IMAGEVIEW CORONARY ANGIOGRAPHY DISPLAY AND REVIEW SYSTEM

K972229 · Heartware, Inc. · IZI · Oct 16, 1997 · Radiology

Device Facts

• Record ID: K972229
• Device Name: IMAGEVIEW CORONARY ANGIOGRAPHY DISPLAY AND REVIEW SYSTEM
• Applicant: Heartware, Inc.
• Product Code: IZI · Radiology
• Decision Date: Oct 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1600
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The ImageView™ Coronary Angiography Display and Review System is a computer program which can be used to view the results of an X-ray cardiac angiography procedure on a personal computer workstation. The digital image record of the X-ray exposures made during a catheterization procedure can be retrieved from a compact disk (CD) and displayed on a computer workstation monitor. ImageView™ also allows the user to change the appearance of the images and export selected frames to other programs for printing and further manipulation.

Device Story

ImageView™ is an angiographic image review software program. It inputs digital image records from X-ray cardiac angiography procedures stored on DICOM 3.0 format CDs. The software runs on a personal computer workstation, allowing clinicians to retrieve, display, and manipulate the appearance of angiographic images. Users can export selected frames to external programs for printing or further processing. The device is intended for use in clinical settings where cardiac catheterization results are reviewed. It assists healthcare providers by providing a digital interface for viewing and managing angiographic data, facilitating clinical review of cardiac procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Software-based image review system provided on 3.5-inch 1.44 MB floppy disk. Operates on personal computer workstations. Supports DICOM 3.0 image format. Features include image retrieval from CD, display on monitor, image appearance adjustment, and frame export. Employs a graphical user interface.

Indications for Use

Indicated for viewing and reviewing digital X-ray cardiac angiography images obtained during catheterization procedures on a personal computer workstation.

Regulatory Classification

Identification

An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• DICOMview™ (K954479)
• Kodak Digital Science Cardiac Review Station CRS 2000 (K960043)

Submission Summary (Full Text)

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

# 4972229

# 510(k) Summary

# for

OCT 16 1997

ImageView™ Coronary Angiography Display and Review System

## Applicant 1.

HeartWare, Inc. Laurston Court Durham, NC 27712

Laurence A. Spero Contact Person: 919-471-6613 Telephone:

June 12, 1997 Date Prepared:

## Device Name 2.

ImageView™ Coronary Angiography Display and Review Proprietary Name: System

Cardiac Image Review Software Common Name:

Accessory to Angiographic X-Ray Systems Classification Name:

Class II Classification Status:

## Predicate Devices 3.

.

- DICOMview™ . Heartlab, Inc. K954479
- Kodak Digital Science Cardiac Review Station CRS 2000 Jamieson Film Co. K960043

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

#### Device Description 4.

The ImageView™ Coronary Angiography Display and Review System is an angiographic image review software program. It is provided on a 3½-inch 1.44 MB floppy disk. The disk contains the installation program, ImageView™ executable files, a Readme file and Dynamic Link Library files. ImageView™ is designed to read and display angiographic images which have been stored using the DICOM 3.0 format for medical images.

#### 5. Intended Use

The ImageView™ Coronary Angiography Display and Review System is a computer program which can be used to view the results of an X-ray cardiac angiography procedure on a personal computer workstation. The digital image record of the X-ray exposures made during a catheterization procedure can be retrieved from a compact disk (CD) and displayed on a computer workstation monitor. ImageView™ also allows the user to change the appearance of the images and export selected frames to other programs for printing and further manipulation.

#### Technological Characteristics 6.

The ImageView™ Coronary Angiography Display and Review System is intended for the same general purposes as the predicate devices identified above. The functional performance of all of the devices is comparable. The ImageView™ System and the predicate devices employ graphical user interfaces to perform the necessary functions required to display and review a DICOM image record. All systems access images from a DICOM CD and can display images either directly from the CD or by loading the images into RAM for improved performance.

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cynthia A. Sinclair Senior Staff Consultant Heartware, Inc. c/o Medical Device Consultants, Inc. 49 Plain St. North Attleboro, MA 02760

Re:

K972229

ImageView Coronary Angiography Display and Review System (Cardiac Device Accessory) Dated: September 25, 1997 Received: September 26, 1997 Regulatory class: II 21 CFR 892.1600/Procode: 90 IZI

Dear Ms. Sinclair:

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 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 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 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 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 question 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 yours

h.7 liau thi

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

{3}------------------------------------------------

510(k) Number (if known): __

Device Name: ImageView™ Coronary Angiography Display and Review System_

Indications For Use:

The ImageView™ Coronary Angiography Display and Review System is a computer program which can be used to view the results of an X-ray cardiac angiography procedure on a personal computer workstation. The digital image record of the X-ray exposures made during a catheterization procedure can be retrieved from a compact disk (CD) and displayed on a computer workstation monitor. ImageView™ also allows the user to change the appearance of the images and export selected frames to other programs for printing and further manipulation.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vain L. Seppanen

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

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

HeartWare ImageView 510(k)

Page vi