(88 days)
Cardiac Stress and Rest SPECT Imaging Processing Software is a diagnostic software program that quantitatively analyzes myocardial perfusion in patients injected with Cardiolite® (Tc Sestamibi) or Thallium following a rest/stress Single Photon Emission Computerized Tomography (SPECT) acquisition protocol.
The program automatically determines the alignment parameters for the stress and rest reconstructed MPS SPECT images and, following operator venification of these parameters, performs a size and shape normalization to a template using a published and independently validated 3D image registration method. The normalized images are then compared to a normal distribution and the results of this comparison are used to generate a visual and quantitative representation of the extent and location of perfusion defects. Results are presented in the form of 3D representation of the normalized images including a visualization of the abnormalities as well as a table indicating the number. extent and location of abnormalities.
Here's an analysis of the provided text regarding the CARDIOMATCH® device, focusing on acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific, quantifiable acceptance criteria (e.g., a specific sensitivity or specificity threshold). Instead, it makes a general claim of "accuracy results obtained with this program are similar or higher to those obtained with previous quantitative analysis programs."
Therefore, the table below reflects this general statement and the lack of specific, numerical criteria in the document.
| Metric / Criterion | Acceptance Criteria (as stated or inferred) | Reported Device Performance |
|---|---|---|
| Overall Accuracy | Similar or higher than previous quantitative analysis programs (e.g., Cedars-Sinai "Bullseye" and C-Equal™) | "similar or higher" |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Over 50 patients
- Data Provenance: The study was performed at Stanford University. The document does not specify the country of origin of the patients, but given Stanford University's location in the United States, it is highly probable the data is from the US.
- Retrospective or Prospective: Not explicitly stated. The phrasing "independent validation study...performed at Stanford University" could suggest either. However, without further details, it's impossible to confirm.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed or reported in the provided text. The device is referred to as an "adjunctive diagnostic tool" for the physician. There is no information about how much human readers improve with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was done. The "independent validation study on over 50 patients performed at Stanford University" assessed the "accuracy results obtained with this program" in a standalone capacity, as it quantifies myocardial perfusion defects. The device itself is "diagnostic software" that "quantitatively analyzes" images. The results are "adjunctive," implying the software's analysis is performed independently before a physician integrates it.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). Given the nature of cardiac SPECT imaging for perfusion defects, it is likely that the ground truth would have involved a combination of:
- Clinical Diagnosis: Based on patient history, stress/rest EKG, and visual interpretation of images by experts.
- Follow-up Outcomes: Potentially, though less common for initial validation.
- Expert Consensus: A panel of cardiologists or nuclear medicine physicians reviewing all available clinical data and images.
However, this is inference, as the document is silent on this specific detail.
8. Sample Size for the Training Set
The document does not specify the sample size for the training set. It mentions the software uses "a published and independently validated 3D image registration method" and "compared to a normal distribution," which implies pre-existing data or models were used, but the size of any specific training set for CARDIOMATCH® is not provided.
9. How Ground Truth for the Training Set Was Established
The document does not specify how ground truth for the training set (if CARDIOMATCH® had a distinct training phase beyond using existing validated methods) was established. It refers to comparing normalized images to a "normal distribution," which suggests using a database of images from healthy individuals, but the method for establishing "normalcy" within that distribution is not detailed.
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FOCUS MEDICAL S.A.
SMDA Summary of Safety and Effectiveness - "510(k) Summary" 9.
- A. Sponsor Information
JUN 1 3 1997
Manufacturer:
Focus Medical SA 4. Chemin de Maupertuis 38240 Meylan, France
Telephone:
Contact Person:
Date Prepared:
Johan Brag
(33)-4-7604-1070 (33)-4-7641-9064 Fax
ﺔ ﺍﻟﻤﻮﺿﻮﻋﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ
February 25, 1997
B. Device Identification
Common/Usual Name
Cardiac Stress and Rest SPECT Imaging Processing Software
Proprietary Name:
CARDIOMATCH®
- C. Identification of Predicate Device(s)
CARDIOMATCH® is substantially equivalent to the following previously cleared and currently marketed devices:
| General Electric | C-Equal ™ | K914527 | November 22, 1991 |
|---|---|---|---|
| NUC Cardiac | C-Equal | K914296 | November 27, 1991 |
.
D. Indications for Use
is a diagnostic software program that quantitatively analyzes CARDIOMATCH® myocardial perfusion in patients injected with Cardiolite® (Tc Sestamibi) or Thallium following a rest/stress Single Photon Emission Computerized Tomography (SPECT) acquisition protocol.
- E. Device Description
The program automatically determines the alignment parameters for the stress and rest reconstructed MPS SPECT images and, following operator venification of these parameters, performs a size and shape normalization to a template using a published and independently validated 3D image registration method. The normalized images are then compared to a normal distribution and the results of this comparison are used to generate a visual and quantitative representation of the extent and location of perfusion defects.
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Results are presented in the form of 3D representation of the normalized images including a visualization of the abnormalities as well as a table indicating the number. extent and location of abnormalities.
F. Marketing history
There has been other diagnostic software programs marketed in the past, in particular CEqual™, which perform similar functions to those performed by CARDIOMATCH®. These programs are used to quantitatively analyze the myocardial perfusion of patients These programs are "asod to quantitatively andiyze the myocardial perfusion and managem. The most widely utilized quantitative programs are the Cedars-Sinai "Bullseve" method. and Emory University and General Electric method embodied in CEqual™. To our knowledge there have been no safety problems with either of these two widely used . Knowledge there have been in the marketplace for over the past nine and six years,
respectively respectively.
G. Potential Adverse Effect on Health
The intent of the program is to provide the physician with an adjunctive diagnostic tool to aid in the diagnostic interpretation of the patients MPS SPECT studies. It is not meant to replace or eliminate the standard visual analysis of the MPS images. The physician should integrate all of the patient's clinical and diagnostic information, i.e. patient's 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 program (as all other diagnostic imaging programs) is not perfect and will be associated with some false positives and false negative results. The physician should be aware of the program's limitations and accuracy when integrating the quantitative results for his final interpretation. Therefore the program has no 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 of the results and interpretation of the study lies with the physician.
H. Conclusions
The safety of this program has been established through the various stages of software development which included the initial design, coding, debugging, testing and in-house validation. The safety and effectiveness has also been established in an independent validation study on over 50 patients performed at Stanford University. The accuracy results obtained with this program are similar or higher to those obtained with previous quantitative analysis programs. We contend that the method employed for the development and the independent validation of the program (CARDIOMATCH®) have demonstrated its safety and effectiveness.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle, there is a stylized representation of three human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jean-Luc Boulnois, Ph.D. President Focus Medical SA c/o Interactive Consulting 70 Walnut Street JUN 1 3 1997 Wellesley, MA 02181
Re: K970970 CardioMatch Dated: March 12, 1997 Received: March 17, 1997 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS
Dear Dr. Boulnois: 分
We have reviewed your Section 5100k) notification of intent to market the device and we have determined the device is substantially equivalent (for the includions for use stated 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 and prohibitions gainst 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 does not affect any obligation you might have under sections 51 through 542 of the Act for devices under the Electronic Product 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 of substantial equivalence of your device to a legally marketed predication 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 (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear. Nose and Throat devices. 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.
Olliac
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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Page 1 of 1
510(k) Number (if known): K970890
Device Name: CardioMatch®
Indications For Use:
- . . . Cardiac diagnostic software program to quantitatively analyze myocardial perfusion in patients injected with Cardiolite® or Thallium-201 following a rest/stress SPECT acquisition protocol.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devices 510(k) Number Over-The-Counter Use __ OR Prescription Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)
§ 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.