(67 days)
Not Found
Not Found
No
The description mentions comparing profiles to a "normal data base" and using an "algorithm" to determine processing parameters, but there is no explicit mention of AI, ML, or related terms like neural networks or deep learning. The comparison to a database and algorithmic processing are common in traditional software and do not necessarily indicate AI/ML.
No.
The "Intended Use / Indications for Use" and "Device Description" clearly state that this software is a "diagnostic software program" that "quantitatively analyzes the myocardial perfusion" to aid in the evaluation of ischemic heart disease. It does not provide any treatment or therapy.
Yes
The 'Intended Use / Indications for Use' section states the software program is for 'evaluation of ischemic heart disease' and 'distinguishing normal from abnormal myocardium', and the 'Device Description' explicitly calls it a 'diagnostic software program'.
Yes
The device description explicitly states it is a "diagnostic software program" and describes its function as analyzing data acquired from a SPECT scanner. There is no mention of any hardware component being part of the device itself.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The software is intended to "quantitatively analyze the myocardial perfusion of patients' who have been injected with Cardiolite® (Technetium Tc99m Sestamibi)". Cardiolite® is a diagnostic agent used to evaluate ischemic heart disease. The software processes data derived from the patient after the administration of this diagnostic agent to provide information about the patient's condition.
- Device Description: The device is described as a "diagnostic software program" that "quantitatively analyzes the myocardial perfusion". It uses data from a SPECT acquisition protocol, which is a medical imaging technique that relies on the distribution of a radioactive tracer (Cardiolite® in this case) within the body. The analysis of this distribution provides diagnostic information.
- Relationship to a Diagnostic Agent: The software's function is directly tied to the use of Cardiolite®, which is explicitly stated as a "myocardial perfusion agent that is useful in the evaluation of ischemic heart disease". The software processes the data generated by the body's interaction with this diagnostic agent.
While the software itself is not a physical reagent or instrument used in vitro (outside the body), it is a crucial component of a diagnostic process that involves an in vivo diagnostic agent (Cardiolite®) and provides diagnostic information about the patient's condition. Regulatory bodies often classify software that analyzes data from diagnostic tests or agents as IVDs, especially when the output is used for diagnosis or evaluation of a disease state.
The fact that it analyzes data from a SPECT acquisition protocol using a radioactive tracer administered to the patient aligns with the broader definition of IVDs, which includes devices used to examine specimens derived from the human body to provide information for diagnostic purposes. In this case, the "specimen" is the distribution of the radioactive tracer within the myocardium, and the software analyzes this distribution to provide diagnostic information.
N/A
Intended Use / Indications for Use
This software program should be used to guantitatively 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 protocol. Cardiolite®, Kit for the Preparation of Technetium Tc99m Sestamibi is a myocardial perfusion agent that is useful in the evaluation of ischemic heart disease. Cardiolite®, Kit for the Preparation of 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.
Cardiolite®, Kit for the Preparation of Technetium Tc99m Sestamibi is 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.
To detect or image the distribution of radionuclides in the body or organ, using the following technique(s):
C. Tomographic imaging (SPECT) for non Positron emitter
Product codes (comma separated list FDA assigned to the subject device)
90 KPS
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
Not Found
Input Imaging Modality
Single Photon Emission Computerized Tomography (SPECT)
Anatomical Site
Myocardium, Heart, Body or Organ
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)
Prospective validation, 35 patients. The accuracy results obtained with this program are similar to those obtained with previous quantitative analysis programs of the TI-201 myocardial perfusion agent (1,2) and Cardiolite® (3,4).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
972500
ITEM I
SUMMARY OF SAFETY AND EFFECTIVENESS
SEP - 8 1997
1. Indications for use:
This software program should be used to guantitatively 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 protocol. Cardiolite®, Kit for the Preparation of Technetium Tc99m Sestamibi is a myocardial perfusion agent that is useful in the evaluation of ischemic heart disease. Cardiolite®, Kit for the Preparation of 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.
Cardiolite®, Kit for the Preparation of Technetium Tc99m Sestamibi is 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:
୍ୟୁ
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 utilize for his final interpretation. The final responsibility for integration 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, debugging, testing, and in-house validation. 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 TI-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
1 . Depasquale EE, Nody AC, DePuey EG, et al: Quantitative rotational thallium-201 tomography for identifying and localizing coronary artery Circulation 77:316-327, 1988. disease.
Van Train K, Maddahi J, Berman DS, et al: Quantitative Analysis of 2. 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. Quantitative Analysis of Same-Day Validation for Rest-Stress Technetium-99m-Sestamibi Myocardial Tomograms. J Nucl Med 1994; 35:609-618.
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Image /page/3/Picture/0 description: The image shows a logo for the Department of Health. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH &" is arranged in a circular fashion around the eagle. The logo is black and white and appears to be scanned from a document.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 1997
Kenneth F. Van Train President NucCardiac Software, Inc. 21520-"G" Yorba Linda Blvd., Suite 420 Yorba Linda, CA 92887
Re: K972509
C Equal - Quantitative Analysis SPECT Software Dated: July 2, 1997 Received: July 3, 1997 Regulatory Class: II 21 CFR 892.1200/Procode: 90 KPS
Dear Mr. Van Train:
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, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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 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" (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 vours.
h7liau Yu
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): K972509
Dovice Name: CEqual for Toshiba Corporation (Diagnostic Software)
Nuclear Medicine Device
Indication For Use: To detect or image the distribution of radionuclides in the body or organ, using the following technique(s).
| YES | NO | Energy Range (keV) | ||
|---|---|---|---|---|
| A. | Planar imaging | X | ||
| B. | Whole body imaging | X | ||
| C. | Tomographic imaging (SPECT) for non Positron emitter | X | 140 keV | |
| D. | Positron imaging by coincidence | X | ||
| E. | Positron imaging without coincidence | X | ||
| F. | Other indication(s) in the device label, but not included in above list | None |
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ V (Per 21 CFR 801.109)
OR
Over-the-Counter Use
(Optional Romar 1-2-96)
David le hopman
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 78507 510(k) Number _
P UNT