(51 days)
No
The description focuses on standard 3D rendering and visualization techniques, user interaction with the data, and mentions "industry standard rendering methods and algorithms." There is no mention of AI, ML, or any related concepts like deep learning, neural networks, or automated analysis beyond basic image processing and measurement.
No.
The device is used for the display and visualization of 3D medical image data for planning and visualization purposes, not for direct therapeutic treatment.
Yes
Explanation: The device is described as an "Image Processing System" that processes 3D medical image data from CT and MRI scans for display and visualization, and allows users to manipulate, highlight, and measure structures. This functionality directly supports diagnostic activities by enabling medical professionals to analyze medical images. Additionally, the predicate device (Vitrea 2) is a known diagnostic workstation.
No
The device description explicitly mentions hardware components like an "interactive console and display system" (Dextroscope™) and a "stereoscopic projection system" (DextroBeam™), indicating it is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Volume Interactions Pte Ltd's Image Processing System processes and visualizes medical image data (CT and MRI scans) that are already acquired from the patient. It does not perform tests on biological samples.
- Intended Use: The intended use is for the display and visualization of 3D medical image data for surgery planning and visualization purposes by medical professionals. This is a diagnostic imaging tool, not an in vitro diagnostic test.
Therefore, the device falls under the category of medical imaging software/systems, not In Vitro Diagnostics.
N/A
Intended Use / Indications for 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 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.
Product codes
LLZ
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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT and MRI scans
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified and trained medial 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
Not Found
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
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)
| 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
Image Processing System
(VizDexter ™ 2.0,
Dextroscope™,
DextroBeam™) | Voxar Plug n View 3D,
version 1.0 |
|--------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | | K992654 |
| Intended use | Intended for the display and
3D visualization of medical
image data derived from CT
and MRI scans. It is intended
to be used by qualified and
trained medical professionals,
after proper installation. | Intended for use by
radiologists, clinicians and
referring physicians to
acquire, process, render,
review, store, print and
distribute DICOM 3.0
complaint image studies,
utilizing standard PC |
| | | hardware. |
| Type of software
Program | Stand alone application
program | Stand alone application
program |
| Software platform used | Windows NT, Windows 2000
professional | Windows 95/98/NT |
| Stereoscopic Interactive
console | Dextroscope or DextroBeam | None |
| Communications | TCP/IP | TCP/IP |
| Image Format In | DICOM 3.0, Classic SGI, TIFF,
RAW | ACR NEMA 2.0, DICOM 3.0 |
| Image Format out | TIFF image format | DICOM 3.0 |
| Image Display | Color CRT or
Stereoscopic Projection
System | Color/Grayscale, CRT or
Laptop LCD |
| Image Archive | SCSI 10-30 Gbytes, CD-ROM | SCSI 2-20 Gbytes, CD ROM |
| Printing | No | Printing to standards window
printers |
| Prescriptive Device | Prescription use only | Prescription use only |
| Segmentation by
Threshold selection | Yes | Yes (Window level Presets) |
| Morphology
Segmentation Manager | Yes | Yes (Limited) |
| Segmentation by
Contour Editor | Yes | Yes (Shape & Sculpt) |
| Volume Rendering,
Triplanar Mode and 3D
view | | |
| Simultaneous display
of coronal + saggital
- axial plane | Yes (Triplanar Mode) | Yes (Multi Planar Reformatting
(MPR) view) |
| Translate 3 Planes | Yes | Yes |
| Display lines of
intersection between
planes | Yes (shown as actual 3D plane
intersections) | No |
| Patient orientation
Labels | No | Yes |
| Patient Labels | Yes | Yes |
| Adjustable text on
labels | Yes | Yes |
| Borders to highlight
"current" plane | Yes | Yes |
| Reset
pan/zoom/orientation | Yes | Yes |
| Show Volume
Rendering and
Triplanar view
concurrently | Yes | Yes (shows Volume Rendering
and 3 quadrant views) |
| Adjustable clipping in
Triplanar Mode | Yes | Yes (in 3 quadrant views) |
| Volume Rendered 3D
Display mode | Yes | Yes |
| Polygonal Surface
object display mode | Yes | No |
| Multi-modality
Volume Rendered
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
image movement) |
| View Box | Yes | Unknown |
| Color and
transparency editing | Yes (Volume Console) | Yes (Active Color Presets) |
| Image Processing | | |
| Rotation | Yes | Yes |
| Pan | Yes | Yes |
| Zoom | Yes | Yes |
| Flip according to
patient orientation | Yes (Manual Flipping) | Yes |
| Opacity | Yes | Yes |
| Orthogonal clipping | Yes | Yes |
| Sculpting | Yes (Contour Editor) | Yes (Shape & Sculpt tool) |
| Window level
protocols | No | Yes |
| Image Layout | | |
| Show Single Screen | Yes | Yes |
| Show four quadrants
view (coronal +
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
Image Processing System
(VizDexterTM 2.0,
DextroscopeTM,
DextroBeamTM) | Vital Images Vitrea 2,
Version 2.1 |
| 510(k) number | | K002519 |
| Intended use | Intended for the display and 3D
visualization of medical image
data derived from CT and MRI
scans. It is intended to be used
by qualified and trained medial
professionals, after proper
installation. | Intended for processing /
analyzing 2D/3D images from
CT / MR scanners. |
| Type of software program | Stand alone application
program | Stand alone application
program |
| Software platform
required | Windows NT, Windows 2000
professional | Windows NT |
| Stereoscopic Interactive
console | Dextroscope or DextroBeam | None |
| Medical Image Modalities | | |
| All DICOM 3.0
recognized modalities
where datasets are
comprised of parallel,
2D images with know
inter-image spacing | Yes | Yes |
| Measurements | | |
| Distance | Yes | Yes |
| Area | No | Yes |
| Volume | Yes | Yes |
| Interactive contour
definition of lesions | Yes (Contour Editor) | No |
| Safety: Clinician
review/editing of data | Yes (distance and volume
measurements are displayed,
can be modified and be
accepted or rejected by
clinician) | Yes (clinician interactive
reviews and edits the data) |
| Data Source | CT/MR scanners | CT/MR scanners |
| Stereoscopic view | Yes | No |
| Dextroscope Technology
(direct hand access of 3D
objects using 3D joystick
and 3D stylus) | Yes | No |
2
3
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4
Image Processing System
Volume Interactions Pte Ltd
5
,
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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 _