(11 days)
Not Found
No
The summary describes software for remote review of existing outputs and mentions standard software development and validation procedures, with no indication of AI/ML capabilities.
No
The device is described as software for remote review and processing of medical images, which is a diagnostic or viewing tool, not a device that directly treats or provides therapy to a patient.
No
The device is intended for remote review of outputs from other imaging devices, not for directly diagnosing medical conditions itself. It facilitates communication and media interchange of images, which are then used by other devices or professionals for diagnosis.
Yes
The device description explicitly states "VitreaACCESS software" and the intended use describes it as "VitreaACCESS software". There is no mention of any accompanying hardware component being part of the device itself. The description of performance studies focuses solely on software development, testing, and validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "remote review of Vitrea2 Software outputs," which are "multidimensional digital images acquired from a variety of imaging devices." This clearly indicates the device is for reviewing medical images, not for testing samples taken from the human body (like blood, urine, tissue, etc.) to diagnose disease or other conditions.
- Device Description: The description reinforces the intended use by stating it "specifically allows remote review of Vitrea® outputs."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
In summary, the device is a software tool for reviewing medical images, which falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
VitreaACCESS software is intended to be used for remote review of Vitrea2 Software outputs, such as: processing, analysis, communication and media interchange of multidimensional digital images acquired from a variety of imaging devices.
Product codes
LLZ
Device Description
VitreaACCESS software specifically allows remote review of Vitrea® outputs.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
The software utilized was 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.
VitreaACCESS software will successfully complete 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
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
Kot 2328
6.0 510(k) Summary
Submitter's Name / Contact Person
AUG 2 1 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 | VitreaACCESS TM 1.0 - 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 | VITALConnectTM System- formally The iConnection System |
| (K040876) | |
| Vital Images, Inc. | |
| Vitrea Version 3.9 (K061624) | |
| Vital Images, Inc. |
Device Description
VitreaACCESS software specifically allows remote review of Vitrea® outputs.
Intended Use
VitreaACCESS software is intended to be used for remote review of Vitrea2 Software outputs, such as: processing, analysis, communication and media interchange of multidimensional digital images acquired from a variety of imaging devices.
Predicate Device Comparison
VitreaACCESS software 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.
1
Summary of Studies
The software utilized was 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.
VitreaACCESS software will successfully complete 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
VitreaACCESS software has a similar intended use as the predicate device and has very similar technological characteristics. Minor technological differences do not raise any new questions regarding safety or effectiveness. Thus, VitreaACCESS software is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
AUG 2 1 2006
Vital Images. Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K062328
Trade/Device Name: VitreaACCESS™ 1.0 Medical Image Processing Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 8, 2006 Received: August 10, 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/2/Picture/10 description: The image is a circular logo with the text "1906 - 2006" at the top. Below the text is the abbreviation "FDA" in large, bold letters. Underneath the abbreviation is the word "Centennial" in a smaller font. There are three stars at the bottom of the logo. The logo appears to be a commemorative emblem for the centennial anniversary of the FDA.
Protecting and Promoting Public Health
3
Page 2 -
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that I Dri- 3 issualles of a complies with other requirements of the Act that I DA has made a concentrations administered by other Federal agencies. You must of any I coclar statutes and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CrK Fart 607), favoring (21 CFR Part 800), go CFR Part 820); and If applicable, the electronic forth in the quality systems (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) I ins letter with anow you'ls begin mains of substantial equivalence of your device to a legally premits thousand. The PDF mailing of basis on 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 If you desire specific actives 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" Also, prease note the regulation other general information on your responsibilities under (21CTN I at 601.577). 10d may 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 C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
3.0 Intended Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: VitreaACCESS™ 1.0 Medical Image Processing Software
VitreaACCESS software is intended to be used for remote review of Vitrea2 Software outputs, such as: processing, analysis, communication and media interchange of multidimensional digital images acquired from a variety of imaging devices.
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)
Daniel A. Searson
Page __ of ___________________________________________________________________________________________________________________________________________________________________
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number _