(13 days)
Not Found
No
The document describes standard image processing and visualization tools without mentioning AI or ML.
No
The device is a medical diagnostic software system intended to process, analyze, review, and distribute images to aid clinicians in their analysis of anatomy and pathology, and to assist in the planning and monitoring of vascular therapies. It is not indicated to directly provide therapy.
Yes
The 'Intended Use / Indications for Use' section explicitly states, "ViTALConnect, Version 4.0 is a medical diagnostic software system..." and the 'Device Description' section also reiterates, "The ViTALConnect system is a medical diagnostic device..." Furthermore, its functions like "quantification of stenosis, distance measurements and cross-sectional diameters, volume measurements" are characteristic of diagnostic tools.
Yes
The device description and intended use clearly define the system as a "medical diagnostic software system" and a "medical diagnostic device" that processes, analyzes, reviews, and distributes digital images. There is no mention of accompanying hardware components that are part of the device itself, only the imaging devices from which the software acquires data.
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 ViTALConnect system processes, analyzes, reviews, and distributes digital images acquired from various imaging devices (CT, MR, etc.). It aids clinicians in analyzing anatomy and pathology based on these images.
- Lack of Biological Sample Analysis: The description does not mention the analysis of any biological samples from the patient. The input is image data, not biological specimens.
The device is a medical diagnostic software system that works with medical imaging data, which falls under a different regulatory category than in vitro diagnostics.
N/A
Intended Use / Indications for Use
ViTALConnect, Version 4.0 is a medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a variety of imaging devices including: CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF, etc. In addition, the ViTALConnect system has the following specific intended uses:
Advanced Vessel Analysis is an option within the ViTALConnect system intended to aid clinicians in the study and analysis of selected vessels, the inspection of circulatory anatomy, the quantification of stenosis, distance measurements and cross-sectional diameters, volume measurements, and assist in the planning and monitoring of vascular therapies. The feature operates with CT and MRI data.
Pet Visualization is an option within the ViTALConnect system that provides for the overlay, inspection, and measurement of two different image modalities (primarily directed at PET/CT). The option also includes the ability to measure Standard Uptake Values on PET datasets.
The overlay operation enables clinicians to obtain a better understanding of the joint information that would otherwise have to be compared separately. It is important to note that the clinician retains the ultimate responsibility for making pertinent diagnosis based on their standard procedures, including visual comparison of separate images.
Collaboration Mode is a capability within the ViTALConnect system that allows multiple users to collaboratively interact with ViTALConnect system features and tools.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The ViTALConnect 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 ViTALConnect system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The ViTALConnect 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
CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF
Anatomical Site
Selected vessels, circulatory anatomy
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 procedures. These procedures specify individuals within the organization responsible for developing and approving product specifications, coding, testing, validating and maintenance.
The ViTALConnect 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.
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
AUG 1 0 2006
Timothy J. Kappers, MBA, RAC Director, Quality Systems, Regulatory & Clinical Affairs Vital Images, Inc. 5850 Opus Parkway, Suite 300 Minnetonka, MN 55343
General Information
| Device Trade Name | VITALConnect™ 4.0 - Medical Image Processing Software | |
|---|---|---|
| Common / Usual Name | System, Image Processing, Radiological | |
| Classification | 892.2050 Picture Archiving and Communications System | |
| (LLZ; Class II) | ||
| Identification of | ||
| Predicate Devices | VITALConnect System- formally The iConnection System | |
| (K040876) | ||
| Vital Images, Inc. |
Device Description
The ViTALConnect 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 ViTALConnect system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The ViTALConnect 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
ViTALConnect, Version 4.0 is a medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a variety of imaging devices including: CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF, etc. In addition, the ViTALConnect system has the following specific intended uses:
Advanced Vessel Analysis is an option within the ViTALConnect system intended to aid clinicians in the study and analysis of selected vessels, the inspection of circulatory anatomy, the quantification of stenosis, distance measurements and cross-sectional diameters, volume measurements, and assist in the planning and monitoring of vascular therapies. The feature operates with CT and MRI data.
Pet Visualization is an option within the ViTALConnect system that provides for the overlay, inspection, and measurement of two different image modalities (primarily directed at PET/CT). The option also includes the ability to measure Standard Uptake Values on PET datasets.
The overlay operation enables clinicians to obtain a better understanding of the joint information that would otherwise have to be compared separately. It is important to note that the clinician retains the ultimate responsibility for making pertinent diagnosis based on their standard procedures, including visual comparison of separate images.
Collaboration Mode is a capability within the ViTALConnect system that allows multiple users to collaboratively interact with ViTALConnect system features and tools.
Predicate Device Comparison
The ViTALConnect 4.0 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.
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.
2
The ViTALConnect 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 ViTALConnect 4.0 system has the same intended uses as the predicate device and has very similar technological characteristics. Minor technological differences do not raise any new questions regarding safety or effectiveness of the device. Thus, the ViTALConnect 4.0 system is substantially equivalent to the predicate device.
3
Image /page/3/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the edge. In the center of the seal is a stylized image of an eagle with its wings spread. The eagle is facing to the right and has three stripes on its wings.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
AUG 1 0 2006
Vital Images, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services 1394 25th Street NW BUFFALO MN 55313
Re: K062154
Trade/Device Name: ViTAL Connect™ 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: July 24, 2006 Received: July 28, 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 is a black and white circular logo. The logo commemorates the centennial anniversary from 1906-2006. The letters "FDA" are in the center of the logo. The word "Centennial" is written below the letters "FDA".
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/cdrlvindustry/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
3.0 Intended Use Statement
510(k) Number (if known): __ K o L 2 15 1 Device Name: ViTALConnect™ 4.0 Medical Image Processing Software
ViTALConnect, Version 4.0 is a medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a variety of imaging devices including: CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF, etc. In addition, the ViTALConnect system has the following specific intended uses:
Advanced Vessel Analysis is an option within the ViTALConnect system intended to aid clinicians in the study and analysis of selected vessels, the inspection of circulatory anatomy, the quantification of stenosis, distance measurements and cross-sectional diameters, volume measurements, and assist in the planning and monitoring of vascular therapies. The feature operates with CT and MRI data.
Pet Visualization is an option within the ViTALConnect system that provides for the overlay, inspection, and measurement of two different image modalities (primarily directed at PET/CT). The option also includes the ability to measure Standard Uptake Values on PET datasets.
The overlay operation enables clinicians to obtain a better understanding of the joint information that would otherwise have to be compared separately. It is important to note that the clinician retains the ultimate responsibility for making pertinent diagnosis based on their standard procedures, including visual comparison of separate images.
Collaboration Mode is a capability within the ViTALConnect system that allows multiple users to collaboratively interact with ViTALConnect system features and tools.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Hodgson
Page of
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K062154