(15 days)
Not Found
Not Found
Yes
The summary explicitly mentions "computer-aided detection algorithms" which are a form of AI/ML used to assist users in identifying structures of interest.
No.
This device is described as a tool for medical image reading and review, aiding in diagnosis and analysis, rather than directly treating or mitigating a disease or condition.
Yes
The device provides tools for the reading and review of medical images, aids trained medical imaging professionals in their review of data, and includes specialist tools and workflows for specific clinical applications such as colon screening for polyps and tumors, vessel analysis for occlusive and aneurismal diseases, and coronary and functional cardiac analysis. These functions are inherently diagnostic in nature as they involve interpreting medical images to identify health conditions.
Yes
The description focuses entirely on software functionalities for processing and analyzing medical images (DICOM data). There is no mention of any accompanying hardware components or hardware-specific functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "reading and review of a DICOM compliant series of medical images." This involves analyzing images of the human body, not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: While not found in the provided text, the description of the functionality (image processing, 3D rendering, analysis of anatomical structures) further supports that it's an imaging analysis tool.
- Input: The input is "DICOM compliant series of medical images," which are images of the patient's anatomy.
- Anatomical Site: The anatomical sites mentioned (Colon, vessels, coronary arteries, heart) are all parts of the human body being imaged.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health status. This device is for analyzing images of the body itself.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The provided text only describes the device's intended use and characteristics.
Intended Use / Indications for Use
The Voxar 3D product family is a suite of products that is intended to provide tools for the reading and review of a DICOM compliant series of medical images which can be interpreted as representing a volume of data. These tools are meant for the use of trained medical Imaging professionals to aid in their reading and review of such data.
The Voxar 3D product family provides several levels of functionality:
- Basic analysis tools used on a daily basis, such as 2D review, orthogonal Multi Planar Reconstructions (MPRs), oblique MPRs, curved MPRs, slab MPRs, slab MPRs, AvelP, MIP, MinIP, measurements, annotations, reporting, and distribution.
- Tools for in-depth analysis, such as regional segmentation of anatomical structures within the image data, endoscopic review, color volume rendering of finite thickness data cross-sections, 3D review of data volumes, path definition through vescular and other tubular structures, boundary detection, and PET image analysis.
- Specialist tools and workflow enhancements for specific clinical applications which provide directed workflows, custom User Interfaces, and special measurement and reporting functions optimized for the specific clinical applications. Also included are computer-sided detection signithms which are the user on possible structures of interest. Specialized dinical applications include:
- Colon Screening (which Is intended for the screening of patients for colonic polyps, turnours and other o lesions using tomographic Colonography),
- Vessel Analysis (which is intended for the qualitative and quantitative analysis of tomographic o anglographic studies to evaluate occusive and aneurismal diseases and the effectiveness of stents and stent grafts)
- Coronary analysis (which is Intended for the qualitative and quantitative analysis of coronary 0 arteries to evaluate occlusive and aneurismal disease).
- Functional cardiac analysis (which is intended to evaluate the functional characteristics of the heart),
Product codes
LLZ
Device Description
Not Found
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
DICOM compliant series of medical images, tomographic Colonography, tomographic anglographic studies, PET image analysis.
Anatomical Site
Colon, vessels (occlusive and aneurismal diseases), Coronary arteries, heart.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained medical Imaging professionals.
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)
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAY 2 5 2006
BarcoView MIS Edinburgh c/o Mr. Jeff D. Rongero Senior Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive P.O. Box 13995 RESEARCH TRIANGLE PARK NC 27709-3995
Re: K061326
Trade/Device Name: Voxar 3D Enterprise with CardiaMetrix Regulation Number: 21 CFR $892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 10, 2006 Received: May 10, 2006
Dear Mr. Rongero:
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/0/Picture/10 description: The image is a black and white circular logo. The logo has the text "1906-2006 FDA Centennial" arranged in a circular fashion. The letters "FDA" are in the center of the logo in a large, bold font. There are three stars below the word "Centennial".
Preventing and Promoting Public Health
1
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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
2
Indications For Use
Applicant:
BarcoView MIS Edinburgh, Bonnington Bond, 2 Anderson Place, Edinburgh, EH6 5NP, UK
510(k) Number (if known): Unknown
Device Name:
Voxar 3D Enterprise with CardiaMatrix
Indications For Use:
The Voxar 3D product family is a suite of products that is intended to provide tools for the reading and review of a DICOM compliant series of medical images which can be interpreted as representing a volume of data. These tools are meant for the use of trained medical Imaging professionals to aid in their reading and review of such data.
The Voxar 3D product family provides several levels of functionality:
- Basic analysis tools used on a daily basis, such as 2D review, orthogonal Multi Planar Reconstructions ● (MPRs), oblique MPRs, curved MPRs, slab MPRs, slab MPRs, AvelP, MIP, MinIP, measurements, annotations, reporting, and distribution.
- Tools for in-depth analysis, such as regional segmentation of anatomical structures within the image data, . endoscopic review, color volume rendering of finite thickness data cross-sections, 3D review of data volumes, path definition through vescular and other tubular structures, boundary detection, and PET image analysis.
- Specialist tools and workflow enhancements for specific clinical applications which provide directed workflows, . custom User Interfaces, and special measurement and reporting functions optimized for the specific clinical applications. Also included are computer-sided detection signithms which are the user on possible structures of interest. Specialized dinical applications include:
- Colon Screening (which Is intended for the screening of patients for colonic polyps, turnours and other o lesions using tomographic Colonography),
- Vessel Analysis (which is intended for the qualitative and quantitative analysis of tomographic o anglographic studies to evaluate occusive and aneurismal diseases and the effectiveness of stents and stent grafts)
- Coronary analysis (which is Intended for the qualitative and quantitative analysis of coronary 0 arteries to evaluate occlusive and aneurismal disease).
- Functional cardiac analysis (which is intended to evaluate the functional characteristics of the heart), ರ
Prescription Use (21 CFR 801.109) OR
Over-The counter Use _
IR LEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE (ENFEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Rante Pales's
(Division Sign-Off) Division of Reprodu and Radiological D 510(k) Number
510K Submission Page C1