K Number
K970970
Device Name
CARDIOMATCH
Manufacturer
Date Cleared
1997-06-13

(88 days)

Product Code
Regulation Number
892.1200
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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.
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. 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.
More Information

No
The description focuses on a "published and independently validated 3D image registration method" and comparison to a "normal distribution," which are standard image processing and statistical techniques, not explicitly AI/ML. There is no mention of AI, ML, or related terms like neural networks or deep learning.

No
Explanation: The device is described as diagnostic software that analyzes myocardial perfusion. It does not provide treatment or modify bodily function.

Yes
The "Intended Use / Indications for Use" section explicitly states that the software "is a diagnostic software program." The "Device Description" also details how it analyzes images to identify and quantify perfusion defects, which is a diagnostic function.

Yes

The device description explicitly states it is a "diagnostic software program" that processes existing SPECT images. There is no mention of accompanying hardware or control of hardware.

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: This device processes and analyzes SPECT images of the myocardial perfusion. These images are generated from a SPECT acquisition protocol after a patient is injected with a radioactive tracer. This is an in vivo process (occurring within the living body), not an in vitro process (occurring outside the living body).
  • Input: The input is imaging data (SPECT images), not biological samples.
  • Output: The output is a quantitative analysis and visualization of myocardial perfusion based on the processed images.

Therefore, while it is a diagnostic tool, it falls under the category of medical imaging software rather than an In Vitro Diagnostic device.

N/A

Intended Use / 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.
Cardiac diagnostic software program to quantitatively analyze myocardial perfusion in patients injected with Cardiolite® or Thallium-201 following a rest/stress SPECT acquisition protocol.

Product codes

90 KPS

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.

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Single Photon Emission Computerized Tomography (SPECT)

Anatomical Site

myocardial

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)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K914527, K914296

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

FOCUS MEDICAL S.A.

K970970

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 ElectricC-Equal ™K914527November 22, 1991
NUC CardiacC-EqualK914296November 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.

1

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.

2

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

3

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)