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 Description

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.

AI/ML Overview

Here's an analysis of the provided text regarding the ImageView™ Coronary Angiography Display and Review System, focusing on acceptance criteria and supporting studies.

Based on the provided 510(k) summary for the ImageView™ Coronary Angiography Display and Review System, no specific acceptance criteria or an explicit study proving the device meets quantitative performance metrics are detailed. The document primarily focuses on establishing substantial equivalence to predicate devices based on intended use and technological characteristics, rather than presenting a performance study with defined criteria.

Here's a breakdown of the requested information, indicating where the document lacks specific details:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document does not describe specific quantitative acceptance criteria (e.g., accuracy, sensitivity, specificity, processing speed thresholds) for the ImageView™ system, nor does it report numerical device performance against such criteria. The basis for substantial equivalence is functional similarity.

2. Sample Size Used for the Test Set and Data Provenance

Not specified. The document does not mention any test set or data used for performance evaluation beyond general statements about "reading and displaying angiographic images." Therefore, sample size and data provenance are unknown.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The concept of "ground truth" and expert consensus for a performance study is not discussed, as no such study is presented.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document does not indicate that an MRMC comparative effectiveness study was performed, nor does it quantify any effect size of AI astounding human readers. The device is a display and review system, not an AI-powered diagnostic tool in the sense of providing automated interpretations.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

Not applicable. As the device's primary function is to display and allow user manipulation of images, the concept of a "standalone" algorithm performance in the typical diagnostic sense (e.g., detecting disease independently) does not apply. The device's performance is intrinsically linked to its functionality as a display and review tool for human operators.

7. Type of Ground Truth Used

Not specified. Since no performance study is described, there's no mention of the type of ground truth used.

8. Sample Size for the Training Set

Not applicable. The document describes a software program for display and review, not a machine learning model that would typically require a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set mentioned, the method for establishing its ground truth is not applicable.

Summary of the Device's Basis for Approval:

The ImageView™ Coronary Angiography Display and Review System received 510(k) clearance based on substantial equivalence to existing predicate devices (DICOMview™ and Kodak Digital Science Cardiac Review Station CRS 2000). The arguments for substantial equivalence are:

Intended Use: The ImageView™ system shares the same general intended use as the predicate devices: to view and manipulate angiographic images from X-ray cardiac angiography procedures on a personal computer workstation.
Technological Characteristics: The functional performance is comparable, both using graphical user interfaces to display and review DICOM image records, and both accessing images from a DICOM CD.

The 510(k) process for this type of device in 1997 focused on demonstrating that the new device introduced no new questions of safety or effectiveness compared to legally marketed predicate devices, rather than requiring extensive quantitative performance studies for a display and review system.

Summary

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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

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Device Description 4.

5. Intended Use

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.

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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 (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

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510(k) Number (if known): __

Device Name: ImageView™ Coronary Angiography Display and Review System_

Indications For Use:

(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)

Over-The-Counter Use

(Optional Format 1-2-96)

HeartWare ImageView 510(k)

Page vi

Regulation Number and Section

§ 892.1600 Angiographic x-ray system.

(a)
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.(b)
Classification. Class II.