Who is the manufacturer of Emory Cardiac Toolbox 4.3?

Syntermed filed the 510(k) submission for Emory Cardiac Toolbox 4.3 (K223422).

What is the FDA product code for Emory Cardiac Toolbox 4.3?

KPS. It is classified under 21 CFR 892.1200 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Emory Cardiac Toolbox 4.3?

510(k) clearance (submission type: Special).

What are the predicate devices for Emory Cardiac Toolbox 4.3?

Emory Cardiac Toolbox™ 4.0 (K123646); Syngo.CT Ca Scoring (K201034); TOMTEC-Arena (AutoStrain Suite) (K201632).

Who can help prepare an FDA 510(k) submission like Emory Cardiac Toolbox 4.3?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Emory Cardiac Toolbox 4.3

K223422 · Syntermed · KPS · Mar 30, 2023 · Radiology

Device Facts

Record ID	K223422
Device Name	Emory Cardiac Toolbox 4.3
Applicant	Syntermed
Product Code	KPS · Radiology
Decision Date	Mar 30, 2023
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.1200
Device Class	Class 2
Attributes	Software as a Medical Device

Intended 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.

Device Story

Emory Cardiac Toolbox™ 4.3 is a software suite for processing and analyzing cardiac SPECT, PET, and CT coronary angiography data. It ingests medical imaging data to perform quantitative analysis of myocardial perfusion, left-ventricular function, wall motion, and wall thickening. Key features include 3D alignment of coronary artery models onto epicardial surfaces, calcium scoring (Agatston scores/plaque volumes), and strain analysis (longitudinal, radial, circumferential). The software generates tomograms, perfusion maps, and structured reports to assist clinicians in interpreting cardiac studies and assessing coronary artery disease. Used in clinical settings by physicians, the device provides automated measurements and decision support, aiding in the diagnosis and management of cardiac conditions. It leverages 3D segmentation algorithms for lesion evaluation and compares patient data against established normal limits to identify abnormalities in cardiac function and perfusion.

Clinical Evidence

Validation included clinical comparison studies. CACS module validated against Siemens SyngoVia™ (n=52 patients, 110 vessels); linear plaque volume regression r2=0.99, Agatston score r2>0.99. Strain analysis validated against TTE (n=80 high-risk CAD, n=22 low-risk); longitudinal strain correlated at stress (r=0.68, p<0.001) and rest (r=0.58, p<0.001). Radial and circumferential strain also showed high correlation with TTE (p<0.001). Results demonstrate high reproducibility and correlation with reference standards.

Technological Characteristics

Software-based cardiac image processing system. Features 3D segmentation algorithms for lesion evaluation, phase analysis for dyssynchrony, and strain analysis. Supports SPECT (FBP, MLEM/OSEM reconstruction) and PET data. Provides automated reorientation, quantification of myocardial blood flow, and coronary flow reserve. Integrates CT data for calcium scoring and coronary artery modeling. Standalone software application.

Indications for Use

Indicated for quantification of myocardial perfusion, wall motion, and left-ventricular function from SPECT/PET studies; evaluation of coronary artery calcified plaques via CT; assessment of cardiac mechanical dyssynchrony; and quantification of myocardial blood flow/coronary flow reserve in patients undergoing cardiac imaging.

Regulatory Classification

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.

Predicate Devices

Emory Cardiac Toolbox™ 4.0 (K123646)
Syngo.CT Ca Scoring (K201034)
TOMTEC-Arena (AutoStrain Suite) (K201632)

Related Devices

K080575 — CORRIDOR4DM · Invia · May 13, 2008
K123646 — EMORY CARDIAC TOOLBOX 4.0 · Syntermed, Inc. · Feb 22, 2013
K130383 — SYNAPSE 3D CARDIAC TOOLS · Fujifilm Medical System U.S.A., Inc. · Apr 9, 2013
K101279 — CORRIDOR4DM V2010 MODEL: V2010 · Invia · Aug 4, 2010
K120636 — SYNAPSE 3D CARDIAC TOOLS · Fujifilm Medical System U.S.A., Inc. · Jul 5, 2012

Submission Summary (Full Text)

{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) | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov *"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."* {3}------------------------------------------------ # 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. 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- 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 | {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).