(141 days)
Not Found
No
The document describes standard image processing and visualization techniques without mentioning AI or ML.
No
The device is described as a medical diagnostic system that processes and analyzes images to aid in the assessment of cerebral perfusion disturbances, which is a diagnostic function, not a therapeutic one.
Yes
The text explicitly states multiple times that "Vitrea is a medical diagnostic system" and "The Vitrea system is a medical diagnostic device." It also describes its use in aiding the assessment of cerebral perfusion disturbances.
Unknown
The summary describes a software system for processing and visualizing medical images, but it doesn't explicitly state that the device is only software and does not include any dedicated hardware components. While it processes images from external imaging devices, the description of the "Vitrea system" itself doesn't rule out the possibility of it being a hardware-software combination.
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 Vitrea system processes and analyzes digital images acquired from imaging devices (specifically dynamic CT images in this case). It does not perform tests on biological samples.
- Intended Use: The intended use describes the processing and visualization of images to aid in the assessment of cerebral perfusion disturbances. This is a diagnostic process based on imaging data, not on in vitro testing.
Therefore, the Vitrea system, as described, falls under the category of a medical imaging diagnostic system, not an In Vitro Diagnostic device.
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. In addition, Vitrea 4DCT has the following indication:
The Vitrea 4DCT Brain Perfusion option is intended for post processing based on dynamic CT images continuously acquired during the injection of contrast, for the visualization of apparent blood flow in brain tissue and pictorial illustration of perfusionrelated parameters to aid in the assessment of the type and extent of cerebral perfusion disturbances.
Product codes
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
dynamic CT
Anatomical Site
brain tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinicians
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Vitrea, Version 4.0 (K071331)
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).
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Image /page/0/Picture/1 description: The image shows the text "6.0 510(k) Summary". The text is in bold font and is likely a section heading within a document. The number 6.0 suggests it is the sixth section of the document. The term 510(k) refers to a type of premarket submission made to the FDA to demonstrate that a medical device is safe and effective.
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
Fre 26 =
General Information
| Trade Name | Vitrea® 4DCT Medical Image Processing Software |
|---|---|
| Common / Usual | |
| Name | System, Image Processing, Radiological |
| Classification Name | LLZ, Class II, CFR 21 892.2050 |
| Predicate Device | Vitrea, Version 4.0 (K071331) |
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 .
1
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. In addition, Vitrea 4DCT has the following indication:
The Vitrea 4DCT Brain Perfusion option is intended for post processing based on dynamic CT images continuously acquired during the injection of contrast, for the visualization of apparent blood flow in brain tissue and pictorial illustration of perfusion-related parameters to aid in the assessment of the type and extend of cerebral perfusion disturbances.
Predicate Device Comparison
The Vitrea 4DCT system and its predicate device 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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection.
Public Health Service
'AU6 7 2008 Food and Drug Administration 9200 Corporate Boulevard 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: K072821
Trade/Device Name: Vitrea® 4DCT Medical Image Processing Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 19, 2008 Received: January 22, 2008
Dear Mr. Job:
This letter corrects our substantially equivalent letter of February 20, 2008.
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 (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 vour 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
3
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 continue 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 (240) 276-0120. 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/dsma/dsmamain.html
Sincerely yours,
cy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K072821
Device Name: Vitrea® 4DCT Medical Image Processing Software
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. In addition, Vitrea 4DCT has the following indication:
The Vitrea 4DCT Brain Perfusion option is intended for post processing based on dynamic CT images continuously acquired during the injection of contrast, for the visualization of apparent blood flow in brain tissue and pictorial illustration of perfusionrelated parameters to aid in the assessment of the type and extent of cerebral perfusion disturbances.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herber Perman
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number