(245 days)
No
The summary describes image analysis software using digital image processing and visualization tools, but there is no mention of AI, ML, or related concepts like deep learning or neural networks.
No
The device provides advanced visualization for diagnosis but does not directly treat or prevent a disease, nor does it restore, modify, or correct body function or structure.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is for "visual assessment by a radiologist" to identify, mark, and report "pathologies such as skull fractures and hematomas," which is a diagnostic purpose.
Yes
The device is described as "image analysis software" that receives and returns DICOM images, indicating it is a software application processing existing medical images without requiring or including any specific hardware components for its primary function.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: syngo.CT Skull Unfolding is image analysis software that processes CT volume data sets acquired from a CT scanner. It works with images of the skull and brain surface, not biological specimens.
- Intended Use: The intended use is for visual assessment by a radiologist of curved MIP images derived from CT scans. This is a diagnostic process based on imaging, not laboratory testing of biological samples.
The description clearly indicates that the device operates on medical images obtained through a non-invasive imaging modality (CT) and provides visualization tools for interpretation by a qualified clinician. This aligns with the definition of a medical imaging software device, not an IVD.
N/A
Intended Use / Indications for Use
syngo.CT Skull Unfolding provides curved MIP images of skull and brain surface for visual assessment by a radiologist.
Product codes
JAK
Device Description
syngo.CT Skull Unfolding is image analysis software for CT volume data sets which has been continuously acquired with computed tomography (CT) imaging systems. syngo.CT Skull Unfolding provides advanced visualization of the skull and brain surface for easy manual identification, marking and reporting of pathologies such as skull fractures and hematomas. It receives images from a hosting application and returns DICOM images to a hosting application, which can display the results within its user interface. The device does not mark, highlight, or direct users' attention to a specific location in the original image.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
skull and brain surface
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified clinicians
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Skull Unfolding 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 result of all conducted testing was found acceptable to support the claim of substantial equivalence.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. The full name of the agency is "U.S. Food & Drug Administration".
Siemens Medical Solutions USA, Inc. % Tabitha Estes Regulatory Affairs Specialist 810 Innovation Drive KNOXVILLE TN 37932
Re: K203411
Trade/Device Name: syngo.CT Skull Unfolding Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: June 18, 2021 Received: June 21, 2021
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 (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/cfpmp/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 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
July 22, 2021
1
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 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,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203411
Device Name syngo.CT Skull Unfolding
Indications for Use (Describe)
syngo.CT Skull Unfolding provides curved MIP images of skull and brain surface for visual assessment by a radiologist.
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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3
510(k) Summary
FOR
SYNGO.CT SKULL UNFOLDING
Identification of the Submitter l.
Importer/Distributor
Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355
Establishment Registration Number
2240869
Manufacturing Site
Siemens Healthcare GmbH Siemensstr 1 D-91301 Forchheim, Germany
Establishment Registration Number
3004977335
Submitter Contact Person:
Tabitha Estes Regulatory Affairs Specialist Siemens Medical Solutions, Inc. USA 810 Innovation Drive Knoxville, TN 37932 Phone: (865) 804-4553 Email: tabitha.estes@siemens-healthineers.com
Alternate Contact:
Alaine Medio
Device Name and Classification II.
| Product Name: | syngo.CT Skull Unfolding |
|---|---|
| Propriety Trade Name: | syngo.CT Skull Unfolding |
| Classification Name: | System, X-Ray, Tomography, Computed |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
4
lll. Predicate Device
Predicate Device:
| Trade Name: | syngo.CT Bone Reading |
|---|---|
| 510(k) Number: | K123584 |
| Clearance Date: | 03/12/2013 |
| Classification Name: | System, X-Ray, Tomography, Computed |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
Reference Device:
| Trade Name: | syngo.via VB40 |
|---|---|
| 510(k) Number: | K191040 |
| Clearance Date: | 05/16/2019 |
| Classification Name: | System, X-Ray, Tomography, Computed |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
IV. Device Description
This section describes the technical features and workflow for subject device syngo.CT Skull Unfolding. syngo.CT Skull Unfolding is image analysis software for CT volume data sets which has been continuously acquired with computed tomography (CT) imaging systems. syngo.CT Skull Unfolding provides advanced visualization of the skull and brain surface for easy manual identification, marking and reporting of pathologies such as skull fractures and hematomas. It receives images from a hosting application and returns DICOM images to a hosting application, which can display the results within its user interface. The device does not mark, highlight, or direct users' attention to a specific location in the original image.
V. Indications for Use
syngo.CT Skull Unfolding provides curved MIP images of skull and brain surface for visual assessment by a radiologist.
Comparison of Technological Characteristics with the Predicate Device VI.
The differences and similarities between the above referenced predicate device are listed at a highlevel in the following table:
5
| Features | Subject Device | Predicate Device | Reference Device | Summary |
|---|---|---|---|---|
| Siemens | ||||
| syngo.CT Skull Unfolding | Siemens | |||
| syngo.CT Bone Reading | Siemens | |||
| syngo.via VB40 | ||||
| Advanced | ||||
| Visualization | Unfolded view of the | |||
| skull | Unfolded view of the | |||
| ribs | Advanced visualization of | |||
| Curved spine ranges | Comparable | |||
| Both subject and | ||||
| predicate device provide | ||||
| unfolded views of the | ||||
| respective anatomy as | ||||
| advanced visualization | ||||
| Visualization | ||||
| Techniques | Curved maximum | |||
| intensity projection | ||||
| (MIP) | Curved multiplanar | |||
| reconstruction (MPR) | ||||
| and other filter | ||||
| techniques (multiplanar | ||||
| reconstruction (MPR) | ||||
| thin/thick, maximum | ||||
| intensity projection | ||||
| (MIP) thin/thick, inverted | ||||
| MIP thin/thick, volume | ||||
| rendering technique | ||||
| (VRT)) | Curved multiplanar | |||
| reconstruction (MPR) | ||||
| and other filter | ||||
| techniques (multiplanar | ||||
| reconstruction (MPR) | ||||
| thin/thick, maximum | ||||
| intensity projection | ||||
| (MIP) thin/thick, inverted | ||||
| MIP thin/thick, volume | ||||
| rendering technique | ||||
| (VRT)) | Similar | |||
| Both, the subject device, | ||||
| and the reference device | ||||
| provide curved | ||||
| visualizations. The subject | ||||
| device represents a | ||||
| subset of functionalities. | ||||
| Localization of | ||||
| Anatomy | Head localization via | |||
| anatomical range "Head | ||||
| Orbitomeatal" based on | ||||
| landmark detection | Spine Localization via | |||
| spine range based on | ||||
| landmark detection | Anatomical auto views | |||
| and anatomical ranges | ||||
| (by selecting anatomical | ||||
| presets, e.g. "Head | ||||
| Orbitomeatal") based on | ||||
| landmark detection. | Similar | |||
| The subject device uses | ||||
| the same anatomical | ||||
| range "Head | ||||
| Orbitomeatal" of the | ||||
| reference device. | ||||
| For both subject and | ||||
| predicate device, the | ||||
| fundamental technology | ||||
| is the same but different | ||||
| landmarks are used due | ||||
| to different anatomy. | ||||
| Bone | ||||
| Segmentation | Thresholding based skull | |||
| segmentation | Rib segmentation by | |||
| model fitting | HU-based threshold | |||
| segmentation in the | ||||
| Anatomy Visualizer | Similar | |||
| Both subject and | ||||
| predicate device | ||||
| comprise a bone | ||||
| segmentation, but use | ||||
| different well-established | ||||
| techniques | ||||
| Output Image | ||||
| Туре | Curved MIP Ranges | Curved CPR Ranges | Various types, including | |
| curved ranges and MIP | ||||
| ranges | Comparable | |||
| For both subject and | ||||
| predicate device, the | ||||
| output image types are | ||||
| commonly used image | ||||
| representations for 3D CT | ||||
| data | ||||
| Additional | ||||
| Functionality | Picking on 2D view with | |||
| automatic | ||||
| synchronization of 3D | ||||
| views | Picking on 2D view with | |||
| automatic | ||||
| synchronization of 3D | ||||
| views | Various functionality for | |||
| viewing, manipulation, | ||||
| communication, and | ||||
| storage of medical | ||||
| images | Same | |||
| Subject and predicate | ||||
| device both provide | ||||
| picking and | ||||
| synchronization | ||||
| functionality | ||||
| Features | Subject Device | Predicate Device | Reference Device | Summary |
| Siemens | ||||
| syngo.CT Skull Unfolding | Siemens | |||
| syngo.CT Bone Reading | Siemens | |||
| syngo.via VB40 | ||||
| Measurement | ||||
| Tools | Non-measurement tools | |||
| (e.g. marker, arrow) | Geometric tools, HU | |||
| measurement tools, non- | ||||
| measurement tools (e.g. | ||||
| marker, arrow) | Geometric tools, HU | |||
| measurement tools, non- | ||||
| measurement tools (e.g. | ||||
| marker, arrow) | Similar | |||
| The subject device | ||||
| provides a subset of tools | ||||
| of the predicate device | ||||
| and the reference device. | ||||
| Editing and | ||||
| Creation Tools | N/A | Tools to create and edit | ||
| anatomical centerline | ||||
| paths and anatomical | ||||
| labels | Tools to create and edit | |||
| anatomical centerline | ||||
| paths and anatomical | ||||
| labels | Different | |||
| The subject device | ||||
| provides no editing and | ||||
| creation tools as no labels | ||||
| and centerlines are | ||||
| created. | ||||
| Intended User | Qualified clinicians | Qualified clinicians | Qualified clinicians | Same |
| Radiological | ||||
| images format | DICOM | DICOM | DICOM | Same |
| Independent of | ||||
| standard of care | ||||
| workflow | Yes; Advanced | |||
| visualization in addition | ||||
| to standard images | Yes; Advanced | |||
| visualization in addition | ||||
| to standard images | N/A | Same | ||
| Modality | Non-contrast CT | Non-contrast CT | Multi-modal, e.g. CT, MR | Same |
| Subject and predicate | ||||
| device work on non- | ||||
| contrast CT images | ||||
| Archiving/Storing | CD-R, film, DVD, USB, | |||
| Network | CD-R, film, DVD, USB, | |||
| Network | CD-R, film, DVD, USB, | |||
| Network | Same | |||
| Communication | DICOM compatible | DICOM compatible | DICOM compatible | Same |
6
IFU Comparison
The subsection provides a comparison discussion of the IFU statement for the subject device and predicate device.
| Subject Device | Predicate Device |
|---|---|
| Siemens | |
| syngo.CT Skull Unfolding | Siemens |
| syngo.CT Bone Reading | |
| syngo.CT Skull Unfolding provides curved MIP images of | |
| skull and brain surface for visual assessment by a | |
| radiologist. | The syngo.CT Bone Reading is image analysis software for |
| CT volume data sets which has been continuously acquired | |
| with computed tomography (CT) imaging systems. The | |
| software combines following digital image processing and | |
| visualization tools: |
multiplanar reconstruction (MPR) thin/thick, maximum
intensity projection (MIP) thin/thick, inverted MIP
thin/thick, volume rendering technique (VRT) geometric measurement tools (distance line, polyline,
marker, arrow, angle) HU measurement tools (Pixel lens, ROI circle, ROI
polygonal, ROI freehand, VOI sphere) curved MPR visualization (unfolded ribs and spine
views), cross-section MPRs |
7
| | tools for creation and editing of anatomical centerline paths tools for creation and editing of anatomical labels The specific visualizations of spine and rib structures allow for easy manual identification and marking of pathologies such as bone lesions or fractures.
Reporting and documentation of results is facilitated by using of appropriate reporting tool, statistics and creation of ranges and snapshots. |
| -- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
The IFU statement of the subject device is not identical as compared to the predicate device, but similar. The predicate device used for this submission is syngo.CT Bone Reading (K123584, clearance date 03/12/2013).
Both devices provide technology to unfold bones. The main difference is that the predicate device is designed for unfolding spine and rib structures and the subject device for the skull.
The subject device represents a visualization method. Despite addressing a different anatomical region, the subject device's IFU can be considered as a subset of the predicate device's IFU. The differences are not critical to the intended use:
- Visualization techniques: Besides showing the unfolded ribs/spine in curved MPR format, the predicate device provides different filtering techniques for visualization of the input CT dataset ("multiplanar reconstruction (MPR) thin/thick, maximum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT)"). These possibilities are not unique to the predicate device, but are offered by many standard diagnostic viewing systems (e.g. syngo.via (K191040)). In comparison, the subject device only provides a single visualization technique for the skull and brain surface (curved MIP). However, the user can use a standard diagnostic viewing system to also apply different visualization techniques to the input CT datasets.
- . Measurement tools: The predicate device IFU lists geometric and HU measurement tools. Due to the distortions in the subject device, linear measurement tools (e.g. distance line, angle) cannot be used. The subject device enables the use of non-measurement tools (e.g. marker, arrow), but they are not listed within the IFU.
- . Tools for creation and editing: The predicate device offers tools to create and edit anatomical centerline paths and anatomical labels. This possibility is specific for the anatomical regions of predicate device (i.e. for spine and ribs) and is not required, and therefore not offered, for the subject device (i.e. skull and brain surface).
Conclusion of the Comparison
To summarize, the IFU differences in the technological characteristics do not affect the subject device's intended use. For the subject device, syngo.CT Skull Unfolding, Siemens used the same testing methods with same workflows as used to clear the predicate device. The development and testing process remain unchanged. Siemens considers syngo.CT Skull Unfolding to be as safe, as effective and with performance substantially equivalent to the commercially available predicate device.
In addition, completion of risk/hazard analysis, non-clinical data-based software validation supports that the used technology in the subject device does not raise different questions of safety and effectiveness.
8
VII. 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 Skull Unfolding 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 result of all conducted testing was found acceptable to support the claim of substantial equivalence.
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.
Standards and utilized FDA Guidances
Siemens hereby certifies that syngo.CT Skull Unfolding will meet the following voluntary standards covering electrical and mechanical safety listed below, prior to introduction into interstate commerce:
| Recognition
Number | Product
Area | Title of Standard | Date of
Recognition | Standards
Development
Organization |
|-----------------------|--------------------------|------------------------------------------------------------------------------------------------------------|------------------------|------------------------------------------|
| 12-300 | Radiology | Digital Imaging and Communications in
Medicine (DICOM) Set; PS 3.1 – 3.20 | 06/27/2016 | NEMA |
| 13-79 | Software | Medical Device Software - Software Life
Cycle Processes; 62304:2006 (1st Edition) | 01/14/2019 | AAMI, ANSI, IEC |
| 5-40 | Software/
Informatics | Medical devices – Application of risk
management to medical devices; 14971
Second Edition 2007-03-01 | 06/27/2016 | ISO |
| 5-114 | General I
(QS/RM) | Medical devices - Part 1: Application of
usability engineering to medical devices
IEC 62366-1:2015 | 12/23/2016 | IEC |
For the development of the product as well as the 510(k) submission, the following FDA guidances has been considered:
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
- . Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]
- Deciding When to Submit a 510(k) for a Software Change to an Existing Device
- Format for Traditional and Abbreviated 510(k)s
9
VIII. Conclusion
syngo.CT Skull Unfolding 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, 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. For the subject device, syngo.CT Skull Unfolding, Siemens used the same testing with the same workflows as used to clear the predicate device. Siemens considers syngo.CT Skull Unfolding to be as safe, as effective and with performance substantially equivalent to the commercially available predicate device.