(29 days)
Yes
The text explicitly mentions "Segmentation of opacity regions inside the lung using an Al algorithm."
No
The device is intended for diagnostic purposes, specifically for advanced visualization and analysis of medical images to assist in diagnosis, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "diagnostic purpose" and that "Resulting images created with the syngo.CT Extended Functionality software package can be used to assist trained technicians or physicians in diagnosis."
Yes
The device is described as a "software bundle" and its function is to process and visualize medical images acquired from external hardware (CT and MR scanners). There is no mention of the device including or requiring any specific hardware components beyond the software itself and the interface to the imaging modalities.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that syngo.CT Extended Functionality is a software package that processes and visualizes medical images acquired from imaging modalities like CT and MR scanners. It assists in the analysis of clinical data derived from these images.
- No Sample Analysis: There is no mention of the device analyzing biological samples or performing tests on bodily fluids or tissues. Its function is solely focused on the manipulation and interpretation of medical images.
Therefore, while it is a medical device used for diagnostic purposes, it falls under the category of medical imaging software rather than an in vitro diagnostic device.
No
The clearance letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
syngo.CT Extended Functionality is intended to provide advanced visualization tools to prepare and process medical images for diagnostic purpose. The software package is designed to support technicians and physicians in qualitative and quantitative measurements and in the analysis of clinical data that was acquired and reconstructed by Computed Tomography (CT) scanners, and possibly other medical imaging modalities (e.g. MR scanners).
An interface shall enable the connection between the syngo.CT Extended Functionality software package and the interconnected CT Scanner system.
Resulting images created with the syngo.CT Extended Functionality software package can be used to assist trained technicians or physicians in diagnosis.
Product codes
JAK
Device Description
syngo.CT Extended Functionality is a software bundle that offers tools to support special clinical evaluations. The "tools" are represented by the so-called Extensions. syngo.CT Extended Functionality can be used to create advanced visualizations and measurements on clinical data that was acquired and reconstructed by Computed Tomography (CT) scanners or other medical imaging modalities (e.g. MR scanners) by using the Extensions. Advanced visualizations and measurements are listed as follows. The subject device in the current software version SOMARIS/8 VB60 has been extended/modified as follows:
- Support of the extension "Trauma"
- Modifications to the extension "Interactive Spectral Imaging"
- Modifications to the extension "Vascular"
- "Osteo" Extension - No changes
- "Neuro DSA" Extension – No changes
- . "ROI HU Threshold" Extension – No changes
- . "Dual Energy" Extension – No changes
- . "Endoscopic Viewing" Extension - No changes
- . "Pulmonary Density" Extension – No changes
- "General" (Extension Independent Features) – No changes
- . "Oncology" Extension – No Changes
Mentions image processing
syngo.CT Extended Functionality is intended to provide advanced visualization tools to prepare and process medical images for diagnostic purpose.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT) scanners, and possibly other medical imaging modalities (e.g. MR scanners).
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
technicians and physicians
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 Extended Functionality 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.
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
January 20, 2022
Image /page/0/Picture/1 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 and 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 reads "U.S. Food & Drug Administration".
Siemens Medical Solutions USA, Inc. % Alaine Medio Regulatory Affairs 810 Innovation Drive KNOXVILLE TN 37932
Re: K214019
Trade/Device Name: syngo.CT Extended Functionality Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: December 20, 2021 Received: December 22, 2021
Dear Alaine Medio:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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,
Laurel Burk Assistant Director Diagnostic X-ray Systems Team 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) K214019
Device Name syngo.CT Extended Functionality
Indications for Use (Describe)
syngo.CT Extended Functionality is intended to provide advanced visualization tools to prepare and process medical images for diagnostic purpose. The software package is designed to support technicians and physicians in qualitative and quantitative measurements and in the analysis of clinical data that was acquired and reconstructed by Computed Tomography (CT) scanners, and possibly other medical imaging modalities (e.g. MR scanners).
An interface shall enable the connection between the syngo.CT Extended Functionality software package and the interconnected CT Scanner system.
Resulting images created with the syngo.CT Extended Functionality software package can be used to assist trained technicians or physicians in diagnosis.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary SYNGO.CT EXTENDED FUNCTIONALITY
K214019 January 20, 2022
l. Identification of the Submitter
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:
Alaine Medio Regulatory Affairs Siemens Medical Solutions, Inc. USA 810 Innovation Drive Knoxville, TN 37932 Phone: (865) 206-0337 Fax: (865) 218-3019 Email: alaine.medio@siemens-healthineers.com Alternate: Clayton Ginn Regulatory Affairs Siemens Medical Solutions, Inc. USA 810 Innovation Drive Knoxville, TN 37932 Phone (865) 898-2692 Email: clayton.ginn@siemens-healthineers.com
ll. Device Name and Classification
Product Name: syngo.CT Extended Functionality Propriety Trade Name: syngo.CT Extended Functionality Classification Name: Computed Tomography X-ray System Classification Panel: Radiology 21 CFR §892.1750 CFR Section: Device Class: Class II Product Code: JAK
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III. Predicate Devices
Predicate Device
| Trade Name: | syngo.CT Extended Functionality |
|---|---|
| 510(k) Number: | K203699 |
| Clearance Date: | April 30, 2021 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
Reference Device:
| Trade Name: | syngo.CT Dual Energy |
|---|---|
| 510(k) Number: | K191468 |
| Clearance Date: | July 3, 2019 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
IV. Device Description
syngo.CT Extended Functionality is a software bundle that offers tools to support special clinical evaluations. The "tools" are represented by the so-called Extensions. syngo.CT Extended Functionality can be used to create advanced visualizations and measurements on clinical data that was acquired and reconstructed by Computed Tomography (CT) scanners or other medical imaging modalities (e.g. MR scanners) by using the Extensions. Advanced visualizations and measurements are listed as follows. The subject device in the current software version SOMARIS/8 VB60 has been extended/modified as follows:
- Support of the extension "Trauma"
- Modifications to the extension "Interactive Spectral Imaging"
- Modifications to the extension "Vascular" ●
- "Osteo" Extension - No changes
- "Neuro DSA" Extension – No changes
- . "ROI HU Threshold" Extension – No changes
- . "Dual Energy" Extension – No changes
- . "Endoscopic Viewing" Extension - No changes
- . "Pulmonary Density" Extension – No changes
- "General" (Extension Independent Features) – No changes
- . "Oncology" Extension – No Changes
Indications for Use V.
syngo.CT Extended Functionality is intended to provide advanced visualization tools to prepare and process medical images for diagnostic purpose. The software package is designed to support technicians and physicians in qualitative and quantitative measurements and in the analysis of
5
clinical data that was acquired and reconstructed by Computed Tomography (CT) scanners, and possibly other medical imaging modalities (e.g. MR scanners).
An interface shall enable the connection between the syngo.CT Extended Functionality software package and the interconnected CT Scanner system.
Resulting images created with the syngo.CT Extended Functionality software package can be used to assist trained technicians or physicians in diagnosis.
VI. Comparison of Technological Characteristics with the Predicate Device
The differences and similarities between the above referenced predicate device are listed at a highlevel in the following table:
| Feature | Subject Device | Predicate Device |
|---|---|---|
| syngo.CT Extended Functionality | ||
| (SOMARIS/8 VB60) | syngo.CT Extended Functionality | |
| (SOMARIS/8 VB51) | ||
| 1. Trauma | The trauma reading plugin allows the user | |
| convenient sorting of a large number of | ||
| reconstruction series and displays them | ||
| into body region specific layouts. The | ||
| features are: | ||
| • Set of pre-configured layouts for | ||
| reading trauma reconstructions. | ||
| • The reconstruction series | ||
| corresponding to different body regions | ||
| are assigned to body region specific | ||
| layouts. | N/A | |
| 2. Interactive Spectral | ||
| Imaging | Display different representations of Dual | |
| Energy data. | ||
| Modifications: | ||
| The software has been modified to: | ||
| • accept and display additional data sets | ||
| received from CT scanners, and | ||
| • display mean values of ROIs in addition | ||
| to the measured values. | Display different representations of Dual | |
| Energy data. | ||
| 3. Vascular Extension | The user can perform a vascular | |
| evaluation supporting the following main | ||
| functionalities: | ||
| • Measuring vessels | ||
| • Creating DICOM snapshots or result | ||
| series for documenting findings | ||
| • Working on images that are acquired | ||
| with CT or MR scanner systems | ||
| constituting one or more volumes of | ||
| vascular structures | ||
| Modification: | ||
| Support for display and processing of | ||
| images > 512x512. | The user can perform a vascular | |
| evaluation supporting the following main | ||
| functionalities: | ||
| • Measuring vessels | ||
| • Creating DICOM snapshots or result | ||
| series for documenting findings | ||
| • Working on images that are acquired | ||
| with CT or MR scanner systems | ||
| constituting one or more volumes of | ||
| vascular structures |
The remaining functions in syngo.CT Extended Functionality remain unchanged compared to the predicate version.
- . Osteo Extension - Evaluation of Bone Mineral Density (BMD) values (mg CA-HA/ml).
- Neuro DSA Extension - Selective bone removal from a CT angiography dataset
- ROI HU Threshold Extension – Evaluation of HU Value distributions
- Dual Energy Extension – Simultaneous evaluation for low and high kV dual energy images
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- . Endoscopic Viewing Extension – Interactive fly through tubular structures that are filled by either low-intensity or high-intensity material
- . Pulmonary Density - Segmentation of opacity regions inside the lung using an Al algorithm.
- . General (Extension Independent features) – Multiphase support for merged 4D series and editing tool for pre-generated results.
- . Oncology Extension – Tools for localization and evaluation of nodules.
The core modification of the subject device as compared to its predicate device (syngo.CT Extended Functionality (SOMARIS/8 VB51)) are the modifications shown in the table above.
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 Extended Functionality 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.
Siemens hereby certifies that syngo.CT Extended Functionality 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)/A1:2016 | 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 |
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VIII. Conclusion
syngo.CT Extended Functionality has the same intended use and same indications for use as the predicate device. The technological characteristics such as image visualization, operating platform, and image measurement are the same as the predicate device.
For the subject device, syngo.CT Extended Functionality, Siemens used the same testing with the same workflows as used to clear the primary predicate device. Siemens considers syngo.CT Extended Functionality to be as safe, as effective, and with performance substantially equivalent to the commercially available predicate devices.