(90 days)
Not Found
NOT FOUND
No
The description focuses on quantitative analysis using algorithms and comparison to a normal database, without mentioning AI or ML techniques.
No.
The device is described as a "diagnostic software program" and its intended use is to "quantitatively analyze the myocardial perfusion of patients," which falls under diagnostic purposes, not therapeutic.
Yes
The "Device Description" explicitly states, "This medical device (CEqual®) is a diagnostic software program..." and it is used to analyze myocardial perfusion for the evaluation of ischemic heart disease, which is a diagnostic purpose.
Yes
The device description explicitly states it is a "diagnostic software program" and describes its function as analyzing data from a SPECT acquisition protocol. There is no mention of any accompanying hardware component being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: An IVD is a medical device that is used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to provide information about a person's health.
- Device function: This software program analyzes images generated from a SPECT scan after a patient has been injected with a radioactive tracer (Cardiolite®). It processes and quantifies the distribution of the tracer within the myocardial tissue.
- Input: The input to the software is image data from a SPECT scanner, not a biological sample taken from the patient.
- Output: The output is quantitative analysis and visualization of the myocardial perfusion based on the image data, not a result from a test performed on a biological sample.
While the software is used in conjunction with a diagnostic procedure involving a substance injected into the patient, the software itself is processing imaging data, not performing an in vitro test on a biological specimen.
N/A
Intended Use / Indications for Use
This software program should be used to quantitatively analyze the myocardial perfusion of patients' who have been injected with Cardiolite® (Technetium Tc99m Sestamibi) for a rest/stress same-day Single Photon Emission Computerized Tomography (SPECT) acquisition Cardiolite®, Kit for the Preparation of Technetium Tc99m protocol. Sestamibi is a myocardial perfusion agent that is useful in the evaluation Cardiolite®, Kit for the Preparation of of ischemic heart disease. Technetium Tc99m Sestamibi is useful in distinguishing normal from abnormal myocardium and in the localization of the abnormality, in patients with suspected myocardial infarction, ischemic heart disease or Evaluation of ischemic heart disease or coronary artery disease. coronary artery disease is accomplished using rest and stress techniques.
Preparation of Technetium Tc99m Sestamibi is Cardiolite®, Kit for the also useful in the evaluation of myocardial function using the first pass technique.
Rest-exercise imaging with Tc99m Sestamibi in conjunction with other diagnostic information may be used to evaluate ischemic heart disease and its localization.
In clinical trials, using a template consisting of the anterior wall, inferior-posterior wall and isolated apex, localization in the anterior or inferior-posterior wall in patients with suspected angina pectoris or coronary artery disease was shown. Disease localization isolated to the apex has not been established. Tc99m Sestamibi has not been studied or evaluated in other cardiac diseases.
It is usually not possible to differentiate recent from old myocardial infarction or to differentiate recent myocardial infarction from ischemia.
Product codes
Not Found
Device Description
This medical device (CEqual®) is a diagnostic software program that quantitatively analyzes the myocardial perfusion of patients' injected with Cardiolite® (99mTc Sestamibi) following a rest/stress same-day SPECT acquisition protocol. The algorithm automatically determines the processing parameters and, following operator verification of these parameters, samples the myocardium using maximum count profiles. These stress and rest profiles are then used to generate relative count "raw data" polar maps. In addition, the profiles are compared to a normal data base and the results of this comparison are used to generate quantitative stress and rest polar maps which indicate defect extent, severity, and reversibility for all abnormal perfusion areas of the patients' study. The final results are presented in the form of polar maps as well as a table indicating the % abnormal pixels in territories supplied by the left anterior descending, left circumflex, and right coronary arteries.
Mentions image processing
Yes
Mentions AI, DNN, or ML
No
Input Imaging Modality
Single Photon Emission Computerized Tomography (SPECT)
Anatomical Site
myocardium
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
The effectiveness of the program has been established in a prospective validation which included 35 patients acquired and processed at another institution.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The effectiveness of the program has been established in a prospective validation which included 35 patients acquired and processed at another institution. The accuracy results obtained with this program are similar to those obtained with previous quantitative analysis programs of the Tl-201 myocardial perfusion agent (1,2) and Cardiolite® (3,4).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
APR 2 4 1997
ITEM I
SUMMARY OF SAFETY AND EFFECTIVENESS
1. Indications for use:
This software program should be used to quantitatively analyze the myocardial perfusion of patients' who have been injected with Cardiolite® (Technetium Tc99m Sestamibi) for a rest/stress same-day Single Photon Emission Computerized Tomography (SPECT) acquisition Cardiolite®, Kit for the Preparation of Technetium Tc99m protocol. Sestamibi is a myocardial perfusion agent that is useful in the evaluation Cardiolite®, Kit for the Preparation of of ischemic heart disease. Technetium Tc99m Sestamibi is useful in distinguishing normal from abnormal myocardium and in the localization of the abnormality, in patients with suspected myocardial infarction, ischemic heart disease or Evaluation of ischemic heart disease or coronary artery disease. coronary artery disease is accomplished using rest and stress techniques.
Preparation of Technetium Tc99m Sestamibi is Cardiolite®, Kit for the also useful in the evaluation of myocardial function using the first pass technique.
Rest-exercise imaging with Tc99m Sestamibi in conjunction with other diagnostic information may be used to evaluate ischemic heart disease and its localization.
In clinical trials, using a template consisting of the anterior wall, inferior-posterior wall and isolated apex, localization in the anterior or inferior-posterior wall in patients with suspected angina pectoris or coronary artery disease was shown. Disease localization isolated to the apex has not been established. Tc99m Sestamibi has not been studied or evaluated in other cardiac diseases.
It is usually not possible to differentiate recent from old myocardial infarction or to differentiate recent myocardial infarction from ischemia.
2. Device Description:
This medical device (CEqual®) is a diagnostic software program that quantitatively analyzes the myocardial perfusion of patients' injected
1
with Cardiolite® (99mTc Sestamibi) following a rest/stress same-day SPECT acquisition protocol. The algorithm automatically determines the processing parameters and, following operator verification of these parameters, samples the myocardium using maximum count profiles. These stress and rest profiles are then used to generate relative count "raw data" polar maps. In addition, the profiles are compared to a normal data base and the results of this comparison are used to generate quantitative stress and rest polar maps which indicate defect extent, severity, and reversibility for all abnormal perfusion areas of the patients' study. The final results are presented in the form of polar maps as well as a table indicating the % abnormal pixels in territories supplied by the left anterior descending, left circumflex, and right coronary arteries.
3. Marketing History:
There have been other diagnostic programs marketed in the past which perform similar functions to those performed by CEqual®. These programs were used to quantitatively analyze the myocardial perfusion of patients' injected with T1201, another myocardial perfusion agent. The most widely utilized T1201 quantitative programs are the Cedars-Sinai and General Electric's "Bullseye" methods. To our knowledge there have been no safety problems with either of these two methods which have been in the marketplace for over the past five years. In addition, the CEqual program executing on the Siemens and General Electric computer systems have been in the marketplace since October 1992 with no safety problems reported.
4. Potential Adverse Effect On Health:
The intent of this program was to provide the physician with an adjunctive diagnostic tool to aid in the diagnostic interpretation of the patients' Cardiolite® same-day study. It was not meant to replace or eliminate the standard visual analysis of the Cardiolite® images. The physician should integrate all of the patients' clinical and diagnostic information, i.e. patients' history, stress and/or rest EKG, quality control images, visual interpretation of the tomographic images, and quantitative results, prior to making his final interpretation. This comprehensive processing technique (as with all diagnostic imaging) is not perfect, and will be associated with some false positive and false negative results. The accuracy of the program is listed in the operators manual and the physician should be aware of the accuracy when integrating the quantitative results for his final interpretation.
2
Therefore, this program has no direct adverse effect on health since the results represent only a part of the information which the physician will The final responsibility for integration utilize for his final interpretation. and interpretation of the study lies with the physician. of the results
5. Conclusions:
The safety of this program has been determined through the various stages of software development which included the code translation, The effectiveness of the debugging, testing, and in-house validation. program has been established in a prospective validation which included 35 patients acquired and processed at another institution. The accuracy results obtained with this program are similar to those obtained with previous quantitative analysis programs of the Tl-201 myocardial perfusion agent (1,2) and Cardiolite® (3,4). We contend that the method employed for the development and the final multicenter trial validation results of this quantitative software program (CEqual®) have proven its safety and effectiveness.
References
Depasquale EE, Nody AC, DePuey EG, et al: Quantitative rotational 1. thallium-201 tomography for identifying and localizing coronary artery disease. Circulation 77:316-327, 1988.
- Van Train K, Maddahi J, Berman DS, et al: Quantitative Analysis of Tomographic Stress Thallium-201 Myocardial Scintigrams: A Multicenter Trial. J Nucl Med 31:1168-1179, 1990.
Van Train KF, Areeda J, Garcia EV, et al: Quantitative same-day 3. rest-stress Technetium-99m sestamibi SPECT: definition and validation of stress normal limits and criteria for abnormality. J Nucl Med 1993; 34:1494-1502.
Van Train KF, Garcia EV, Maddahi J, et al: Multicenter Trial 4. Validation for Quantitative Analysis of Same-Day Rest-Stress Technetium-99m-Sestamibi Myocardial Tomograms. J Nucl Med 1994; 35:609-618.