(79 days)
Not Found
No
The summary describes standard image processing and analysis techniques (MPR, MIP, volume rendering, segmentation, color coding, polar maps, measurements, comparison ratios) without mentioning AI or ML. The "Mentions AI, DNN, or ML" field explicitly states "Not Found".
No
The software is an image analysis tool that assists in visualizing and analyzing myocardial tissue, but it does not directly treat or diagnose a disease. It provides information to healthcare professionals who then make therapeutic decisions.
Yes
Explanation: The "Intended Use" states that the software is used for "visualize cardiovascular anatomy and pathology and to highlight and color code the presence of hypo/hyper dense areas of myocardial tissue," and the "Device Description" states it "assists in analyzing the hyperhypo dense areas of myocardial tissue." This indicates the software is used to identify and characterize medical conditions or diseases.
Yes
The device is described as a "software application" and a "post-processing software option" for an existing software platform. The description focuses entirely on software functionalities for image analysis and visualization, with no mention of accompanying hardware components or hardware-specific validation.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). This device analyzes images of the human body (CT scans).
- The intended use is image analysis and visualization. It helps radiologists and cardiologists interpret existing medical images.
- The device description focuses on software features for image processing and analysis. It doesn't mention any interaction with biological samples or reagents.
The device is clearly a medical image analysis software used for post-processing and interpreting CT scans of the heart.
N/A
Intended Use / Indications for Use
Vitrea® CT Myocardial Analysis is an image analysis software application for cardiac Computer Tomography (CT) studies to visualize cardiovascular anatomy and pathology and to highlight and color code the presence of hypo/hyper dense areas of myocardial tissue.
Product codes
LLZ
Device Description
Vitrea CT Myocardial Analysis is a post-processing software option for the Vitrea® software platform. it leverages existing Vites functionality such as multiplanar reconstruction (MPR) images, maximum intensity projections (MIP), and volume rendering. Vitrea CT Myocardial Analysis enables the visualization and analysis of the myocardium. It assists in analyzing the hyperhypo dense areas of myocardial tissue. Its visualization tools include segmentation, color coding, and polar maps. Its analysis tools include measurements and companison ratios. It also includes reporting tools for formatting findings and user selected areas of interest.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computer Tomography (CT)
Anatomical Site
cardiovascular, myocardium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologists and cardiologists
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
Testing included verification, validating previously acquired diagnostic images. Software testing confirmed that the feature firetions according to its requirements without impacting existing function found that no round that users can operate the software and successfully perform the desired function.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The software was designed, developed, and tested according to written procedures and applying risk management. Testing included verification, validating previously acquired diagnostic images. Software testing confirmed that the feature functions according to its requirements without impacting existing function and users can operate the software and successfully perform the desired function. The software is designed to meet NEMA PS 3.1 - 3.18 Digital Imaging and Communications in Medicine (DICOM). Testing supports a determination 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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary
NOV 1 8 2011
This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part 807.92.
| Submitter: | Vital Images, Inc.
5850 Opus Parkway
Suite 300
Minnetonka, MN 55343-4414 |
|-----------------|-----------------------------------------------------------------------------------|
| Contact Person: | Daniel T. Biank
Regulatory Affairs Manager |
| Telephone: | 952 - 487 - 9514 |
| Fax: | 952 - 487 - 9510 |
| Email: | dbiank@vitalimages.com |
| Date Prepared: | August 30, 2011 |
| Device Name | Trade Name: Vitrea® CT Myocardial Analysis |
Picture Archiving and Communications System
System, Image Processing, Radiological (21 C.F.R. 892.2050, LLZ)
Predicate Devices:
Common Name:
Classification Name:
GE Medical Systems CardIQ Express Version 2.0 (K073138) Siemens AG syngo.CT Cardiac Functions (K110366)
Device Description:
Vitrea CT Myocardial Analysis is a post-processing software option for the Vitrea® software platform. it leverages existing Vites functionality such as multiplanar reconstruction (MPR) images, maximum intensity projections (MIP), and volume rendering. Vitrea CT Myocardial Analysis enables the visualization and analysis of the myocardium. It assists in analyzing the hyperhypo dense areas of myocardial tissue. Its visualization tools include segmentation, color coding, and polar maps. Its analysis tools include measurements and companison ratios. It also includes reporting tools for formatting findings and user selected areas of interest.
Intended Use:
Vitrea CT Myocardial Analysis is an image analysis software application for cardiac Computer Tomography (CT) studies to visualize cardiovascular andiomy and pathology and to highlight and color code the presence of hypo/hyper dense areas of myocardial tissue.
Comparison with Predicate Devices:
The Vitrea® CT Myocardial Analysis application provides radiologists and cardiologists workflows similar to Cardia Xpress 2.0 and syngo.CT Cardiac Function. These devices all include the ability to display two and three dinensional images of the cardiovascular anatomy generated from CTA exams of the heart. Vitrea CT Myocardial Analysis is an option to enable a particular cardial postprocessing workflow for the myocardium. CardIQ Xpress 2.0 and syngo.CT Cardian include the myocardium tool as part of a package of additional cardiac functions. Vitrea" CT Myocardial Analysis is substantially equivalent to the relevant Cardid Xpress 2.0 and syngo. CT Cardian Function tools.
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Summary of Studies:
The software was designed, developed, and tested according to written procedures and applying risk management. Testing included verification, valider procedures and applying rise.
management. Testing included verification, validating previously acquired diagnostic images. Software testing confirmed that the feature firetions according to its requirements without impacting existing function found that no round that users can operate the software and successfully perform the desired function. The software is designed to meet NEMA PS 3.1 - 3.18 Digital Inaging and Communications in Medicine (DICOM).
Testing supports a determination of substantial equivalence.
Conclusion:
Vitrea CT Myocardial Analysis is substantially equivalent to the current cleared and marketed GE Medical Systems CardIQ Express Version 2.0 (K073138) and Siemens AG syngo.CT Cardiac Functions (K110366) based on the included studies.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol appears to be a stylized representation of human figures within a circle. The text is in a bold, sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Daniel Biank Regulatory Affairs Manager Vital Images, Inc. 5850 Opus Parkway, Suite 300 MINNETONKA MN 55343
MAR - 8 2012
Re: K112531
Trade/Device Name: Vitrea® CT Myocardial Analysis Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 30, 2011 Received: August 31, 2011
Dear Mr. Biank:
This letter corrects our substantially equivalent letter of November 18, 2011.
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Form
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Vitrea® CT Myocardial Analysis
Indications for Use:
Vitrea® CT Myocardial Analysis is an image analysis software application for cardiac Computer Tomography (CT) studies to visualize cardiovascular anatomy and pathology and to highlight and color code the presence of hypo/hyper dense areas of myocardial tissue.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign Off
ision Sign-Off Office of In Vitro Diagnostic Device Evaluatio
510(k) K112531
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