Emory Cardiac Toolbox 4.3

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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). 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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) | <span> <span style="padding-right:5px;">X</span>Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="padding-left:5px;"></span>Over-The-Counter Use (21 CFR 801 Subpart C) </span> | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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. 7. 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-<br>Arena | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|-----------|----------|------------------| | 2D and 3D Display of<br>perfusion and left-ventricular<br>function from gated SPECT &<br>PET myocardial perfusion<br>studies | Yes | Yes | NA | NA | | Quantitative analysis of<br>perfusion for extent, severity,<br>reversibility, mass, and<br>viability | Yes | Yes | NA | NA | | Quantitative analysis of<br>function for ejection fraction,<br>end-diastolic volume, end-<br>systolic volume, myocardial<br>mass volumes, wall<br>thickening, and transient<br>ischemic dilation (TID) | Yes | Yes | NA | NA | | Provides computer assisted<br>visual scoring and prognostic<br>information | Yes | Yes | NA | NA | | Decision support for image<br>interpretation | Yes | Yes | NA | NA | | 3D alignment of coronary | Yes | Yes | NA | NA | | artery models from CT<br>coronary angiography onto left<br>ventricular 3D epicardial<br>surface | | | | | | Can be used with the following<br>myocardial protocols: Same<br>Day and two Day Sestamibi,<br>Dual-Isotope (Tc-99m/TI-201),<br>Tetrofosmin, Thallium,<br>Rubidium-82, N-13 Ammonia,<br>and FDG | Yes | Yes | NA | NA | | Provides automatic and<br>manual reorientation of<br>SPECT gated and non-gated<br>data sets. | Yes | Yes | NA | NA | | Measurement of Left<br>ventricular dyssyncrony | Yes | Yes | NA | NA | | Provides a method for<br>analyzing Myocardial Blood<br>Flow and Coronary Flow<br>Reserve | Yes | Yes | NA | NA | | Automatic highlighting of<br>coronary calcifications. The<br>calcified plaques are<br>assigned manually to their<br>respective coronary artery by<br>mouse click. | NA | Yes | Yes | NA | | Automatic highlighting of meta<br>using a default threshold of<br>1000 HU. | NA | Yes | Yes | NA | | Ability to calculate Agatston<br>scores and plaque volumes | NA | Yes | Yes | NA | | Automatic evaluation of<br>lesions by a 3D segmentation<br>algorithm | NA | Yes | Yes | NA | | Ability to split a lesion into 2<br>territories. | NA | Yes | Yes | NA | | Ability to window the Calcium<br>Scoring CT | NA | Yes | Yes | NA | | Ability to generate a report<br>related to the calcium<br>scoring data. | NA | No | Yes | NA | | Quantitatively evaluate the<br>wall motion and wall<br>thickening of the heart using<br>longitudinal, radial, and<br>circumferential strain<br>measurements. | NA | Yes | NA | Yes | | Quantitative strain analysis | NA | No | NA | Yes | | Regional strain (by wall and<br>by 17-segment polar maps) | NA | Yes | NA | Yes | | Comparison to a normal limit<br>(with color-coding) for global<br>and 17-segment regional<br>analysis | NA | Yes | NA | No | {5}------------------------------------------------ {6}------------------------------------------------ # 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 <.001) and rest (r= 0.58, p<.001). PET MPI radial strain was also highly correlated with TTE at stress (r=-0.70, p<.001) and at rest (r=-0.59, p<.001). Similarly, PET MPI circumferential strain was highly correlated with TTE at stress (r=0.67, p<.001) and at rest (r=0.69.p<.001). The results de monstrate that all values between ECTb™ Strain and TTE correlated strongly and were found to be highly reproducible. ## 9: Conclusion The current device has the same indication for use and has the same technological characteristics as the predicate device(s). The performance of the additional new features have been tested and the results have met the predefined acceptance criteria, and it has been determined to be substantially equivalent to predicate device(s).