OPTIVIEW

K972520 · Optimed Technologies, Inc. · LLZ · Sep 29, 1997 · Radiology

Device Facts

• Record ID: K972520
• Device Name: OPTIVIEW
• Applicant: Optimed Technologies, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Sep 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

OptiView is a digital image recording and display system for use in a cardiac cath lab or optivion is a digital many suite. It is a digital upgrade for the cardiac catheterization lab. It interfaces with new or existing systems to provide high quality diagnostic images and an instant increase in productivity. Integrated with the room's x-ray equipment OptiView acquires the flickered images from the video camera, gets rid of the flicker, and provides flicker-free live images displayed on a monitor in the cath lab and in the control room. The OptiView system records patient demographics and the images from the cardiac catheterization procedure (as well as radiography/fluoroscopy suite). The images on the screen can be enhanced to allow for easier, better diagnosis, and the images and the information can be reviewed during the case as well as after the case is completed.

Device Story

OptiView functions as a digital upgrade for cardiac catheterization and radiography/fluoroscopy suites. It interfaces with existing x-ray equipment to acquire video camera signals; performs signal processing to eliminate flicker; and outputs flicker-free live images to monitors in the cath lab and control room. The system records patient demographics and procedure images, allowing for image enhancement to facilitate diagnosis. Clinicians review images and information in real-time during procedures or post-procedure. The device aims to improve diagnostic quality and lab productivity.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Digital image recording and display system; interfaces with x-ray video camera outputs; provides flicker-free image processing; displays images on monitors in cath lab and control room; records patient demographics and procedure data; supports image enhancement.

Indications for Use

Indicated for use in cardiac catheterization or radiography/fluoroscopy suites to record, display, and enhance diagnostic images for clinical review during and after procedures.

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).

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 9 1997

Moshe Zchut Vice President, Technology OptiMed Technologies, Inc. 293 Eisenhower Parkway Livingston, NJ 07039

Re: K972520

> OptiView/Medical Image Record and Display System Dated: July 1, 1997 Received: July 7, 1997 Regulatory class: Unclassified Procode: 90 LLZ / 90 LMB

Dear Mr. Zchut:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Wisbranding by reference to premarket notification" (2) CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

h. Tiau Yu.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Ofti Vicw

Indications For Use:

OptiView is a digital image recording and display system for use in a cardiac cath lab or optivion is a digital many suite. It is a digital upgrade for the cardiac catheterization lab. It interfaces with new or existing systems to provide high quality diagnostic images and an instant increase in productivity.

Integrated with the room's x-ray equipment OptiView acquires the flickered images from the video camera, gets rid of the flicker, and provides flicker-free live images displayed on a monitor in the cath lab and in the control room.

The OptiView system records patient demographics and the images from the cardiac catheterization procedure (as well as radiography/fluoroscopy suite). The images on the screen can be enhanced to allow for easier, better diagnosis, and the images and the information can be reviewed during the case as well as after the case is completed.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Ushrid A. kymm

Division of Reproductive, Abdominal, ENT and Radiological Dev 510(k) Number

Frescription Use_X (Per 21 CFR 801.109)

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Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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