REALVIEW TELEMEDICINE SYSTEM

K973065 · Vcom Systems, Inc. · LLZ · Nov 13, 1997 · Radiology

Device Facts

• Record ID: K973065
• Device Name: REALVIEW TELEMEDICINE SYSTEM
• Applicant: Vcom Systems, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Nov 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The RealView Telemedicine System is used for medical digital image capture, storage, retrieval, and transmission over telecommunications media. A physician would use our system to take images of a patient for a permanent record of their condition and also to send them to a colleague for referral purposes or a consultation.

Device Story

RealView Telemedicine System facilitates medical image management via telecommunications. System components include hardware attachments for physician examining equipment, video camera, PC with video capture card, sound card, modem, and foot pedals for hands-free image capture. Software runs on Windows 95. Physicians operate the system in clinical settings to capture patient images, store them locally, or transmit them to colleagues for remote consultation or referral. Output consists of digital image files used for clinical decision-making and patient record maintenance. Benefits include improved access to specialist consultation and efficient documentation of patient conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System comprises PC-based hardware, video capture card, sound card, modem, video camera, and foot pedals. Operates on Windows 95 platform. Connectivity via telecommunications media (modem).

Indications for Use

Indicated for use by physicians to capture, store, retrieve, and transmit medical digital images of patients for permanent record-keeping, clinical referral, or consultation purposes.

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)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines that suggest a head, body, and legs. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wayne Jacobs Vice President, COO VCOM Systems, Inc. 809 North Dixie Highway Suite 200 West Palm Beach, FL 33401 Re:

K973065

RealView Telemedicine System Dated: August 15, 1997 Received: August 18, 1997 Regulatory class: Unclassified Procode: 90 LLZ

NOV 1 3 1997

Dear Mr. Jacobs:

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, 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 II (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. 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 Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing 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/dsmamain.html".

Sincerely vours.

William 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

{1}------------------------------------------------

510(k) Number (if known): K973065

Device Name: RealView Telemedicine System

Indications For Use:

The RealView Telemedicine System is used for medical digital image capture, storage, retrieval, and transmission over telecommunications media. A physician would use our system to take images of a patient for a permanent record of their condition and also to send them to a colleague for referral purposes or a consultation. The condition. The system consists of hardware that attaches to a physician's examining equipment, video camera, Personal Computer (PC) containing a video capture card, sound card and modem, and running Windows 95® operating system and RealView™ Telemedicine Software and foot pedals for image capture.

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segerson

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number

Prescription Use × (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optimal Format 1-2-96)