MODIFICARION TO WACKERS-LIU CQ SOFTWARE

K032500 · Eclipse Systems, Inc. · KPS · Aug 25, 2003 · Radiology

Device Facts

• Record ID: K032500
• Device Name: MODIFICARION TO WACKERS-LIU CQ SOFTWARE
• Applicant: Eclipse Systems, Inc.
• Product Code: KPS · Radiology
• Decision Date: Aug 25, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The revised Wackers-Liu CQ® Software is a stand-alone software package for quantification of emission computed tomography (ECT) myocardial perfusion images. The data generated by the Wackers-Liu CQ® Software is intended to be used by the physician in addition to other complementary data in the evaluation of cardiac function and blood supply. It is not meant to replace or eliminate the physician's standard visual interpretation of the patient study or the integration of additional clinical and/or diagnostic information (patient history, stress and/or rest EKG, echocardiogram, etc.) prior to making any final clinical diagnostic or treatment decision. The Wackers-Liu CQ® Software also provides for transmission of ECT images over the internet.

Device Story

Wackers-Liu CQ® Software is a stand-alone software package for cardiac imaging analysis; processes emission computed tomography (ECT) myocardial perfusion images. Inputs include ECT image data; software performs automated quantification of cardiac function and blood supply; outputs include left ventricular chamber volume, ejection fraction, wall thickening, wall motion, and 3D rendered cardiac surfaces. Used in clinical settings by physicians to assist in evaluating cardiac function; provides internet transmission of ECT images. Software integrates with standard clinical workflows; results are intended to supplement, not replace, physician visual interpretation and clinical judgment. Benefits include standardized, automated quantification of perfusion data to aid diagnostic decision-making.

Clinical Evidence

No clinical data provided. Verification and validation testing demonstrated that the software fulfills performance specifications equivalent to the original predicate and correlates favorably with clinical judgment.

Technological Characteristics

Stand-alone software package; compatible with most nuclear medical computers and PCs. Features include automated and manual processing, slice-by-slice viewing, 3D imaging, and quantification of left ventricular volume, ejection fraction, wall thickening, and wall motion. Provides polar maps and 3D rendered cardiac surfaces. Connectivity includes internet transmission of ECT images.

Indications for Use

Indicated for quantification of emission computed tomography (ECT) myocardial perfusion images in patients undergoing cardiac evaluation. Intended for use by physicians as an adjunct to standard visual interpretation and clinical diagnostic information.

Regulatory Classification

Identification

An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Predicate Devices

• Wackers-Liu CQ® Software (K002229)

Submission Summary (Full Text)

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K032500
page 1 of 3

AUG 2 5 2003

# 510(k) Summary for the ECLIPSE Systems, Inc., Modified Wackers-Liu CQ® Software (per 21 CFR 807.92)

#### 1. SPONSOR

ECLIPSE Systems, Inc. 540-15 East Main Street Branford, CT 06405

Mr. William Carroll Contact Person: 203-483-0665 Telephone:

#### August 5, 2003 2. DATE PREPARED:

#### 3. DEVICE NAME

| Proprietary Name: | Wackers-Liu CQ® Software |
|----------------------|--------------------------------------------------------------------|
| Common/Usual Name: | ECT Quantitative Analysis and image communication<br>software |
| Classification Name: | Emission Computed Tomography System and Medical<br>Image Digitizer |

#### PREDICATE DEVICE 4.

Wackers-Liu CQ® Software (K002229)

#### DEVICE DESCRIPTION ട.

The revised Wackers-Liu CQ® Software is a stand-alone software package. This original product is the automated commercial version of a totally integrated and manually operated cardiac imaging analysis package developed by Drs. Wackers and Liu, and others at the Yale University Cardiovascular Nuclear Imaging Laboratory and described extensively in the peer-reviewed literature. Modifications to the cleared Wackers-Liu CQ® Software consist of changes to the handling of non-circular left ventricular edges and counting voxels. Changes to the Wackers-Liu CQ® Software are transparent to the user.

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#### 6. INTENDED USE

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The revised Wackers-Liu CQ® Software is a stand-alone software package for quantification of emission computed tomography (ECT) myocardial perfusion images. The data generated by the Wackers-Liu CQ® Software is intended to be used by the physician in addition to other complementary data in the evaluation of cardiac function and blood supply. It is not meant to replace or eliminate the physician's standard visual interpretation of the patient study or the integration of additional clinical and/or diagnostic information (patient history, stress and/or rest EKG, echocardiogram, etc.) prior to making any final clinical diagnostic or treatment decision. The Wackers-Liu CQ® Software also provides for transmission of ECT images over the internet.

#### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 7.

The claim of substantial equivalence is based on indications for use, operational principles, and technological characteristics. A side-by-side comparison of the Wackers-Liu CQ® Software to the cleared Wackers-Liu CQ® Software is provided in Table E-1 below.

| Characteristic | Revised<br>ECLIPSE<br>Systems, Inc.<br>Wackers-Liu CQ® | ECLIPSE<br>Systems, Inc.<br>Wackers-Liu CQ®<br>K002229 |
|--------------------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------|
| Used to quantify ECT images | Yes | Yes |
| Automatic processing | Yes | Yes |
| Manual processing capability | Yes | Yes |
| Slice-by-slice viewing | Yes | Yes |
| 3D imaging | Yes | Yes |
| Computes and displays left ventricular chamber volume | Yes | Yes |
| Computes and displays ejection fraction | Yes | Yes |
| Compares data to "normal" database | Yes | Yes |
| Display left ventricular endocardial/epicardial surfaces | Yes | Yes |
| Displays polar maps indicating perfusion | Yes | Yes |
| Displays wall thickening | Yes | Yes |
| Displays wall motion | Yes | Yes |
| Displays 3D rendered image of cardiac surfaces | Yes | Yes |
| Displays short axis, vertical long, and horizontal long slice data | Yes | Yes |
| Displays single data set or comparison of related data sets | Yes | Yes |
| Can be executed on most nuclear medical computers | Yes | Yes |
| Can be executed on PC computers | Yes | Yes |
| Can be executed on Macintosh computers | No | No |

## Table E-1. Comparison of the Revised and Original Wackers-Liu CQ® Software

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#### 8. PERFORMANCE TESTING

K032550
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Verification and validation testing of the revised Wackers-Liu CQ® Software demonstrates that the ECLIPSE Systems, Inc., Wackers-Liu CQ® Software fulfills performance specifications, equivalent to those obtained with the original Wackers-Liu CQ® Software, and correlates favorably with clinical judgment.

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Image /page/3/Picture/1 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" around the perimeter. Inside the circle is an abstract image of an eagle with three wavy lines extending from its body, representing the department's mission to protect and promote the health and well-being of Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 5 2003

ECLIPSE Systems, Inc. % Ms. Rosina Robison, RN, Med, RAC Senior Staff Consultant Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760

### Re: K032500

Trade/Device Name: Wackers-Liu CQ® Software . Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: August 11, 2003 Received: August 13, 2003

Dear Ms. Robinson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K د 3 2500

### Device Name: ECLIPSE Systems, Inc., Revised Wackers-Liu CQ® Software

Indications for Use:

The revised Wackers-Liu CQ® Software is a stand-alone software package for quantification of emission computed tomography (ECT) myocardial perfusion images. The data generated by the Wackers-Liu CQ® Software is intended to be used by the physician in addition to other complementary data in the evaluation of cardiac function and blood supply. It is not meant to replace or eliminate the physician's standard visual interpretation of the patient study or the integration of additional clinical and/or diagnostic information (patient history, stress and/or rest EKG, echocardiogram, etc.) prior to making any final clinical diagnostic or treatment decision. The Wackers-Liu CO® Software also provides for transmission of ECT images over the internet.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Leymm

eproductive, Abdominal 510(k) Number

Prescription Use u (Per 21 CFR 801.109)

OR

Over-the-Counter Use

ECLIPSE Systems, Inc., Special 510(k) Revised Wackers-Liu CQ® Software

August 11, 2003