(15 days)
Not Found
No
The summary describes standard image processing and visualization tools, with no mention of AI, ML, or related concepts.
No
The device is described as a medical diagnostic system intended to process, review, analyze, and communicate multi-dimensional digital images, primarily to assist physicians in stratifying patients with coronary disease. It provides tools for measurement and visualization, but does not directly treat or manage a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Vitrea2 is a medical diagnostic system," and the "Device Description" section reiterates, "The Vitrea2 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". It details software functionalities like retrieving, displaying, manipulating, annotating, and outputting images. While it processes images from hardware imaging devices (CT), the device itself, as described, is the software system performing these functions. The SUREPlaque™ tool kit is also described as "application software package". There is no mention of hardware components being part of the Vitrea2 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.
- Device Function: The Vitrea2 system and its SUREPlaque™ tool are described as processing, reviewing, analyzing, and visualizing digital images acquired from imaging devices like CT scanners. They work with image data, not biological samples.
- Intended Use: The intended use is to assist physicians in the stratification of patients with coronary disease by processing and visualizing CT images of coronary arteries. This is image analysis, not a diagnostic test performed on a biological sample.
While the device is used for medical diagnosis (interpreting images to aid in diagnosis), it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Vitrea2® 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. In addition, Vitrea2 Version 3.9 has the following additional indication:
The SUREPlaque™ tool kit application software package is intended to assist trained physicians in the stratification of patients identified to have coronary disease (CAD). This software post processes images obtained using a multidetector Aquilion CT. The package provides tools for the measurement and visualization (color coded maps) of coronary arteries.
Product codes
LLZ
Device Description
The Vitrea2 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 Vitrea2 system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea2 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
multidetector Aquilion CT
Anatomical Site
coronary arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physicians
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 utili: I 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 Vitrea2, Verri testing prior to Bet validation. Software Beta testing/validation will be successfully completed prior to Dlease. 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)
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
6.0 510(k) Summary
JUN 2 7 2006
Submitter's Name / Contact Person
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 | Vitrea2®, Version 3.9 Medical Image Processing Software |
|---|---|
| Common / Usual Name | System, Image Processing, Radiological |
| Classification Name | LLZ, Class II, CFR 21 892.2050 |
| Predicate Devices | Vitrea2, Version 3.8 (K052632) |
| Vital Images, Inc. SUREPlaque™ (K043111) | |
| Toshiba America Medical Systems, Inc. |
Device Description
The Vitrea2 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 Vitrea2 system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea2 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 .
1
- 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
Vitrea2® 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. In addition, Vitrea2 Version 3.9 has the following additional indication:
The SUREPlaque tool kit application software package is intended to assist trained physicians in the stratification of patients identified to have coronary disease (CAD). This software post proc sses images obtained using a multidetector Aquilion CT. The package provides tools for t a measurement and visualization (color coded maps) of coronary arteries.
Predicate Device Comparison
The Vitrea2, Version 3.9 system and its predicate devices allow for the analysis, communication a: media interchange of digital images acquired from a variety of acquisition devices. All device support the DICOM protocol for communication of images with other medical imaging devices.
Summary of Stus s
The software utili: I 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 Vitrea2, Verri testing prior to Bet validation. Software Beta testing/validation will be successfully completed prior to Dlease. In addition, potential hazards have been studied and controlled by a Risk Management Plan.
Conclusion
The Vitrea2, Versi very similar techn:
2
ling safety or effectiveness of the device. Thus, the Vitrea2, Version 3.9 new questions re: ·'ly equivalent to the predicate devices. system is substar.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with flowing lines, suggesting movement or flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUN 2 7 2006
Vital Images, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25" Street NW BUFFAI.O MN 55313
Re: K061624
Trade/Device Name: Vitrea26, Version 3.9 Medical Image Processing Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 8, 2006 Reccived: June 12, 2006
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 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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/3/Picture/10 description: The image shows a logo with the text "FDA Centennial 1906-2006" in a circular design. Below the logo, the text "Protecting and Promoting Public Health" is displayed in a decorative font. The logo appears to be a commemorative emblem for the FDA's centennial anniversary.
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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/cdrh/industrv/support/index.html.
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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3.0 Intended Use Statement
510(k) Number (if known): 《んしくんとイ Device Name: Vitrea2 , Version 3.9 Medical Image Processing Software
Vitrea2 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. In addition, Vitrea2 Version 3.9 has the following additional indication:
The SUREPlaque™ tool kit application software package is intended to assist trained physicians in the stratification of patients identified to have coronary disease (CAD). This software post processes images obtained using a multidetector Aquilion CT. The package provides tools for the measurement and visualization (color coded maps) of coronary arteries.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)
Page of of a
Laird A. Lynam
(Division Sie. Off) · Septoductive, Abdominal rest revices