(36 days)
Not Found
No
The description focuses on standard 3D rendering, manipulation, and visualization techniques using "industry standard rendering methods and algorithms." There is no mention of AI, ML, or any learning-based processes for image analysis or interpretation.
No
The device is described as an "Image Processing System" for "display and visualization of 3D medical image data" and for "surgery planning and visualization purposes," which are diagnostic and planning functions, not therapeutic.
Yes
The device is described as an "Image Processing System" that processes medical image data for "display and visualization," allowing "clinical users" to "spatially manipulate, process to highlight structures and volumes of interest, and measure distances and volumes." This indicates its role in aiding medical professionals in interpreting and understanding medical images, which is a key function of a diagnostic device. RadioDexter™ is specified for "surgery planning and visualization purposes."
No
The device description explicitly states that the system consists of three product modules, two of which (Dextroscope™ and Dextrobeam™) are described as interactive console and display systems that use hardware components. While RadioDexter™ is software, the overall system includes hardware.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- This device processes medical images: The description clearly states that the device processes and visualizes 3D medical image data derived from tomographic radiology images. It does not interact with or analyze biological samples.
The device is a medical imaging processing and visualization system intended for use by medical professionals for tasks like surgery planning and visualization. This falls under the category of medical devices, but not specifically 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 visualization of 3D medical image data derived from tomographic radiology images, excluding mammography images. It is intended to be used by qualified and trained medical professionals, after proper installation.
Product codes (comma separated list FDA assigned to the subject device)
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 PC compatible computers and hardware components with the Microsoft Windows NT and 2000 operating systems.
The system consists of three product modules namely, RadioDexter™, Dextroscope™ and Dextrobeam™. The modules are described as follows:
RadioDexter™ 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 uses various user selectable industry standard rendering methods and algorithms.
DTI (Diffusion Tensor Imaging) is an add-on module to RadioDexter™. This module allows the user to visualize white matter anatomy in the form of fiber tracks. The intended use of this module is to generate and provide a visual reference of white matter fiber tracks in a 3D virtual reality environment during the process of neurosurgery planning using the Dextroscope™ or during a discussion/collaboration using the Dextrobeam™. It is not intended to be used otherwise.
Dextroscope™ is an interactive console and display system that allows the user to interact with two hands with the 3D images generated by the RadioDexter™ 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
tomographic radiology images (e.g.: Computer Tomography, Magnetic Resonance Imaging), DICOM 3.0, classic SGI formats, TIFF, Raw volume chunk or slices
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified and trained medical 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the logo for Volume Interactions Bracco Group. The logo is black and white. The word "Volume" is in large, bold letters, with a hand pointing to the "o" in Volume, which is a sphere made of dots. Below Volume is the word "INTERACTIONS" in smaller, bold letters, and below that is "Bracco Group" in a smaller, non-bold font.
Tuvalu
K07/1054
510(k) Summary Of Safety and Effectiveness | MAY 22 2007 | |
---|---|---|
RadioDexter™™, Dextroscope™ and Dextrobeam™™ | ||
Submitter Information | ||
Manufacturer: | Volume Interactions Pte Ltd | |
1 Kim Seng Promenade #12-01 | ||
Great World City East Tower | ||
Singapore 237994 | ||
Phone: + 65 62226962 ext 232 | ||
Facsimile: + 65 62226215 | ||
Contact Person: | Michael Sim, Director, Worldwide Operations | |
Summary Date: | 9th April 2007 | |
Device Name | ||
Common Name: | Image Processing System | |
Trade Name: | ||
& Model No. | RadioDexter™™ 1.0, Dextroscope™™ MK10, Dextrobeam™ MK3 & | |
MK4 | ||
Classification Name: | Picture Archiving and Communications System (per 21 CFR | |
892.2050) | ||
Classification Number: | LLZ |
Intended 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 tomographic radiology images, excluding mammography images. It is intended to be used by qualified and trained medical professionals, after proper installation.
Predicate device
| Trade Name & Model No.: | RadioDexter™ 1.0, Dextroscope™ MK10,
Dextrobeam™ MK3 & MK4 |
|-------------------------|---------------------------------------------------------------|
| 510(k) number: | K063730 |
1
Image /page/1/Picture/0 description: The image shows the logo for Volume Interactions, a Bracco Group company. The logo features the word "Volume" in a bold, sans-serif font, with a graphic of a hand touching a dotted sphere in place of the "o". Below "Volume", the word "INTERACTIONS" is written in a smaller, sans-serif font. Underneath "INTERACTIONS" is the text "Bracco Group".
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 PC compatible computers and hardware components with the Microsoft Windows NT and 2000 operating systems.
The system consists of three product modules namely, RadioDexter™, Dextroscope™ and Dextrobeam™. The modules are described as follows:
RadioDexter™ 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 uses various user selectable industry standard rendering methods and algorithms.
DTI (Diffusion Tensor Imaging)
DTI (Diffusion Tensor Imaging) is an add-on module to RadioDexter™. This module allows the user to visualize white matter anatomy in the form of fiber tracks. The intended use of this module is to generate and provide a visual reference of white matter fiber tracks in a 3D virtual reality environment during the process of neurosurgery planning using the Dextroscope™ or during a discussion/collaboration using the Dextrobeam™. It is not intended to be used otherwise.
Dextroscope™ is an interactive console and display system that allows the user to interact with two hands with the 3D images generated by the RadioDexter™ 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.
2
Image /page/2/Picture/0 description: The image shows a logo for Volume Interactions, a Bracco Group company. The logo features the word "Volume" in bold, with a hand pointing towards a sphere made of interconnected lines. Below "Volume" is the word "INTERACTIONS" in a smaller, sans-serif font, and below that is "Bracco Group" in a similar font.
Substantial Equivalence
The Image Processing System in this submission remains unchanged as previously received 510(k)063730, in the following aspects:
- Use the same operating principle .
- Have the same technological characteristics .
- Incorporate similar basic software and hardware design .
- Have the same fundamental scientific technology .
The only differences are as follows:
Intended Use
The following statement has been removed from the intended use:
"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."
The device's input is derived from tomographic radiology images and the data format of the input is in either DICOM 3.0 or other common imaging formats (classic SGI formats. TIFF, Raw volume chunk or slices). It is clear that the input is not derived from patients directly which is why our company finds it redundant to highlight that there is no direct patient contact and connection to equipment that is used in direct contact with the patient. Removal of the statement does not affect the safety and effectiveness of the device as this does not change the system in terms of performance, design and technological characteristics.
DTI (Diffusion Tensor Imaging)
DTI (Diffusion Tensor Imaging) is an add-on module to RadioDexter™. This module allows the user to visualize white matter anatomy in the form of fiber tracks. The intended use of this module is to generate and provide a visual reference of white matter fiber tracks in a 3D virtual reality environment during the process of neurosurgery planning using the Dextroscope™ or during a discussion/collaboration using the Dextrobeam™. It is not intended to be used otherwise.
DTI has been verified and validated according to Volume Interactions' procedures for product design and development. The validation proves the safety and effectiveness of the module.
Conclusion
In summary, the Image Processing System (Dextroscope™, Dextrobeam™ with RadioDexter™ ) described in this submission are, in our opinion, substantially equivalent to the predicate device.
3
Image /page/3/Picture/13 description: The image is a seal for the Department of Health & Human Services (HHS). The seal features the HHS logo, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the logo.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Michael Sim Director, Worldwide Operations Volume Interactions Pte Ltd 1 Kim Seng Promenade #12-01 Great World City East Tower SINGAPORE 237994
MAY 2 2 2007
Re: K071054
Trade/Device Name: Image Processing System (Dextroscope™ MK10. Dextrobeam™ MK3 and MK4, and RadioDexter™ 1.0) Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 9, 2007 Received: April 16, 2007
Dear Mr. Sim:
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/3/Picture/10 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the logo. The letters "FDA" are in the center of the logo, with the word "Centennial" underneath. The text "FDA Centennial" is in a stylized font. The text "Health is Confidence Protected" is around the perimeter of the logo.
Protecting and Promoting Public Health
4
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
5
INDICATION FOR USE STATEMENT
510(k) Number
KD71054
Image Processing (Dextroscope™ MK10, Device Name System . . Dextrobeam™ MK3 and MK4, RadioDexter™ 1.0)
Indication 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 tomographic radiology images, excluding mammography images. It is intended to be used by qualified and trained medical professionals, after proper installation.
Over-The-Counter Use Prescription Use AND/OR (21 CFR 801 Subpart C) (Per 21CFR 801 Subpart D) .
IPLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancyc brogdon
(Division Sign Off)
(Division Sign-Off Division of Reproductive, Abdominal, a Radiological Devices 510(k) Number