VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSION

K070831 · Barcoview Mis Edinburgh · LLZ · May 22, 2007 · Radiology

Device Facts

• Record ID: K070831
• Device Name: VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSION
• Applicant: Barcoview Mis Edinburgh
• Product Code: LLZ · Radiology
• Decision Date: May 22, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended 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/cross-curved 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 vascular and other tubular structures and boundary detection. - 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. Specialized clinical applications include: - Colon Screening (which is intended for the screening of patients for colonic polyps, tumours and other o lesions using tomographic Colonography), - Vessel Analysis (which is intended for the qualitative and quantitative analysis of tomographic o angiographic studies to evaluate occlusive and aneurismal diseases and the effectiveness of stents and stent grafts) - Coronary Artery Analysis (which is intended for the qualitative and quantitative analysis of coronary o arteries to evaluate occlusive and aneurismal disease), - Functional Cardiac Analysis (which is intended to evaluate the functional characteristics of the heart), O - PET-CT Reading (which is intended for analysis of lesions using FDG imaging from hybrid PET-CT o scanners) This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.

Device Story

Voxar 3D is a software suite for DICOM medical image review; inputs include tomographic data (CT, PET/CT, angiographic studies). Transforms data via 2D/3D visualization, MPRs, segmentation, and boundary detection; provides quantitative/qualitative analysis tools for specific clinical workflows (colon, vessel, cardiac, PET-CT). Used in clinical settings by radiologists/trained professionals; output displayed on workstations to assist in lesion detection, anatomical measurement, and disease evaluation. Enhances diagnostic workflow; supports clinical decision-making by providing advanced visualization and quantification of anatomical structures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based image processing suite; DICOM compliant; supports 2D/3D visualization, MPR, MIP, MinIP, segmentation, and volume rendering. Operates on standard medical imaging hardware; connectivity via DICOM standards.

Indications for Use

Indicated for trained medical imaging professionals to aid in reading/reviewing DICOM-compliant medical image volumes. Includes specialized applications for colon screening (polyps/tumors), vessel analysis (occlusive/aneurysmal disease, stent evaluation), coronary artery analysis, functional cardiac analysis, and PET-CT lesion analysis. Not for primary diagnostic interpretation of mammography.

Regulatory Classification

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.

Special Controls

*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).

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a circular logo with text around the perimeter and a stylized design in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The central design features three curved lines that resemble a stylized human figure or a symbol representing health and well-being. The logo appears to be a seal or emblem associated with the U.S. Department of Health and Human Services.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

BarcoView MIS Edinburgh % Mr. Jeff D. Rongero Senior Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle Park, NC 27709

MAY 2 2 2007

Re: K070831

Trade/Device Name: Voxar 3D Entreprise with ColonMetrix and PET/CT Perfusion Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 4, 2007 Received: May 9, 2007

# 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 shows a circular logo with the text "1906-2006" at the top. Below that is the acronym "FDA" in large, bold letters. Underneath the acronym, the word "Centennial" is written in a cursive font. At the bottom of the logo, there are some smaller characters that are difficult to read.

Protecting and Promoting Public Health

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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 [phone] or [phone]

or at its Internet address http://www.fda.gov/cdrl/industry/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

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### Indications For Use

#### Applicant:

BarcoView MIS Edinburgh, Bonnington Bond, 2 Anderson Place, Edinburgh, EH6 5NP, UK.

510(k) Number (if known): Ko70831 Unknown

Device Name:

Voxar 3D Product Family

#### 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/cross-curved 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 vascular and other tubular structures and boundary detection.
- 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. Specialized clinical applications include:
- Colon Screening (which is intended for the screening of patients for colonic polyps, tumours and other o lesions using tomographic Colonography),
- Vessel Analysis (which is intended for the qualitative and quantitative analysis of tomographic o angiographic studies to evaluate occlusive and aneurismal diseases and the effectiveness of stents and stent grafts)
- Coronary Artery Analysis (which is intended for the qualitative and quantitative analysis of coronary o arteries to evaluate occlusive and aneurismal disease),
- Functional Cardiac Analysis (which is intended to evaluate the functional characteristics of the heart), O
- PET-CT Reading (which is intended for analysis of lesions using FDG imaging from hybrid PET-CT o scanners)

This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.

Prescription Use (Part 21 CFR 801 Subpart D) OR

Over-The-counter Use (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)

Nancy Brogdon

510(k) Submission Page C2