DIGITAL VIDEO RECORDING SYSTEM

K991738 · Kay Elemetrics Corp. · LLZ · Aug 13, 1999 · Radiology

Device Facts

• Record ID: K991738
• Device Name: DIGITAL VIDEO RECORDING SYSTEM
• Applicant: Kay Elemetrics Corp.
• Product Code: LLZ · Radiology
• Decision Date: Aug 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The intended use of the DVRS is for viewing, acquiring, archiving and retrieving video images of endoscopic and fluoroscopic procedures. The images may be monochrome or color. The professionals or practitioners using this system would be medical doctors or clinicians such as speech pathologists. The device is a prescription device.

Device Story

Digital Video Recording System (DVRS) captures, archives, and retrieves video data from endoscopic and fluoroscopic procedures. Operated by physicians or speech pathologists in clinical settings; device records monochrome or color video signals. System facilitates review of procedural imagery to assist clinical documentation and diagnostic assessment. Output provided via display for clinician evaluation; aids in procedural monitoring and patient record maintenance.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Digital video recording system for endoscopic and fluoroscopic imaging. Supports monochrome and color video input/output. System architecture designed for image acquisition, archiving, and retrieval. Regulatory class II, 21 CFR 892.2050.

Indications for Use

Indicated for medical doctors and clinicians, including speech pathologists, to view, acquire, archive, and retrieve monochrome or color video images during endoscopic and fluoroscopic 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

AUG 13 1999

William D. Harbeson Director of R&D Kay Elemetrics Corp. 2 Bridgewater Lane Lincoln Park, New Jersey 07035-1488 Re:

K991738 Digital Video Recording System (DVRS) Dated: May 18, 1999 Received: May 21, 1999 Regulatory Class: II 21 CFR 892.2050/Procode: 90 LLZ

Dear Mr. Harbeson:

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 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 redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act). 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 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 requirements, 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 submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product 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, "Misbranding by reference to premarket notification"(21 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting 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 K991738

Device Name:

Digital Video Recording System

## Indications for Use:

The intended use of the DVRS is for viewing, acquiring, archiving and retrieving video images of endoscopic and fluoroscopic procedures. The images may be monochrome or color. The professionals or practitioners using this system would be medical doctors or clinicians such as speech pathologists. The device is a prescription device.

Concurrence of CDRH, Office of Device Evaluation (ODE)

David C. Bergman
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devi

510(k) Number K991738

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use (Option Format 1-2-96)

い