(18 days)
No
The document describes image processing and visualization tools but does not mention AI, ML, or related terms like deep learning. The performance studies focus on software verification and validation, not AI/ML model performance.
No.
The device is a software application for viewing and evaluating CT images and is used to support radiologists and physicians in diagnosis and evaluation, not to provide therapy.
Yes
The device is designed to support radiologists and physicians in the "evaluation" of various bodily structures and conditions, using advanced visualization, measurement, and post-processing of CT images. This evaluation is a key aspect of diagnosis.
Yes
The device is described as a set of software applications for post-processing and evaluating CT images, and the documentation focuses on software verification and validation, indicating it is a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the software as being for "advanced visualization, measurement, and evaluation for specific body regions" using CT images. This is focused on interpreting images of the human body, not on examining specimens derived from the human body (like blood, urine, tissue samples, etc.).
- Device Description: The device is described as "post-processing software applications to be used for viewing and evaluating CT images provided by a CT diagnostic device." This reinforces its role in image analysis, not in analyzing biological samples.
- Input Imaging Modality: The input is explicitly stated as "CT images," which are generated from a medical imaging scanner, not from a biological specimen.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease. This software operates on medical images of the body itself.
N/A
Intended Use / Indications for Use
syngo.CT Applications is a set of software applications for advanced visualization, measurement, and evaluation for specific body regions.
This software package is designed to support the radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice e.g. in the:
- · Evaluation of perfusion of organs and tumors and myocardial tissue perfusion
- · Evaluation of bone structures and detection of bone lesions
- · Evaluation of CT images of the heart
- · Evaluation of the coronary lesions
- · Evaluation of the mandible and maxilla
- · Evaluation of dynamic vessels and extended phase handling
- · Evaluation of the liver and its intrahepatic vessel structures to identify the vascular territories of sub-vessel systems in the liver
- · Evaluation of neurovascular structures
- Evaluation of the lung parenchyma
- · Evaluation of non-enhanced Head CT images
- · Evaluation of vascular lesions
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
The syngo.CT Applications are syngo based post-processing software applications to be used for viewing and evaluating CT images provided by a CT diagnostic device and enabling structured evaluation of CT images.
The syngo.CT Applications is a combination of thirteen (13) former separately cleared medical devices which are now handled as features / functionalities within syngo.CT Applications. These functionalities are combined unchanged compared to their former cleared descriptions; however, some minor enhancements and improvements are made for the application syngo.CT Pulmo 3D only.
Mentions image processing
Digital image processing and visualization tools (2D, 3D and 4D display of dynamic data),
Combination of 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), curved planar reformation (CPR))
Visualization tools (multiplanar reconstruction (MPR) thin/thick, maximum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT), curved planar reformation (CPR), processing tools (bone removal (based both on single energy and Dual Energy), table removal)
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT images
dynamic CT data
cardiac CT angiography (CTA) volume data sets
contrast enhanced CT images
CT Angiography (CTA) data sets
non enhanced CT (NECT) scan
continuously acquired CT data
information from different CT and MR phase volumes
Anatomical Site
organs and tumors
myocardial tissue
bone structures
heart
coronary
mandible and maxilla
dynamic vessels
liver
intrahepatic vessel structures
neurovascular structures
lung parenchyma
Head (non-enhanced)
vascular lesions
spine and ribs
cerebral vasculature
brain
blood brain barrier
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice
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)
The following performance data were provided in support of the substantial equivalence determination.
Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. The Risk Analysis was completed, and risk control implemented 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.
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.
The result of all testing conducted was found acceptable to support the claim of substantial equivalence. The comparison of technological characteristics 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 Applications, Siemens used the same testing with the same workflows as used to clear the predicate devices. Siemens considers syngo.CT Applications to be as safe, as effective and with performance substantially equivalent to the commercially available predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K092013, K123584, K123585, K173637, K150785, K120331, K133643, K150713, K053024, K202213, K203411, K173637
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
§ 892.1750 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.
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March 7, 2022
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left is the Department of Health & Human Services logo, and on the right is the FDA logo. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
Siemens Medical Solutions USA, Inc. % Mr. Clayton Ginn Regulatory Affairs Specialist 810 Innovation Drive KNOXVILLE TN 37932
Re: K220450
Trade/Device Name: syngo.CT Applications Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: February 15, 2022 Received: February 17, 2022
Dear Mr. Ginn:
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, Ph.D. 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)
K220450
Device Name syngo.CT Applications
Indications for Use (Describe)
syngo.CT Applications is a set of software applications for advanced visualization, measurement, and evaluation for specific body regions.
This software package is designed to support the radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice e.g. in the:
- · Evaluation of perfusion of organs and tumors and myocardial tissue perfusion
- · Evaluation of bone structures and detection of bone lesions
- · Evaluation of CT images of the heart
- · Evaluation of the coronary lesions
- · Evaluation of the mandible and maxilla
- · Evaluation of dynamic vessels and extended phase handling
- · Evaluation of the liver and its intrahepatic vessel structures to identify the vascular territories of sub-vessel systems in the liver
- · Evaluation of neurovascular structures
- Evaluation of the lung parenchyma
- · Evaluation of non-enhanced Head CT images
- · Evaluation of vascular lesions
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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K220450
510(k) Summary
Identification of the Submitter 1.
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:
Clayton Ginn Regulatory Affairs Siemens Medical Solutions, Inc. USA Molecular Imaging 810 Innovation Drive Knoxville, TN 37932 Email: clayton.ginn@siemens-healthineers.com Phone: +1 (865) 898-2692
Alternate/Backup Contact Person:
Alaine Medio Regulatory Affairs Siemens Medical Solutions, Inc. USA Molecular Imaging 810 Innovation Drive Knoxville, TN 37932 Email: alaine.medio@siemens-healthineers.com Phone: +1 (865) 206-0337
II. Device Name and Classification
Product Name: syngo.CT Applications Propriety Trade Name: syngo.CT Applications Classification Name: Computed Tomography X-ray System Classification Panel: Radiology CFR Section: 21 CFR §892.1750 Device Class: Class II Product Code: JAK
Predicate Device lll.
Primary Predicate: Trade Name: syngo.CT Pulmo 3D
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| 510(k) Number: | K123540 |
|---|---|
| Clearance Date: | 08/29/2013 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
Reference Predicates:
| Trade Name: | syngo.CT Body Perfusion |
|---|---|
| 510(k) Number: | K092013 |
| Clearance Date: | 07/17/2009 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| Trade Name: | syngo.CT Bone Reading |
|---|---|
| 510(k) Number: | K123584 |
| Clearance Date: | 03/12/2013 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| Trade Name: | syngo.CT Cardiac Function |
|---|---|
| 510(k) Number: | K123585 |
| Clearance Date: | 12/20/2012 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| Trade Name: | syngo.CT Coronary Analysis |
|---|---|
| 510(k) Number: | K173637 |
| Clearance Date: | 03/30/2018 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| Trade Name: | syngo.CT Dental |
|---|---|
| 510(k) Number: | K150785 |
| Clearance Date: | 05/18/2015 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| Trade Name: | syngo.CT Dynamic Angio |
| 510(k) Number: | K120331 |
| Clearance Date: | 04/13/2012 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| Trade Name: | syngo.CT Liver Analysis |
| 510(k) Number: | K133643 |
| Clearance Date: | 11/13/2014 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| Trade Name: | syngo.CT Myocardial Perfusion |
| 510(k) Number: | K150713 |
| Clearance Date: | 11/02/2015 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| Trade Name: | syngo.CT Neuro DSA |
| 510(k) Number: | K053024 |
| Clearance Date: | 11/04/2005 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| Trade Name: | syngo.CT Neuro Perfusion |
| 510(k) Number: | K202213 |
| Clearance Date: | 10/11/2020 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| Trade Name: | syngo.CT Skull Unfolding |
| 510(k) Number: | K203411 |
| Clearance Date: | 07/22/2021 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| Trade Name: | syngo.CT Vascular Analysis |
| 510(k) Number: | K173637 |
| Clearance Date: | 03/30/2018 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
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Image /page/5/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 words is a graphic of several orange dots arranged in a circular pattern.
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Image /page/6/Picture/1 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots.
Device Description IV.
The syngo.CT Applications are syngo based post-processing software applications to be used for viewing and evaluating CT images provided by a CT diagnostic device and enabling structured evaluation of CT images.
The syngo.CT Applications is a combination of thirteen (13) former separately cleared medical devices which are now handled as features / functionalities within syngo.CT Applications. These functionalities are combined unchanged compared to their former cleared descriptions; however, some minor enhancements and improvements are made for the application syngo.CT Pulmo 3D only.
The table below shows the functionalities of syngo.CT Applications:
| Single
| Application | Functionality and description |
|---|---|
| syngo.CT Body | |
| Perfusion | • Evaluation of perfusion of organs and tumors. |
| • Calculation blood flow, blood volume and permeability from sets of images reconstructed from | |
| dynamic CT data acquired after the injection of contrast media | |
| • Separate calculation of arterial and portal venous component of hepatic perfusion | |
| • Evaluation of regions of interest and visual inspection of time density curves | |
| • Deconvolution methods | |
| syngo.CT Bone | |
| Reading | • visualizations of spine and rib structures |
| • 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), crosssection MPRs | |
| • tools for creation and editing of anatomical centerline paths | |
| • tools for creation and editing of anatomical labels | |
| Single | |
| Application | Functionality and description |
| syngo.CT | |
| Cardiac | |
| Function | Evaluation of CT images of the heart. |
| Digital image processing and visualization tools (2D, 3D and 4D display of dynamic data), | |
| Evaluation tools (structural and functional analysis of heart chambers and valves, and analysis | |
| of myocardial tissue) | |
| Reporting tools | |
| syngo.CT | |
| Coronary | |
| Analysis | Evaluating of cardiac CT angiography (CTA) volume data sets |
| Combination of 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), curved planar reformation (CPR)) | |
| • Evaluation tools (coronary vessel centerline calculation, stenosis calculation and plaque | |
| analysis) and reporting tools (lesion location, lesion characteristics and key images), | |
| Designed to support the physician in confirming the presence or absence of physician- | |
| identified coronary lesions and evaluation, documentation and follow-up of any such lesion | |
| These visualization/evaluation tools allow for characterization (geometry (length, lumen | |
| diameter, cross section area, stenos is grade) and appearance (HU values)) of coronary lesions | |
| and lesion size over time, helping the physician to assess the changes in their growth. It is also | |
| designed to help the physician classify conspicuous regions of tissue. | |
| syngo.CT Dental | Basic reading tools (multiplanar reconstruction (MPR), maximum intensity projection (MIP), |
| volume rendering technique (VRT), minimal intensity projection (MinIP) | |
| Basic geometric measurement tools (distance line, polyline, marker, arrow, angle) | |
| Basic HU measurement tools (Pixel lens, ROI Circle, ROI polygonal, ROI freehand, VOI sphere, | |
| VOI freehand) | |
| Dedicated dental visualization tools (Dental panoramic views (curved MPRs) and dental | |
| paraxial views (cross-section MPRs) that are calculated based on a manually defined | |
| centerline) | |
| • Tool to manually outline the mandibular canal | |
| • Tool that allows paraxial and panoramic result images to be saved as dental range series. | |
| True Size (1:1) printing of panoramic and paraxial images to allow anatomy to be printed in its | |
| actual size on the film sheet. | |
| syngo.CT | |
| Dynamic Angio | • Visualization of flow of contrast from the arteries to the veins with contrast enhanced CT |
| images | |
| • Supports in the evaluation of regions of interest, the visual inspection of time attenuation | |
| curves, and the creation of specific CT volumes, for example, arterial or venous phase. | |
| syngo.CT Liver | |
| Analysis | Evaluation of the liver volume and examination of the vessels of the liver |
| Computation and manual correction of liver volumes | |
| • Computation and manual correction of tumor volumes and extent | |
| • Computation and manual correction of liver vessel tree structure | |
| Computation of territories based on vessel branches | |
| Tumor position in relation to vessels (i.e., 3D visualization of liver, tumor, and vessels) | |
| Manual definition of separation plane proposals | |
| Computation of volume of liver parts | |
| Combination of information from different CT and MR phase volumes | |
| syngo.CT | |
| Myocard | |
| Perfusion | Evaluation of the perfusion of the myocardium |
| Calculation of blood flow, blood volume, and other hemodynamic parameters from sets of | |
| images reconstructed from dynamic CT data acquired after the injection of contrast media | |
| Evaluation of regions of interest and the visual inspection of time attenuation curves | |
| syngo.CT Neuro | |
| DSA | Removing of bone structures from CT Angiography (CTA) data sets of the cerebral vasculature |
| Bone removal is based on a bone mask created from an additional non enhanced CT (NECT) | |
| scan that was three-dimensionally registered to the CTA data set | |
| Single | |
| Application | Functionality and description |
| syngo.CT Neuro | |
| Perfusion | The syngo.CT Neuro Perfusion software package is designed to evaluate areas of brain perfusion. The software processes images or volumes that were reconstructed from continuously acquired CT data after the injection of contrast media. Generation of the following result volumes: Cerebral blood flow (CBF), Cerebral blood volume (CBV), Local bolus timing (time to start (TTS), time to peak (TTP), time to drain (TTD)), Mean transit time (MTT), Transit time to the center of the IRF (TMax), Flow extraction product (permeability), Temporal MIP, Temporal Average, Baseline Volume, Modified dynamic input data The software allows the calculation of mirrored regions of interest and the visual inspection of time attenuation curves. One clinical application is to visualize the apparent blood perfusion and to calculate Hypoperfused Area and Mismatch Ratio in the brain tissue affected by acute stroke. Areas of decreased perfusion appear as areas of changed signal intensity: Lower signal, intensity for CBF and CBV, Higher signal intensity for TTP, TTD, MTT, and TMax A second application is to visualize blood brain barrier disturbances by modeling extra-vascular leakage of blood into the interstitial space. This additional capability may improve the differential diagnosis of brain tumors and may be helpful in therapy monitoring. |
| syngo.CT Pulmo | |
| 3D | syngo.CT Pulmo 3D analyses the lung, either completely or in parts, identifying areas with lower or higher Hounsfield values in comparison to a predefined threshold. These areas are evaluated using statistical methods such as histograms and percentiles. Examination of the lung parenchyma and the airways of the lung Evaluation Tools (computation of lung volumes, display of statistics related to the lung, setting of markers, airway measurements) |
| syngo.CT Skull | |
| Unfolding | This software provides advanced visualization of the skull and brain surface for easy manual identification, marking and reporting of pathologies such as skull fractures and hematomas. |
| syngo.CT | |
| Vascular | |
| Analysis | syngo.CT Vascular Analysis is an image analysis software package for evaluating enhanced CT images. Visualization tools (multiplanar reconstruction (MPR) thin/thick, maximum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT), curved planar reformation (CPR), processing tools (bone removal (based both on single energy and Dual Energy), table removal) Evaluation tools (vessel centerline calculation, lumen calculation, stenosis calculation) Reporting tools (lesion location, lesion characteristics and key images), the software package is designed to support the physician in confirming the presence or absence of physician-identified lesions in blood vessels and evaluation, documentation and follow-up of any such lesion. These visualization/processing/evaluation tools allow for characterization (geometry (length, lumen diameter, cross section area, stenosis grade) and appearance (HU values)) of vascular lesions and lesion size over time, helping the physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue. |
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Image /page/8/Picture/1 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots arranged in a circular pattern.
The Appendix D – Revision Level History outlines the clearance dates for all applications and all modifications/bug fixes completed in each release of the devices since. These changes did not constitute the need for a 510(k) according to "Deciding When to Submit a 510(k) for a Software Change to an Existing Device", October 25, 2017. (i.e. these modifications did not change the indication for use or safety or effectiveness, change clinical functionality or performance specifications, or introduce new risks or necessitate new risk control measures.)
Except for the new product composition, the only change with this release includes some minor improvements and enhancements of the existing functionalities within the syngo.CT Pulmo 3D application:
For verification purposes, syngo.CT Pulmo 3D in the software version SOMARIS/8 VB70 provides an assignment of different colors to the lobe borders in the lobe visualization. In this software version,
9
the same colors are used which were previously provided to the end-user as table headings for each lobe in the previous version. The colors are as follows:
- Upper Left Lobe: orange
- Lower Left Lobe: pink
- Upper Right Lobe: yellow
- . Middle Right Lobe: green
- Lower Right Lobe: light blue
This coloring will be disabled as soon as one of the analysis modes is activated to avoid confusion with the colors used for the various analyzes of the lung parenchyma.
V. Indications for Use
syngo.CT Applications is a set of software applications for advanced visualization, measurement, and evaluation for specific body regions.
This software package is designed to support the radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice e.g. in the:
- Evaluation of perfusion of organs and tumors and myocardial tissue perfusion
- Evaluation of bone structures and detection of bone lesions ●
- Evaluation of CT images of the heart ●
- . Evaluation of the coronary lesions
- Evaluation of the mandible and maxilla
- . Evaluation of dynamic vessels and extended phase handling
- . Evaluation of the liver and its intrahepatic vessel structures to identify the vascular territories of sub-vessel systems in the liver
- Evaluation of neurovascular structures
- . Evaluation of the lung parenchyma
- Evaluation of non-enhanced Head CT images
- Evaluation of vascular lesions
VI. Comparison of Technological Characteristics with the Predicate Device
The subject device is a combination of the thirteen (13) former separate medical devices. The main functionalities of the predicate devices are used unchanged for syngo.CT Applications SOMARIS/VB70 except the minor changes within syngo.CT Pulmo 3D.
| Subject Device | Predicate Device Information | |||
|---|---|---|---|---|
| Application within the bundle | ||||
| device syngo.CT Applications | Product Name | Product Code | K-Number | Clearance Date |
| syngo.CT Body Perfusion | syngo.CT Body Perfusion | JAK | K092013 | 07/17/2009 |
| syngo.CT Bone Reading | syngo.CT Bone Reading | JAK | K123584 | 03/12/2013 |
| syngo.CT Cardiac Function | syngo.CT Cardiac Function | JAK | K123585 | 12/20/2012 |
| syngo.CT Coronary Analysis | syngo.CT Coronary Analysis | JAK | K173637 | 03/30/2018 |
| syngo.CT Dynamic Angio | syngo.CT Dynamic Angio | JAK | K120331 | 04/13/2012 |
| syngo.CT Dental | syngo.CT Dental | JAK | K150785 | 05/18/2015 |
10
| Subject Device | Predicate Device Information | |||
|---|---|---|---|---|
| Application within the bundle | ||||
| device syngo.CT Applications | Product Name | Product Code | K-Number | Clearance Date |
| syngo.CT Liver Analysis | syngo.CT Liver Analysis | JAK | K133643 | 11/13/2014 |
| syngo.CT Myocardial Perfusion | syngo.CT Myocardial Perfusion | JAK | K150713 | 11/02/2015 |
| syngo.CT Neuro DSA | syngo.CT Neuro DSA | JAK | K053024 | 11/04/2005 |
| syngo.CT Neuro Perfusion | syngo.CT Neuro Perfusion | JAK | K202213 | 10/11/2020 |
| syngo.CT Pulmo 3D | syngo.CT Pulmo 3D | JAK | K123540 | 08/29/2013 |
| syngo.CT Skull Unfolding | syngo.CT Skull Unfolding | JAK | K203411 | 07/22/2021 |
| syngo.CT Vascular Analysis | syngo.CT Vascular Analysis | JAK | K173637 | 03/30/2018 |
Performance Data VII.
The following performance data were provided in support of the substantial equivalence determination.
Software Verification and Validation
Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. The Risk Analysis was completed, and risk control implemented 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.
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 Dual Energy meets the following FDA Recognized Consensus standards listed below:
| 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 |
| 5-125 | Software/
Informatics | Medical devices – Application of risk
management to medical devices; 14971 Third
Edition 2019-12 | 12/23/2016 | 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 | AAMI, ANSI, IEC |
11
Image /page/11/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots.
| 5-117 | General
(QS/RM) | Medical devices - Symbols to be used with
medical device labels, labelling, and
information to be supplied - Part 1: General
requirements
ISO 15223-1 Third Edition 2016-11-01 | 08/21/2017 | ISO |
| ------- | -------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------ | ----- |
|---|
VIII. Conclusion
The syngo.CT Applications are intended for similar indications as cleared in their according predicate devices.
Since the thirteen (13) formerly cleared separate medical devices have been consolidated into one (1) medical device, the Indications for Use has been updated. However, the newly revised indication for use does not introduce any new specific clinical indications/features. The intended use of the former devices remains unchanged. The fundamental scientific technology and technological characteristics are the same as the predicate devices.
The result of all testing conducted was found acceptable to support the claim of substantial equivalence. The comparison of technological characteristics 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 Applications, Siemens used the same testing with the same workflows as used to clear the predicate devices. Siemens considers syngo.CT Applications to be as safe, as effective and with performance substantially equivalent to the commercially available predicate devices.
Therefore, Siemens believes that the subject device, the syngo.CT Applications does not raise new questions of safety and effectiveness and is substantially equivalent to their primary predicate devices listed above in Table 1.