(224 days)
Not Found
Yes
The device description explicitly states that it uses an "artificial intelligence algorithm".
No.
The device is described as image-processing software intended for informational purposes only, to assist in prioritizing cases, and not for diagnostic or therapeutic use.
No.
The "Intended Use / Indications for Use" section explicitly states: "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."
Yes
The device description explicitly states it is "an image-processing software" and a "notification-only processing application," with no mention of accompanying hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use explicitly states that the output is "for informational purposes only and is not intended for diagnostic use." It is designed to assist in prioritizing cases, not to provide a diagnosis.
- Device Description: The description reinforces this by stating it's a "notification-only processing application" and "does not mark, highlight, or direct users' attention to a specific location in the original image." It facilitates a parallel workflow for flagging cases, not for direct diagnostic interpretation.
- Nature of IVDs: IVDs are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device processes medical images, not biological samples.
Therefore, syngo.CT Brain Hemorrhage falls under the category of medical imaging software or a clinical decision support tool, not an In Vitro Diagnostic device.
No
The input document does not contain any language indicating that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
QAS
Device Description
The subject device syngo.CT Brain Hemorrhage is an image-processing software that uses an artificial intelligence algorithm to support qualified clinicians in the analysis and prioritization of non-contrast head CT images. It is a notification-only processing application that algorithmically identifies findings suspicious of acute intracranial hemorrhage (ICH) and acute subarachnoid hemorrhage (SAH). The device facilitates a parallel workflow, where cases suspected of presence of ICH or SAH are flagged. 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Non-contrast CT
Anatomical Site
Head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiologists and clinical administrators / Acute Care
Description of the training set, sample size, data source, and annotation protocol
29 713 cases
Description of the test set, sample size, data source, and annotation protocol
The data cohort consisted of 900 anonymized head CT cases from 5 sites in US and Europe with approximately equal distribution of positive (case with ICH) and negative (case without ICH) cases. Ground truth established by majority read of 3 US board certified neuroradiologists with more than 10 years of experience.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Standalone performance study. Data cohort of 900 anonymized head CT cases from 5 sites in US and Europe. For the triage of intracranial hemorrhage, the sensitivity was 95.0% (95% Cl: 92.5%-96.7%) and the specificity was 93.1% (95% Cl: 90.5%-95.1%). For the triage of subarachnoid hemorrhage, the sensitivity was 86.1% (95% Cl: 81.1%-90.0%) and the specificity was 85.2% (95% Cl: 82.3%-87.7%). Thus, sensitivity and specificity exceeded the 80% performance goal. The average per-case processing time was 13.34 seconds (95% Cl: 9.16-17.51 seconds).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Intracranial Hemorrhage: Sensitivity 95.0% (95% Cl: 92.5%-96.7%), Specificity 93.1% (95% Cl: 90.5%-95.1%).
Subarachnoid Hemorrhage: Sensitivity 86.1% (95% Cl: 81.1%-90.0%), Specificity 85.2% (95% Cl: 82.3%-87.7%).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2080 Radiological computer aided triage and notification software.
(a)
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.(b)
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.
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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 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.
Siemens Medical Solutions USA, Inc. Monsuru Bello Regulatory Affairs Specialist 810 Innovation Drive Knoxville, TN 37932
Re: K232431
March 22, 2024
Trade/Device Name: syngo.CT Brain Hemorrhage Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological computer aided triage and notification software Regulatory Class: Class II Product Code: QAS Dated: February 21, 2024 Received: February 21, 2024
Dear Monsuru 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" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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.
Jessica Lamb
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
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Indications for Use
Submission Number (if known)
Device Name
syngo.CT Brain Hemorrhage
Indications for Use (Describe)
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.
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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Image /page/3/Picture/1 description: The image contains 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 word "Healthineers" is a graphic of orange dots.
510(k) Summary
1. Identification of the Submitter
| Submitter / Primary Contact Person | Monsuru (Kenny) Bello
Regulatory Affairs
monsuru.bello@siemens-healthineers.com
+1(240) 601-3848 |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Secondary Contact Person | Clayton Ginn
Regulatory Affairs
clayton.ginn@siemens-healthineers.com
+1 (865) 898-2692 |
| Submitter Address | Siemens Medical Solutions, Inc. USA
Molecular Imaging
810 Innovation Drive
Knoxville, TN 37932
Establishment Registration Number: 1034973 |
| Legal Manufacturer | Siemens Healthcare GmbH
SIEMENSSTRASSE 1 -OR-
Rittigfeld 1
FORCHHEIM Bavaria, DE 91301
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 Brain Hemorrhage |
|---|---|
| Propriety 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 |
3. Predicate Device
| Trade Name: | syngo.CT Brain Hemorrhage |
|---|---|
| 510(k) Number: | K203260 |
| Clearance Date: | 01/28/2022 |
| 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 |
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Image /page/4/Picture/0 description: The image contains 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.
4. Device Description
The subject device syngo.CT Brain Hemorrhage is an image-processing software that uses an artificial intelligence algorithm to support qualified clinicians in the analysis and prioritization of non-contrast head CT images. It is a notification-only processing application that algorithmically identifies findings suspicious of acute intracranial hemorrhage (ICH) and acute subarachnoid hemorrhage (SAH). The subject device facilitates a parallel workflow, where cases suspected of presence of ICH or SAH are flagged. 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 subject device syngo.CT Brain Hemorrhage is an improved and extended version of the predicate device (syngo.CT Brain Hemorrhage, K203260, clearance date 01/28/2022). The differences to the predicate device can be summarized as:
- . Improved algorithm model for the triage of intracranial hemorrhage (ICH), targeting a higher sensitivity for cases with smaller hemorrhages.
- . Extension of the device output to the triage of subarachnoid hemorrhages (SAH), a subtype of intracranial hemorrhages (ICH).
- . Support of DICOM conformant head CT reconstructions fulfilling diagnostic quality for the identification of ICH, without restriction to be acquired with a Siemens CT scanner
- . Additional deployment compatibility with the syngo.via host system.
5. Indications for Use
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.
6. Comparison of Technological Characteristics with the Predicate Device
The differences and similarities between the above referenced predicate device are listed at a high-level in the following table:
| Feature | Subject Device | Predicate Device | Comparison Table |
|---|---|---|---|
| syngo.CT Brain Hemorrhage | |||
| (SOMARIS/8 VB80) | syngo.CT Brain Hemorrhage | ||
| (SOMARIS/8 VB60) | |||
| 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 |
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| Feature | Subject Device | Predicate Device | Comparison
Table |
|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------|---------------------|
| | syngo.CT Brain Hemorrhage
(SOMARIS/8 VB80) | syngo.CT Brain Hemorrhage
(SOMARIS/8 VB60) | |
| Identify patients with a
prespecified clinical
condition | Yes | Yes | Same |
| Clinical condition | Intracranial hemorrhage,
Subarachnoid hemorrhage | Intracranial hemorrhage | Extended |
| Alert to finding | Yes; flagged for review | Yes; flagged for review | Same |
| Independent of standard
of care workflow | Yes; No cases are removed from
worklist | Yes; No cases are removed from
worklist | Same |
| Modality | Non-contrast CT | Non-contrast CT | Same |
| Body Part | Head | Head | Same |
| Artificial Intelligence
algorithm | Yes | Yes | Same |
| Training Data | 29 713 cases | 28 814 cases | Improved |
| Limited to analysis of
imaging data | Yes | Yes | Same |
| Scanner Manufacturer of
Input Data | Siemens and other vendors | Siemens | Extended |
| Output | Suspected hemorrhage / Suspected
hemorrhage including the
subarachnoid space / Processing
finished | Suspected hemorrhage / Processing
finished | Extended |
| Deployment Compatibility | SOMARIS-X platform,
syngo.via platform | SOMARIS-X platform | Extended |
The subject device syngo.CT Brain Hemorrhage does not have changes in fundamental scientific technology compared to the predicate device. The post-processing software functionality remains unchanged from the subject device and the predicate device. The operating principle and the scientific technology are the same; therefore, Siemens believes that syngo.CT Brain Hemorrhage application is substantially equivalent to the predicate device.
7. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Non-Clinical Testing
This submission contains performance tests (Non-clinical test reports) to demonstrate continued conformance with special controls for medical devices containing software. Non-clinical tests (integration and functional) were conducted for syngo.CT Brain Hemorrhage during product development. These tests have been performed to test the ability of the included features of the subject device. The results of these tests demonstrate that the subject device performs as intended. The results of all conducted testing were found acceptable to support the claim of substantial equivalence.
Performance Evaluation of the Algorithm
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The performance of the syngo.CT Brain Hemorrhage device has been va alone performance study. Sensitivity and specificity of syngo.CT Brain Hemorrhage in processing of noncontrast head CT have been analyzed by comparison to a ground truth established by majority read of 3 US board certified neuroradiologists with more than 10 years of experience. The data cohort consisted of 900 anonymized head CT cases from 5 sites in US and Europe with approximately equal distribution of positive (case with ICH) and negative (case without ICH) cases.
For the triage of intracranial hemorrhage, the sensitivity was 95.0% (95% Cl: 92.5%-96.7%) and the specificity was 93.1% (95% Cl: 90.5%-95.1%). Thus, sensitivity and specificity exceeded the 80% performance goal.
For the triage of subarachnoid hemorrhage, the sensitivity was 86.1% (95% Cl: 81.1%-90.0%) and the specificity was 85.2% (95% Cl: 82.3%-87.7%). Thus, sensitivity and specificity exceeded the 80% performance goal.
The average per-case processing time was 13.34 seconds (95% Cl: 9.16-17.51 seconds). This is comparable to the predicate device (13.67 seconds, 95% Cl: 7.48-19.86).
To conclude, syngo.CT Brain Hemorrhage is a safe and effective triage and notification device for intracranial hemorrhages which is substantially equivalent to the predicate device.
Siemens hereby certifies that syngo.CT Brain Hemorrhage will meet the following voluntary standards covering electrical and mechanical safety listed below, prior to introduction into interstate commerce:
| Standard | Version | Content | FDA Recognition
Number
(if applicable) |
|-----------------------------|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| ANSI AAMI IEC 62304 | :62304:2006/A1:20
16 | Medical device software - Software life cycle processes
[Including Amendment 1 (2016)] | 13-79 |
| NEMA PS 3.1 - 3.20
2022d | :2022 | Digital Imaging and Communications in Medicine
(DICOM) Set | 12-349 |
| ISO 14971 | :2019 | 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 |
| 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 |
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8. Conclusion
syngo.CT Brain Hemorrhage 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 Brain Hemorrhage to be as safe, as effective and with performance substantially equivalent to the commercially available predicate device.