(126 days)
Not Found
No
The summary describes standard image processing and analysis techniques (MPR, MIP, VRT, CPR, centerline calculation, stenosis calculation, plaque analysis, bone removal, table removal) and focuses on improvements to existing algorithms for tracing and centeredness. There is no mention of AI, ML, deep learning, or any related concepts. The performance testing described is based on comparing the results of these algorithms to the predicate device, not on evaluating the performance of a learned model.
No
The device is an image analysis software package designed to support physicians in evaluating and documenting lesions for diagnosis and follow-up, not to provide therapy.
Yes
The device is designed to support physicians in "confirming the presence of physician-identified coronary lesions and evaluation, documentation and follow-up of any such lesion" and "confirming the presence or absence of physician-identified lesions in blood vessels," and helps "characterization (geometry ... and appearance ...) of coronary lesions" and "classify conspicuous regions of tissue," all of which are diagnostic functions.
Yes
The device description explicitly states that the device is a "software application" and describes its function as "image analysis post-processing software". There is no mention of any accompanying hardware components being part of the device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The syngo.CT Coronary Analysis and syngo.CT Vascular Analysis software packages are image analysis tools that process and visualize medical images (CT angiography and enhanced CT images) acquired from the human body. They do not analyze specimens taken from the body.
- Intended Use: The intended use is to support physicians in evaluating and documenting lesions in blood vessels based on imaging data. This is distinct from analyzing biological samples.
Therefore, while this device is a medical device used in diagnosis and treatment planning, it falls under the category of medical imaging software rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
syngo.CT Coronary Analysis
syngo.CT Coronary Analysis is an image analysis so0ftware package for evaluating cardiac CT angiography (CTA) volume data sets. Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, maximum intensity projection (MP) thin/thick, inverted MP 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), the software package is designed to support the physician in confirming the presence of physician-identified coronary lesions and evaluation, documentation and follow-up of any such lesion. These visualization tools allow for characterization (geometry (length, lumen diameter, cross section area, stenosis 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 Vascular Analysis
syngo.CT Vascular Analysis is an image analysis software package for evaluating enhanced CT images. Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, maximum intensity projection (MIP) thin/thick, inverted MIP think, volume rendering technique (VRT), curved planar reformation (CPR), processing tools (bone removal (based both on single energy and Dual Energy), table removal) and evaluation tools (vessel centerline calculation, lumen calculation) and 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 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.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
syngo.CT Coronary Analysis
syngo.CT Coronary Analysis is an image analysis post-processing software application designed to support evaluation of the vessels of the heart. This submission describes the following modifications that were made to predicate device syngo.CT Coronary Analysis (K100637, clearance date 5/26/2010):
-
- Support of software version SOMARIS/8 VB30 which supports the following functionality:
- a. Coronary Tracing Quality Improvement
- Rapid Results Technology Support for Curved Vessel Ranges ڪ
-
- Update 510(k) Information
Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT), curved planar reformation (CPR)), evaluation tools (coronary vessel centerline calculation, stencils calculation and plaque analysis) and reporting tools (lesion location, lesion characteristics and kev images), the software package is designed to support the physician in confirming the presence of physician-identified coronary lesions and evaluation, documentation and follow-up of any such lesion. These visualization/evaluation tools allow for characterization 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 Vascular Analysis
syngo.CT Vascular Analysis is a post-processing software application to support evaluation of the large vessels of the body. This submission describes the following modifications that were made to predicate device syngo.CT Vascular Analysis (K112020, clearance date 08/18/2011):
- Modified Indications for Use Statement 1)
- Support of software version SOMARIS/8 VB30 which supports the following 2) functionality:
- a. Rapid Results Technology Support for curved vessel ranges
- Bone Removal Quality Improvement b.
- Vessel Tracing Quality Improvement C.
-
- Update 510(k) Information
Combining 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), processing tools (bone removal (based both on single energy and Dual Energy), table removal) and evaluation tools (vessel centerline calculation, lumen calculation, stenosis calculation) and 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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT angiography (CTA) volume data sets, enhanced CT images
Anatomical Site
vessels of the heart, blood vessels (large vessels of the body)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
Non-clinical tests (integration and functional) were conducted for syngo.CT Coronary Analysis and syngo.CT Vascular Analysis during product development. Performance tests were conducted to test the functionality of syngo.CT Coronary Analysis and syngo.CT Vascular Analysis. The modifications described in this Premarket Notification were supported with verification/validation testing. 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.
Non-Clinical Performance (Bench) Testing
To demonstrate the coronary tracing quality improvement for subject device syngo.CT Coronary Analysis, quantitative performance testing was conducted to test the following functions:
- Centeredness of the Centerlines ●
- Tracing of branches ●
- Coverage of Centerlines .
As part of this testing, a sampling of centerlines from a predetermined number of datasets were evaluated. To test for accuracy of centeredness, the derived centerlines were assessed in comparison to the predicate device to demonstrate an improvement in the ability of the subject device application to more accurately follow the vessels in the lumen. Testing for the tracing of branches and coverage of centerlines was conducted on branches that were considered both clinically relevant and clinically irrelevant to assess sensitivity and specificity of branch tracing and coverage. The results of this test demonstrated an increased sensitivity and specificity and improved vessel coverage for the subject device tracing feature in comparison to the predicate device.
To demonstrate the functionality of the vessel tracing quality improvement for subject device syngo.CT Vascular Analysis, the detection rate of a predetermined set of vessels was evaluated to determine whether a vessel was successfully traced if a vessel was expected based on activation of the algorithm. The result of this test demonstrated that the subject device had a higher level of traced vessels in comparison to the predicate device, which supports an improvement of vessel tracing quality in comparison to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
"an increased sensitivity and specificity" (for syngo.CT Coronary Analysis branch tracing and coverage)
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
§ 892.1750 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 contains 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 text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".
Siemens Medical Solutions USA, Inc. % Ms. Kimberly Mangum Regulatory Affairs Specialist 40 Liberty Boulevard MALVERN PA 19355
March 30, 2018
Re: K173637
Trade/Device Name: syngo.CT Coronary Analysis; syngo.CT Vascular Analysis Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 2, 2018 Received: March 9, 2018
Dear Ms. Mangum:
We have reviewed vour 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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs, Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173637
Device Name
syngo.CT Coronary Analysis
Indications for Use (Describe)
syngo.CT Coronary Analysis is an image analysis so0ftware package for evaluating cardiac CT angiography (CTA) volume data sets. Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/ thick, maximum intensity projection (MP) thin/thick, inverted MP 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), the software package is designed to support the physician in confirming the presence of physician-identified coronary lesions and evaluation, documentation and follow-up of any such lesion. These visualization tools allow for characterization (geometry (length, lumen diameter, cross section area, stenosis 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.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K173637
Device Name
syngo.CT Vascular Analysis
Indications for Use (Describe)
syngo.CT Vascular Analysis is an image analysis software package for evaluating enhanced CT images. Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, maximum intensity projection (MIP) thin/thick, inverted MIP think, volume rendering technique (VRT), curved planar reformation (CPR), processing tools (bone removal (based both on single energy and Dual Energy), table removal) and evaluation tools (vessel centerline calculation, lumen calculation) and 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 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.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------------- | ----------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The color of the text is a light blue or teal. The letters are bold and evenly spaced, creating a clear and recognizable logo. The background is plain and white, which makes the text stand out.
510(K) Summary FOR SYNGO.CT CORONARY ANALYSIS AND SYNGO.CT VASCULAR ANALYSIS
Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Date Prepared: March 29, 2018
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
l. 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
Contact Person
Kimberly Mangum Regulatory Affairs Specialist Siemens Medical Solutions, Inc. USA 40 Liberty Boulevard Malvern, PA 19355 Phone: (610) 448 - 6477 Fax: (610) 640 - 4481 Email: kimberly.mangum@siemens-healthineers.com
II. Device Name and Classification
| Product Name: | syngo.CT Coronary Analysis |
|---|---|
| Proprietary Name: | syngo.CT Coronary Analysis |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| Product Name: | syngo.CT Vascular Analysis |
| Proprietary Name: | syngo.CT Vascular Analysis |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
III. Predicate Device Predicate Device for syngo.CT Coronary Analysis: Trade Name: syngo.CT Coronary Analysis 510(k) Number: K100637
5
SIEMENS
Clearance Date: 05/26/2010 Classification Name: Computed tomography X-ray system Classification Panel: Radiology CFR Section: 21 CFR §892.1750 Device Class: Class II JAK Product Code: This predicate has not been subject to a design-related recall Recall Information:
Predicate Device for syngo.CT Vascular Analysis:
Trade Name: syngo.CT Vascular Analysis 510(k) Number: K112020 Clearance Date: 08/18/2011 Classification Name: Computed tomography X-ray system Classification Panel: Radiology 21 CFR §892.1750 CFR Section: Device Class: Class II Product Code: JAK Recall Information: This predicate has not been subject to a design-related recall
IV. Device Description
syngo.CT Coronary Analysis
syngo.CT Coronary Analysis is an image analysis post-processing software application designed to support evaluation of the vessels of the heart. This submission describes the following modifications that were made to predicate device syngo.CT Coronary Analysis (K100637, clearance date 5/26/2010):
-
- Support of software version SOMARIS/8 VB30 which supports the following functionality:
- a. Coronary Tracing Quality Improvement
- Rapid Results Technology Support for Curved Vessel Ranges ڪ
-
- Update 510(k) Information
Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT), curved planar reformation (CPR)), evaluation tools (coronary vessel centerline calculation, stencils calculation and plaque analysis) and reporting tools (lesion location, lesion characteristics and kev images), the software package is designed to support the physician in confirming the presence of physician-identified coronary lesions and evaluation, documentation and follow-up of any such lesion. These visualization/evaluation tools allow for characterization 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 Vascular Analysis
syngo.CT Vascular Analysis is a post-processing software application to support evaluation of the large vessels of the body. This submission describes the following modifications that were made to predicate device syngo.CT Vascular Analysis (K112020, clearance date 08/18/2011):
- Modified Indications for Use Statement 1)
- Support of software version SOMARIS/8 VB30 which supports the following 2) functionality:
- a. Rapid Results Technology Support for curved vessel ranges
- Bone Removal Quality Improvement b.
- Vessel Tracing Quality Improvement C.
-
- Update 510(k) Information
Combining 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), processing tools (bone removal (based both on single energy and Dual Energy), table removal) and evaluation tools (vessel centerline calculation, lumen calculation, stenosis calculation) and reporting tools (lesion location, lesion characteristics and key images), the software package is designed to support
6
SIEMEN
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 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.
V. Indications for Use
Indications for Use for syngo.CT Coronary Analysis
syngo.CT Coronary Analysis is an imaqe analysis soOftware package for evaluating cardiac CT angiography (CTA) volume data sets. Combining 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 characteristics and key images), the software package is 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, stenosis 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.
Indications for Use for syngo.CT Vascular Analysis
syngo.CT Vascular Analysis is an image analysis software package for evaluating enhanced CT images. Combining 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), processing tools (bone removal (based both on single energy and Dual Energy), table removal) and evaluation tools (vessel centerline calculation, lumen calculation, stenosis calculation) and reporting tools (lesion location, lesion characteristics and kev images), the software package is designed to support the physician in confirming the presence or absence of physicianidentified 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.
VI. Comparison of Technological Characteristics with the Predicate Device
At a very high-level overview, the subject and predicate devices are based on the following same/modified technological characteristics.
- Software operating platform SOMARIS8/8 .
- Support of basic reading Functionality ●
- 2D/3D vessel visualization tools ●
- Automated segmentation and removal of obstructive bones and/or vessels ●
- . Support of automated pre-processing and layouts
- Measurement tools that support quantitative assessment and documentation ●
The following technological differences exist between the subject devices and the predicate devices:
- Software version SOMARIS/8 VB30 ●
- Support of Rapid Results Technology feature ●
- lmproved bone removal functionality ●
- Improved vessel tracing functionality ●
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SIEMENS
A tabular summary of the subject and predicate device technological differences is provided as Table 1 and Table 2 below:
| Table 1: syngo.CT Coronary Analysis Predicate and Subject Device Technological | |||||
|---|---|---|---|---|---|
| Characteristics Comparison |
| Property | Subject Device
syngo.CT Coronary
Analysis | Predicate Device
syngo.CT Coronary
Analysis
(K100637) | Comparison Results |
|-----------------------------------------|-------------------------------------------------|----------------------------------------------------------------|--------------------|
| Software Operating
Platform | SOMARIS/8 VB30 | SOMARIS/8 VA10 | Modified |
| | Basic Visualization and
Navigation Tools | Basic Visualization and
Navigation Tools | Same |
| | Automatic Organ
Segmentation | Automatic Organ
Segmentation | Same |
| | Automatic Vessel
Tracing | Automatic Vessel
Tracing | Modified. |
| | 3D Vessel Visualization
Tools | 3D Vessel Visualization
Tools | Same |
| Visualization and
Segmentation Tools | 2D Vessel Visualization
Tools | 2D Vessel Visualization
Tools | Same |
| | Vessel Navigation
Tools | Vessel Navigation
Tools | Same |
| | Vessel Definition Tools | Vessel Definition Tools | Same |
| | Vessel Evaluation
Tools | Vessel Evaluation
Tools | Same |
| | Result Image Creation | Result Image Creation | Same |
| | Integrated Reporting | Integrated Reporting | Same |
| | Workflow Automation
Support | Workflow Automation
Support | Modified |
| | User Interface | User Interface | Same |
| Archiving and
Reporting | Archiving/Storing | Archiving/Storing | Same |
| | Communication | Communication | Same |
Table 2: syngo.CT Vascular Analysis Predicate and Subject Device Technological Characteristics Comparison
| Property | Subject Device
syngo.CT Coronary
Analysis | Predicate Device
syngo.CT Vascular
Analysis
(K112020) | Comparison Results |
|-----------------------------------------|-------------------------------------------------|----------------------------------------------------------------|--------------------|
| Software Operating
Platform | SOMARIS/8 VB30 | SOMARIS/8 VA10 | Modified |
| Visualization and
Segmentation Tools | Basic Visualization and
Navigation Tools | Basic Visualization and
Navigation Tools | Same |
| | Automatic Organ
Segmentation | Automatic Organ
Segmentation | Modified |
| | Automatic Vessel
Tracing | Automatic Vessel
Tracing | Modified. |
| | 3D Vessel Visualization
Tools | 3D Vessel Visualization
Tools | Same |
| | 2D Vessel Visualization
Tools | 2D Vessel Visualization
Tools | Same |
8
| Property | Subject Device
syngo.CT Coronary
Analysis | Predicate Device
syngo.CT Vascular
Analysis
(K112020) | Comparison Results |
|-----------------------------------------|-------------------------------------------------|----------------------------------------------------------------|--------------------|
| Visualization and
Segmentation Tools | Vessel Navigation
Tools | Vessel Navigation
Tools | Same |
| | Vessel Definition Tools | Vessel Definition Tools | Same |
| | Vessel Evaluation
Tools | Vessel Evaluation
Tools | Same |
| | Result Image Creation | Result Image Creation | Same |
| | Integrated Reporting | Integrated Reporting | Same |
| | Workflow Automation
Support | Workflow Automation
Support | Modified |
| Archiving and
Reporting | User Interface | User Interface | Same |
| | Archiving/Storing | Archiving/Storing | Same |
| | Communication | Communication | Same |
The subject device modifications do not alter the fundamental scientific technology of the 510(k) cleared predicate devices syngo.CT Coronary Analysis and syngo.CT Vascular Analysis. The software version has been modified to support improved clinical workflows.
VII. Performance Data
Non-Clinical Testing Summary
Non-clinical tests (integration and functional) were conducted for syngo.CT Coronary Analysis and syngo.CT Vascular Analysis during product development. Performance tests were conducted to test the functionality of syngo.CT Coronary Analysis and syngo.CT Vascular Analysis. The modifications described in this Premarket Notification were supported with verification/validation testing. 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. Siemens claims conformance to the following performance standards:
| Product
Area | Title of Standard | Publicatio
n Date | Standards
Development
Organization |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|------------------------------------------|
| Radiology | Digital Imaging and Communications in
Medicine (DICOM) Set; PS 3.1 – 3.20 | 06/27/2016 | NEMA |
| Software | Medical Device Software -Software Life
Cycle Processes; 62304:2006 (1st
Edition) | 08/20/2012 | AAMI, ANSI, IEC |
| Software/
Informatics | Medical devices - Application of risk
management to medical devices; 14971
Second Edition 2007-03-01 | 08/20/2012 | ISO |
| General I
(QS/RM) | Medical devices - Part 1: Application of
usability engineering to medical devices
IEC 62366-1:2015 | 06/27/2016 | IEC |
| General II
(ES/EMC) | AAMI / ANSI ES60601-1:2005/(R)2012
and A1:2012, Medical electrical
equipment - part 1: general requirements
for basic safety and essential
performance (IEC 60601-1:2005, mod) | 07/09/2014 | AAMI, ANSI |
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SIEMENS
Non-Clinical Performance (Bench) Testing
Additional non-clinical quantitative performance testing was conducted to demonstrate the functionality and applicability of the subject devices modified features. To demonstrate the coronary tracing quality improvement for subject device syngo.CT Coronary Analysis, quantitative performance testing was conducted to test the following functions:
- Centeredness of the Centerlines ●
- Tracing of branches ●
- Coverage of Centerlines .
As part of this testing, a sampling of centerlines from a predetermined number of datasets were evaluated. To test for accuracy of centeredness, the derived centerlines were assessed in comparison to the predicate device to demonstrate an improvement in the ability of the subject device application to more accurately follow the vessels in the lumen. Testing for the tracing of branches and coverage of centerlines was conducted on branches that were considered both clinically relevant and clinically irrelevant to assess sensitivity and specificity of branch tracing and coverage. The results of this test demonstrated an increased sensitivity and specificity and improved vessel coverage for the subject device tracing feature in comparison to the predicate device.
To demonstrate the functionality of the vessel tracing quality improvement for subject device syngo.CT Vascular Analysis, the detection rate of a predetermined set of vessels was evaluated to determine whether a vessel was successfully traced if a vessel was expected based on activation of the algorithm. The result of this test demonstrated that the subject device had a higher level of traced vessels in comparison to the predicate device, which supports an improvement of vessel tracing quality in comparison to the predicate device.
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 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.
Siemens Healthcare conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Cybersecurity information in accordance with quidance document "Content of Premarket Submissions for Management of Cybersecurity Medical Devices issues on October 2, 2014" is included within this submission.
Summary
This subject devices provide tools designed for the evaluation of CT images. The fundamental software technology which is provided within the scope of the subject devices is already cleared and remains unchanged in comparison to the predicate devices. The Indications for Use for the subject devices have been adapted to provide a more specific description of the subject device functionality, but does not represent a new intended use. The modifications described in this Premarket Notification were supported with non-clinical performance testing as well as verification and validation testing. The Risk analysis was completed and risk control implemented to mitigate identified hazards.
General Safety and Effectiveness Concerns
The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device. Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled during development, verification and validation testing. syngo.CT Coronary Analysis and syngo.CT Vascular Analysis is designed to fulfill the requirements of the applicable safety and performance standards as listed above.
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VIII. Conclusions
The subject devices have the same intended use as the predicate devices. The technological characteristics such as image visualization, operating platform, and image manipulation remain unchanged from the predicate device. The predicate devices were cleared based on non-clinical testing including verification and validation testing. The results of these tests demonstrate that the predicate devices are adequate for the intended use. The subject devices are also tested using the same methods and workflows as used for the predicate devices. The comparison of technological characteristics, non-clinical performance data, and software validation included in this submission demonstrates that the subject device is as safe and effective when compared to the predicate devices that are currently marketed for the same intended use. Since both devices were tested using the same methods, Siemens believes that the data generated from the subject devices syngo.CT Coronary Analysis and syngo.CT Vascular Analysis testing supports a finding of substantial equivalence.