(134 days)
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.
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.
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.
The provided text describes the Siemens SOMATOM Pro.Pulse CT system, its modifications, and its substantial equivalence to predicate devices, but it does not contain a detailed study proving the device meets specific acceptance criteria in the format requested. Instead, it refers to broad categories of non-clinical testing and general statements about meeting pre-determined acceptance criteria.
Here's an attempt to structure the answer based on the available information. Many fields will be marked as "Not Provided" due to the nature of the document being a 510(k) summary, which often focuses on establishing substantial equivalence rather than detailed study results for specific performance metrics.
Acceptance Criteria and Device Performance Study for SOMATOM Pro.Pulse
The K232206 submission for the SOMATOM Pro.Pulse focuses on demonstrating substantial equivalence to its predicate devices (SOMATOM go.Top (K211373) and SOMATOM Drive (K230421)). The document details non-clinical testing performed to verify and validate modifications and ensure the device's functionality, image quality, and safety are comparable to the predicates.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific quantitative acceptance criteria alongside numerical performance results for the device. Instead, it offers qualitative descriptions of performance objectives and outcomes for various features based on bench testing.
| Feature/Test | Acceptance Criteria (Stated Objective from Text) | Reported Device Performance (Summary from Text) |
|---|---|---|
| ZeeFree (Cardiac Stack Artefact Correction) | 1. Reduction of misalignment artifacts (e.g., discontinuities in vessel structures, anatomical steps at air-soft-tissue interfaces, doubling of anatomy) in SAC reconstruction compared to standard reconstruction. 2. No introduction of new artifacts by SAC reconstruction. 3. Equivalent image quality (noise, homogeneity, high-contrast resolution, slice thickness, CNR) in phantom-based measurements compared to standard reconstruction. 4. Equivalent image quality with metal objects compared to standard reconstruction. 5. Successful application of SAC algorithm to phantom data, demonstrating correct technical function and independence from physical detector width. | 1. "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." 2. "The SAC reconstruction does not introduce new artefacts, which were previously not present in the non-corrected standard reconstruction." 3. "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." 4. "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." 5. "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 (DSDE) | Successful implementation of DSDE with 80 kV / Sn140 kV and 100 kV / Sn140 kV voltage combinations. Image quality and spectral properties (iodine ratio) comparable to the reference device (SOMATOM Drive). All applied image quality tests passed. | "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 | Accuracy of FAST Isocentering, FAST Range, and FAST Direction comparable to the predicate device with syngo CT VA40 (old camera hardware, ceiling mount). | "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." "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 (with myNeedle Detection) | 1. High accuracy of automatic needle detection algorithm. 2. Reduction of necessary user interactions for navigating to a needle-oriented view. | 1. "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." 2. "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." |
| CARE kV | Effective mAs settings of low and high kV acquisitions in TwinkV scan adapted by CARE kV to maintain image quality (CNR). Consistency of image qualities (CNR values) in certain phantoms under different kV settings in "Manual kV" mode. Consistency of contrast, noise, and CNR values in mix images for all voltage combinations. | "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 | No artifacts should be observed due to missing data, indicating correct trajectory functioning, even with pitch setting changes. | "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 | Technical parameters specific to Low-Dose Lung Cancer Screening comparable to predicate and subject devices. | "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." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "phantom studies" and "phantom data" for several tests (ZeeFree, Dual Source Dual Energy, CARE kV, Flex 4D Spiral). For FAST 3D Camera, it tested the subject device against the predicate. For myNeedle Guide, it states the algorithm was able to consistently detect needle-tips in "90.76% of cases" over "a wide variety of scans." However,
- Specific sample sizes (N) for phantom studies or "a wide variety of scans" are not provided.
- Data Provenance (e.g., country of origin, retrospective/prospective) is not explicitly stated for these performance tests. Given they are "bench tests" and "phantom studies," they implicitly suggest a controlled laboratory setting (likely at the manufacturing locations in Germany or China) rather than clinical patient data. The reference to the National Lung Screening Trial (NLST) is supportive literature for the additional lung cancer screening Indications for Use, not a test set for the device's technical performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Provided. The non-clinical tests described in the document appear to be technical performance evaluations, primarily using phantoms and comparing against known technical specifications or established predicate device performance. There is no mention of experts establishing ground truth for these technical tests.
4. Adjudication Method for the Test Set
- Not Provided. This is typically relevant for studies involving human interpretation or clinical outcomes, which are not detailed for the device's technical performance validation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study is not described for the SOMATOM Pro.Pulse's performance relative to its predicate devices. The document focuses on demonstrating comparable technical performance through non-clinical bench testing.
- Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as no MRMC study comparing human readers with and without AI assistance is detailed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Yes, the described "bench tests" and "phantom studies" are effectively standalone algorithm-only performance evaluations. For example, the ZeeFree reconstruction and myNeedle Detection algorithm evaluations are reported based on their intrinsic technical performance in a controlled setting without human intervention in the loop of image acquisition or primary interpretation for the purpose of the validation described.
7. The Type of Ground Truth Used
The ground truth for the non-clinical tests appears to be:
- Known phantom properties and measurements: For image quality metrics (noise, homogeneity, resolution, CNR, slice thickness).
- Known mechanical or digital parameters: For features like FAST 3D Camera (accuracy of Isocentering, Range, Direction) and Flex 4D Spiral (absence of artifacts due to missing data).
- Predicate device performance: Used as a reference for comparison, implying its performance is considered a benchmark or "ground truth" for equivalence.
- Quantifiable algorithm outputs: For myNeedle Detection, the algorithm's ability to consistently detect needle tips (90.76% accuracy).
8. The Sample Size for the Training Set
- Not Provided. The document describes bench testing for verification and validation, but it does not specify details about the training data used for any machine learning components (such as the optimization of the FAST 3D Camera algorithms or myNeedle Detection, if they involve machine learning).
9. How the Ground Truth for the Training Set Was Established
- Not Provided. Similar to the training set size, the method for establishing ground truth for any potential training data is not detailed in this submission summary.
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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).
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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
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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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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
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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 clearedSiemens stand-alone software applications. This feature will be supported for the |
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| Term | Definition |
|---|---|
| subject device with software version SOMARIS/10 syngo CT VB10 and is substantiallyequivalent 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/ orreference 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.PulseSOMARIS/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.PulseSOMARIS/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 – myExamCompass/myExam Cockpit | modified |
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| # | Software properties | SOMATOM Pro.PulseSOMARIS/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.
| Hardwareproperty | Subject deviceSOMATOM Pro.Pulsewith SOMARIS/10 syngoCT VB10 | Primary predicate deviceSOMATOM go.Topwith SOMARIS/10 syngoCT VA40(K211373) | Reference deviceSOMATOM Drivewith SOMARIS/7 syngo CTVB30(K230421) |
|---|---|---|---|
| scanner | Whole body ComputedTomography (CT) ScannerSystem | Whole body ComputedTomography (CT) ScannerSystem | Whole body ComputedTomography (CT) ScannerSystem |
| Systemconfiguration | Dual Source | Single Source | Dual Source |
| Environment ofUse | Professional HealthcareFacility | Professional HealthcareFacility | Professional HealthcareFacility |
| GeneratorMax. power (kW) | 150 (2 × 75) | 75 | 200 (2 × 100) |
| Detectortechnology | Stellar detector based onMultislice UFC (Ultra FastCeramic) | Stellar detector based onMultislice UFC (Ultra FastCeramic) | StellarInfinity Detector (UFCdetector)with TrueSignal and Edgetechnology |
| Detectorvolume coverage | 38.4 mm | 38.4 mm | 32 mm |
| Detectorphysical rows | 2 × 64 | 64 | 2 × 64 |
| DetectorSlice width | 0.6 mm | 0.6 mm | 0.5 mm |
| Detector | 840 (detector A) | 840 | 1472 (detector A) |
| Hardwareproperty | Subject deviceSOMATOM Pro.Pulsewith SOMARIS/10 syngoCT VB10 | Primary predicate deviceSOMATOM go.Topwith SOMARIS/10 syngoCT VA40(K211373) | Reference deviceSOMATOM Drivewith SOMARIS/7 syngo CTVB30(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 VolumeReconstruction, IVR)2 x 384 | (with Interleaved VolumeReconstruction, IVR)384 | (acquired slices through z-Sharp technology)2 x 384 |
| (reconstructed slices) | (reconstructed slices) | (reconstructed slices) | |
| Tubetechnology | 2 x Athlon® DS X-ray tube | Athlon® X-ray tube | 2 x Straton MX Sigma X-raytubes |
| Tubecollimator | Tube collimator DS4-A,DS4-B• Equivalent to 0.5 mm Alin the isocenter• 1 mm Al with cardiowedge | Tube collimator• Equivalent to 0.5 mm Alin the isocenter• 1 mm Al with cardiowedge | Detector ScatterCollimatorFor improved low-contrastresolution, e.g., in neuroand abdominal imaging |
| TubekV steps | 70–140 kV in 10 kV steps | 70–140 kV in 10 kV steps | 70–140 kV in 10 kV steps |
| TubeMax. current | Single Source: 13-825 mADual Source: 26-1650 mA | Standard range: 13 - 825 mA | Single source 20-800 mADual 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° |
| TubeHeat storagecapacity | 2 x 7.0 MHU | 7.0 MHU | 0 MHU (0.6 MHU capacitycombined with 7.3 MHU/min (5,400 kJ/min)cooling rate is comparableto the performance of aconventional tube withapproximately 50 MHU(37,000 kJ) anode heatstorage capacity) |
| TubeCooling rate(MHU/ min) | up to 1.7 | up to 1.7 | 7.3 |
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| Hardwareproperty | Subject deviceSOMATOM Pro.Pulsewith SOMARIS/10 syngoCT VB10 | Primary predicate deviceSOMATOM go.Topwith SOMARIS/10 syngoCT VA40(K211373) | Reference deviceSOMATOM Drivewith SOMARIS/7 syngo CTVB30(K230421) |
|---|---|---|---|
| GantryBore size | 70 | 70 | 78 |
| GantryScan FoV (cm) | 50 | 50 | 50 |
| GantryExtended FoV(cm) | 70 | 70 | 78 |
| GantryRot. time (sec) | 0.33 (optional), 0.5, 1.0 | 0.33 (optional), 0.5, 1.0 | 0.28, 0.33, 0.5, 1.0 |
| GantryTilt (degree) | n.a. | + 30° | n.a. |
| Maximumtemporalresolution in ECGgated or triggeredexamination(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 scanspeed 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 tableType | 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 tableMax. weightcapacity (kg) | 307 | 227307 | 227307 |
| Max. scan lengthtopogram | 2080 mm with tableextension | 1680 mm with tableextension2080 mm with tableextension | 2000 mm |
| Hardwareproperty | Subject deviceSOMATOM Pro.Pulsewith SOMARIS/10 syngoCT VB10 | Primary predicate deviceSOMATOM go.Topwith SOMARIS/10 syngoCT VA40(K211373) | Reference deviceSOMATOM Drivewith SOMARIS/7 syngo CTVB30(K230421) |
| Max. scan lengthImage acquisition | Max. 2000 mm withpatient table extension | Max. 1600 mm withpatient table extensionMax. 2000 mm withpatient table extension | Max. 1840 mm |
| Spectral filtration | Tin Filter | Combined Tin Filter / SplitFilter | Tin Filter |
| FAST 3D Camera | option for patientpositioning with 3DCamera:• Ceiling mounted• Gantry mounted | option for patientpositioning with 3DCamera:• Ceiling mounted | option for patientpositioning with 3DCamera:• 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 patientmovement | Option for table patientmovement | N/A |
| i-joystick | Option for patient tablemovements, including anelectrical connection forthe tablet dock whichallows charging the tabletwhen mounted. | Option for patient tablemovements, including anelectrical connection forthe tablet dock whichallows charging the tabletwhen mounted. | i-control:option to operate some ofthe CT functions includingpatient table movement asan alternative to thegantry operating panel andthe input units at theconsole. |
| Tablet dock | Option for mounting of thetablet on the patient table. | Option for mounting of thetablet on the patient table. | N/A |
| Softwareproperty | Subject device | Primary predicate device | Reference device |
| SOMATOM Pro.PulseSOMARIS/10 syngo CTVB10 | SOMATOM go.TopSOMARIS/10 syngo CTVA40(K211373) | SOMATOM DriveSOMARIS/7 syngo CT VB30(K230421) | |
| Operating System | Windows basedSOMARIS/10 syngo CTVB10Note: Note: the shortversion syngo CT VB10 isalso used as labelinginformation | Windows basedSOMARIS/10 syngo CTVA40Note: Note: the shortversion syngo CT VA40 isalso used as labelinginformation | Windows basedSOMARIS/7 syngo CT VB20Note: Note: the shortversion syngo CT VB20 is alsoused as labeling information |
| AcquisitionWorkplace | syngo AcquisitionWorkplace named as"myExam Console"syngo Viewing, syngoFilming and syngoArchiving & NetworkingImage Reconstruction(IRS)2nd Acquisition Workplacenamed as "myExamSatellite" | syngo AcquisitionWorkplace named as"myExam Console"syngo Viewing, syngoFilming and syngoArchiving & NetworkingImage Reconstruction(IRS)2nd Acquisition Workplacenamed as "myExamSatellite" | syngo® AcquisitionWorkplace (AWP)optional second operatingconsole (RRWP) |
| Teamplay | Support of Teamplayprotocols | Support of Teamplayprotocols | Support of Teamplayprotocols |
| Protocols | Support of:Protocols for Radiation Therapy Planningsupport patient markingProtocols supportingcontrast bolus-triggered dataacquisitionContrast mediaprotocols (includingcoronary CTA)Pediatric ProtocolsFlex Dose Profile | Support of:Protocols for Radiation Therapy Planningsupport patient markingProtocols supportingcontrast bolus-triggered dataacquisitionContrast mediaprotocols (includingcoronary CTA)Pediatric ProtocolsFlex Dose Profile | Support of:Protocols for Radiation Therapy PlanningProtocols supportingcontrast bolus-triggereddata acquisitionContrast media protocols(including coronary CTA)Pediatric ProtocolsDual Source Dual EnergyprotocolsDual Source Dual Energyprotocols for RadiationTherapy Planning |
| Softwareproperty | Subject device | Primary predicate device | Reference device |
| SOMATOM Pro.PulseSOMARIS/10 syngo CTVB10 | SOMATOM go.TopSOMARIS/10 syngo CTVA40(K211373) | SOMATOM DriveSOMARIS/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 | |
| Softwareproperty | Subject device | Primary predicate device | Reference device |
| SOMATOM Pro.PulseSOMARIS/10 syngo CTVB10 | SOMATOM go.TopSOMARIS/10 syngo CTVA40(K211373) | SOMATOM DriveSOMARIS/7 syngo CT VB30(K230421) | |
| AdvancedReconstruction | Recon&GO:- DE SPP (Spectral Post-Processing)- Spectral Recon (DualEnergy Reconstructionincluding None, low (L3D)and high (H3D) energyimages)- Inline Anatomical ranges(Parallel/Radial) incl.Virtual Unenhanced,Monoenergetic plus- Inline Spine and RibRanges- Inline table and boneremoval | Recon&GO:- DE SPP (Spectral Post-Processing)- Spectral Recon (DualEnergy Reconstructionincluding, None, low (L3D)and high (H3D) energyimages, VirtualUnenhanced,Monoenergetic plus) | Advanced reconstructiontools supported:The syngo acquisitionworkplace provides, imagereconstruction, and routinepostprocessing. Variousadvanced reconstructionfeatures supported by the CTScanner, e.g. FAST and CAREapplications. |
| Post-Processinginterface | Recon&GO InlineResults:Software interface topost-processingalgorithms which areunmodified when loadedonto the CT scanners and510(k) cleared as medicaldevices in their own right- software interfaces forpost-processingfunctionalities toprovide advancedvisualization tools toprepare and processmedical images fordiagnostic purpose.Note: The clearance ofstandalone AdvancedVisualization Application | Recon&GO InlineResults:Software interface topost-processingalgorithms which areunmodified when loadedonto the CT scanners and510(k) cleared as medicaldevices in their own right.- software interfaces forpost-processingfunctionalities toprovide advancedvisualization tools toprepare and processmedical images fordiagnostic purpose.Note: The clearance ofstandalone AdvancedVisualization Application | syngo.via - Wide Range ofindividual applications,syngo.via is a softwaresolution intended to be usedfor viewing, manipulation,communication, and storageof medical images. It can beused as a standalone deviceor together with a variety ofcleared and unmodifiedsyngo based softwareoptions. |
| Softwareproperty | Subject device | Primary predicate device | Reference device |
| SOMATOM Pro.PulseSOMARIS/10 syngo CTVB10 | SOMATOM go.TopSOMARIS/10 syngo CTVA40(K211373) | SOMATOM DriveSOMARIS/7 syngo CT VB30(K230421) | |
| CT View&GO | software is mandatoryprecondition.These advancedvisualization tools aredesigned to support thetechnician & physician inthe qualitative andquantitativemeasurement & analysisof clinical data acquiredand reconstructed byComputed Tomographyscanners. Additionalinformation regarding thepoints of interface andinputs for this feature isprovided in Section 16.- 2D and 3D (MPR, VRT,MIP and minIP)- Evaluation tools, Filming,Printing- Interactive SpectralImaging (ISI)- Basic visualization tools:Endo View- Basic manipulation tools:DE ROI, ROI HU, Average | software is mandatoryprecondition.These advancedvisualization tools aredesigned to support thetechnician & physician inthe qualitative andquantitativemeasurement & analysisof clinical data acquiredand reconstructed byComputed Tomographyscanners. Additionalinformation regarding thepoints of interface andinputs for this feature isprovided in Section 16.- 2D and 3D (MPR, VRT,MIP and minIP)- Evaluation tools, Filming,Printing | syngo.via - Wide Range ofindividual applications,syngo.via is a softwaresolution intended to be usedfor viewing, manipulation,communication, and storageof medical images. It can beused as a standalone deviceor together with a variety ofcleared and unmodifiedsyngo based softwareoptions. |
| Cybersecurity | IT Hardening | IT Hardening | IT Hardening |
| Standardtechnologies | • FAST Features• CARE Features• GO technology | • FAST Features• CARE Features• GO technology | • FAST Features• CARE Features |
| IterativeReconstructionMethods | ADMIREiMAR | ADMIREiMARSAFIRE | ADMIREiMARSAFIRE |
| HD FoV | HD FoV 4.0 | HD FoV 4.0 | HD FoV 4.0 |
| Softwareproperty | Subject device | Primary predicate device | Reference device |
| SOMATOM Pro.PulseSOMARIS/10 syngo CTVB10 | SOMATOM go.TopSOMARIS/10 syngo CTVA40(K211373) | SOMATOM DriveSOMARIS/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 (Precisionmatrix) | |
| DirectDensityTM | DirectDensityTM | DirectDensityTM | DirectDensityTM |
| Image values can beinterpreted as showing | Image values can beinterpreted as showing | Image values can beinterpreted as showing | |
| relative electron densityor relative mass density, | relative electron densityor relative mass density, | relative electron density orrelative mass density, | |
| independent from tubevoltage and beamfiltration settings | independent from tubevoltage and beamfiltration settings | independent from tubevoltage and beam filtrationsettings |
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Table 5: Technical software characteristics for subject device SOMATOM Pro.Pulse (software version SOMARIS/10 syngo CT VB10) compared to the predicat/reference devices.
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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 ●
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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-clinicalsupportive 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-clinicalsupportive testing | Bench Testing performed |
| The SAC algorithm can be successfully applied to phantom data ifderived from a suitable motion phantom demonstrating its correcttechnical function on the tested device. The SAC algorithm is independent from the physical detector width ofthe acquired data | |
| Dual Source Dual Energy | The bench test verifies the successful implementation of the Dual Source DualEnergy (DSDE) scan mode on the SOMATOM Pro.Pulse with the two voltagecombinations:- 80 kV / Sn140 kV (80/Sn140 kV)- 100 kV / Sn140 kV (100/Sn140 kV)Image quality and spectral properties are evaluated based on phantom studiesusing ex-factory scan protocols for head and abdomen. The presentedevaluation includes low-kV and high-kV images as well as Mixed images.The measurements show that the spectral characteristics of the system in termsof iodine ratio are well comparable to the reference device SOMATOM Drive. Allapplied tests concerning image quality passed. |
| FAST 3D Camera/ FASTIntegrated Workflow | The bench test evaluates and compares the accuracy of the three sub-featuresFAST Isocentering, FAST Range, and FAST Direction to the accuracy of thepredicate device with syngo CT VA40 using the old camera hardware and thethen only available ceiling mount.The objectives of the bench test are to demonstrate that the FAST 3D Camerafeature of the subject device with SOMARIS/10 syngo CT VB10, where thealgorithms have been optimized for a new camera hardware in two mountingpositions, achieves comparable results as the predicate device with syngo CTVA40.The FAST Isocentering accuracy of the subject device with syngo CT VB10 iscomparable to the predicate device with syngo CT VA40, regardless of thecamera mounting position.For the FAST Range feature, the detection accuracy of all body regionboundaries is comparable between the subject device with syngo CT VB10 andpredicate device with syngo CT VA40. In the gantry mounting position, the legsare 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 forsubject and predicate device, regardless of the camera mounting position.Overall, the SOMARIS/10 syngo CT VB10 delivers comparable accuracy to theSOMARIS/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 needledetection algorithm. Two individual tests were performed. The accuracy of the |
| Feature/Non-clinicalsupportive testing | Bench Testing performed |
| (with myNeedleDetection) | automatic needle detection algorithm was tested. The reduction of necessaryuser interactions for navigating to a needle-oriented view with and without thesupport of the automatic needle detection algorithm was analyzed.It has been shown that the algorithm was able to consistently detect needle-tipsover a wide variety of scans in 90.76% of cases.Further, the results of this bench test clearly shows that the auto needledetection functionality reduces the number of interactions steps needed togenerate a needle-aligned view in the CT Intervention SW. Zero user interactionsare 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, thetest is already passed if only a single user interaction is necessary to achieve aneedle-oriented view in the manual workflow. |
| CARE kV | The bench test evaluates that the effective mAs settings of both the low andhigh kV acquisitions of a TwinkV scan (Dual Source Dual Energy scan mode) areadapted 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 kVsettings in "Manual kV" mode are consistent.Using CARE kV for TwinkV, contrast, noise, and CNR values in the mix images areconsistent for all voltage combinations. In all cases, CNR values do not deviate bymore 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. Noartifacts had been observed for any F4DS scan mode due to missing data,indicating that the trajectories work properly in hand. This also accounts for thescenario, where the user may change the pitch setting to get access to anotherrange of scan coverages. |
| Low-Dose Lung CancerScreening | The bench test provides a comparison of technical parameters specific to Low-Dose Lung Cancer Screening of the predicate and subject devices, following theestablished concept of our previous 510(k) submissions.It can be concluded that the subject and predicate devices are substantiallyequivalent for the task of Low-Dose Lung Cancer Screening since the bench testresults showed comparable technical parameters. |
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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 ofEntry | RecognitionNumber | StandardDevelopingOrganization | Standard DesignationNumber and Date | Title of Standard |
|---|---|---|---|---|
| 12/19/2022 | 12-349 | NEMA | PS 3.1 - 3.20 2022d | Digital Imaging andCommunications in Medicine(DICOM) Set |
| 07/06/2020 | 12-325 | NEMA | XR 25-2019 | Computed Tomography DoseCheck |
| 07/06/2020 | 12-330 | NEMA | XR 28-2018 | Supplemental Requirementsfor User Information andSystem Function Related toDose in CT |
| 12/23/2019 | 12-328 | IEC | 61223-3-5 Edition 2.02019-09 | Evaluation and routine testingin medical imagingdepartments - Part 3-5:Acceptance tests and constancytests - Imaging performance ofcomputed tomography X-rayequipment [Including:Technical Corrigendum 1(2006)] |
| 03/14/2011 | 12-226 | IEC | 61223-2-6 Second Edition2006-11 | Evaluation and routine testingin medical imagingdepartments - Part 2-6:Constancy tests - Imagingperformance of computedtomography X-ray equipment |
| 01/14/2014 | 12-269 | IEC | 60601-1-3 Edition 2.12013-04 | Medical electrical equipment -Part 1-3: General requirementsfor basic safety and essentialperformance - CollateralStandard: Radiation protectionin diagnostic X-ray equipment |
| 06/27/2016 | 12-302 | IEC | 60601-2-44 Edition 3.2:2016 | Medical electrical equipment -Part 2-44: Particularrequirements for the basic |
| Date ofEntry | RecognitionNumber | StandardDevelopingOrganization | Standard DesignationNumber and Date | Title of Standard |
| 12/23/2019 | 5-125 | ANSI AAMIISO | 14971: 2019 | Medical devices - Applicationsof risk management to medicaldevices |
| ISO | 14971 Third Edition 2019-12 | Medical devices - Application ofrisk management to medicaldevices | ||
| 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 2015-06CONSOLIDATED 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 requirementsfor basic safety and essentialperformance (IEC 60601-1:2005, MOD) [IncludingAmendment 2 (2021)] |
| 09/17/2018 | 19-36 | ANSI AAMI IEC | 60601-1-2:2014 [IncludingAMD 1:2021] | Medical electrical equipment -Part 1-2: General requirementsfor basic safety and essentialperformance - CollateralStandard: Electromagneticdisturbances - Requirementsand tests |
| IEC | 60601-1-2 Edition 4.12020-09 CONSOLIDATEDVERSION | Medical electrical equipment -Part 1-2: General requirementsfor basic safety and essentialperformance - CollateralStandard: Electromagneticdisturbances - Requirementsand 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 essentialperformance of x-rayequipment for computedtomography | ||||
| Date ofEntry | RecognitionNumber | StandardDevelopingOrganization | Standard DesignationNumber 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 - Part1: Equipment classification, andrequirements |
| 12/21/2020 | 5-132 | IEC | 60601-1-6 Edition 3.22020-07 CONSOLIDATEDVERSION | Medical electrical equipment -Part 1-6: General requirementsfor basic safety and essentialperformance - Collateralstandard: Usability |
| 12/23/2019 | 12-309 | IEC | 60601-2-28 Edition 3.02017-06 | Medical electrical equipment -Part 2-28: Particularrequirements for the basicsafety and essentialperformance of X-ray tubeassemblies for medicaldiagnosis |
| 12/20/2021 | 12-341 | IEC | 62563-1 Edition 1.2 2021-07 CONSOLIDATEDVERSION | Medical electrical equipment -Medical image display systems- Part 1: Evaluation methods |
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Table 8: General Use consensus standards.
| StandardDevelopingOrganization | Standard DesignationNumber and Date | Title of Standard | How was Standard Used |
|---|---|---|---|
| IEC | 60601–1:2005+A1:2012+A2:2020 | Medical electricalequipment - part 1:general requirements forbasic safety and essentialperformance | 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 ofconformity – Part 1:General requirements | Declaration of conformanceto FDA recognized consensusstandards. |
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| StandardDevelopingOrganization | Standard DesignationNumber and Date | Title of Standard | How was Standard Used |
|---|---|---|---|
| IEC/ISO | 17050-2 | Conformity assessment -Supplier's declaration ofconformity - Part 2:Supportingdocumentation. | General consensus standardsnot currently recognized byFDA. |
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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§ 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.