(54 days)
No
The document describes standard image processing and analysis techniques for medical images, including CAD, but does not mention AI or ML.
No
The device is a medical diagnostic workstation, not intended for treatment or therapy. It processes, reviews, analyzes, and communicates medical images to aid in diagnosis and planning, but does not provide therapeutic intervention.
Yes
Explanation: The "Intended Use / Indications for Use" explicitly states, "Vitrea™2 is a medical diagnostic workstation..." and provides several specific indications for use such as "non-invasive detection and quantification of atherosclerotic plaque," "stenosis analysis," and "analysis/quantification of tumor volumes." The "Device Description" also refers to it as a "medical diagnostic workstation."
No
The device is described as a "medical diagnostic workstation," which typically implies a combination of hardware and software. While the summary focuses on the software functionalities, it doesn't explicitly state that the device is software-only or that it doesn't include any dedicated hardware components. The description of retrieving data over a network and outputting to printers also suggests interaction with hardware.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: In Vitro Diagnostics are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device analyzes medical images: The description clearly states that Vitrea™2 processes, reviews, and analyzes multi-dimensional digital images acquired from imaging devices like CT and MR scanners. It does not interact with or analyze biological samples.
- The intended uses are image-based: All the listed intended uses (cardiac scoring from CT, vascular measurement, tumor volume measurement from MR, CT brain perfusion, chest CT analysis) are based on the analysis of medical images, not biological samples.
Therefore, Vitrea™2 falls under the category of medical imaging software or a medical diagnostic workstation, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Vitrea™2, Version 3.4 is a medical diagnostic workstation that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. In addition, VitreaTM2 has the following specific indications.
VScore™ (K990442) is an option within the Vitrea™2 application and is intended for cardiac scoring from whole body CT derived measurements, including non-invasive detection of atherosclerotic plaque. Two image processing options. EKG Gate (K001682) and Auto Gate (K003230), allow the operator to select images with reduced motion artifacts when processing data for Coronary Artery Calcification Scoring.
Automated Vascular Measurement (K002519) is an option within the Vitrea™2 application and is intended for study/analysis of selected vessels for stenosis analysis, pre/post stent planning and directional vessel tortuosity evaluation.
Tumor Volume Measurement (K002519) is an option within the Vitrea™2 application and is intended for the analysis/quantification of tumor volumes obtained from MR brain series scans.
CT Brain Perfusion (K003639) is an option within the Vitrea™2 application and 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 related parameters to aid in the assessment of the type and extent of cerebral perfusion disturbances.
ImageCheckerCT is an option within the Vitea™2 application and is intended for the display of a composite view of 2D cross-sections, and 3D volumes of Chest CT images, including findings of regions of interest ("ROI") identified by the radiologist, or Computer Assisted Detection ("CAD") findings.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
Vitrea™2 is a medical diagnostic workstation that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea™2, version 3.4 is an upgrade to Vitrea™2, version 2.1 initially released for commercial distribution by FDA on K002519.
Vitrea 2 provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea2 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
CT, MR
Anatomical Site
Cardiac, Vessels, Brain, Chest
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)
The software utilized was designed, developed, tested, and validated according to written Design Control procedures. These procedures specify individuals within the organization responsible for developing and approving product specifications, coding, testing, validating and maintenance.
The Vitrea2, Version 3.4 Workstation will successfully complete Integration testing/verification prior to Beta validation. The software Beta testing validating the workstation 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.
Vital Images, Inc., Vitrea2, Version 2.1 (K002519), GE, Advantage Workstation 4.1 (K020483), R2 Technologies, Inc., ImageChecker-CT Workstation (K023003), GE, Advanced Lung Analysis (K013381)
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.
K990442, K001682, K003230, K002519, K003639
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
Attachment 1 - 510(k) Summary
Submitter's Name / Contact Person
Stephen S. Andersen Sr. Director of Quality and Customer Satisfaction Vital Images, Inc. 3300 Fernbrook Lane N, Suite 200 Plymouth, MN 55447
General Information
| Trade Name | Vitrea2, Version 3.4 Medical Image Processing Software | |
|---|---|---|
| Common / Usual Name | System, Image Processing, Radiological | |
| Classification Name | LLZ, Class II, CFR 21 892.2050 | |
| Predicate Devices | Vital Images, Inc., Vitrea2, Version 2.1 (K002519) | |
| GE, Advantage Workstation 4.1 (K020483) | ||
| R2 Technologies, Inc., ImageChecker-CT Workstation (K023003) | ||
| GE, Advanced Lung Analysis (K013381) |
Device Description
Vitrea™2 is a medical diagnostic workstation that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea™2, version 3.4 is an upgrade to Vitrea™2, version 2.1 initially released for commercial distribution by FDA on K002519.
Vitrea 2 provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea2 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 .
Intended Use
Vitrea™2, Version 3.4 is a medical diagnostic workstation that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. In addition, VitreaTM2 has the following specific indications.
1
VScore™ (K990442) is an option within the Vitrea™2 application and is intended for cardiac scoring from whole body CT derived measurements, including non-invasive detection of atherosclerotic plaque. Two image processing options. EKG Gate (K001682) and Auto Gate (K003230), allow the operator to select images with reduced motion artifacts when processing data for Coronary Artery Calcification Scoring.
Automated Vascular Measurement (K002519) is an option within the Vitrea™2 application and is intended for study/analysis of selected vessels for stenosis analysis, pre/post stent planning and directional vessel tortuosity evaluation.
Tumor Volume Measurement (K002519) is an option within the Vitrea™2 application and is intended for the analysis/quantification of tumor volumes obtained from MR brain series scans.
CT Brain Perfusion (K003639) is an option within the Vitrea™2 application and 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 related parameters to aid in the assessment of the type and extent of cerebral perfusion disturbances.
ImageCheckerCT is an option within the Vitea™2 application and is intended for the display of a composite view of 2D cross-sections, and 3D volumes of Chest CT images, including findings of regions of interest ("ROI") identified by the radiologist, or Computer Assisted Detection ("CAD") findings.
Predicate Device Comparison
The Vitrea2, Version 3.4 Workstation and the predicate devices allow for the analysis, communication and media interchange of digital images acquired from a variety of acquisition devices support the DICOM protocol for communication of images with other medical imaging devices.
Summary of Studies
The software utilized was designed, developed, tested, and validated according to written Design Control procedures. These procedures specify individuals within the organization responsible for developing and approving product specifications, coding, testing, validating and maintenance.
The Vitrea2, Version 3.4 Workstation will successfully complete Integration testing/verification prior to Beta validation. The software Beta testing validating the workstation will be successfully completed prior to release. In addition, potential hazards have been studied and controlled by a Risk Management Plan.
Conclusion
The Vitrea2, Version 3.4 Workstation has the same intended use as the predicate devices and very similar indications and technological characteristics. Any technological differences do not raise any new questions regarding safety or effectiveness. Thus, the Vitrea2, Version 3.4 Workstation is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows a circular logo with an abstract depiction of an eagle in the center. The eagle is composed of three curved lines that suggest its head, body, and wings. Encircling the eagle is text that reads 'DEPARTMENT OF HEALTH & HUMAN SVC'. The text is arranged along the circumference of the circle, with 'DEPARTMENT' at the bottom left and 'SVC' at the top right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 2003
Mr. Stephen S. Anderson Sr. Director, Quality and Customer Satisfaction Vital Images, Inc. 3300 Fernbrook Lane North, Suite 200 PLYMOUTH MN 55447-5341
Re: K032748
Trade/Device Name: Vitrea2, Version 3.4 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: 90 LLZ Dated: September 4, 2003
Received: September 5, 2003
Dear Mr. Anderson:
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 (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); 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.
3
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 the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
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
4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): _ 11 6 3 27 48
Device Name: Vitrea™2, Version 3.4 Medical Image Processing Software
Indications for Use:
Vitrea™2 is a medical diagnostic workstation 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™2 has the following specific indications.
VScore™ (K990442) is an option within the Vitrea™2 application and is intended for cardiac scoring from whole body CT derived measurements, including non-invasive detection and quantification of atherosclerotic plaque. Two image processing options, EKG Gate (K001682) and Auto Gate (K003230), allow the operator to select images with reduced motion artifacts when processing data for Coronary Artery Calcification Scoring.
Automated Vascular Measurement (K002519) is an option within the Vitrea™2 application and is intended for study/analysis of selected vessels for stenosis analysis, pre/post stent planning and directional vessel tortuosity evaluation.
Tumor Volume Measurement (K002519) is an option within the Vitrea™2 application and is intended for the analysis/quantification of tumor volumes obtained from MR brain series scans.
CT Brain Perfusion (K003639) is an option within the Vitrea™2 application and 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 type and extent of cerebral perfusion disturbances.
ImageCheckerCT is an option within the Vitrea™2 application and is intended for the display of a composite view of 2D crosssections, and 3D volumes of Chest CT images, including findings of regions of interest ("ROI") identified by the radiologist, or Computer Assisted Detection ("CAD") findings.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✓
David A. Symm
Division of Reproductive, Abdom and Radiological Devices 510(k) Number