syngo.CT LVO Detection

K243145 · Siemens Medical Solutions USA, Inc. · QAS · Apr 10, 2025 · Radiology

Device Facts

• Record ID: K243145
• Device Name: syngo.CT LVO Detection
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: QAS · Radiology
• Decision Date: Apr 10, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2080
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

syngo.CT LVO Detection is a radiological post-processing application for the analysis of CT angiography (CTA) head images. syngo.CT LVO Detection supports computer-aided triage, and it addresses vascular abortions in the CTA of the brain, commonly referred to as large vessel occlusion (LVO), in the ICA, M1, and M2 segment. It is intended for all patient populations of age ≥ 22 years, without any of the following contraindications: old infarcts or other diseases impacting the brain vasculature (for example, brain tumors), metal artifacts (for example, coils), surgical signs in the images. The output for triage is intended for informational purposes only. It is not intended for diagnostic use and does not alter the original medical image.

Device Story

Software application for acute care settings; analyzes head CT angiography (CTA) images to identify potential large vessel occlusions (LVO) in ICA, M1, and M2 segments. Uses AI-based algorithms to process images; provides notification to clinicians (radiologists, neurologists) via external notification device or PACS. Does not highlight image regions or alter original images. Intended for triage prioritization; informational use only. Benefits include faster identification of suspected stroke-related occlusions, potentially accelerating clinical decision-making and patient care workflows.

Clinical Evidence

Retrospective study of 602 CT datasets from 4 US clinical sites. Ground truth established by two board-certified neuroradiologists with third-party adjudication. Sensitivity: 90.6% [86.8% - 93.3%]; Specificity: 88.8% [84.7% - 91.9%]. Performance consistent across subgroups (age, sex, ethnicity, scanner manufacturer). Median processing time: 42 seconds.

Technological Characteristics

Software-only device; AI-based algorithm. Compatible with syngo.via platform. Complies with IEC 62304 (software lifecycle), ISO 14971 (risk management), and NEMA PS 3.1-3.20 (DICOM).

Indications for Use

Indicated for patients ≥ 22 years old undergoing head CT angiography (CTA) to support triage of suspected large vessel occlusion (LVO) in ICA, M1, and M2 segments. Contraindications: old infarcts, brain tumors, metal artifacts (e.g., coils), or surgical signs in images.

Regulatory Classification

Identification

Radiological computer aided triage and notification software is an image processing prescription device intended to aid in prioritization and triage of radiological medical images. The device notifies a designated list of clinicians of the availability of time sensitive radiological medical images for review based on computer aided image analysis of those images performed by the device. The device does not mark, highlight, or direct users' attention to a specific location in the original image. The device does not remove cases from a reading queue. The device operates in parallel with the standard of care, which remains the default option for all cases.

Special Controls

Radiological computer aided triage and notification software must comply with the following special controls: 1. Design verification and validation must include: i. A detailed description of the notification and triage algorithms and all underlying image analysis algorithms including, but not limited to, a detailed description of the algorithm inputs and outputs, each major component or block, how the algorithm affects or relates to clinical practice or patient care, and any algorithm limitations. ii. A detailed description of pre-specified performance testing protocols and dataset(s) used to assess whether the device will provide effective triage (e.g., improved time to review of prioritized images for pre-specified clinicians). iii. Results from performance testing that demonstrate that the device will provide effective triage. The performance assessment must be based on an appropriate measure to estimate the clinical effectiveness. The test dataset must contain sufficient numbers of cases from important cohorts (e.g., subsets defined by clinically relevant confounders, effect modifiers, associated diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals for these individual subsets can be characterized with the device for the intended use population and imaging equipment. iv. Standalone performance testing protocols and results of the device. v. Appropriate software documentation (e.g., device hazard analysis; software requirements specification document; software design specification document; traceability analysis; description of verification and validation activities including system level test protocol, pass/fail criteria, and results). 2. Labeling must include the following: i. A detailed description of the patient population for which the device is indicated for use. ii. A detailed description of the intended user and user training that addresses appropriate use protocols for the device. iii. Discussion of warnings, precautions, and limitations must include situations in which the device may fail or may not operate at its expected performance level (e.g., poor image quality for certain subpopulations), as applicable. iv. A detailed description of compatible imaging hardware, imaging protocols, and requirements for input images. v. Device operating instructions. vi. A detailed summary of the performance testing, including: test methods, dataset characteristics, triage effectiveness (e.g., improved time to review of prioritized images for pre-specified clinicians), diagnostic accuracy of algorithms informing triage decision, and results with associated statistical uncertainty (e.g., confidence intervals), including a summary of subanalyses on case distributions stratified by relevant confounders, such as lesion and organ characteristics, disease stages, and imaging equipment.

*Classification.* Class II (special controls). The special controls for this device are:(1) Design verification and validation must include: (i) A detailed description of the notification and triage algorithms and all underlying image analysis algorithms including, but not limited to, a detailed description of the algorithm inputs and outputs, each major component or block, how the algorithm affects or relates to clinical practice or patient care, and any algorithm limitations. (ii) A detailed description of pre-specified performance testing protocols and dataset(s) used to assess whether the device will provide effective triage ( *e.g.,* improved time to review of prioritized images for pre-specified clinicians).(iii) Results from performance testing that demonstrate that the device will provide effective triage. The performance assessment must be based on an appropriate measure to estimate the clinical effectiveness. The test dataset must contain sufficient numbers of cases from important cohorts ( *e.g.,* subsets defined by clinically relevant confounders, effect modifiers, associated diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals for these individual subsets can be characterized with the device for the intended use population and imaging equipment.(iv) Stand-alone performance testing protocols and results of the device. (v) Appropriate software documentation ( *e.g.,* device hazard analysis; software requirements specification document; software design specification document; traceability analysis; description of verification and validation activities including system level test protocol, pass/fail criteria, and results).(2) Labeling must include the following: (i) A detailed description of the patient population for which the device is indicated for use; (ii) A detailed description of the intended user and user training that addresses appropriate use protocols for the device; (iii) Discussion of warnings, precautions, and limitations must include situations in which the device may fail or may not operate at its expected performance level ( *e.g.,* poor image quality for certain subpopulations), as applicable;(iv) A detailed description of compatible imaging hardware, imaging protocols, and requirements for input images; (v) Device operating instructions; and (vi) A detailed summary of the performance testing, including: test methods, dataset characteristics, triage effectiveness ( *e.g.,* improved time to review of prioritized images for pre-specified clinicians), diagnostic accuracy of algorithms informing triage decision, and results with associated statistical uncertainty (*e.g.,* confidence intervals), including a summary of subanalyses on case distributions stratified by relevant confounders, such as lesion and organ characteristics, disease stages, and imaging equipment.

Predicate Devices

• syngo.CT Brain Hemorrhage (K232431)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

April 10, 2025

Siemens Medical Solutions USA, Inc.
Kenny M. Bello
Regulatory Affairs Professional
810 Innovation Drive
Knoxville, Tennessee 37932

Re: K243145
Trade/Device Name: syngo.CT LVO Detection
Regulation Number: 21 CFR 892.2080
Regulation Name: Radiological computer aided triage and notification software
Regulatory Class: Class II
Product Code: QAS
Dated: March 4, 2025
Received: March 4, 2025

Dear Kenny M. Bello:

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"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K243145 - Kenny M. Bello
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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

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

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K243145 - Kenny M. Bello
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,


Jessica Lamb, Ph.D.
Assistant Director
Imaging Software 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

Enclosure

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K243145 | |
| Device Name syngo.CT LVO Detection | |
| Indications for Use (Describe) syngo.CT LVO Detection is a radiological post-processing application for the analysis of CT angiography (CTA) head images. syngo.CT LVO Detection supports computer-aided triage, and it addresses vascular abortions in the CTA of the brain, commonly referred to as large vessel occlusion (LVO), in the ICA, M1, and M2 segment. It is intended for all patient populations of age ≥ 22 years, without any of the following contraindications: old infarcts or other diseases impacting the brain vasculature (for example, brain tumors), metal artifacts (for example, coils), surgical signs in the images. The output for triage is intended for informational purposes only. It is not intended for diagnostic use and does not alter the original medical image. | |
| 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. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

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K243145

SIEMENS Healthineers

# 510(k) Summary

## 1. Identification of the Submitter

| Submitter / Primary Contact Person | Kenny M Bello
Regulatory Affairs
[e-mail]
[phone] |
| --- | --- |
| Secondary Contact Person | Clayton Ginn
Regulatory Affairs
[e-mail]
[phone] |
| Submitter Address | Siemens Medical Solutions, Inc. USA
Molecular Imaging
810 Innovation Drive
Knoxville, TN 37932
Establishment Registration Number: 1034973 |
| Legal Manufacturer | Siemens Healthineers AG
Siemensstr 1
D-91301 Forchheim, Germany
Establishment Registration Number: 3004977335 |
| Importer/Distributor | Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern, PA 19355
Establishment Registration Number: 2240869 |

## 2. Device Name and Classification

Product Name: syngo.CT LVO Detection

Propriety Trade Name: syngo.CT LVO Detection

Classification Name: Radiological Computer-Assisted Triage and Notification Software

Classification Panel: Radiology

CFR Section: 21 CFR §892.2080

Device Class: Class II

Product Code: QAS

## 3. Predicate Devices

### Predicate Device:

Trade Name: syngo.CT Brain Hemorrhage

Classification Name: Radiological Computer-Assisted Triage and Notification Software

Classification Panel: Radiology

CFR Section: 21 CFR §892.2080

Device Class: Class II

Product Code: QAS

K-Number: K232431

Siemens Medical Solutions USA, Inc.

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SIEMENS Healthineers

# 4. Device Description

The subject device syngo.CT LVO Detection is an image processing software that utilizes artificial intelligence learning algorithms to support qualified clinicians (Radiologists, Neuroradiologists, Neurologists) in prioritization of CT-angiography images by algorithmically identifying findings suspicious of a large vessel occlusion and providing notification to the user. syngo.CT LVO Detection provides a reproducible detection of large vessel occlusions (LVO) on contrast-enhanced CT examinations of the head for detection of ICA, M1, and M2 vessel occlusions in patients suspected of having stroke related circulation occlusion. syngo.CT LVO Detection analyses CT-angiography (CTA) images of the head. The subject device provides a pipeline for the analysis and identification of potential LVO The output which can be send to an external notification device does not highlight or direct attention of the reading physician to any portion of the image.

# 5. Indications for Use

syngo.CT LVO Detection is a radiological post-processing application for the analysis of CT angiography (CTA) head images. syngo.CT LVO Detection supports computer-aided triage, and it addresses vascular abortions in the CTA of the brain, commonly referred to as large vessel occlusion (LVO), in the ICA, M1, and M2 segment. It is intended for all patient populations of age $\geq 22$ years, without any of the following contraindications: old infarcts or other diseases impacting the brain vasculature (for example, brain tumors), metal artifacts (for example, coils), surgical signs in the images. The output for triage is intended for informational purposes only. It is not intended for diagnostic use and does not alter the original medical image.

# 6. Indications for Use Comparison to the Predicate Device

| Subject Device syngo.CT LVO Detection (SOMARIS/8 VB80) | Predicate Device syngo.CT Brain Hemorrhage (SOMARIS/8 VB80) |
| --- | --- |
| syngo.CT LVO Detection is a radiological post-processing application for the analysis of CT angiography (CTA) head images. syngo.CT LVO Detection supports computer-aided triage, and it addresses vascular abortions in the CTA of the brain, commonly referred to as large vessel occlusion (LVO), in the ICA, M1, and M2 segment. The output for triage is intended for informational purposes only. It is not intended for diagnostic use and does not alter the original medical image. | syngo.CT Brain Hemorrhage is designed to assist the radiologist in prioritizing cases of suspected intracranial hemorrhage, also in the subarachnoid space, on non-contrast CT examinations of the head. It makes case-level output available to a CT scanner or other PACS system for worklist prioritization. The output is intended for informational purposes only and is not intended for diagnostic use. The device does not alter the original medical image and is not intended to be used as a standalone diagnostic device. |

Siemens Medical Solutions USA, Inc.

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SIEMENS Healthineers

Both applications are designed to analyze head CT scans using artificial intelligence-based algorithms. The intention is to assist the radiologist in prioritizing cases by providing a notification of suspected acute findings on CT.

# 7. Comparison of Technological Characteristics with the Predicate Device

The differences between the above referenced predicate device are listed at a high-level in the following table:

| Feature | Subject Device | Predicate Device | Comparison |
| --- | --- | --- | --- |
| | syngo.CT LVO Detection (SOMARIS/8 VB80) (K243145) | syngo.CT Brain Hemorrhage (SOMARIS/8 VB80) (K232431) | |
| Notification-only, parallel workflow tool | Yes | Yes | Same |
| Intended User | Radiologists and clinical administrators | Radiologists and clinical administrators | Same |
| Setting | Acute Care | Acute Care | Same |
| Identify patients with a prespecified clinical condition | Yes | Yes | Same |
| Clinical condition | Suspected Stroke/LVO | Suspected Stroke/Brain Hemorrhage | Same |
| Alert to finding | Yes; flagged for review | Yes; flagged for review | Same |
| Primary Imaging Modalities | CT | CT | Same |
| Body Part | Head | Head | Same |
| Artificial Intelligence algorithm | Yes | Yes | Same |
| Limited to analysis of imaging data | Yes | Yes | Same |
| Scanner Manufacturer of Input Data | Siemens and other vendors | Siemens and other vendors | Same |
| Output | Suspected LVO/ Processing finished | Suspected hemorrhage/ Processing finished | Similar |
| Deployment Compatibility | syngo.via platform | syngo.via platform, SOMARIS-10 platform | Similar |

# 8. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

# Software Verification and Validation

Software Documentation for Enhanced documentation Level per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Device Software Functions" issued on June 14, 2023, is also included as part of this submission. The Risk Analysis was completed, and risk control implemented

Siemens Medical Solutions USA, Inc.

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to mitigate identified hazards. The testing supports that all software specifications have met the acceptance criteria. Testing for verification and validation support the claim of substantial equivalence.

# Summary of Performance Testing

Standalone testing was performed on 602 retrospective CT data sets from 602 individual patients from 4 different clinical sites in the US. Median patient age was 66 years (IQR: [54 years, 76 years]). 51.9% were female patients. Ethnicity was known for 290 cases (48.2%), out of which 66.2% were white, 26.9% were black or African American, 4.1% were hispanic and 2.8% were others. NIHSS score was known for 296 cases (49.2%) with median of 10 (IQR: [4,19]). Four different CT manufacturers were present in the data: Canon/Toshiba (40.4%), GE Medical Systems (16.3%), Philips (32.3%) and Siemens (11.0%).

Ground truth was established by two US-board certified neuroradiologists independently assessing the cases. In case of disagreement, adjudication was performed by a third US-board certified neuroradiologists. The data set contained 307 positive cases (with 134 occlusions in the ICA, 109 in the M1 segment and 64 in the M2 segment, respectively). The observed sensitivity and specificity with 95%-confidence intervals were 90.6% [86.8% - 93.3%] and 88.8% [84.7% - 91.9%], respectively, exceeding the predefined acceptance threshold of >80% sensitivity and specificity.

The performance results were consistent on all relevant subgroups including manufacturers, data origin, image quality ranges but also patient sex, age and ethnicity and different stroke symptom severity levels (measured by NIHSS).

In addition, the processing time was measured as the time elapsed between the completion of the data transfer to the application and the completion of writing of the results. Processing time was <110 seconds for all cases with a median of 42 seconds.

# Risk Analysis

The risk analysis was completed, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence.

Siemens hereby certifies that syngo.CT LVO Detection meets the following FDA Recognized Consensus standards listed below:

| Standard | Version | Content | FDA Recognition Number (if applicable) |
| --- | --- | --- | --- |
| IEC 62304 | 62306 Edition 1.1 2015-06 CONSOLIDATED VERSION | Medical device software - Software life cycle processes | 13-79 |
| NEMA PS 3.1 - 3.20 2022d | :2022 | Digital Imaging and Communications in Medicine (DICOM) Set | 12-349 |
| ISO 14971 | Third Edition 2019-12 | Application of Risk Management to Medical Devices | 5-125 |
| IEC 62366-1 | Edition 1.1 2020-06 CONSOLIDATED VERSION | Medical devices - Part 1: Application of usability engineering to medical devices | 5-129 |

Siemens Medical Solutions USA, Inc.

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| Standard | Version | Content | FDA Recognition Number (if applicable) |
| --- | --- | --- | --- |
| ISO 15223-1 | Fourth edition 2021-07 | Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements | 5-134 |
| ISO 20417:2021 | First edition 2021-04 Corrected version 2021-12 | Medical devices - Information to be supplied by the manufacturer | 5-135 |

# 9. Conclusion

syngo.CT LVO Detection has the same intended use and similar indication for use as the predicate device. The result of all testing conducted was found acceptable to support the claim of substantial equivalence. The comparison of technological characteristics, clinical and non-clinical performance data, and software validation demonstrates that the subject device is as safe and effective when compared to the predicate device that is currently marketed for the same intended use. Siemens considers syngo.CT LVO Detection to be as safe, as effective and with performance substantially equivalent to the commercially available predicate device.

Siemens Medical Solutions USA, Inc.