(14 days)
Not Found
No
The document describes standard image processing and visualization tools without mentioning AI or ML algorithms.
No
The device is described as a "medical diagnostic system" and a "medical diagnostic device" that processes and displays images to aid in analysis and assessment, without any mention of directly treating or alleviating diseases.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "Vitrea is a medical diagnostic system". Additionally, the "Device Description" section reiterates, "The Vitrea system is a medical diagnostic device".
Yes
The device description explicitly states it is a "medical diagnostic device that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices." It focuses on software functionalities like retrieval, display, manipulation, annotation, and output of digital images. There is no mention of accompanying hardware components being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine specimens outside of the body.
- Device Function: The Vitrea system processes, reviews, analyzes, and visualizes digital images acquired from imaging devices (like CT scanners). It works with images of the body, not with biological samples taken from the body.
- Intended Use: The intended use describes the device as a "medical diagnostic system" for processing and analyzing images to aid physicians in visualizing and assessing anatomy and pathology. This is consistent with medical imaging software, not IVD.
- Device Description: The description reinforces that the system works with "multi-dimensional digital images" and provides "multi-dimensional visualization."
The device is a medical diagnostic system that utilizes medical imaging data, which is distinct from in vitro diagnostics.
N/A
Intended Use / Indications for Use
Vitrea is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image interpretation in mammography. In addition, Vitrea Version 4.0 has the following additional indications:
Cardiac EP Planning is a post-processing advanced visualization that is intended to be used for the analysis and assessment of the heart including the atria, pulmonary veins, and coronary sinus. The application provides analysis tools which include a number of display, quantitative measurement and 3D model export capabilities for use with the St. Jude Ensite® System. The application can be used to aid trained physicians in the visualization and assessment of cardiac anatomy.
The SUREPlaque™ software application is intended to assist trained physicians in the stratification of patients identified to have atherosclerosis. This software post processes images obtained using a multidetector CT. The package provides tools for the measurement and visualization (color coded maps) of arterial vessels.
The Vessel Probe option is intended for viewing the anatomy and pathology of a patient's peripheral arteries. Clinicians can select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotate-able curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel. Cross-sectional measurements can be obtained using standard Vitrea software measuring tools. Clinicians can semi-automatically determine contrasted lumen boundaries, stenosis measurements, and maximum and minimum lumen diameters. In addition, clinicians can edit lumen boundaries and examine Houndsfield unit or signal intensity statistics. Clinicians can also manually measure vessel length along the centerline in standard curved MPR views.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The Vitrea system is a medical diagnostic device that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices.
The Vitrea system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea system user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including:
- . Retrieve image data over the network via DICOM
- Display images that are automatically adapted to exam type via dedicated protocols
- Select images for closer examination from a gallery of up to six 2D or 3D views .
- Interactively manipulate an image in real-time to visualize anatomy and pathology
- Annotate, tag, measure, and record selected views .
- Output selected views to standard film or paper printers, or post a report to an intranet . Web server or export views to another DICOM device
- Retrieve reports that are archived on a Web server .
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart (atria, pulmonary veins, coronary sinus), arterial vessels, peripheral arteries.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physicians / Not Found
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 software utilized was designed, developed, tested, and validated according to written procedures. These procedures specify individuals within the organization responsible for developing and approving product specifications, coding, testing, validating, and maintenance.
The Vitrea, Version 4.0 system will successfully complete integration testing/verification testing prior to Beta validation. Software Beta testing/validation will be successfully completed prior to release. In addition, potential hazards have been studied and controlled by a Risk Management Plan.
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.
K061624, K051840, K031261, K043111
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
§ 892.2050 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
6.0 510(k) Summary
Submitter's Name / Contact Person
MAY 2 5 2007
Timothy J. Kappers, MBA, RAC Director, Quality Systems, Regulatory & Clinical Affairs Vital Images, Inc. 5850 Opus Parkway, Suite 300 Minnetonka, MN 55343
General Information
| Trade Name | Vitrea ®, Version 4.0 Medical Image Processing
Software |
|------------------------|------------------------------------------------------------------|
| Common / Usual
Name | System, Image Processing, Radiological |
| Classification Name | LLZ, Class II, CFR 21 892.2050 |
| Predicate Devices | • Vitrea®, Version 3.9 (K061624)
Vital Images, Inc. |
| | • EnSite Verismo™ (K051840)
St. Jude, Inc. |
| | • CARD EP (K031261)
GE Medical Systems |
| | • SUREPlaque™ (K043111)
Toshiba America Medical Systems, Inc. |
Device Description
The Vitrea system is a medical diagnostic device that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices.
The Vitrea system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea system user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including:
- . Retrieve image data over the network via DICOM
- Display images that are automatically adapted to exam type via dedicated protocols �
- Select images for closer examination from a gallery of up to six 2D or 3D views .
- Interactively manipulate an image in real-time to visualize anatomy and pathology �
1
- Annotate, tag, measure, and record selected views .
- Output selected views to standard film or paper printers, or post a report to an intranet . Web server or export views to another DICOM device
- Retrieve reports that are archived on a Web server .
Intended Use
Vitrea is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image interpretation in mammography. In addition, Vitrea Version 4.0 has the following additional indications:
Cardiac EP Planning is a post-processing advanced visualization that is intended to be used for the analysis and assessment of the heart including the atria, pulmonary veins, and coronary sinus. The application provides analysis tools which include a number of display, quantitative measurement and 3D model export capabilities for use with the St. Jude Ensite® System. The application can be used to aid trained physicians in the visualization and assessment of cardiac anatomy.
The SUREPlaque™ software application is intended to assist trained physicians in the stratification of patients identified to have atherosclerosis. This software post processes images obtained using a multidetector CT. The package provides tools for the measurement and visualization (color coded maps) of arterial vessels.
The Vessel Probe option is intended for viewing the anatomy and pathology of a patient's peripheral arteries. Clinicians can select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotate-able curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel. Cross-sectional measurements can be obtained using standard Vitrea software measuring tools. Clinicians can semi-automatically determine contrasted lumen boundaries, stenosis measurements, and maximum and minimum lumen diameters. In addition, clinicians can edit lumen boundaries and examine Houndsfield unit or signal intensity statistics. Clinicians can also manually measure vessel length along the centerline in standard curved MPR views.
Predicate Device Comparison
The Vitrea, Version 4.0 system and its predicate devices allow for the analysis, communication and media interchange of digital images acquired from a variety of acquisition devices. All devices support the DICOM protocol for communication of images with other medical imaging devices.
Page 27
2
Summary of Studies
The software utilized was designed, developed, tested, and validated according to written procedures. These procedures specify individuals within the organization responsible for developing and approving product specifications, coding, testing, validating, and maintenance.
The Vitrea, Version 4.0 system will successfully complete integration testing/verification testing prior to Beta validation. Software Beta testing/validation will be successfully completed prior to release. In addition, potential hazards have been studied and controlled by a Risk Management Plan.
Conclusion
The Vitrea, Version 4.0 system has similar intended uses as the predicate devices and has very similar technological characteristics. Minor technological differences do not raise any new questions regarding safety or effectiveness of the device. Thus, the Vitrea, Version 4.0 system is substantially equivalent to the predicate devices.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings or feathers. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Vital Images, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K071331
Trade/Device Name: Vitrea®, Version 4.0 Medical Image Processing Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 10, 2007 Received: May 11, 2007
Dear Mr. Job:
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 Corneric Act (Act) that do not require approval of a premarket approval application (PMA). You costi. 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 levelocal manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affective 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.
Image /page/3/Picture/10 description: The image is a black and white circular logo. The logo contains the letters "DA" in a bold, sans-serif font. Above the letters, the numbers "1888-1988" are printed. Below the letters, the word "Centennial" is printed in a cursive font. There are four stars at the bottom of the logo.
Protecting and Promoting Public Health
4
Page 2 -
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); 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.
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy Cbrogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Vital Images, Inc. Vitrea™ Version 4:0
3.0 Intended Use Statement
610(k) Number (if known): KOJ 133 Device Name: Vitrea , Version 4.0 Medical Image Processing Software
Vitrea is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea is not meant for primary Image interpretation in mammography. In addition, Vitrea Version 4.0 has the following additional indication:
Cardiac EP Planning is a post processing advanced visualization application that is intended to be used for the analysis and assessment of the heart including the atria, pulmonary veins, and coronary sinus. The application provides analysis tools which include a number of display, quantitative measurement and 3D model export capabilities for use with the St. Jude Ensite® System. The application can be used to aid trained physicians in the visualization and assessment of cardiac anatomy.
The SUREPlaque™ software application is intended to assist trained physicians in the stratification of patients identified to have atherosclerosis. This software post processes images obtained using a multidetector CT. The package provides tools for the measurement and visualization (color coded maps) of arterial vessels.
The Vessel Probe option is intended for viewing the anatomy and pathology of a patient's peripheral arteries. Clinicians can select any artery to view the following anatomical portional arterloor unities vessel in 3D, two rotate-able curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel. Cross-sectional at angles on to calned using standard Vitrea software measuring tools. Clinicians modeline attematically determine contrasted lumen boundaries, stenosis measurements, and maximum and minimum lumen diameters. In addition, clinicians can edit lumen boundaries and examine Houndsfield unlt or signal intensity statistics. Clinicians can also manually measure vessel length along the centerline in standard curved MPR views.
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|---|---|
| ---------------------------------------------- | --- |
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 Device Evaluation (ODE) | |
|---|---|
Nancy brogdon
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K07133/ |
| Page | of |
|---|---|
| ------ | ---- |
May 04, 2007 Abbreviated 510{k} Premarket Notification
Page 10