(237 days)
Not Found.
No
The document describes standard image processing and visualization techniques (MPR, VRT, pSSD, Virtual Flight, Panoramic View, Polyp Lens, Stool Tagging, Stool Subtraction, PEV, Movie, Semi-automatic measurements) and workflow management tools. There is no mention of AI, ML, deep learning, or any related concepts in the intended use, device description, or performance studies sections. The focus is on facilitating physician review and measurement, not automated detection or analysis using AI/ML.
No.
The device is a post-processing software for CT data that aids in the visualization, navigation, and evaluation of colon lesions, supporting the physician in diagnosis, but it does not directly treat or prevent a disease.
Yes
The device is used to facilitate the search and diagnosis of colon lesions and helps the physician classify conspicuous regions of tissue, which are diagnostic functions.
Yes
The device is described as a "self-contained image analysis software package" and its function is post-processing and analysis of CT volume data sets. There is no mention of accompanying hardware components that are part of the medical device itself.
Based on the provided text, 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 Colonography is an image analysis software package for evaluating CT volume data sets. It processes medical images (CT scans) of the colon.
- No Biological Samples: The device does not interact with or analyze biological samples from the patient. Its input is imaging data.
Therefore, syngo.CT Colonography falls under the category of medical imaging software or a medical device for image processing and analysis, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
syngo. CT Colonography is used for easy-to-perform and efficient inspection of the colonic surface. It facilitates the search and diagnosis of colon lesions. The workflow management ensures that the required data and tools are offered to you according to your role and task.
syngo. CT Colonography is a clinical post-processing workflow for basic virtual colonoscopy. It is designed to support the following image reconstruction techniques:
- Multiplanar Reconstruction (MPR)
- Volume Rendering Technique (VRT)
- Perspective surface shaded display (pSSD)
The following evaluation tools are provided with this workflow: - Virtual Flight
- Panoramic View
- Polyp Lens
- Stool Tagging Stool Subtraction
- Polyp Enhanced Viewing (PEV)
- Movie
syngo.CT Colonography supports reporting with appropriate reporting tools such as lesion location, lesion characterization, and key image creation. Commercially available digital image processing tools with an optimized workflow and reporting tools, the software is designed to support the physician on confirming the presence or absence of physician identified colon lesions (for example, polyps) in addition to evaluation, and follow-up of any such lesions using standard or low-dose spiral CT scanning.
Product codes
NWE
Device Description
syngo.CT Colonography is a self-contained image analysis software package for evaluating CT volume data sets. The software is designed to support the physician in studying the inside, wall, and outside of the colon. It helps the physician to classify conspicuous regions of tissue with respect to their size, shape, and position.
Therefore, it combines tools for
- visualization of the data:
- Panoramic Endoluminal View
- Stool Tagging
- Workflow Improvements
- Virtual Dissection
- Polyp Lens
- Stool Subtraction
- navigation through the CT volume data sets
- evaluation of potential findings:
- Semi-automatic measurements
- reporting of results:
For the inspection of the colonic surface and diagnosis of colon lesions clinically, two workflows have been established:
- 2-dimensional search and 3-dimensional diagnosis: Multiplanar Reconstructions (MPRs) are used for the detection of lesions. If a suspicious structure has been detected, the virtual endoscope is located and the final diagnosis can be performed.
- 3-dimensional search and 2-dimensional diagnosis: A virtual flight is performed starting at the rectum position of one data set. If a suspicious structure has been detected, the final diagnosis is performed using the MPRs.
syngo.CT Colonography is a post processing application operating on the multi-user syngo.via client server platform. The subject device syngo.CT Colonography provides similar evaluation, processing, reporting and visualization tools, and functionality as the predicate device syngo Colonography with extended functionality (K042605, clearance date October 8, 2004). This includes various image processing and visualization. At a high level, the subject and predicate devices are based on the following same technical elements:
- Polyp Enhanced Viewing
- Segmentation in Global View
- Size measurements of polyps
- 3D Inspection of colon in Endoluminal view
The subject device contains additional automatic and semi-automatic visualization and evaluation tools which support assessment of colonic lesions.
Mentions image processing
Yes. "Commercially available digital image processing tools with an optimized workflow and reporting tools, the software is designed to support the physician on confirming the presence or absence of physician identified colon lesions (for example, polyps) in addition to evaluation, and follow-up of any such lesions using standard or low-dose spiral CT scanning." and "This includes various image processing and visualization."
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
CT volume data sets / standard or low-dose spiral CT scanning.
Anatomical Site
Colon / colonic surface
Indicated Patient Age Range
Not Found.
Intended User / Care Setting
Physician. Not Found for care setting.
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
Non clinical tests (integration and functional) were conducted for the syngo.CT Colonography during product development. The modifications described in this Premarket Notification were supported with verification/validation testing.
The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports 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.
Clinical performance tests were conducted to demonstrate performance. safety, and effectiveness of syngo.CT Colonography. Testing was provided to cover a variety of clinical situations that would be seen in daily clinical use of the subject device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance tests were conducted to test the functionality of the syngo.CT Colonography post processing application. These tests have been performed to test the ability of the included features of syngo.CT Colonography. The results of these tests demonstrate that this application is able to inspect the colonic surface and colon lesions. Furthermore, clinical performance testing information was provided to demonstrate the functionality of supported application features.
The result of all conducted testing was found acceptable to support the claim of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found.
Predicate Device(s)
Reference Device(s)
Not Found.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines extending from the bottom of the profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Siemens Medical Solutions USA, Inc. % Ms. Kimberly Mangum Regulatory Affairs Specialist 51 Valley Stream Parkway MALVEN PA 19355
December 3, 2014
Re: K140920
Trade/Device Name: syngo.CT Colonography Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: NWE Dated: October 31, 2014 Received: November 04, 2014
Dear Ms. Mangum:
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. 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 (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
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A Ocks
for
Janine M. Morris 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) K140920
Device Name syngo.CT Colonography
Indications for Use (Describe)
syngo. CT Colonography is used for easy-to-perform and efficient inspection of the colonic surface. It facilitates the search and diagnosis of colon lesions. The workflow management ensures that the required data and tools are offered to you according to your role and task.
syngo. CT Colonography is a clinical post-processing workflow for basic virtual colonoscopy. It is designed to support the following image reconstruction techniques:
- · Multiplanar Reconstruction (MPR)
- · Volume Rendering Technique (VRT)
- · Perspective surface shaded display (pSSD)
- The following evaluation tools are provided with this workflow:
- Virtual Flight
- · Panoramic View
- Polyp Lens
- Stool Tagging Stool Subtraction
- Polyp Enhanced Viewing (PEV)
- Movie
syngo.CT Colonography supports reporting with appropriate reporting tools such as lesion location, lesion characterization, and key image creation. Commercially available digital image processing tools with an optimized workflow and reporting tools, the software is designed to support the physician on confirming the presence or absence of physician identified colon lesions (for example, polyps) in addition to evaluation, and follow-up of any such lesions using standard or low-dose spiral CT scanning.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are all capitalized and are a light blue color. The word is centered and takes up most of the frame.
510(K) SUMMARY FOR syngo.CT Colonography Submitted by: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355 Date Prepared: October 30, 2014
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.
-
- General Information
Importer/Distributor:
- General Information
Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355
Establishment Registration Number: 2240869
Manufacturing Site: Siemens AG Medical Solutions Henkestraße 127 D-91052 Erlangen, Germany
Establishment Registration Number: 3002808157
2. Contact Person:
Mrs. Kimberly Mangum Technical Specialist, Requlatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway D02 Malvern, PA 19355-1406 Phone: (610) 448-1772 Fax: (610) 448-1778 Email: kimberly.mangum@siemens.com
3. Device Name and Classification
| Product Name: | syngo.CT Colonography |
|---|---|
| Propriety Trade Name: | syngo.CT Colonography |
| Classification Name: | Colon Computed Tomography System, |
| Computer Aided Detection | |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.2050 |
| Device Class: | Class II |
4
Image /page/4/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The word is written in all capital letters. The color of the text is a light blue or teal color.
| Product Code: | NWE |
|---|---|
| Legally Marketed Predicate Devices | |
| Trade Name: | syngo Colonography – Software Package |
| with Extended Functionality | |
| 510(k): | K042605 |
| Clearance Date: | October 08, 2004 |
| Classification Name: | Colon Computed Tomography System, |
| Computer Aided Detection | |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR § 892.2050 |
| Device Class: | II |
| Product Code: | NWE |
Substantial Equivalence 4.
The subject device syngo.CT Colonography is substantially equivalent to following medical devices in commercial distribution:
| Predicate Device Name | FDA Clearance
Number | FDA Clearance Date |
|--------------------------------------------------------------|-------------------------|--------------------|
| Colonography Software Package
with extended functionality | K042605 | 10/08/2004 |
5. Device Description
syngo.CT Colonography is a self-contained image analysis software package for evaluating CT volume data sets. The software is designed to support the physician in studying the inside, wall, and outside of the colon. It helps the physician to classify conspicuous regions of tissue with respect to their size, shape, and position.
Therefore, it combines tools for
- visualization of the data: ●
- Panoramic Endoluminal View a)
- Stool Tagging b)
- Workflow Improvements C)
- Virtual Dissection d)
- e) Polyp Lens
- Stool Subtraction f)
- navigation through the CT volume data sets ●
- evaluation of potential findings: ●
- a) Semi-automatic measurements
- reporting of results:
- a)
5
SIEMENS
For the inspection of the colonic surface and diagnosis of colon lesions clinically, two workflows have been established:
- 2-dimensional search and 3-dimensional diagnosis: . Multiplanar Reconstructions (MPRs) are used for the detection of lesions. If a suspicious structure has been detected, the virtual endoscope is located and the final diagnosis can be performed.
- 3-dimensional search and 2-dimensional diagnosis: . A virtual flight is performed starting at the rectum position of one data set. If a suspicious structure has been detected, the final diagnosis is performed using the MPRs.
Comparison of Technological Characteristics with the 6. Predicate Device
syngo.CT Colonography is a post processing application operating on the multi-user syngo.via client server platform. The subject device syngo.CT Colonography provides similar evaluation, processing, reporting and visualization tools, and functionality as the predicate device syngo Colonography with extended functionality (K042605, clearance date October 8, 2004). This includes various image processing and visualization. At a high level, the subject and predicate devices are based on the following same technical elements:
- Polyp Enhanced Viewing
- Segmentation in Global View
- Size measurements of polyps ●
- 3D Inspection of colon in Endoluminal view ●
The subject device contains additional automatic and semi-automatic visualization and evaluation tools which support assessment of colonic lesions. syngo.CT Colonography does not have significant changes in technological characteristics when compared to the predicate devices. The indication for use, intended use, operating principle, and fundamental scientific technology are similar; therefore, Siemens believes that syngo.CT Colonography is substantially equivalent to the predicate devices.
6
SIEMEN
Performance Data 7.
Nonclinical Testing:
syngo.CT Colonography is designed to fulfill the requirements of the following safety and performance standards:
| Recognition
Number | Product
Area | Title of Standard | Reference
Number and
Date | Publication
Date | Standards
Development
Organization |
|-----------------------|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|---------------------|------------------------------------------|
| 12-238 | Radiology | Digital Imaging and
Communications in Medicine
(DICOM) Set | PS 3.1 - 3.18 | 03/16/2012 | NEMA |
| 13-8 | Software | Medical device software -
Software life cycle processes | 62304 First
edition 2006-05 | 08/20/2012 | IEC |
| 5-40 | General | Medical devices - Application of
risk management to medical
devices | 14971 Second
Edition 2007-
03-01 | 08/20/2012 | ISO |
| 5-85 | General | Medical electrical equipment --
Part 1-6: General requirements
for basic safety and essential
performance -- Collateral
Standard: Usability | 60601-1-6
Edition 3.0
2010-01 | 1/30/2014 | IEC |
| 5-41 | General | Medical electrical equipment -
Part 1-4: General requirements
for safety -- Collateral standard:
Programmable electrical medical
systems, edition 1.1 | 60601-1-
4:2000, Consol.
Ed. 1.1 | | IEC |
This submission contains performance data to demonstrate continued conformance with special controls for medical devices containing software. Non clinical tests (integration and functional) were conducted for the syngo.CT Colonography during product development. The modifications described in this Premarket Notification were supported with verification/validation testing.
The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports 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.
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
7
SIEMENS
Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission.
Clinical Testing:
Clinical performance tests were conducted to demonstrate performance. safety, and effectiveness of syngo.CT Colonography. Testing was provided to cover a variety of clinical situations that would be seen in daily clinical use of the subject device.
Summary:
Performance tests were conducted to test the functionality of the syngo.CT Colonography post processing application. These tests have been performed to test the ability of the included features of syngo.CT Colonography. The results of these tests demonstrate that this application is able to inspect the colonic surface and colon lesions. Furthermore, clinical performance testing information was provided to demonstrate the functionality of supported application features.
The result of all conducted testing was found acceptable to support the claim of substantial equivalence.
8. Indications for Use
syngo.CT Colonography is used for easy-to-perform and efficient inspection of the colonic surface. It facilitates the search and diagnosis of colon lesions. The workflow management ensures that the required data and tools are offered to you according to your role and task.
syngo.CT Colonography is a clinical post-processing workflow for basic virtual colonoscopy. It is designed to support the following image reconstruction techniques:
- Multiplanar Reconstruction (MPR) ●
- Volume Rendering Technique (VRT)
- Perspective surface shaded display (pSSD)
The following evaluation tools are provided with this workflow:
- Virtual Flight ●
- · Stool Subtraction
- . Panoramic View
- · Polyp Enhanced Viewing
- Polyp Lens
- (PEV)
- Stool Taqqing .
- · Movie
syngo.CT Colonography supports reporting with appropriate reporting tools such as lesion location, lesion characterization, and key image creation. Combining enhanced commercially available digital image processing tools with an optimized workflow and reporting tools, the software is designed to support the physician on confirming the presence or absence of physician identified colon lesions (for example,
8
SIEMENS
polyps) in addition to evaluation, documentation, and follow-up of any such lesions using standard or low-dose spiral CT scanning.
General Safety and Effectiveness Concerns 9.
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. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.
10. Conclusion as to Substantial Equivalence
In summary, Siemens is of the opinion that the syngo.CT Colonography does not introduce any new potential safety risk and is substantially equivalent to and performs as well as the predicate devices.