Whole body Computed
Tomography (CT) Scanner
System |
| System
configuration | Dual Source | Single Source | Dual Source |
| Environment of
Use | Professional Healthcare
Facility | Professional Healthcare
Facility | Professional Healthcare
Facility |
| Generator
Max. power (kW) | 150 (2 × 75) | 75 | 200 (2 × 100) |
| Detector
technology | Stellar detector based on
Multislice UFC (Ultra Fast
Ceramic) | Stellar detector based on
Multislice UFC (Ultra Fast
Ceramic) | StellarInfinity Detector (UFC
detector)
with TrueSignal and Edge
technology |
| Detector
volume coverage | 38.4 mm | 38.4 mm | 32 mm |
| Detector
physical rows | 2 × 64 | 64 | 2 × 64 |
| Detector
Slice width | 0.6 mm | 0.6 mm | 0.5 mm |
| Detector | 840 (detector A) | 840 | 1472 (detector A) |
| Hardware
property | Subject device
SOMATOM Pro.Pulse
with SOMARIS/10 syngo
CT VB10 | Primary predicate device
SOMATOM go.Top
with SOMARIS/10 syngo
CT VA40
(K211373) | Reference device
SOMATOM Drive
with SOMARIS/7 syngo CT
VB30
(K230421) |
| DAS channel no. | 600 (detector B) | 600 (detector B) | 960 (detector B) |
| Detector | 2 x 128 | 128 | 2 x 128 |
| Image slices | (with Interleaved Volume
Reconstruction, IVR)
2 x 384 | (with Interleaved Volume
Reconstruction, IVR)
384 | (acquired slices through z-
Sharp technology)
2 x 384 |
| | (reconstructed slices) | (reconstructed slices) | (reconstructed slices) |
| Tube
technology | 2 x Athlon® DS X-ray tube | Athlon® X-ray tube | 2 x Straton MX Sigma X-ray
tubes |
| Tube
collimator | Tube collimator DS4-A,
DS4-B
• Equivalent to 0.5 mm Al
in the isocenter
• 1 mm Al with cardio
wedge | Tube collimator
• Equivalent to 0.5 mm Al
in the isocenter
• 1 mm Al with cardio
wedge | Detector Scatter
Collimator
For improved low-contrast
resolution, e.g., in neuro
and abdominal imaging |
| Tube
kV steps | 70–140 kV in 10 kV steps | 70–140 kV in 10 kV steps | 70–140 kV in 10 kV steps |
| Tube
Max. current | Single Source: 13-825 mA
Dual Source: 26-1650 mA | Standard range: 13 - 825 mA | Single source 20-800 mA
Dual source 40–1600 mA |
| Tube | • 0.8 × 0.8 / 7° | • 0.8 × 0.8 / 7° | • 0.7 × 0.7/7° |
| focus | • 1.0 × 1.2 / 7° | • 1.0 × 1.2 / 7° | • 0.9 x 1.1/7° |
| Tube
Heat storage
capacity | 2 x 7.0 MHU | 7.0 MHU | 0 MHU (0.6 MHU capacity
combined with 7.3 MHU/min (5,400 kJ/min)
cooling rate is comparable
to the performance of a
conventional tube with
approximately 50 MHU
(37,000 kJ) anode heat
storage capacity) |
| Tube
Cooling rate
(MHU/ min) | up to 1.7 | up to 1.7 | 7.3 |
10
11
| Hardware
property | Subject device
SOMATOM Pro.Pulse
with SOMARIS/10 syngo
CT VB10 | Primary predicate device
SOMATOM go.Top
with SOMARIS/10 syngo
CT VA40
(K211373) | Reference device
SOMATOM Drive
with SOMARIS/7 syngo CT
VB30
(K230421) |
|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Gantry
Bore size | 70 | 70 | 78 |
| Gantry
Scan FoV (cm) | 50 | 50 | 50 |
| Gantry
Extended FoV
(cm) | 70 | 70 | 78 |
| Gantry
Rot. time (sec) | 0.33 (optional), 0.5, 1.0 | 0.33 (optional), 0.5, 1.0 | 0.28, 0.33, 0.5, 1.0 |
| Gantry
Tilt (degree) | n.a. | + 30° | n.a. |
| Maximum
temporal
resolution in ECG
gated or triggered
examination
(ms) | 86 ms (mono-segment)
43 ms (bi-segment) | 165 ms (mono-segment)
82.5 ms (bi-segment) | 75 ms (mono-segment)
37.5 ms (bi-segment) |
| Maximum scan
speed at pitch
(mm/s at pitch x) | 372 mm/s at pitch 3.2 | 175 mm/s at pitch 1.5 | 458 mm/s at pitch 3.4 |
| Touch panels | Yes | Yes | Yes |
| Patient table
Type | Vario 2 (2000 mm)
Vario 2.D (2000 mm) | Vario1 (1600 mm)
Vario RT (1600 mm)
Vario 2 (2000mm) | PHS 2000 (type PHS4n)
Multi-purpose patient
(MPT) table (optional) |
| Patient table
Max. weight
capacity (kg) | 307 | 227
307 | 227
307 |
| Max. scan length
topogram | 2080 mm with table
extension | 1680 mm with table
extension
2080 mm with table
extension | 2000 mm |
| Hardware
property | Subject device
SOMATOM Pro.Pulse
with SOMARIS/10 syngo
CT VB10 | Primary predicate device
SOMATOM go.Top
with SOMARIS/10 syngo
CT VA40
(K211373) | Reference device
SOMATOM Drive
with SOMARIS/7 syngo CT
VB30
(K230421) |
| Max. scan length
Image acquisition | Max. 2000 mm with
patient table extension | Max. 1600 mm with
patient table extension
Max. 2000 mm with
patient table extension | Max. 1840 mm |
| Spectral filtration | Tin Filter | Combined Tin Filter / Split
Filter | Tin Filter |
| FAST 3D Camera | option for patient
positioning with 3D
Camera:
• Ceiling mounted
• Gantry mounted | option for patient
positioning with 3D
Camera:
• Ceiling mounted | option for patient
positioning with 3D
Camera:
• Ceiling mounted |
| High Power 70/
High Power 80 | up to 825 mA (@70 kV)
up to 825 mA (@80 kV) | up to 825 mA (@70 kV)
up to 825 mA (@80 kV) | 750 mA (@ 80 kV)
650 mA (@ 70 kV) |
| 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 | N/A |
| i-joystick | Option for patient table
movements, including an
electrical connection for
the tablet dock which
allows charging the tablet
when mounted. | Option for patient table
movements, including an
electrical connection for
the tablet dock which
allows charging the tablet
when mounted. | i-control:
option to operate some of
the CT functions including
patient table movement as
an alternative to the
gantry operating panel and
the input units at the
console. |
| Tablet dock | Option for mounting of the
tablet on the patient table. | Option for mounting of the
tablet on the patient table. | N/A |
| Software
property | Subject device | Primary predicate device | Reference device |
| | SOMATOM Pro.Pulse
SOMARIS/10 syngo CT
VB10 | SOMATOM go.Top
SOMARIS/10 syngo CT
VA40
(K211373) | SOMATOM Drive
SOMARIS/7 syngo CT VB30
(K230421) |
| Operating System | Windows based
SOMARIS/10 syngo CT
VB10
Note: Note: the short
version syngo CT VB10 is
also used as labeling
information | Windows based
SOMARIS/10 syngo CT
VA40
Note: Note: the short
version syngo CT VA40 is
also used as labeling
information | Windows based
SOMARIS/7 syngo CT VB20
Note: Note: the short
version syngo CT VB20 is also
used as labeling information |
| Acquisition
Workplace | syngo Acquisition
Workplace named as
"myExam Console"
syngo Viewing, syngo
Filming and syngo
Archiving & Networking
Image Reconstruction
(IRS)
2nd Acquisition Workplace
named as "myExam
Satellite" | syngo Acquisition
Workplace named as
"myExam Console"
syngo Viewing, syngo
Filming and syngo
Archiving & Networking
Image Reconstruction
(IRS)
2nd Acquisition Workplace
named as "myExam
Satellite" | syngo® Acquisition
Workplace (AWP)
optional second operating
console (RRWP) |
| Teamplay | Support of Teamplay
protocols | Support of Teamplay
protocols | Support of Teamplay
protocols |
| Protocols | Support of:
Protocols for Radiation Therapy Planning
support patient markingProtocols supporting
contrast bolus-
triggered data
acquisitionContrast media
protocols (including
coronary CTA)Pediatric ProtocolsFlex Dose Profile | Support of:
Protocols for Radiation Therapy Planning
support patient markingProtocols supporting
contrast bolus-
triggered data
acquisitionContrast media
protocols (including
coronary CTA)Pediatric ProtocolsFlex Dose Profile | Support of:
Protocols for Radiation Therapy PlanningProtocols supporting
contrast bolus-triggered
data acquisitionContrast media protocols
(including coronary CTA)Pediatric ProtocolsDual Source Dual Energy
protocolsDual Source Dual Energy
protocols for Radiation
Therapy Planning |
| Software
property | Subject device | Primary predicate device | Reference device |
| | SOMATOM Pro.Pulse
SOMARIS/10 syngo CT
VB10 | SOMATOM go.Top
SOMARIS/10 syngo CT
VA40
(K211373) | SOMATOM Drive
SOMARIS/7 syngo CT VB30
(K230421) |
| | Dynamic imaging (Flex 4D Spiral) interventional scan protocols (scan modes: i-sequence, i-spiral, i-Fluoro) Protocols supporting Cardiac Scanning, Spectral imaging for child examination, Spectral imaging with high resolution Turbo Flash Spiral various i-spiral and i-sequence scan protocols (applying different scanning parameters such as different slice thicknesses, kV settings or reconstructions kernels to support different clinical scenarios) and using features like iMAR, CARE Dose4D and CARE kV TwinkV (Dual Source Dual Energy acquisition) | Dynamic imaging (Flex 4D Spiral) interventional scan protocols (i-sequence, i-spiral, i-Fluoro) Protocols supporting Cardiac Scanning, Spectral imaging for child examination, Spectral imaging with high resolution Turbo Flash Spiral various i-spiral and i-sequence scan protocols (applying different scanning parameters such as different slice thicknesses, kV settings or reconstructions kernels to support different clinical scenarios) and using features like iMAR, CARE Dose4D and CARE kV TwinBeam (Single Source Dual Energy acquisition) TwinSpiral (Single Source Dual Energy acquisition) Protocols that allow scanning with support of an external respiratory gating system (ANZAI, Varian BGSC) | Protocols for CT intervention Protocols that allow triggering of breath hold scanning from external devices ECG gated Flash protocols |
| Software
property | Subject device | Primary predicate device | Reference device |
| | SOMATOM Pro.Pulse
SOMARIS/10 syngo CT
VB10 | SOMATOM go.Top
SOMARIS/10 syngo CT
VA40
(K211373) | SOMATOM Drive
SOMARIS/7 syngo CT VB30
(K230421) |
| Advanced
Reconstruction | Recon&GO:
- DE SPP (Spectral Post-
Processing) - Spectral Recon (Dual
Energy Reconstruction
including None, low (L3D)
and high (H3D) energy
images) - Inline Anatomical ranges
(Parallel/Radial) incl.
Virtual Unenhanced,
Monoenergetic plus - Inline Spine and Rib
Ranges - Inline table and bone
removal | Recon&GO: - DE SPP (Spectral Post-
Processing) - Spectral Recon (Dual
Energy Reconstruction
including, None, low (L3D)
and high (H3D) energy
images, Virtual
Unenhanced,
Monoenergetic plus) | Advanced reconstruction
tools supported:
The syngo acquisition
workplace provides, image
reconstruction, and routine
postprocessing. Various
advanced reconstruction
features supported by the CT
Scanner, e.g. FAST and CARE
applications. |
| 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 in their own right - 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 | 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 in their own right. - 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 | syngo.via - Wide Range of
individual applications,
syngo.via is a software
solution intended to be used
for viewing, manipulation,
communication, and storage
of medical images. It can be
used as a standalone device
or together with a variety of
cleared and unmodified
syngo based software
options. |
| Software
property | Subject device | Primary predicate device | Reference device |
| | SOMATOM Pro.Pulse
SOMARIS/10 syngo CT
VB10 | SOMATOM go.Top
SOMARIS/10 syngo CT
VA40
(K211373) | SOMATOM Drive
SOMARIS/7 syngo CT VB30
(K230421) |
| CT View&GO | software is mandatory
precondition.
These advanced
visualization tools are
designed to support the
technician & physician in
the qualitative and
quantitative
measurement & analysis
of clinical data acquired
and reconstructed by
Computed Tomography
scanners. Additional
information regarding the
points of interface and
inputs for this feature is
provided in Section 16. - 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, Average | software is mandatory
precondition.
These advanced
visualization tools are
designed to support the
technician & physician in
the qualitative and
quantitative
measurement & analysis
of clinical data acquired
and reconstructed by
Computed Tomography
scanners. Additional
information regarding the
points of interface and
inputs for this feature is
provided in Section 16. - 2D and 3D (MPR, VRT,
MIP and minIP) - Evaluation tools, Filming,
Printing | syngo.via - Wide Range of
individual applications,
syngo.via is a software
solution intended to be used
for viewing, manipulation,
communication, and storage
of medical images. It can be
used as a standalone device
or together with a variety of
cleared and unmodified
syngo based software
options. |
| Cybersecurity | IT Hardening | IT Hardening | IT Hardening |
| Standard
technologies | • FAST Features
• CARE Features
• GO technology | • FAST Features
• CARE Features
• GO technology | • FAST Features
• CARE Features |
| Iterative
Reconstruction
Methods | ADMIRE
iMAR | ADMIRE
iMAR
SAFIRE | ADMIRE
iMAR
SAFIRE |
| HD FoV | HD FoV 4.0 | HD FoV 4.0 | HD FoV 4.0 |
| Software
property | Subject device | Primary predicate device | Reference device |
| | SOMATOM Pro.Pulse
SOMARIS/10 syngo CT
VB10 | SOMATOM go.Top
SOMARIS/10 syngo CT
VA40
(K211373) | SOMATOM Drive
SOMARIS/7 syngo CT VB30
(K230421) |
| Matrix sizes | 256 x 256 pixels | 256 x 256 pixels | 256 x 256pixels |
| | 512 x 512 pixels | 512 x 512 pixels | 512 x 512 pixels |
| | 768 x 768 pixels | 768 x 768 pixels | 768 x 768 pixels |
| | 1024 x 1024 pixels
(Precision matrix) | 1024 x 1024 pixels
(Precision matrix) | 1024 x 1024 pixels (Precision
matrix) |
| DirectDensityTM | DirectDensityTM | DirectDensityTM | DirectDensityTM |
| | Image values can be
interpreted as showing | Image values can be
interpreted as showing | Image values can be
interpreted as showing |
| | relative electron density
or relative mass density, | relative electron density
or relative mass density, | relative electron density or
relative mass density, |
| | independent from tube
voltage and beam
filtration settings | independent from tube
voltage and beam
filtration settings | independent from tube
voltage and beam filtration
settings |
12
13
Table 5: Technical software characteristics for subject device SOMATOM Pro.Pulse (software version SOMARIS/10 syngo CT VB10) compared to the predicat/reference devices.
14
15
16
17
Any differences in technological characteristics do not raise different questions of safety and effectiveness. Testing and validation are completed. Test results show that the subject device SOMATOM Pro.Pulse with syngo CT VB10 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 SOMATOM Pro.Pulse 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 ●
18
System Verification test:
- System Integration Test (functional) ●
- . Functionality verification
- . Image Quality (IQ) Evaluation
Tests are conducted for all software components 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 device modification on Non-Clinical Performance Testing as listed in Table 6 below.
Table 6: Non-clinical performance testing (bench testing).
| Feature/Non-clinical
| supportive testing | Bench Testing performed |
|---|---|
| ZeeFree | The bench tests evaluate the performance of ZeeFree reconstruction. |
| The objectives of the tests are to demonstrate: |
|
| | that the number of artefacts which can be attributed to a stack misalignment (e.g. discontinuities in vessel structures, anatomical steps at air-soft-tissue interfaces, doubling of vessel or other anatomy) and which are often caused by incomplete patient breath-hold can be reduced in a "Cardiac Stack Artefact Correction" (SAC) reconstruction compared to the standard reconstruction with otherwise matching reconstruction parameters. |
| | that no artefacts are introduced by a SAC reconstruction. |
| | The test results show: |
| | If misalignment artefacts are identified in non-corrected standard ECG- gated reconstructed sequence or spiral images, the feature "Cardiac Stack Artefact Correction" (SAC, marketing name: ZeeFree) enables optional stack artefact corrected images, which reduce the number of alignment artefacts. |
| | The SAC reconstruction does not introduce new artefacts, which were previously not present in the non-corrected standard reconstruction. The SAC reconstruction does realize equivalent image quality in quantitative standard physics phantom-based measurements (ACR, Gammex phantom) in terms of noise, homogeneity, high-contrast resolution, slice thickness and CNR compared to a non-corrected standard reconstruction. |
| | The SAC reconstruction does realize equivalent image quality in quantitative and qualitative phantom-based measurements with respect to metal objects compared to a non-corrected standard reconstruction. |
| Feature/Non-clinical
supportive testing | Bench Testing performed |
| | The SAC algorithm can be successfully applied to phantom data if
derived from a suitable motion phantom demonstrating its correct
technical function on the tested device. The SAC algorithm is independent from the physical detector width of
the acquired data |
| Dual Source Dual Energy | The bench test verifies the successful implementation of the Dual Source Dual
Energy (DSDE) scan mode on the SOMATOM Pro.Pulse with the two voltage
combinations:
- 80 kV / Sn140 kV (80/Sn140 kV)
- 100 kV / Sn140 kV (100/Sn140 kV)
Image quality and spectral properties are evaluated based on phantom studies
using ex-factory scan protocols for head and abdomen. The presented
evaluation includes low-kV and high-kV images as well as Mixed images.
The measurements show that the spectral characteristics of the system in terms
of iodine ratio are well comparable to the reference device SOMATOM Drive. All
applied tests concerning image quality passed. |
| FAST 3D Camera/ FAST
Integrated Workflow | The bench test evaluates and compares the accuracy of the three sub-features
FAST Isocentering, FAST Range, and FAST Direction to the accuracy of the
predicate device with syngo CT VA40 using the old camera hardware and the
then only available ceiling mount.
The objectives of the bench test are to demonstrate that the FAST 3D Camera
feature of the subject device with SOMARIS/10 syngo CT VB10, where the
algorithms have been optimized for a new camera hardware in two mounting
positions, achieves comparable results as the predicate device with syngo CT
VA40.
The FAST Isocentering accuracy of the subject device with syngo CT VB10 is
comparable to the predicate device with syngo CT VA40, regardless of the
camera mounting position.
For the FAST Range feature, the detection accuracy of all body region
boundaries is comparable between the subject device with syngo CT VB10 and
predicate device with syngo CT VA40. In the gantry mounting position, the legs
are often occluded by the torso when the patient is lying head-first on the table.
This is not a severe limitation, as leg examinations are usually performed feet-
first.
The FAST Direction pose detection results are of comparable accuracy for
subject and predicate device, regardless of the camera mounting position.
Overall, the SOMARIS/10 syngo CT VB10 delivers comparable accuracy to the
SOMARIS/10 syngo CT VA40 predicate for the new FAST 3D Camera hardware,
also in the new gantry position. |
| myNeedle Guide | Tests were performed to ensure clinical usability of the myNeedle Guide needle
detection algorithm. Two individual tests were performed. The accuracy of the |
| Feature/Non-clinical
supportive testing | Bench Testing performed |
| (with myNeedle
Detection) | automatic needle detection algorithm was tested. The reduction of necessary
user interactions for navigating to a needle-oriented view with and without the
support of the automatic needle detection algorithm was analyzed.
It has been shown that the algorithm was able to consistently detect needle-tips
over a wide variety of scans in 90.76% of cases.
Further, the results of this bench test clearly shows that the auto needle
detection functionality reduces the number of interactions steps needed to
generate a needle-aligned view in the CT Intervention SW. Zero user interactions
are required and a needle-aligned view is displayed right away after a new scan,
if auto needle detection is switched on in the SW configuration. Therefore, the
test is already passed if only a single user interaction is necessary to achieve a
needle-oriented view in the manual workflow. |
| CARE kV | The bench test evaluates that the effective mAs settings of both the low and
high kV acquisitions of a TwinkV scan (Dual Source Dual Energy scan mode) are
adapted by CARE kV so that the image quality in terms of (CNR) is maintained.
The image qualities (i.e. CNR values) of certain phantom under different kV
settings in "Manual kV" mode are consistent.
Using CARE kV for TwinkV, contrast, noise, and CNR values in the mix images are
consistent for all voltage combinations. In all cases, CNR values do not deviate by
more than 10% from the average CNR over the available voltage combinations. |
| Flex 4D Spiral -
Neuro/Body | With Somaris/10 VB10, the F4DS mode is enabled on SOMATOM Pro.Pulse.
F4DS requires a teamwork of several trajectories and curves - table trajectory, x-
ray beam on trajectory, collimator trajectory, and reconstruction curve. No
artifacts had been observed for any F4DS scan mode due to missing data,
indicating that the trajectories work properly in hand. This also accounts for the
scenario, where the user may change the pitch setting to get access to another
range of scan coverages. |
| Low-Dose Lung Cancer
Screening | 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. |
19
20
21
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 |
| 06/27/2016 | 12-302 | IEC | 60601-2-44 Edition 3.2:
2016 | Medical electrical equipment -
Part 2-44: Particular
requirements for the basic |
| Date of
Entry | Recognition
Number | Standard
Developing
Organization | Standard Designation
Number and Date | Title of Standard |
| 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 |
| | | 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 |
| | | | | safety and essential
performance of x-ray
equipment for computed
tomography |
| Date of
Entry | Recognition
Number | Standard
Developing
Organization | Standard Designation
Number and Date | Title of Standard |
| | | | | engineering to medical devices,
including Amendment 1 |
| 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 CONSOLIDATED
VERSION | Medical electrical equipment -
Medical image display systems
- Part 1: Evaluation methods |
22
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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. |
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| Standard
Developing
Organization | Standard Designation
Number and Date | Title of Standard | How was Standard Used |
|----------------------------------------|-----------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| IEC/ISO | 17050-2 | Conformity assessment -
Supplier's declaration of
conformity - Part 2:
Supporting
documentation. | General consensus standards
not currently recognized by
FDA. |
A list of applicable guidance documents considered for this submission is provided as Table 9 below.
Table 9: FDA guidance document
| FDA Guidance Document | Issue date |
|---|---|
| User Fees and Refunds for Premarket Notification Submissions (510(k)s): Guidance for Industry and Food and Drug Administration Staff | 10/05/2022 |
| Refuse to Accept Policy for 510(k)s: Guidance for Industry and Food and Drug Administration Staff | 04/21/2022 |
| Format for Traditional and Abbreviated 510(k)s: Guidance for Industry and FDA Staff | 09/13/2019 |
| Deciding When to Submit a 510(k) for a Change to an Existing Device: Guidance for Industry and Food and Drug Administration Staff | 10/25/2017 |
| The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]: Guidance for Industry and Food and Drug Administration Staff | 07/28/2014 |
| Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices: Guidance for Industry and FDA Staff | 05/11/2005 |
| Off-The-Shelf Software Use in Medical Devices: Guidance for Industry and Food and Drug Administration Staff | 09/27/2019 |
| Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff | 02/03/2016 |
| Pediatric Information for X-ray Imaging Device Premarket Notifications: Guidance for Industry and Food and Drug Administration Staff | 11/28/2017 |
| Content of Premarket Submissions for Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff | 10/02/2014 |
| Electromagnetic Compatibility (EMC) of Medical Devices: Guidance for Industry and Food and Drug Administration Staff | 06/06/2022 |
| Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices: Guidance for Industry and Food and Drug Administration Staff | 09/06/2017 |
| Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices: Guidance for Industry and Food and Drug Administration Staff | 09/14/2018 |
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Verification and Validation
Software documentation at an Enhanced Documentation level per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on June 14, 2023 is included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. The Risk Analysis was completed, and risk control implemented to mitigate identified hazards. The testing supports that all software specifications have met the acceptance criteria. Testing for verification and validation support the claims of substantial equivalence.
Cybersecurity
Siemens conforms to the Cybersecurity requirementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Cybersecurity information in accordance with guidance document "Content of Premarket Submissions for Management of Cybersecurity Medical Devices issues on October 2, 2014" is included within this submission.
Wireless and Wireless Coexistence
Siemens SOMATOM Pro.Pulse conform 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 tablets 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 CT Scanners and respective Scatter Radiation diagrams for typical room installations are provided in the User Documentation and Planning Guide of the intended Scanners in accordance 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 the 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
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- 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 documentation.
Additional Supportive Data
The National Lung Screening Trial (NLST), sponsored by the National Cancer Institute, is used to support the additional lung cancer screening Indications for Use. The study was a randomized trial of screening with the use of low-dose CT compared to chest radiography to determine whether screening with low-dose CT could reduce mortality from lung cancer. The study start date was August, 2002 and the completion date was October, 2010. The interpretation task with CT for this study was to detect lung nodules of 4mm diameter or greater.
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 the software specifications have met the predetermined acceptance criteria. Verification and validation testing of the device was found acceptable to support the claim of substantial equivalence.
General Safety and Effectiveness Concerns
The device labeling contains instructions for use as well as necessary cautions and warnings to provide for safe and effective use of the device. Risk management is ensured via a system related risk analysis, which is used to identify potential hazards. These potential hazards are controlled during development, verification and validation testing according to the risk management process. In order to minimize electrical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.
IX. Conclusions
The predicate devices were cleared based on the results of non-clinical testing including verification and validation, phantom tests, and supportive literature. The subject device is also tested using the same methods as used for the predicate devices. The non-clinical data supports the safety of the device and the hardware and software verification and validation demonstrates that the subject device SOMATOM Pro.Pulse should perform as intended in the specified use conditions. The data included in this submission demonstrates that the SOMATOM Pro.Pulse perform comparably to the predicate devices currently marketed for the same intended use. Since all predicate devices were tested using the same methods, Siemens believes that the data generated from the SOMATOM Pro.Pulse testing supports a finding of substantial equivalence.
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