(12 days)
No
The summary describes an automated software package for image quantification based on previously developed methods, with modifications focused on handling specific image features. There is no mention of AI, ML, or related concepts like training or test sets, which are typically associated with AI/ML development and validation.
No.
The software is intended for quantification of images to aid in evaluation, not for direct treatment or therapy.
Yes
The software quantifies myocardial perfusion images for evaluating cardiac function and blood supply, and its output is intended to be used by a physician in the evaluation of cardiac function and blood supply, which are aspects of diagnosis.
Yes
The device is explicitly described as a "stand-alone software package" and the description focuses solely on software modifications and validation. There is no mention of accompanying hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Wackers-Liu CQ® Software processes emission computed tomography (ECT) images of the myocardium. This is an imaging modality that uses radioactive tracers injected into the patient's body to visualize and quantify blood flow and function. It does not analyze samples taken from the body.
- Intended Use: The software is used to quantify data from these images to aid physicians in evaluating cardiac function and blood supply. This is a form of medical imaging analysis, not an in vitro test.
Therefore, while it is a medical device used in diagnosis, it falls under the category of medical imaging software rather than an in vitro diagnostic device.
N/A
Intended Use / 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 CQ® Software also provides for transmission of ECT images over the internet.
Product codes
90 KPS
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
emission computed tomography (ECT)
Anatomical Site
myocardial (cardiac)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1200 Emission computed tomography system.
(a)
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.(b)
Classification. Class II.
0
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 |
| software | |
| Classification Name: | Emission Computed Tomography System and Medical |
| 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.
1
6. INTENDED USE
Image /page/1/Picture/1 description: The image shows a handwritten text with the characters "K032500" on the top line and "page 213" on the bottom line. The text is written in a cursive style, and the characters are somewhat distorted. The background of the image is white.
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
ECLIPSE
Systems, Inc.
Wackers-Liu CQ® | ECLIPSE
Systems, Inc.
Wackers-Liu CQ®
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
2
8. PERFORMANCE TESTING
K032550
page 3/3
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.
3
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.
4
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion 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" (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 (800) 638-2041 or (301) 443-6597 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
5
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