(89 days)
No
The description details a fixed algorithm for image processing controlled by user input (knobs and presets), not a system that learns or adapts from data. The algorithm is explicitly provided and does not mention AI/ML techniques.
No
The device is used to enhance video signals from imaging devices to aid in diagnosis and treatment, not to directly treat the disease itself.
No
The CE-3000 is described as a "Contrast Enhancer" that optimizes video signals from viewing devices (like fluoroscopes, endoscopes) to aid in diagnosis and treatment. It processes existing video signals to improve visualization, rather than itself performing a diagnosis. The "intended use" states it "may be used...to aid in diagnosis and treatment," indicating it's a tool that supports, but doesn't directly perform, the diagnostic function.
No
The device description explicitly states it has a metal enclosure, a main processor circuit board, and other commercially available hardware and electronic components. While it incorporates embedded software, it is not solely software.
Based on the provided information, the CE-3000 Contrast Enhancer is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- CE-3000 Function: The CE-3000 processes video signals from imaging devices like fluoroscopes, endoscopes, and laparoscopes. It enhances the visual quality of these images for viewing on a monitor.
- No Sample Analysis: The device does not analyze biological samples. Its input is a video signal, not a bodily fluid or tissue sample.
- Intended Use: The intended use is to aid in diagnosis and treatment by improving the visualization from imaging devices, not by performing a diagnostic test on a biological sample.
The CE-3000 is a medical device that processes and enhances medical images, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CE-3000 Contrast Enhancer like the FluoroVision, may be used in any application where a viewing device (fluoroscope, endoscope, laparoscope, etc.) and monitor is incorporated to aid in diagnosis and treatment of a disease such as an arthroscopy or cholecystectomy.
Product codes
Not Found
Device Description
The CE-3000 takes a video signal in and allows an operator to control, via three knobs on the front panel, the local gain of spatial frequencies, through high specd signal processing, to generate video optimized for specific functions in real time. The three knohs on the front of the device, DETAIL (kernel size), CONTRAST and BACKGROUND, allow the operator to "dial-in" the picture to his preference or he may press the PRESET button to set the cnhancement to predetermined factory settings. A SPLIT screen button is available to help the user to set the optimum enhancement. Selecting the BYPASS switch displays original unprocessed video.
The CE-3000 has a main processor circuit board (core board) which incorporates DigiVision. Inc.'s patented V-Lace technology (for video locally adaptive contrast enhancement) can be adjusted to give the appropriate enhancement to any video scene. The enclosure for the CE-3000 is metal (aluminum). The other components are commercially available hardware and electronic components and printed circuit cards manufactured to DigiVision, Inc. specifications.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video signal
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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
K9622660
Image /page/0/Picture/1 description: The image shows the logo for DigiVision. The logo consists of a stylized, three-dimensional shape on the left, resembling three interconnected cubes. To the right of the shape is the word "DigiVision" in a bold, sans-serif font. The overall design is simple and modern.
SEP - 9 COS
DigiVision, Inc.
5626 Oberlin Drive
San Diego, CA 92121
(619) 458-1111
FAX (619) 458-0652
510K SUMMARY
For
DEVICE TRADE NAME: CE-3000 CONTRAST ENHANCER
COMMON NAME: VIDEO CONTRAST ENHANCER
CLASSIFICATION NAME: ENDOSCOPE AND ACCESSORIES ( 876.1500)
SUBMITTED BY: CHARLES A. BRASS - ADMINISTRATOR, QA/QC
DIGIVISION, INC.
5626 OBERLIN DRIVE
SAN DIEGO, CA 92121
CONTACT PERSON: CHARLES A. BRASS
CLAIMING SUBSTANTIAL EQUIVALENCE TO:
DIGIVISION - FLUOROVISION
COMMON NAME: VIDEO CONTRAST ENHANCER
CLASSIFICATION NAME: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
(ACCESSORY) (PER 21 CFR 892.1650)
510K NUMBER K864584
PREPARED June 7, 1996
DATE
1
510K SUMMARY
Description
The CE-3000 takes a video signal in and allows an operator to control, via three knobs on the front panel, the local gain of spatial frequencies, through high specd signal processing, to generate video optimized for specific functions in real time. The three knohs on the front of the device, DETAIL (kernel size), CONTRAST and BACKGROUND, allow the operator to "dial-in" the picture to his preference or he may press the PRESET button to set the cnhancement to predetermined factory settings. A SPLIT screen button is available to help the user to set the optimum enhancement. Selecting the BYPASS switch displays original unprocessed video.
The CE-3000 has a main processor circuit board (core board) which incorporates DigiVision. Inc.'s patented V-Lace technology (for video locally adaptive contrast enhancement) can be adjusted to give the appropriate enhancement to any video scene. The image processing algorithm is expressed as:
$$\mathbf{Y} = \mathbf{c}(\mathbf{X} \cdot \bar{\mathbf{X}}(\mathbf{d})) + (\mathbf{l} \cdot \mathbf{b})\bar{\mathbf{X}}(\mathbf{d}) + \mathbf{b}\mathbf{M}.$$
The CE-3000 incorporates software as embedded software in the micro controller which is used, in turn to program an EEPROM. There exists no user changeable software.
The enclosure for the CE-3000 is metal (aluminum). The other components are commercially available hardware and electronic components and printed circuit cards manufactured to DigiVision, Inc. specifications.
Intended use
The CE-3000 Contrast Enhancer like the FluoroVision, may be used in any application where a viewing device (fluoroscope, endoscope, laparoscope, etc.) and monitor is incorporated to aid in diagnosis and treatment of a disease such as an arthroscopy or cholecystectomy. Despite the different indication statements, both devices have the same function and purpose and the differences in intended use does not create new safety or effectiveness issues.
2
510K SUMMARY
Technological Characteristics
The technology of both the CE-3000 and the FluoroVision are similar. The CE-3000 takes advantage of advances in electronics technology (since the development of the Fluoro Vision) which allows the reduction of the size and quantity of components. All other comparable (i.e., Hospital power cord, Input/Output cords, metal case, etc.).
Performance
Since these two devices use the same algorithm, the output and performance is identical. We have included some pictures of examples of processing (see Pictures of Processing).
Safety and Effectiveness
DigiVision has no knowledge of any adverse safety or effectiveness issues nor do we expect such problems. The CE-3000 design and use precludes any output of information that could plausibly produce a decision-maker to cause an error. Should the CE-3000 fail in any way it may be removed from the system (i.e., connect the camera directly to the monitor).
The CE-3000 has been evaluated by Underwriters Laboratories and found to pass electrical safety tests to UL 544, IEC 601-1, and approved to bear the UL 544 Listing Mark, IEC 601 Classification Mark and the C-UL IEC 601 Classification Mark.
The CE-3000 is in compliance with the EMC requirements as defined in European Standard EN60601-1-2: 1993.
Classification
Although the cover sheet of this submission indicates that the classification sought is Endoscope and/or Accessories, we request clearance to market the device for similar applications where video image enhancement is desired classified elsewhere in the Code of Federal Regulations. The CE-3000 could be classified in the same way monitors or scopes (i.e., broncoscopes, esophagoscope, etc.) are. provided they accept RS-170, RS-170A or CCIR video.