(14 days)
The V-works is a software application for the display and 3D visualization of medical image files from scanning devices, such as CT, MRI or 3D Ultrasound. It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, review, store, print and distribute DICOM 3.0 compliant image studies, utilizing standard PC hardware.
The V-works™ is a software application for the display and 3D visualization of medical image files from scanning devices, such as CT, MRI or 3D Ultrasound. It is intended for use by radiologists, clinicians and referring physicians to acquire, mocess, render, review, store, print and distribute DICOM 3.0 complaint image process, reliaer, 101107, 1011, 1978, dware. All of the functions are supported on standard personal computer platform for ease of cost and maintenance. The use of Microsoft personal compacer pratessional/NT 4.0 operating system makes the V-works™ software easy to use and capable of being integrated with other computer needs.
The provided text is a 510(k) Summary for the CyberMed Inc., V-works™ device. It describes the device, its intended use, and its substantial equivalence to a predicate device (Voxar Limited Plug'n View 3D). However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications in the way a clinical validation study typically reports it.
The document focuses on establishing substantial equivalence based on technical characteristics and intended use, rather than presenting a performance study with specific acceptance criteria and results.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present in the document.
- Sample sized used for the test set and the data provenance: This information is not present in the document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present in the document.
- Adjudication method for the test set: This information is not present in the document.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size: This information is not present in the document.
- If a standalone performance (i.e. algorithm only without human-in-the loop performance) was done: This information is not present in the document.
- The type of ground truth used: This information is not present in the document.
- The sample size for the training set: This information is not present in the document.
- How the ground truth for the training set was established: This information is not present in the document.
The document mainly emphasizes that the V-works™ software is "designed, developed, tested and validated according to written procedures" and that "hazard analysis on this product has been performed throughout the definition, design, coding and testing phases." It concludes that the "Level of Concern" is "Minor" and that potential hazards are similar to other PACS components and unlikely to result in patient death or injury. This reflects a software development and risk management approach, not a clinical performance study as typically seen for AI/CAD devices.
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510(k) Summary
1. Company Identification
CyberMed, Inc.
5F Won Bldg, 49-16, Nonhyeon-dong Gangnam-gu, Seoul, 135-814, Korea Company Contact: Young-Yin Yoon Tel: +82-2-545-4282 Fax: +82-2-545-6042 http://www.cybermed.co.kr
2. Official Correspondent
Gary J. Allsebrook, Official Correspondent C/o Regulatory Management Services 16303 Panoramic Way San Leandro CA 94578-1116 Tel: 510-276-2648 Fax: 510-276-3559 Email: regman1 @home.com
3. Date of Submission
November 14, 2001
4. Device Name
| Classification Name: | Picture Archiving and Communications System(PACS) |
|---|---|
| Common/Usual Name: | Image processing, management and 3Dvisualization system |
| Proprietary Name: | CyberMed, Inc., V-worksTM |
5. Substantial Equivalence
The CyberMed Inc., V-works™ is substantially equivalent to the Voxar Limited Plug'n View 3D, 510(k) #992654.
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6. Device Description and Intended Use
The V-works™ is a software application for the display and 3D visualization of medical image files from scanning devices, such as CT, MRI or 3D Ultrasound. It is intended for use by radiologists, clinicians and referring physicians to acquire, mocess, render, review, store, print and distribute DICOM 3.0 complaint image process, reliaer, 101107, 1011, 1978, dware. All of the functions are supported on standard personal computer platform for ease of cost and maintenance. The use of Microsoft personal compacer pratessional/NT 4.0 operating system makes the V-works™ software easy to use and capable of being integrated with other computer needs.
7. Software
CyberMed, Inc., certifies that the V-works™ is designed, developed, tested and validated according to written procedures. These procedures identify individuals within the organization responsible for developing and approving product specifications, coding and testing, validation testing and field maintenance.
8. Hazard Analysis
Hazard analysis on this product has been performed throughout the definition, design, coding and testing phases of product development and implementation. This process has emphasized:
- Identification of potential hazards, their causes, and their effects; .
- Development of methodologies to control the occurrence of hazards and to . constrain their effects; and
- Determine any effect on patient safety and system effectiveness. .
The potential hazards associated with this software product are no different than those of other PACS components . These are primarily related to failure of computer system components, and may be variously obviated by decisions taken by the customers of this product. None of these failures are expected to materially contribute to patient death or injury.
It is our conclusion that there is no hardware or software component, operating in a properly configured environment, whose failure or latent design defect would be expected to result in death or injury of a patient. Thus the "Level of Concern" is "Minor".
9. Safety Concerns
The hardware is "off-the-shelf" and complies with applicable electrical safety standards for standard PC hardware and peripherals.
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10. Substantial Equivalence
The following product provides functions, which are substantially equivalent to this product:
| CyberMed,Inc. | PREDICATE DEVICE | |
|---|---|---|
| Voxar Limited | ||
| Characteristics | V-works™ | Plug'n View 3D |
| 510(k) number | K992654 | |
| Type of SoftwareProgram | Stand alone application program | Stand alone application program |
| Computer Platform | Pentium II or III with Windows 98 / ME /NT 4.0 / 2000 Professional | Pentium III with Windows NT 4.0 /Windows 2000 professional |
| Communications | TCP/IP | TCP/IP |
| DICOM compliance | DICOM 3.0 compliance for CT, MRI or3D Ultrasound images | DICOM 3.0 compliance for CT,MRI,NM,CR,SC and Ultrasound (singleframe) images |
| Image Format In | ACR NEMA 2.0 , BMP, DICOM 3.0 | ACR NEMA 2.0, DICOM 3.0 |
| Image Format Out | BMP, JPEG, DICOM 3.0 | DICOM 3.0 |
| Image Archive | SCSI 2-20 Gbytes, CD-ROM | SCSI 2-20 Gbytes, CD-ROM |
| Image Display | Color / Greyscale, CRT or Laptop LCD1024×768 or higher, 8, 16 or 24 Bits | Color / Greyscale, CRT or Laptop LCD |
| Image Processing | Window Level, Pan, Zoom, Rotate, andFlip | Window Level, Pan, Zoom, Rotate, Flipand cine |
| Image Edit | Manual Segmentation by drawing acontour (slice edit, region edit, VOI edit),Semi-automatic Segmentation (Snake),Volume Sculpting, Segmentation by CTnumber threshold, Multi-tissue OpacityControl, Other Segmentation (Selectingobject, Boolean operation, Dilate/Erode) | Advanced SegmentationVolume SculptingMulti-tissue Opacity Control |
| Volume Rendering | Maximum, or Minimum IntensityProjection (MIP, MinIP)Radiographic Projection, ColorRendering, Surface Rendering, QuickSurface Rendering, Volume Rendering,Multi-planar Reconstruction (MPR),Virtual Endoscopy | interactive opacity / transparencycontrol, clipping volume ofinterest(VOI), zoom, pan and rotate |
| Measurements | 2D measurement tools includingdistance, angle, and area.3D measurement tools including volume,distance and angle | 2D measurement tools includingdistance, angle and ROI statistics,3D volume measurement |
| Printing | Printing to standard Windows printers | Printing to standard Windows printers |
| Prescription use only |
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Discussion of the similarities and differences and an explanation of important differences between V-works and Plug'n View 3D
1. Similarities between V-works ™ and Plug'n View3D
The similarities between V-works ™ and Plug'n View3D are as follows;
| Manufacturer: | Cybermed,Inc. | Voxar Limited |
|---|---|---|
| Product Name: | V-works TM | Plug'n View3D |
| ComputerPlatform | Same as right column | Pentium III with Windows NT 4.0 /Windows 2000 professional |
| Communications | Same as right column | TCP/IP |
| DICOMcompliance | Same as right column | DICOM 3.0 compliance for CT, MRI, |
| Image Format In: | Same as right column | ACR NEMA 2.0, DICOM 3.0 |
| Image FormatOut: | Same as right column | DICOM 3.0 |
| Image Archive | Same as right column | SCSI 2-20 Gbytes, CD-ROM |
| Image Display | Same as right column | Color / Greyscale, CRT or LaptopLCD |
| ImageProcessing | Same as right column | Window Level, Pan, Zoom,Rotate, Flip |
| Image Edit | Same as right column | Advanced SegmentationVolume SculptingMulti-tissue Opacity Control |
| Measurements | Same as right column | 2D measurement tools includingdistance, angle, |
| Printing | Same as right column | Printing to standardWindows printers |
V-works ™ and Plug'n View 3D are redefining the concept of medical imaging with its quick, easy-to-use, easy-to-integrate, and affordable PC-based software. V-works ™ and Plug'n View 3D allow the rapid display of CT and MR data on PC, laptop or PACS Workstation. In addition, V-works ™ and Plug'n View 3D are increasing access to this technology for radiologists and referring clinicians, leading to better communication of results, improved workflow and faster and more accurate diagnosis.
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2. Differences between V-works ™ and Plug'n View3D
The differences between V-works ™ and Plug'n View3D are as follows;
| Manufacturer: | Cybermed, Inc. | Voxar Limited |
|---|---|---|
| Product Name: | V-works TM | Plug'n View3D |
| 510(k) number | Unknown | K992654 |
| DICOMcompliance | 3D Ultrasound images | None |
| Image Format In: | BMP | None |
| Image Edit | Manual Segmentation by drawing acontour (slice edit, region edit, VOI edit),Semi-automatic Segmentation (Snake),Other Segmentation (Selecting object,Boolean operation, Dilate/Erode) | None |
| VolumeRendering | Radiographic Projection,Surface Rendering,Quick Surface Rendering,Virtual Endoscopy | None |
| Measurements | 3D measurement tools including volume,distance and angle | None |
V-works ™ has function of Surface Rendering (SSD) and Virtual Endoscopy, but Plug'n View3D does not function of them. The specifications of Surface Rendering (SSD) and Virtual Endoscopy are as follows;
-
- Surface Rendering (SSD; Shaded Surface Display)
- Quick SSD (Shaded Surface Discplay)
- 3D operation
- Import / Export 3D model
- Virtual Endoscopy mode
- Displaying current camera position on classic MPR images
- Free navigation using keyboard and mouse
- Creation of navigation path semi-automatically on 3D external view Creation of navigation path manually on 3D internal view Displaying a path and camera angle and camera position on external view
- Exporting AVI file of navigation
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 7 2001
CyberMed, Inc. % Mr. Justin Gagnon Associate Project Manager Underwriters Laboratories, Inc. 2600 N.W. Lake Road CAMAS WA 98607-8542
Re: K013878
Trade/Device Name: CyberMed Inc., V-Works Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: 90 LLZ Dated: November 21, 2001 Received: November 23, 2001
Dear Mr. Gagnon:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your Section 310(t) promotion is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars comment date of the Medical Device American program commence prior to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices mat nave been roomstiled in quire approval of a premarket approval application (PMA). alla Cosment Act (Act) that do not require appt to the general controls provisions of the Act. The r ou may, therefore, market the ab 100, councements for annual registration, listing of general controls provisions of the rece, 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 your device is classified (500 a00 v) in Existing major regulations affecting your device can be it may of Subject to adultional collistics. This 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 I least of advised that I DA 3 issualles sour device complies with other requirements of the Act that I Dr has made a and regulations administered by other Federal agencies. You must of any I edelul statures and stiments, including, but not limited to: registration and listing comply with and not rece Frequirements, as 801); good manufacturing practice requirements as set (21 CFR Part 007), laborning (21 CFR Part 820); and if applicable, the electronic form in the quant) bybelms (sections 531-542 of the Act); 21 CFR 1000-1050.
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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
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Attachment 1 b Page 1 Revised: 7/1/96
510(k) Number (If Known): ____________________________________________________________________________________________________________________________________________________
Device Name: CyberMed, Inc., V-works
Indications for use:
The V-works is a software application for the display and 3D visualization of medical intege files from The V-works is a soltware application for ultrasound. It is intended for use by radiologists, clinicians
scanning devices, such as CT, MRI or 3D Ultrasound. It is intended fo Scanning devices, sach as CT, MIC OF SE Station Croce, print and distribute DICOM 3.0 compliant image studies, utilizing standard PC hardware.
David A. Seymour
(Please do not write below this line- continue on another page if needed)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
Prescription Use
OR
Over-the-Counter Use
§ 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).