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.

Device Description

The subject device SOMATOM CT Scanner Systems with SOMARIS/7 syngo CT VB30 are Computed Tomography X-ray Systems which feature one (single source) continuously rotating tube-detector system and function according to the fan beam principle. The SOMATOM CT Scanner Systems with Software SOMARIS/7 syngo CT VB30 produces CT images in DICOM format, which 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 and therapy planning support (including, but not limited to, Brachytherapy, Particle including Proton Therapy, External Beam Radiation Therapy, Surgery). The computer system delivered with the CT scanner is able to run optional post processing applications.

The platform software for the SOMATOM CT Scanner Systems, SOMARIS/7 syngo CT VB30, is a commandbased program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on functional verification and validation testing rather than explicit, quantifiable acceptance criteria with corresponding performance metrics for each feature in a tabular format. Instead, it describes the objective of each test and then states that the results were found to be acceptable or passed.

However, we can extract the objectives and the documented outcomes for features where some quantifiable or descriptive performance is mentioned:

Feature Tested	Acceptance Criteria (Objective of Test)	Reported Device Performance
FAST Bolus	Deviation from an ideal post-bolus delay.	Found in an acceptable margin when compared to averaged dynamic scans (ground truth). Supporting publications show: - Median difference between true and personalized delay < ±1 second. - Predicted patient-specific delays within ±2 seconds from true in >90% of patients. - Higher overall and more uniform attenuation in individualized cohort vs. fixed. - Higher contrast-to-noise ratio (CNR) and subjective image quality in individualized cohort. - Able to adjust scan timing to altered protocols to reach diagnostic image quality despite slower injection rate and reduced iodine dose. - Images with individualized post-trigger delay provided higher attenuation for all organs. - Mean vessel enhancement significantly higher in individualized scan timing group.
FAST 3D Camera (Adolescent support)	Achieve comparable or more accurate results than predicate for adults, while supporting adolescent patients (120 cm+) with comparable accuracy as adult patients.	Achieves the objective of the test. (Implies comparable or more accurate results).
FAST Isocentering (Adolescent support)	Lateral isocenter accuracy of subject device comparable to predicate for adult patients, and similar accuracy for adolescent patients.	Comparable to predicate for adult patients; similar accuracy for adolescent patients.
FAST Range (Adolescent support)	Robustness of groin landmark improved; other landmarks detected with comparable accuracy for adults; accuracy of landmark detection for adolescents similar to adults.	Robustness of groin landmark improved; other landmarks with comparable accuracy. For adolescents, similar accuracy to adults.
FAST Direction	Comparable accuracy of pose detection to predicate device.	Comparable accuracy.
FAST Planning	Fraction (percentage) of correct ranges that can be applied without change; calculation time meets interactive requirements.	For >90% of ranges, no editing action was necessary to cover standard ranges. For >95%, the speed of the algorithm was sufficient.
Tin Filtration (New kV combinations)	Successful implementation of new voltage combinations (80/Sn140 kV and 100/Sn140 kV) verified; description of spectral properties given; improved CNR in spectral results (monoenergetic images).	Successful implementation verified via phantom scans and image quality criteria evaluation. All applied tests concerning image quality passed. Different spectral properties with and without Sn filter evident, and Sn filter improves spectral separation considerably. Results support claims related to improved CNR.
General Non-Clinical Testing (Integration & Functional)	Verify and validate functionality of modifications. Ensure safe and effective integration. Conformance with special controls for software medical devices. Risk mitigation.	All software specifications met acceptance criteria. Testing supports claims of substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

FAST Bolus: The test describes using a "real contrast enhancement curve" determined by measurements with a dynamic scan mode. The subsequent supporting peer-reviewed studies provide more detail:
- Korporaal et al. (2015): Not explicitly stated, but implies a cohort undergoing bolus tracking.
- Hinzpeter et al. (2019): 108 patients received patient-specific trigger delay (subject), 108 patients received fixed trigger delay (reference). Prospective CT angiography scans of the aorta.
- Gutjahr et al. (2019): 3 groups, 20, 20, and 40 patients respectively.
- Yu et al. (2021): 104 patients (52 per group, implied) in abdominal multiphase CT, comparing individualized vs. fixed post-trigger delay.
- Yuan et al. (2023): 204 consecutive participants randomly divided into two groups (102 patients each). A prospective study in coronary CT angiography (CCTA).
- Schwartz et al. (2018): Not explicitly stated, but implied patient-specific data.
- Data Provenance: The supporting studies imply a mix of retrospective analysis (e.g., Korporaal et al. simulating retrospectively differences) and prospective studies based on the descriptions provided. The locations of these studies are not explicitly mentioned in the excerpt, but given Siemens' global presence, it's likely multi-national.
FAST 3D Camera, FAST Isocentering, FAST Range, FAST Direction, FAST Planning, Tin Filtration: For these features, the testing is described as "bench testing" using phantoms and internal validation. "Patient data" is mentioned for FAST Planning but without specific numbers.
- Sample Size: Not specified for these internal bench tests; often involves phantom studies rather than patient-level data for performance metrics. For FAST Planning, it refers to "patient data" for validation, but the sample size is not indicated.
- Data Provenance: Implied internal testing, likely at Siemens R&D facilities. No external patient data provenance details are given.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

For FAST Bolus, the "ground truth" for the internal bench test was defined as an "ideal post bolus delay" determined by measurements with a dynamic scan mode. This suggests an objective, data-driven approach rather than expert consensus on individual cases for the initial ground truth. However, the supporting studies mention:
- Hinzpeter et al. (2019): Mentions subjective image quality and CNR, which would typically involve expert readers, but the number and qualifications are not provided.
- Yuan et al. (2023): Mentions "Both readers rated better subjective image quality." suggesting at least two readers, but their qualifications are not provided.
For other features (FAST 3D Camera, FAST Planning, etc.), the ground truth seems to be established through objective measurement against predefined targets (e.g., "calculated by FAST Planning algorithm that are correct and can be applied without change"). No specific expert involvement for ground truth establishment for these features is detailed.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for the establishment of ground truth or for reader studies. Where multiple readers are mentioned (e.g., Yuan et al. for FAST Bolus), it only states their findings without detailing an adjudication process. This suggests either independent readings or consensus where needed, but not a formal adjudication protocol.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

Yes, implicitly for FAST Bolus: The supporting publications function as comparative effectiveness studies where human assessment (e.g., subjective image quality, diagnostic confidence) is evaluated with or without the aid of the FAST Bolus prototype.
- Hinzpeter et al. (2019): "higher overall and more uniform attenuation in the individualized cohort compared to the fixed cohort. No difference between the cohorts for image noise was found, but a higher contrast-to-noise ratio (CNR) and higher subjective image quality in the individualized cohort compared to the fixed cohort." This indicates improvement with the AI-assisted timing.
- Yu et al. (2021): "In the arterial phase, the images of group A with the individualized post-trigger delay provided higher attenuation for all organs... Furthermore, the contrast-to-noise ratio (CNR) of liver, pancreas and portal vein were significantly higher in the group with the individualized scan timing compared to the fixed scan delay. The overall subjective image quality and diagnostic confidence between the two groups were similar." This indicates improved quantitative metrics, with subjective similar.
- Yuan et al. (2023): "Both readers rated better subjective image quality for Group B with the individualized scan timing. Also, the mean vessel enhancement was significantly higher in Group B in all coronary vessels. After adjusting for the patient variation, the FAST Bolus prototype was associated with an average of 33.5 HU higher enhancement compared to the fixed PTD." This provides a direct effect size for enhancement.
For the other features, the description is focused on the device's inherent performance (e.g., accuracy of landmark detection, successful implementation) rather than human reader improvements. So, no MRMC study for those.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

Yes, for multiple features. The "Bench Testing" descriptions primarily evaluate the algorithm's performance in a standalone manner against a defined ground truth or objective:
- FAST Bolus: "the post bolus delay as calculated by FAST Bolus to an ideal post bolus delay... was calculated. The objectives of the test were to investigate the deviation from the post bolus delay as determined by FAST Bolus to an ideal/ground truth delay..." This is standalone.
- FAST 3D Camera, FAST Isocentering, FAST Range, FAST Direction: The tests "demonstrate that the FAST 3D Camera feature... achieves comparable or more accurate results," "lateral isocenter accuracy... comparable," "robustness of the groin landmark is improved," "comparable accuracy of the pose detection." These are assessments of the algorithm's direct performance.
- FAST Planning: "assess the fraction (percentage) of ranges calculated by the FAST Planning algorithm that are correct and can be applied without change." This is a direct measurement of the algorithm's output quality.
- Tin Filtration: Verifies "successful implementation" and investigates "improved contrast-to-noise ratio (CNR) in spectral results." This is standalone performance of the image reconstruction/processing.

7. The Type of Ground Truth Used

Objective/Measured Data:
- FAST Bolus: "ideal post bolus delay" determined by "measurements with a dynamic scan mode" and "averaged dynamic scans."
- FAST 3D Camera, FAST Isocentering, FAST Range, FAST Direction: Implied ground truth based on objective measurements of spatial accuracy relative to predefined targets or phantoms.
- FAST Planning: "correct" ranges are the ground truth, implying comparison to a predefined standard or ideal plan.
- Tin Filtration: Objective image quality criteria and spectral property measurements are used as ground truth indicators.
Expert Consensus/Subjective Assessment (as secondary metric in supporting studies): Some of the supporting publications for FAST Bolus also incorporate subjective image quality ratings by human readers, which would likely involve some form of expert consensus or individual expert assessment.

8. The Sample Size for the Training Set

The document does not provide information on the sample size used for the training set for any of the AI/algorithm features. This information is typically proprietary and not usually disclosed in a 510(k) summary unless specifically requested or deemed critical for demonstrating substantial equivalence.

9. How the Ground Truth for the Training Set was Established

The document does not provide information on how the ground truth for the training set was established. Given the nature of these features (automated bolus timing, patient positioning, scan range planning), the training data would likely involve large datasets of CT scans annotated with physiological events, anatomical landmarks, and optimal scan parameters. These annotations would typically be established by highly qualified medical professionals (e.g., radiologists, technologists) or through automated processes validated against gold standards. However, the specific methodology is not detailed in this excerpt.

Summary

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June 16, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

Siemens Medical Solutions USA Inc. % Clayton Ginn Regulatory Affairs Specialist 810 Innovation Drive KNOXVILLE TN 37932

Re: K230421

Trade/Device Name: SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+. SOMATOM Definition AS Open. SOMATOM Drive, SOMATOM Force, SOMATOM Definition Flash Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: May 16, 2023 Received: May 16, 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

For comprehensive regulatory information about 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).

Sincerely,

Lu Jiang

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

Enclosure

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Indications for Use

Submission Number (if known)

K230421

Device Name
SOMATOM Edge Plus;
SOMATOM Confidence;
SOMATOM Definition Edge;
SOMATOM Definition AS/AS+;
SOMATOM Definition AS Open;
SOMATOM Drive;
SOMATOM Force;
SOMATOM Definition Flash
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*.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K230421

SOMATOM CT Scanner Systems – Software Version SOMARIS/7 syngo CT VB30

for

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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Image /page/4/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots.

II. Device Name and Classification

Product Name	Trade Name
SOMATOM Edge Plus	SOMATOM Edge Plus
SOMATOM Confidence	SOMATOM Confidence
SOMATOM Definition Edge	SOMATOM Definition Edge
SOMATOM Definition AS/AS+	SOMATOM Definition AS/AS+
SOMATOM Definition AS Open	SOMATOM Definition AS Open
SOMATOM Drive	SOMATOM Drive
SOMATOM Force	SOMATOM Force
SOMATOM Definition Flash	SOMATOM Definition Flash

Common Name:	Computed tomography X-ray system
Classification Name:	System, X-Ray, Tomography, Computed
Classification Panel:	Radiology
Regulation Number:	21 CFR §892.1750
Device Class:	Class II
Product Code:	JAK

III. Predicate Device

Trade Name:	SOMATOM CT Scanner Systems
510(k) Number:	K190578
Clearance Date:	June 27, 2019
Common Name:	Computed tomography X-ray system
Classification Name:	System, X-Ray, Tomography, Computed
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 subjectdevice design.

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Image /page/5/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a cluster of orange dots arranged in a circular pattern.

IV. Device Description Summary

Siemens intends to market a new software version, SOMARIS/7 syngo CT VB30 for the following SOMATOM Computed Tomography (CT) Scanner Systems:

Single Source CT Systems:

. SOMATOM Definition AS/AS+
SOMATOM Definition AS Open
SOMATOM Definition Edge
SOMATOM Confidence
SOMATOM Edge Plus

Dual Source CT Systems:

. SOMATOM Force
SOMATOM Drive
. SOMATOM Definition Flash

The subject device SOMATOM CT Scanner Systems with SOMARIS/7 syngo CT VB30 are Computed Tomography X-ray Systems which feature one (single source) continuously rotating tubedetector system and function according to the fan beam principle. The SOMATOM CT Scanner Systems with Software SOMARIS/7 syngo CT VB30 produces CT images in DICOM format, which 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 and therapy planning support (including, but not limited to, Brachytherapy, Particle including Proton Therapy, External Beam Radiation Therapy, Surgery). The computer system delivered with the CT scanner is able to run optional post processing applications.

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.

Software version syngo CT VB30 (SOMARIS/7 syngo CT VB30) is a modified software version of the predicate device, syngo CT VB20 (SOMARIS/7 syngo CT VB20) cleared in K190578.

Software version SOMARIS/7 syngo CT VB30 will be offered ex-factory and as an optional upgrade for the applicable existing SOMATOM CT Systems.

Compared to the predicate devices referenced within this subject devices support the following modifications:

New/Modified Hardware

syngo Acquisition Workplace and syngo CT Workplace computer upgrades due to obsolescence of the predecessor.

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Image /page/6/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.

Software version SOMARIS/7 syngo CT VB30 including the following new/modified features

FAST Bolus update for individualized patient scan trigger. ●
FAST 3D Camera update to to support adolescent patients in addition to adult patients
FAST applications updates (FAST Spine, FAST Planning)
Workflow improvements for FAST 4D
Updated Automatic Patient Instructions
Recon Jobs limit extended up to 18
Additional kV setting for Tin Filtration
Additional default exam scan protocols (e.g. abdomen protocols, Angio-CT, Dual Spiral Dual Energy and ECG gated Flash protocols with tin filtration at high kV)

The bundle approach is feasible for this submission since the subject devices have similar technological characteristics, software operating platform, and supported software characteristics. All subject devices will support previously cleared software and hardware features in addition to the applicable modifications as described within this submission. The intended use remains unchanged compared to the predicate devices.

V. Indications for Use

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

The images delivered by the system can be used by 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.

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 *

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.

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Image /page/7/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.

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 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 staff'. It can be assumed a trained physician is part of the trained staff.

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. This device can and is commonly used as an aid in invasive procedures.

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 Systems are not the principal means of guidance, because the CT Systems does not guide the invasive procedures, the needle orientation and the needle advance and handling is always done under the physicians control.

VII. Comparison of Technological Characteristics with the Predicate Device

The SOMATOM CT Scanner Systems with VB30 software provide the same technological characteristics in terms of materials, energy source, and control mechanisms when compared to the predicate device. The software features of these scanners have been modified or improved in comparison to the predicate devices to support enhanced device functionality compared to the predicate devices. Additionally, the syngo Acquisition Workplace and syngo CT Workplace computers were upgraded due to obsolescence of the predecessor.

The applicable software features are dependent on the SOMATOM CT Scanner Systems technological characteristics and are provided as optional features for updating the installed base. The technological characteristics of the SOMATOM CT Scanner Systems' hardware is a prerequisite for its intended software usage.

The new syngo CT VB30 software reuses all unmodified software features of the legacy software syngo CT VB20 cleared in K190578. Additionally, no features present in the predicate device are de-scoped.

The intended use and fundamental scientific technology for the SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM AS Open, SOMATOM Confidence, SOMATOM Edge Plus 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
Iterative Reconstruction - Support of various iterative reconstruction methods
Workplaces – Support of workplaces that include reconstruction and image evaluation software
Patient table
. Patient table foot switch for movement

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Tin filtration technology
Stellar detector technology

The following technological differences exist between the subject and predicate devices:

Software version SOMARIS/7 syngo CT VB30
FAST Bolus update for individualized patient scan trigger.
FAST 3D Camera update to support adolescent patients in addition to adult patients .
FAST applications updates (FAST Spine, FAST Planning)
Workflow improvements for FAST 4D
Updated Automatic Patient Instructions
Recon Jobs limit extended up to 18
Additional kV setting for Tin Filtration
Additional default exam scan protocols (e.g. abdomen protocols, Angio-CT, Dual Spiral Dual Energy and ECG gated Flash protocols with tin filtration at high kV)
. syngo Acquisition Workplace and syngo CT Workplace computer upgrades

Any differences in technological characteristics do not raise different questions of safety and effectiveness. Testing and validation is completed. Test results show that the subject devices, the SOMATOM CT Scanner Systems with syngo CT VB30, are 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 CT Scanner systems during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.

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

Testing covers 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

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

Bench Testing:

Feature/ Bench Testing performed supportive testing FAST Bolus The bench test evaluates the performance of FAST Bolus. For this purpose, the post bolus delay as calculated by FAST Bolus to an ideal post bolus delay to reach the peak enhancement of a real contrast enhancement curve (determined by measurements with a dynamic scan mode) was calculated. The objectives of the test were to investigate the deviation from the post bolus delay as determined by FAST Bolus to an ideal/ground truth delay measured through three consecutive dynamic scans and respective contrast injections. The results were found in an acceptable margin when compared to averaged dynamic scans, which served as a ground truth for the applied comparison. Supporting Publications for FAST Bolus: Six peer-reviewed scientific studies have been performed before FAST Bolus came to the market. Although these studies have been performed with the prototype(s) of FAST Bolus, there were no functional differences in the FAST Bolus calculation except for in the Korporaal et al. (2015) study described below, which did not consider scan duration. 1. Korporaal JG, Bischoff B, Arnoldi E, Sommer WH, Flohr TG, Schmidt B. Evaluation of A New Bolus Tracking-Based Algorithm for Predicting A Patient-Specific Time of Arterial Peak Enhancement in Computed Tomography Angiography. Investigative Radiology. LWW; 2015;50(8):531–538. This study demonstrated a proof-of-principle and the potential of patient-specific rather than fixed scan delays after bolus tracking. The researchers simulated retrospectively the differences between an optimal personalized scan delay (prototype of FAST Bolus) and a best-case scenario for the conventional bolus tracking technique, using the same group-averaged scan delay for all patients. Main results: Compared with the conventional bolus tracking method, the systematic and random errors of the FAST Bolus prototype were smaller, did not

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

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Feature/supportivetesting	Bench Testing performed
	depend on the IDR, and were predictable over a large range of total iodine doses.The median difference between the true and personalized delay is less than ±1second for all IDRs and injection durations, and the prototype algorithm was ableto predict patient-specific delays within ±2 seconds from the true delay in morethan 90% of patients for almost all injection protocols.
2.	Hinzpeter R, Eberhard M, Gutjahr R, et al. CT Angiography of the Aorta: ContrastTiming by Using a Fixed versus a Patient-specific Trigger Delay. Radiology.Radiological Society of North America (RSNA); 2019;291(2):531–538https://doi.org/10.1148/radiol.2019182223
	This study included prospective CT angiography scans of the aorta. A total of 108patients received a patient-specific trigger delay (FAST Bolus prototype) andanother 108 patients the regular fixed trigger delay of 4 seconds (referencegroup).
	Main results: There was higher overall and more uniform attenuation in theindividualized cohort compared to the fixed cohort. No difference between thecohorts for image noise was found, but a higher contrast-to-noise ratio (CNR) andhigher subjective image quality in the individualized cohort compared to the fixedcohort.
3.	Gutjahr R, Fletcher JG, Lee YS, et al. Individualized Delay for Abdominal ComputedTomography Angiography Bolus-Tracking Based on Sequential Monitoring:Increased Aortic Contrast Permits Decreased Injection Rate and Lower lodineDose. Journal of computer assisted tomography. LWW; 2019;43(4):612–618
	The group studied whether the individualized trigger delay from the FAST Bolusprototype would facilitate reductions in injection rate and iodine dose inabdominal CTA. The study population consisted of three groups: 20 patients withroutine injection rate and iodine dose; 20 patients with an injection rate loweredby 1 mL/s; and 40 patients with an injection rate lowered by 1 mL/s and an iodinedose reduction of 29%.
	Main results: The median trigger delay was significantly longer than withconventional bolus tracking (mean increase 13.3 seconds), with image qualitybeing the same or better. Intra-arterial CT numbers were at least 200 Hounsfieldunits for all CTAs in all three sub-groups with the FAST Bolus prototype. In theinternal control group and the size-matched control patients with the standardfixed scan delay, 12% and 14% of patients did not reach the 200 HU in theabdominal CTA respectively. So the FAST Bolus prototype was able to adjust thescan timing to the altered scan protocols to reach diagnostic image quality in
Feature/supportivetesting	Bench Testing performed
	abdominal CTA examinations despite slower injection rate and reduced iodinedose.
4.	Yu J, Lin S, Lu H, et al. Optimize scan timing in abdominal multiphase CT: BolusTracking with an Individualized Post-trigger Delay. European Journal of Radiology.Elsevier; 2021;110139
	The group conducted a head-to-head comparison on the image quality anddiagnostic confidence between an individualized post-trigger delay with the FASTBolus prototype and a conventional fixed post-trigger delay in abdominalmultiphase CT. Abdominal multiphase CT was performed in 104 patients witheither the FAST Bolus prototype (group A) or a fixed post-trigger delay of 11seconds (group B).
	Main results: In the arterial phase, the images of group A with the individualizedpost-trigger delay provided higher attenuation for all organs (aorta, liver,pancreas, and portal vein). Furthermore, the contrast-to-noise ratio (CNR) of liver,pancreas and portal vein were significantly higher in the group with theindividualized scan timing compared to the fixed scan delay. The overall subjectiveimage quality and diagnostic confidence between the two groups were similar.
5.	Yuan D, Wang Y, Lin S, et al. Patient-specific post-trigger delay in coronary CTangiography: A prospective study comparing with fixed delay. European Journal ofRadiology. Elsevier; 2023;163:110813
	From the same hospital as the previous paper, Yuan et al validated the peakenhancement timing of a patient-specific post-trigger delay (FAST Bolusprototype) in coronary CT angiography (CCTA) and compare its image qualityagainst a fixed scan delay. In this prospective study, 204 consecutive participantswere randomly divided into two groups and underwent CCTA with either a fixed5-second scan delay (Group A, 102 patients) or a patient-specific scan delay withthe FAST Bolus prototype (Group B, 102 patients). Test bolus was also performedin Group B to determine the reference peak enhancement timing.
	Main results: The scan timing from the FAST Bolus prototype demonstrated strongcorrelation and consistency with the reference peak timing from the test bolusscans in Group B. Both readers rated better subjective image quality for Group Bwith the individualized scan timing. Also, the mean vessel enhancement wassignificantly higher in Group B in all coronary vessels. After adjusting for thepatient variation, the FAST Bolus prototype was associated with an average of 33.5HU higher enhancement compared to the fixed PTD.
6.	Schwartz FR, Ramirez-Giraldo JC, Gutjahr R, Boll D, Koweek LM. Poster: Real-Time Patient Specific Scan Initiation for Pulmonary Embolism CTA: Impact on
Feature/supportivetesting	Bench Testing performed
	Image Quality. Society of Computed Body Tomography and Magnetic ResonanceAnnual Meeting. 2018
	Purpose: Real time modulation of scan initiation based on patient specifichemodynamics may allow for optimal timing of contrast enhancement in thepulmonary arteries when using fluoroscopic triggering, especially in segmentaland sub-segmental vessels, and reduce the number of non-diagnostic scans.
	Conclusion: The diagnostic delay calculated by the Real Time Patient SpecificModulation (RTPSM) software achieved higher contrast opacification and imagequality while reducing the number of non-diagnostic PA segments by 7.4% in PEchest CTA compared to a fixed diagnostic delay.A patient specific diagnostic delay determination can target the contrast bolus tothe pulmonary arterial system more efficiently and reduce the amount ofcontrast in the central veins.
	FAST 3D Camera
The objective of the test is to demonstrate that the FAST 3D Camera feature of thesubject devices SOMATOM CT Scanner Systems with SOMARIS/7 syngo CT VB30,which was extended to support adolescent patients, achieves comparable or moreaccurate results than the predicate devices with software version syngo CT VB20 foradult patients, while supporting adolescent patients of height 120 cm or taller withcomparable accuracy as adult patients.
FAST Isocentering:
The lateral isocenter accuracy of the subject device is comparable to the predicatedevice for adult patients. Moreover, the subject device achieves similar accuracy alsofor adolescent patients.
FAST Range:The robustness of the groin landmark is improved in the subject device, while theother landmarks are detected with comparable accuracy. For adolescents, theaccuracy of the landmark detection of the subject device is of similar accuracy as foradults.
FAST Direction:
The subject and predicate device have comparable accuracy of the pose detection.
FAST Planning	The purpose of the test is to provide a clear reporting on the applied algorithm, itsproduct development, validation, and verification on patient data, which enable theclaims.Objective of the test was to assess the fraction (percentage) of ranges calculated by
	the FAST Planning algorithm that are correct and can be applied without change.
Feature/supportivetesting	Bench Testing performed
	Additionally, calculation time was measured to check whether it meets interactiverequirements.
	The test results showed that the editing actions for the scanner technician can bereduced to a minimum and that the calculation time is fast enough for interactivespeed during scanning. For more than 90% of the ranges no editing action wasnecessary to cover standard ranges. For more than 95%, the speed of the algorithmwas sufficient.
Tin Filtration	The bench test contains two aspects. First, the successful implementation of thesetwo new voltage combinations is verified by validation measurements and adescription of the spectral properties is given. Second, tests to support claimsregarding improved contrast-to-noise ratio (CNR) in spectral results, i.e.,monoenergetic images, are provided.
	The results show the successful implementation of the two new voltagecombinations 80/Sn140 kV and 100/Sn140 kV with Sn filter of the Dual Spiral DualEnergy mode on the P46 system is verified via phantom scans and an evaluation ofimage quality criteria. This includes different kinds of images, such as low-kV andhigh-kV images, mixed images, virtual monoenergetic images and Rho/Z images. Allapplied tests concerning image quality passed. The different spectral properties ofthe different voltage combinations with and without Sn filter are evident from thepresented results. The Sn filter improves spectral separation considerably. Theresults support claims related to improved CNR in DE-derived virtual monoenergeticimages due to tin filtration.
	The document serves as collection to document bench tests that have beenperformed for the evaluation of tin filter technology. The reported bench tests havebeen performed on a variety of SOMATOM CT devices. Since the physical principleremains the same, similar results can be expected for all Siemens Healthineers CTscanners equipped with tin filter technology.

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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.

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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 CT Scanner Systems should perform as intended in the specified use conditions. The data included in this submission demonstrates that the SOMATOM CT Scanner Systems 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 CT Scanner Systems testing supports a finding of substantial equivalence.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.