(136 days)
No
The summary describes standard image processing and quantitative analysis techniques for cardiac imaging, without mentioning AI or ML. The performance studies focus on correlation with existing methods and clinical outcomes, not on the performance metrics typically associated with AI/ML model validation (e.g., sensitivity, specificity of a classification task).
No.
The device is described as software used for quantification, display, and analysis of medical images and data, rather than directly treating or preventing disease.
Yes
The device is used for "quantification of myocardial perfusion," "quantitatively evaluate the wall motion and wall thickening of the heart," "analysis of the CT data to evaluate calcified plaques," "assessment of cardiac mechanical dyssynchrony," and "quantification of myocardial blood flow and coronary flow reserve," all of which are activities that identify or measure a disease or condition. The "decision support in interpretation" also indicates diagnosis.
Yes
The device is described as a "software program" and its function is to process and analyze medical images and data. There is no mention of any accompanying hardware component that is part of the device itself.
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 Emory Cardiac Toolbox™ software processes and analyzes medical images (SPECT, PET, and CT) of the heart. It quantifies parameters related to myocardial perfusion, left-ventricular function, wall motion, strain, coronary artery calcification, and blood flow.
- Input Data: The input data is imaging data, not biological samples.
- Output: The output is quantitative data and visual representations derived from the images, not diagnostic results from analyzing biological samples.
While the software provides information that can be used to aid in diagnosis and treatment decisions, it does so by analyzing images of the body, not by performing tests on samples taken from the body. Therefore, it falls under the category of medical imaging software, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Emory Cardiac Toolbox™ 4.0 – 4.3 software program should be used for the quantification of myocardial perfusion for the display of wall motion and quantification of left-ventricular function parameters from SPECT & PET myocardial perfusion studies (EGS™) including to quantitatively evaluate the wall motion and wall thickening of the heart using longitudinal, radial, and circumferential strain measurements, for the 3D alignment of coronary artery models from CT coronary angiography onto the left ventricular 3D epicardial surface and analysis of the CT data to evaluate calcified plaques in the coronary arteries, for the assessment of cardiac mechanical dyssynchrony using phase analysis, for generation of the short axis, vertical, and horizontal long axis tomograms from the SPECT raw data using either filtered back projection (FBP) or iterative reconstruction (MLEM/OSEM), for the quantification of myocardial blood flow and coronary flow reserve, and for the decision support in interpretation (LVX) and automatic structured reporting of the study.
Product codes (comma separated list FDA assigned to the subject device)
KPS, JAK, LLZ
Device Description
The Emory Cardiac Toolbox™ 4.3 is used to display gated wall motion and for quantifying parameters of left-ventricular perfusion and function from gated SPECT & PET myocardial perfusion studies and for the evaluation of dynamic PET studies.
Mentions image processing
Cardiac image processing software for SPECT and PET
The Emory Cardiac Toolbox™ 4.3 is used to display gated wall motion and for quantifying parameters of left-ventricular perfusion and function from gated SPECT & PET myocardial perfusion studies and for the evaluation of dynamic PET studies.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
SPECT & PET myocardial perfusion studies, CT coronary angiography
Anatomical Site
Heart, myocardial, coronary arteries, left ventricular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Emory-CACS: The CACS module was validated against the FDA approved Siemens SynqoVia™ toolbox (K201034). A clinical comparison test was the method used for validation. The test data was comprised a group of 52 patients using 110 vessels with calcified plaques that had been previously scored by Emory radiologists; the same lesions selected by the radiologist were analyzed by the Emory-CACS and SYngo.CT CaScoring modules.
ECTb™ Strain: Validation of strain analysis for ECTb™ 4.3 was performed in 80 patients with variable coronary artery disease (CAD) and 22 patients with low-risk of CAD.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Emory-CACS: A clinical comparison test was the method used for validation. The test data was comprised a group of 52 patients using 110 vessels with calcified plaques that had been previously scored by Emory radiologists; the same lesions selected by the radiologist were analyzed by the Emory-CACS and SYngo.CT CaScoring modules. Regression analysis was performed between the SyngoVia™ and the Emory-CACS module. On a per patient basis, linear plaque volume regression (m = 1.10; b = 0.46) produced an r2 = 0.99 and Agatston score regression (m = 1.01; b = 1.06) produced an r2 > 0.99. The values obtained by the Emory-CACS module demonstrated excellent correlations with the Syngo.CT CaScoring developed by Siemens Medical Solutions.
ECTb™ Strain: MPI measurements were validated for resting global longitudinal strain vs. an accepted reference standard, TTE echo. A clinical comparison test was the method used for validation. Longitudinal, radial, and circumferential strains from a low-risk cohort (n=22) were used to establish normal limits to evaluate against the results of a high-risk cohort (n=80). Positive strain, lower limits of normal were determined as the mean radial strain minus 2-standard deviations (SD). For circumferential and longitudinal strains, both negative in sign, lower limits of normal were determined as the mean strain plus 2-SDs. In the CAD cohort, longitudinal strain assessed with PET MPI and TTE were strongly correlated at stress (r= 0.68, p
§ 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 30, 2023
Syntermed % Kenneth Van Train President 245 South Owens Drive ANAHEIM CA 92808
Re: K223422
Trade/Device Name: Emory Cardiac Toolbox™ 4.3 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: KPS, JAK, LLZ Dated: February 24, 2023 Received: March 1, 2023
Dear Kenneth Van Train:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Dghk
Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K223422
Device Name
Emory Cardiac Toolbox 4.3
Indications for Use (Describe)
The Emory Cardiac Toolbox™ 4.0 – 4.3 software program should be used for the quantification of myocardial perfusion for the display of wall motion and quantification of left-ventricular function parameters from SPECT & PET myocardial perfusion studies (EGS™) including to quantitatively evaluate the wall motion and wall thickening of the heart using longitudinal, radial, and circumferential strain measurements, for the 3D alignment of coronary artery models from CT coronary angiography onto the left ventricular 3D epicardial surface and analysis of the CT data to evaluate calcified plaques in the coronary arteries, for the assessment of cardiac mechanical dyssynchrony using phase analysis, for generation of the short axis, vertical, and horizontal long axis tomograms from the SPECT raw data using either filtered back projection (FBP) or iterative reconstruction (MLEM/OSEM), for the quantification of myocardial blood flow and coronary flow reserve, and for the decision support in interpretation (LVX) and automatic structured reporting of the study.
| Type of Use (Select one or both, as applicable) | XPrescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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510(k) SUMMARY K223422
1. Identification of the Submitter:
Kenneth Van Train President Syntermed. Inc. 333 Sandy Springs Circle Suite 107 Atlanta, GA 30328 Voice: (888) 263-4446 ext. 102, FAX: (714) 281-1290 Date of submission: January 3, 2022
2. Identification of the Product:
Device Proprietary Name: Emory Cardiac Toolbox™ 4.3 Common Name: Cardiac image processing software for SPECT and PET Classification Name: Emission Computed Tomography System Regulation Number: KPS: 21 CFR 892.1200, JAK: 21 CFR 892.1750, and LLZ: 21 CFR 892.2050 Product Code: KPS, JAK, and LLZ Classification Panel: Radiology Device Class: Class II
3. Medical Device Equivalence:
- Emory Cardiac Toolbox™ 4.0 K123646
- Syngo.CT Ca Scoring developed by Siemens Medical Solutions USA, Inc. ● K201034
- TOMTEC-Arena (AutoStrain Suite) developed by TOMTEC Imaging Systems ● GmbH K201632.
4. Device Description:
The Emory Cardiac Toolbox™ 4.3 is used to display gated wall motion and for quantifying parameters of left-ventricular perfusion and function from gated SPECT & PET myocardial perfusion studies and for the evaluation of dynamic PET studies.
5. New features in the current device
The new features added to the Emory Cardiac Toolbox™ are the analysis of the CT data to evaluate calcified plaques in the coronary arteries and analysis of wall motion and wall thickening of the heart using longitudinal, radial, and circumferential strain measurements.
6. Indication for Use
4
The Emory Cardiac Toolbox™ 4.0 – 4.3 software program should be used for the quantification of myocardial perfusion for the display of wall motion and quantification of left-ventricular function parameters from SPECT & PET myocardial perfusion studies (EGS™) including to quantitatively evaluate the wall motion and wall thickening of the heart using longitudinal, radial, and circumferential strain measurements, for the 3D alignment of coronary artery models from CT coronary angiography onto the left ventricular 3D epicardial surface and analysis of the CT data to evaluate calcified plaques in the coronary arteries, for the assessment of cardiac mechanical dyssynchrony using phase analysis, for generation of the short axis, vertical, and horizontal long axis tomograms from the SPECT raw data using either filtered backprojection (FBP) or iterative reconstruction (MLEM/OSEM), for the quantification of myocardial blood flow and coronary flow reserve, and for the decision support in interpretation (LVX) and automatic structured reporting of the study.
- Comparison Table with predicate device(s)
Submitted Device: Emory Cardiac Toolbox™ 4.3 (K223422) Predicate Devices:
- Emory Cardiac Toolbox™ 4.0 (K123646) ●
- Calcium Scoring: Syngo.CT Ca Scoring developed by Siemens Medical Solutions . USA, Inc. (K201034)
- Strain Analysis: TOMTEC-Arena (AutoStrain Suite) developed by TOMTEC Imaging ● Systems GmbH (K201632)
| Function or Parameter | ECTb™ 4.0 | ECTb™ 4.3 | Syngo.CT | TOMTEC-
Arena |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|-----------|----------|------------------|
| 2D and 3D Display of
perfusion and left-ventricular
function from gated SPECT &
PET myocardial perfusion
studies | Yes | Yes | NA | NA |
| Quantitative analysis of
perfusion for extent, severity,
reversibility, mass, and
viability | Yes | Yes | NA | NA |
| Quantitative analysis of
function for ejection fraction,
end-diastolic volume, end-
systolic volume, myocardial
mass volumes, wall
thickening, and transient
ischemic dilation (TID) | Yes | Yes | NA | NA |
| Provides computer assisted
visual scoring and prognostic
information | Yes | Yes | NA | NA |
| Decision support for image
interpretation | Yes | Yes | NA | NA |
| 3D alignment of coronary | Yes | Yes | NA | NA |
| artery models from CT
coronary angiography onto left
ventricular 3D epicardial
surface | | | | |
| Can be used with the following
myocardial protocols: Same
Day and two Day Sestamibi,
Dual-Isotope (Tc-99m/TI-201),
Tetrofosmin, Thallium,
Rubidium-82, N-13 Ammonia,
and FDG | Yes | Yes | NA | NA |
| Provides automatic and
manual reorientation of
SPECT gated and non-gated
data sets. | Yes | Yes | NA | NA |
| Measurement of Left
ventricular dyssyncrony | Yes | Yes | NA | NA |
| Provides a method for
analyzing Myocardial Blood
Flow and Coronary Flow
Reserve | Yes | Yes | NA | NA |
| Automatic highlighting of
coronary calcifications. The
calcified plaques are
assigned manually to their
respective coronary artery by
mouse click. | NA | Yes | Yes | NA |
| Automatic highlighting of meta
using a default threshold of
1000 HU. | NA | Yes | Yes | NA |
| Ability to calculate Agatston
scores and plaque volumes | NA | Yes | Yes | NA |
| Automatic evaluation of
lesions by a 3D segmentation
algorithm | NA | Yes | Yes | NA |
| Ability to split a lesion into 2
territories. | NA | Yes | Yes | NA |
| Ability to window the Calcium
Scoring CT | NA | Yes | Yes | NA |
| Ability to generate a report
related to the calcium
scoring data. | NA | No | Yes | NA |
| Quantitatively evaluate the
wall motion and wall
thickening of the heart using
longitudinal, radial, and
circumferential strain
measurements. | NA | Yes | NA | Yes |
| Quantitative strain analysis | NA | No | NA | Yes |
| Regional strain (by wall and
by 17-segment polar maps) | NA | Yes | NA | Yes |
| Comparison to a normal limit
(with color-coding) for global
and 17-segment regional
analysis | NA | Yes | NA | No |
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8. Performance Validation
Emory-CACS: The CACS module was validated against the FDA approved Siemens SynqoVia™ toolbox (K201034). A clinical comparison test was the method used for validation. The test data was comprised a group of 52 patients using 110 vessels with calcified plaques that had been previously scored by Emory radiologists; the same lesions selected by the radiologist were analyzed by the Emory-CACS and SYngo.CT CaScoring modules. Regression analysis was performed between the SyngoVia™ and the Emory-CACS module. On a per patient basis, linear plaque volume regression (m = 1.10; b = 0.46) produced an r2 = 0.99 and Agatston score regression (m = 1.01; b = 1.06) produced an r2 > 0.99. The values obtained by the Emory-CACS module demonstrated excellent correlations with the Syngo.CT CaScoring developed by Siemens Medical Solutions.
ECTb™ Strain: MPI measurements were validated for resting global longitudinal strain vs. an accepted reference standard, TTE echo A clinical comparison test was the method used for validation. Longitudinal, radial, and circumferential strains from a low-risk cohort (n=22) were used to establish normal limits to evaluate against the results of a high-risk cohort (n=80). Positive strain, lower limits of normal were determined as the mean radial strain minus 2-standard deviations (SD). For circumferential and longitudinal strains, both negative in sign, lower limits of normal were determined as the mean strain plus 2-SDs. Validation of strain analysis for ECTb™ 4.3 was performed in 80 patients with variable coronary artery disease (CAD) and 22 patients with low-risk of CAD. In the CAD cohort, longitudinal strain assessed with PET MPI and TTE were strongly correlated at stress (r= 0.68, p