Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, deep learning, or any related terms in the device description, intended use, or performance studies. While it mentions image processing and algorithms (like myNeedle Guide), these are not explicitly stated to be AI/ML-based.

Therapeutic

No
Explanation: The device is a diagnostic imaging system (Computed Tomography X-ray system) intended to generate images for aid in diagnosis and treatment, not to directly provide therapy. While the images can be used for "therapeutic interventions," the device itself does not perform or deliver therapeutic action.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that "The images delivered by the system can be used by a trained staff as an aid in diagnosis and treatment as well as for diagnostic and therapeutic interventions." This clearly indicates its role in the diagnostic process.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Computed Tomography X-ray system" and features "two continuously rotating tube-detector systems". This indicates it is a hardware device with integrated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The tests are performed outside the body (in vitro).
Device Function: The description clearly states that this device is a computed tomography (CT) system that generates and processes cross-sectional images of patients by computer reconstruction of x-ray transmission data. This is an in vivo imaging technique, meaning it is performed inside the living body.
Intended Use: The intended use is to provide images as an aid in diagnosis and treatment, as well as for diagnostic and therapeutic interventions. This aligns with the function of an imaging device, not a device that analyzes biological samples.

While the device produces images that are used for diagnosis, the diagnostic process itself is based on the interpretation of these images by trained medical professionals, not on the analysis of biological samples by the device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

The images delivered by the system can be used by a trained staff as an aid in diagnosis and treatment as well as for diagnostic and therapeutic interventions.

This CT system can be used for low dose lung cancer screening in high risk populations*.

As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

Product codes

JAK

Device Description

Siemens intends to market a new software version, SOMARIS/10 syngo CT VB10, for the Dual Source CT system NAEOTOM Alpha based on the SOMARIS/10 platform.

The subject device NAEOTOM Alpha with software version SOMARIS/10 syngo CT VB10 is a Computed Tomography X-ray system which features two continuously rotating tube-detector systems, denominated as A- and B-systems respectively (dual source CT scanner system). The detectors' function is based on photon-counting technology. The NAEOTOM Alpha with SOMARIS/10 syngo CT VB10 produces CT images in DICOM format, which can be used by trained staff for postprocessing applications commercially distributed by Siemens and other vendors as an aid in diagnosis and treatment as well as for diagnostic and therapeutic interventions. The computer system delivered with the CT scanner is able to run optional post-processing applications.

Only trained and qualified users, certified in accordance with country-specific regulations, are authorized to operate the system. For example, physicians, radiologists, or technologists. The user must have the necessary U.S. qualifications in order to diagnose or treat the patient with the use of the images delivered by the system.

The platform software for the NAEOTOM Alpha is syngo CT VB10 (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 primary predicate device, syngo CT VA50 (SOMARIS/10 syngo CT VA50) cleared in K220814.

Software version SOMARIS/10 syngo CT VB10 will be offered ex-factory and as optional upgrade for the existing NAEOTOM Alpha systems.

The subject device NAEOTOM Alpha will support previously cleared software and hardware features in addition to the applicable modifications as described within this submission. The intended use and the indications for use remain unchanged compared to the predicate devices.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Computed Tomography X-ray

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Trained staff (physicians, radiologists, or technologists) in a Professional Healthcare Facility.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Non-clinical testing, (integration and functional) including phantom tests were conducted for the NAEOTOM Alpha during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.

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

Testing will cover all related subsystems that contribute to the device modifications. Test levels are defined. For each test level several test activities are performed. The test specification and acceptance criteria are related to the corresponding requirements. Various test activities are performed to specific modifications on different test levels to ensure safe and effective integration in the system. Three test levels are defined:

System Validation test:

Acceptance test (workflow and user manual test)
Legal and Regulatory test

System Verification test:

System Integration Test (functional)
Functionality verification
Image Quality (IQ) Evaluation

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

Additional evaluation tests are performed as bench tests to support the new device or device modification on Non-Clinical Performance Testing as listed in Table 6 below.

Table 6: Non-clinical performance testing (bench testing).

FAST 3D Camera / FAST Integrated Workflow Bench Testing performed: The bench test evaluates and compares the accuracy of the three subfeatures FAST Isocentering, FAST Range, and FAST Direction to the accuracy of the predicate device with syngo CT VA50 using the old camera hardware and the then only available ceiling mount. The objectives of the bench test are to demonstrate that the FAST 3D Camera feature of the subject device with SOMARIS/10 syngo CT VB10, where the algorithms have been optimized for a new camera hardware in two mounting positions, achieves comparable results as the predicate device with syngo CT VA50.

Multi-Purpose Table Bench Testing performed: The range of possible movement for the mobile C-arm in different positions between CT gantry and patient table was tested and documented by measurement of angles.

ZeeFree Bench Testing performed: 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.

myNeedle Guide (with myNeedle Detection) Bench Testing performed: Tests were performed to ensure clinical usability of the myNeedle Guide needle detection algorithm. Two individual tests were performed. The accuracy of the automatic needle detection algorithm was tested. The reduction of necessary user interactions for navigating to a needle-oriented view with and without the support of the automatic needle detection algorithm was analyzed.

Quantum Spectral Imaging Bench Testing performed: Tests were performed to demonstrate that:
T3D reconstructions in Quantumpeak mode are possible with the sharpest available kernels up to Qr89, Br98, etc. Quantumpeak scan mode allows reconstructions of monoenergetic images at energy levels from 40 to 190 keV. The evaluation has been performed based on phantom studies.

Quantum HD Cardiac Bench Testing performed: Quantitative assessment in terms of image noise and a visual assessment of the image quality in ECG gated acquisitions between different scan modes is performed: standard acquisition mode with spectral and nonspectral reconstruction, ultra-high resolution acquisition mode with non-spectral reconstruction (120x0.2 mm and 96x0.2 mm) and spectral image reconstruction (limited to 96x0.2 mm).

HD FoV Bench Testing performed: Tests were performed to evaluate the performance of HD FoV on NAEOTOM Alpha. For this purpose, the HU accuracy in the extended field of view region was measured based on phantom studies. The phantom diameter accuracy has been also evaluated.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

FAST 3D Camera / FAST Integrated Workflow:
The FAST Isocentering accuracy of the subject device with syngo CT VB10 is comparable to the predicate device with syngo CT VA50, 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 VA50. 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 VA50 predicate for the new FAST 3D Camera hardware.

Multi-Purpose Table:
Based on the test results it can be concluded that a CT scanner, equipped with a Multi-Purpose (Vitus) Patient Table, which is installed with enhanced distance (674 mm) to the CT gantry and offers the iCT mode functionality, provides sufficient freedom of movement for a mobile C-arm X-ray system to be used for clinical routine without any significant limitations for my needle Laser or 3D Camera.

ZeeFree:
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. 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.

myNeedle Guide (with myNeedle Detection):
It has been shown that the algorithm was able to consistently detect needle-tips over a wide variety of scans in 90.76% of cases. Further, the results of this bench test clearly shows that the auto needle detection functionality reduces the number of interactions steps needed to generate a needle-aligned view in the CT Intervention SW. Zero user interactions are required and a needle-aligned view is displayed right away after a new scan, if auto needle detection is switched on in the SW configuration. Therefore, the test is already passed if only a single user interaction is necessary to achieve a needle-oriented view in the manual workflow.

Quantum Spectral Imaging:
The results showed that: with T3D reconstructions from Quantumpeak scan modes, high resolution images with sharp kernel up to Br98 are obtained. The resolution is comparable to other Highresultra scan modes of the NAEOTOM Alpha. Monoenergetic reconstructions from Quantumpeak scan modes are free of artifacts. Measured CT values precisely match the reference values. The accuracy of monoenergetic reconstructions in iodine and calcium inserts at the NAEOTOM Alpha is comparable or better than on the secondary predicate device SOMATOM Force.

Quantum HD Cardiac:
Based on the results it can be concluded that substantial equivalence in image quality is achieved by the images derived from the spectral capable cardiac acquisition mode 96x0.2mm for both, the highresolution UHR and the standard resolution spectral image cases, compared to the single source spectral capable 120x0.2mm UHR scan mode.

HD FoV:
Based on the results it can be concluded that HD FoV enables the reconstruction of images while significantly improving the visualization of anatomy in the regions outside the scan field of view of 50 cm. In the phantom study, an HU value accuracy of about +/- 40 HU was achieved with skin-line accuracy of about +/- 3 mm.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

myNeedle Guide (with myNeedle Detection): accuracy of 90.76% for detecting needle-tips.

HD FoV: HU value accuracy of about +/- 40 HU, skin-line accuracy of about +/- 3 mm.

Predicate Device(s)

K220814, K230421

Reference Device(s)

K191040, K220450, K221727

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 28, 2024

Siemens Medical Solutions USA, Inc. % Tabitha Estes Regulatory Affairs Proffecional 810 Innovation Drive KNOXVILLE, TN 37932

Re: K233657

Trade/Device Name: NAEOTOM Alpha Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: February 22, 2024 Received: February 23, 2024

Dear Tabitha Estes:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

1

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological 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

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K233657

Device Name

NAEOTOM Alpha

Indications for Use (Describe)

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

The images delivered by the system can be used by a trained staff as an aid in diagnosis and treatment as well as for diagnostic and therapeutic interventions.

This CT system can be used for low dose lung cancer screening in high risk populations*.

As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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K233657

Image /page/3/Picture/1 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 text is a graphic of orange dots arranged in a circular pattern.

510(k) Summary for

NAEOTOM Alpha CT Scanner System

with software version SOMARIS/10 syngo CT VB10

Date Prepared: March 22, 2024

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.

l. Submitter

Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932 Establishment Registration Number: 1034973

Importer/Distributor Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number: 2240869

Location of Manufacturing Site Siemens Healthcare GmbH Siemensstr. 1 -OR- Rittigfeld 1 D-91301 Forchheim, Germany Establishment Registration Number: 3004977335

Note: Descriptions in this submission use the short company name Siemens. Brand name on all products is Siemens Healthineers.

Submitter Contact Person: Tabitha Estes Regulatory Affairs Siemens Medical Solutions USA, Inc. (865) 804-4553 (work cell) tabitha.estes@Siemens-healthineers.com

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Image /page/4/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" are several orange dots arranged in a circular pattern.

II. Device Name and Classification

Product Name:	NAEOTOM Alpha
Trade Name:	NAEOTOM Alpha
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
Regulation Number:	21 CFR §892.1750
Device Class:	Class II
Product Code:	JAK

III. Predicate Device

Primary Predicate Device:
Trade Name:	NAEOTOM Alpha, Scan&GO
510(k) Number:	K220814
Clearance Date:	July 12, 2022
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
Regulation Number:	21 CFR §892.1750
Device Class:	Class II
Product Code:	JAK
Recall Information:	All predicate device recalls have been considered in the subject
device design.
Secondary Predicate Device:
Trade Name:	SOMATOM Force
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.

Note: K230421 was a bundle submission with various Siemens CT Scanner Systems, including the dual source CT scanner systems SOMATOM Drive, SOMATOM Force, SOMATOM Definition Flash and the single source CT scanner CT systems SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open.

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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" are a series of orange dots arranged in a circular pattern.

IV. Device Description