VIZDEXTER VERSION 2.0; DEXTROSCOPE MK8; DEXTROBEAM MK3

{0}------------------------------------------------ # 510(K) Summary The following safety and effectiveness summary has been prepared pursuant to requirement for 510(K) summaries specified in 21CFR 807.92(a) # Submitter Information Volume Interactions Pte Ltd 5 Shenton Way, #37-04 UIC Building, Singapore 068808 + 65 6226962 Phone: + 65 62226215 Facsimile: ### Contact Person John Baby, Process Development Manager, QA/RA #### Date Prepared August 26, 2002 # Device Name - Trade Name Dextroscope™, DextroBeam™, VizDexter™ 2.0 ### Common Name lmage Processing System #### Classification Name Picture Archiving and Communications System (per 21 CFR 892.2050) #### Classification Number LLZ ## Devices to which substantial equivalence is being claimed The Volume Interactions Image Processing System is substantially equivalent to | 510(k)<br>Number | Device Name | Manufacturer | |------------------|-----------------------------|-------------------| | K992654 | Plug n View 3D, Version 1.0 | Voxar Limited | | K002519 | Vitrea 2, Version 2.1 | Vital Images Inc. | # Device Description Volume Interactions Image Processing System reads DICOM 3.0 format medical image data sets (and other formats) and displays 3D image reconstructions of these data sets through various user selectable industry standard rendering methods and algorithms. The clinical users can spatially manipulate, process to highlight structures and volumes of interest, and measure distances and volumes in the 3D image reconstructions. The processed data can be {1}------------------------------------------------ #### Image Processing System Volume Interactions Pte Ltd stored either as 3D image data in a proprietary format. or as 2D picture projections of the 3D image data in TIFF image format. The system runs on commercially available IBM PC compatible computers and hardware components with the Microsoft Windows NT and 2000 operating systems. The system consists of three product modules namely, VizDexter™ 2.0, Dextroscope™ and DextroBeam™. The modules are described as follows: VizDexter™ 2.0 is software that processes tomographic (e.g.: Computer Tomography, Magnetic Resonance Imaging) data and produces stereoscopic 3D renderings for surgery planning and visualization purposes. The software user selectable industry standard rendering methods and algorithms. Dextroscope™ is an interactive console and display system that allows the user to interact with two hands with the 3D images generated by the VizDexter™ software. The Dextroscope™ user works seated, with both forearms positioned on armrests. Wearing stereoscopic glasses, the user looks into a mirror and perceives the virtual image within comfortable reach of both hands for precise hand-eye coordinated manipulation. The hardware uses various industry standard components. DextroBeam™ is an interactive console intended for group collaborative discussions with 3D images using a stereoscopic projection system. The DextroBeam™ system uses the base of the Dextroscope™ as the 3D interaction interface with the virtual objects. The monitor of the Dextroscope™ is replaced by a screen projection system, so instead of looking into the mirror of the Dextroscope™, the user looks at large stereoscopic screen projections while working with the virtual data in reach of his hands. This enables the discussion of 3D data sets with other specialists in stereoscopic 3D. The hardware uses various industry standard components. # Intended Use Volume Interactions Pte Ltd's Image Processing System is a medical device for the display and 3D visualization of medical image data derived from CT and MRI scans. It is intended to be used by gualified and trained medial professionals, after proper installation. Volume Interactions Pte Ltd's Image Processing System is not intended to be used in direct contact with the patient nor is it intended to be connected to equipment that is used in direct contact with the patient # Comparison of Technological Characteristics The Volume Interactions Image Processing System is substantially equivalent to Voxar Limited Plug n View 3D, Version 1.0 (K992654) for non measurement features and Vital Images Vitrea 2, Version 2.1 (K002519) for measurements. | Feature | Volume Interactions<br>Image Processing System<br>(VizDexter ™ 2.0,<br>Dextroscope™,<br>DextroBeam™) | Voxar Plug n View 3D,<br>version 1.0 | |--------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) number | | K992654 | | Intended use | Intended for the display and<br>3D visualization of medical<br>image data derived from CT<br>and MRI scans. It is intended<br>to be used by qualified and<br>trained medical professionals,<br>after proper installation. | Intended for use by<br>radiologists, clinicians and<br>referring physicians to<br>acquire, process, render,<br>review, store, print and<br>distribute DICOM 3.0<br>complaint image studies,<br>utilizing standard PC | | | | hardware. | | Type of software<br>Program | Stand alone application<br>program | Stand alone application<br>program | | Software platform used | Windows NT, Windows 2000<br>professional | Windows 95/98/NT | | Stereoscopic Interactive<br>console | Dextroscope or DextroBeam | None | | Communications | TCP/IP | TCP/IP | | Image Format In | DICOM 3.0, Classic SGI, TIFF,<br>RAW | ACR NEMA 2.0, DICOM 3.0 | | Image Format out | TIFF image format | DICOM 3.0 | | Image Display | Color CRT or<br>Stereoscopic Projection<br>System | Color/Grayscale, CRT or<br>Laptop LCD | | Image Archive | SCSI 10-30 Gbytes, CD-ROM | SCSI 2-20 Gbytes, CD ROM | | Printing | No | Printing to standards window<br>printers | | Prescriptive Device | Prescription use only | Prescription use only | | Segmentation by<br>Threshold selection | Yes | Yes (Window level Presets) | | Morphology<br>Segmentation Manager | Yes | Yes (Limited) | | Segmentation by<br>Contour Editor | Yes | Yes (Shape & Sculpt) | | Volume Rendering,<br>Triplanar Mode and 3D<br>view | | | | Simultaneous display<br>of coronal + saggital<br>+ axial plane | Yes (Triplanar Mode) | Yes (Multi Planar Reformatting<br>(MPR) view) | | Translate 3 Planes | Yes | Yes | | Display lines of<br>intersection between<br>planes | Yes (shown as actual 3D plane<br>intersections) | No | | Patient orientation<br>Labels | No | Yes | | Patient Labels | Yes | Yes | | Adjustable text on<br>labels | Yes | Yes | | Borders to highlight<br>"current" plane | Yes | Yes | | Reset<br>pan/zoom/orientation | Yes | Yes | | Show Volume<br>Rendering and<br>Triplanar view<br>concurrently | Yes | Yes (shows Volume Rendering<br>and 3 quadrant views) | | Adjustable clipping in<br>Triplanar Mode | Yes | Yes (in 3 quadrant views) | | Volume Rendered 3D<br>Display mode | Yes | Yes | | Polygonal Surface<br>object display mode | Yes | No | | Multi-modality<br>Volume Rendered<br>Display mode | Yes | No | | MIP Display Mode | No | Yes | | Basic Tools | | | | Volume | Yes | Yes | | Crop | Yes | Yes (Shape tool) | | Cut | Yes | No (only orthogonal cuts) | | Pick | Yes | Yes (Selection tool) | | Zoom | Yes | Yes | | Pitch | Yes | Yes (resolution varies during<br>image movement) | | View Box | Yes | Unknown | | Color and<br>transparency editing | Yes (Volume Console) | Yes (Active Color Presets) | | Image Processing | | | | Rotation | Yes | Yes | | Pan | Yes | Yes | | Zoom | Yes | Yes | | Flip according to<br>patient orientation | Yes (Manual Flipping) | Yes | | Opacity | Yes | Yes | | Orthogonal clipping | Yes | Yes | | Sculpting | Yes (Contour Editor) | Yes (Shape & Sculpt tool) | | Window level<br>protocols | No | Yes | | Image Layout | | | | Show Single Screen | Yes | Yes | | Show four quadrants<br>view (coronal +<br>saggital + axial+ 3D) | No | Yes | | Multi-modal volume rendering | | | | 3D registration | Yes | No | | Multimodal fusion of CT and MR scans | Yes | No | | Image Storage | | | | Add captured 3D rendered image to user profiles | Yes (as TIFF files) | Yes | | Record movie clips | Yes | Yes | | Hardcopy generation | | | | Print to DICOM and NON-DICOM printers | No | Yes | | Image Editing Tools | Erase and Restore | Tools for removal of obscuring anatomy | | Measurements | | | | Distance | Yes | Yes | | Area | No | No | | Volume | Yes | Yes | | Feature | Volume Interactions<br>Image Processing System<br>(VizDexterTM 2.0,<br>DextroscopeTM,<br>DextroBeamTM) | Vital Images Vitrea 2,<br>Version 2.1 | | 510(k) number | | K002519 | | Intended use | Intended for the display and 3D<br>visualization of medical image<br>data derived from CT and MRI<br>scans. It is intended to be used<br>by qualified and trained medial<br>professionals, after proper<br>installation. | Intended for processing /<br>analyzing 2D/3D images from<br>CT / MR scanners. | | Type of software program | Stand alone application<br>program | Stand alone application<br>program | | Software platform<br>required | Windows NT, Windows 2000<br>professional | Windows NT | | Stereoscopic Interactive<br>console | Dextroscope or DextroBeam | None | | Medical Image Modalities | | | | All DICOM 3.0<br>recognized modalities<br>where datasets are<br>comprised of parallel,<br>2D images with know<br>inter-image spacing | Yes | Yes | | Measurements | | | | Distance | Yes | Yes | | Area | No | Yes | | Volume | Yes | Yes | | Interactive contour<br>definition of lesions | Yes (Contour Editor) | No | | Safety: Clinician<br>review/editing of data | Yes (distance and volume<br>measurements are displayed,<br>can be modified and be<br>accepted or rejected by<br>clinician) | Yes (clinician interactive<br>reviews and edits the data) | | Data Source | CT/MR scanners | CT/MR scanners | | Stereoscopic view | Yes | No | | Dextroscope Technology<br>(direct hand access of 3D<br>objects using 3D joystick<br>and 3D stylus) | Yes | No | {2}------------------------------------------------ {3}------------------------------------------------ . {4}------------------------------------------------ # Image Processing System Volume Interactions Pte Ltd {5}------------------------------------------------ , . {6}------------------------------------------------ # Discussion of similarities and differences The software module VizDexter™ 2.0 of the Volume Interactions Image Processing System utilizes similar technological characteristics as the predicate devices. All provide multiview user interfaces with combinations of 2D and 3D views correlated together for enhanced visualization. All provide measurement tools for analysis of the observed structures (volumes); and allow virtual lighting parameters to emphasize details. VizDexter™ 2.0 and all predicates, provide 3D views. As with Vitrea 2 and Voxar Plug n View 3D, VizDexter 2.0 utilizes direct volume rendering for all its 3D views, including transparent volume images and visible surface views. For changing the mapping to opacity during translucent views, VizDexter 2.0 is similar to Voxar Plug n View 3D and Vitrea 2. VizDexter™ 2.0 has functions of multi-modal volume rendering and a registration facility, which are not present in Plug n View 3D and Vitrea 2. Volume Interactions Image Processing System and all predicates use identical technology to manipulate and display the 2D image views of the data sets (industry standard mouse and keyboard and a computer monitor). VizDexter™ 2.0 differs from all predicates however in the user interface utilized to manipulate the 3D image data, and in the display of the 3D image data. The user interfaces of the Dextroscope and the DextroBeam utilize an industry standard 3D tracker to position and orient the 3D image data with both hands, for ease of manipulation. The display of the 3D data is achieved by wearing stereoscopic glasses to view the 3D images of a computer monitor through a normal mirror (Dextroscope ™) or to view the 3D images displayed by a stereoscopic projector (DextroBeam ™). Voxar Plug n View 3D and Vital Images Vitrea 2.0 do not provide stereoscopic display nor hand controlled 3D trackers and follow the conventional keyboard and mouse interface for 2D and 3D interactions. # Technological characteristics The device does not contact the patient, nor does it control any life sustaining devices. A physician providing ample opportunity for competent human intervention, interprets images and information being displayed. # Conclusion We conclude that the Volume Interactions Image Processing System (VizDexter™ 2.0, Dextroscope™ and DextroBeam ™) is substantially equivalent to its predicate devices in its ability to render 3D images for use in medical analysis. In comparison of the predicate devices Volume Interactions Image Procession System provides a user interface that utilizes both hands to manipulate the 3D image data, and a stereoscopic display to view the 3D image data, which the predicate devices do not provide. Regarding safety and effectiveness, Volume Interactions Pte Ltd is an ISO 9001;2000 certified company. All processes are controlled and monitored. Risk management including risk analysis, verification and validation tests. and evaluation by hospitals control potential hazards in both software and hardware. The level of concern for the Volume Interactions Image Processing System is minor. {7}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 25 2002 Mr. John Baby Process Development Manager Volume Interactions, Pte., Ltd. 5 Shenton Way #37-04 UIC Building 068808 SINGAPORE Re: K022938 Trade/Device Name: VizDexter Version 2.0; Dextroscope MK8; Dextrobeam MK3 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: August 30, 2002 Received: September 4, 2002 Dear Mr. Baby: 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. Image /page/7/Picture/12 description: The image shows a partial view of a logo or seal, focusing on the upper left quadrant. A portion of the text "DEPARTMENT OF..." is visible, arranged vertically along the left edge. To the right of the text, there are three stylized, curved lines that appear to be a design element of the logo. The overall impression is that the image captures a fragment of an official emblem or seal. {8}------------------------------------------------ This letter will allow you to begin marketing your device as described in your 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: | 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" (21 CFR Part 807.97). 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. Snogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ #### Indications for Use 2. 510(k) Number: Ko 2 2938 Device Name: lmage Processing System Indications for Use: Volume Interactions Pte Ltd's Image Processing System is a medical device for the display and visualization of 3D medical image data derived from CT and MRI scans. It is intended to be used by qualified and trained medial professionals, after proper installation. Volume Interactions Pte Ltd's Image Processing System is not intended to be used in direct contact with the patient nor is it intended to be connected to equipment that is used in direct contact with the patient. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) (Optional Format 1-2-96) Oerist A. Seymour (Division Sign-Off) Division of Reproductive, Abdomina anc Padiological Devices 5 ! (k) Number _