REAL-TIME VIDEO CONTRAST ENHANCER

K962260 · Digivision, Inc. · LLZ · Sep 9, 1996 · Radiology

Device Facts

• Record ID: K962260
• Device Name: REAL-TIME VIDEO CONTRAST ENHANCER
• Applicant: Digivision, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Sep 9, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

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.

Device Story

The CE-3000 is a video contrast enhancer used in clinical settings (e.g., OR, endoscopy suites) to process real-time video signals from medical imaging devices. It accepts standard video inputs (RS-170, RS-170A, CCIR) and uses high-speed signal processing to adjust local gain of spatial frequencies. Operators control enhancement via front-panel knobs (DETAIL, CONTRAST, BACKGROUND) or a PRESET button; a SPLIT screen mode assists in optimization, and a BYPASS switch displays raw video. The device utilizes patented V-Lace (video locally adaptive contrast enhancement) technology to improve image clarity. The output is an enhanced video signal sent to a monitor, assisting clinicians in visualizing anatomical structures during diagnostic or surgical procedures. If the device fails, it can be bypassed to restore direct camera-to-monitor connectivity, ensuring no interruption to clinical decision-making.

Clinical Evidence

No clinical data. Performance evaluation based on bench testing and comparison of processed image examples to demonstrate identical output to the predicate device. Electrical safety verified via UL 544 and IEC 601-1 testing; EMC compliance verified via EN60601-1-2: 1993.

Technological Characteristics

Aluminum enclosure; utilizes high-speed signal processing for local gain adjustment of spatial frequencies; accepts RS-170, RS-170A, and CCIR video signals; embedded micro-controller with EEPROM; complies with UL 544, IEC 601-1, and EN60601-1-2: 1993 standards.

Indications for Use

Indicated for use in conjunction with viewing devices (fluoroscopes, endoscopes, laparoscopes) and monitors to aid in the diagnosis and treatment of diseases, including arthroscopy and cholecystectomy.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• DigiVision - FluoroVision (K864584)

Submission Summary (Full Text)

{0}

K962260
DECISION
DigiVision, Inc.
5626 Oberlin Drive
San Diego, CA 92121
[phone]
FAX [phone]
SEP - 9 1996

# 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

5-1

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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 speed signal processing, to generate video optimized for specific functions in real time. The three knobs 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 enhancement 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:

$$
\mathbf{Y} = \mathbf{c}(\mathbf{X} - \bar{\mathbf{X}}(\mathrm{d})) + (1 - \mathbf{b})\bar{\mathbf{X}}(\mathrm{d}) + \mathbf{b}\mathbf{M}.
$$

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.

5-2

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# 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 FluoroVision) which allows the reduction of the size and quantity of components. All other components are 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.