K Number

Device Name

EMORY CARDIAC TOOLBOX 4.0

Manufacturer

SYNTERMED, INC.

Date Cleared

2013-02-22

(87 days)

Product Code

KPS

Regulation Number

892.1200

Intended Use

The Emory Cardiac Toolbox™ 4.0 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™), for the 3D alignment of coronary artery models from CT coronary angiography onto the left ventricular 3D epicardial surface, 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. The product is intended for use by trained nuclear technicians and nuclear medicine or nuclear cardiology physicians. The clinician remains ultimately responsible for the final interpretation and diagnosis based on standard practices and visual interpretation of all SPECT and PET data.

Device Description

The Emory Cardiac Toolbox™ 4.0 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. These parameters are: perfusion, ejection fraction, end-diastolic volume, end-systolic volume, myocardial mass, transient ischemic dilatation (TID), analysis of coronary blood flow and coronary flow reserve, and assessment of cardiac mechanic dyssynchrony. In addition, the program offers the capability of providing the following diagnostic information: computer assisted visual scoring, prognostic information, and expert system image interpretation. The program can also be used for the 3D alignment of coronary artery models from CT coronary angiography onto the left ventricular 3D epicardial surface and for generation of the short axis, vertical, and horizontal long axis tomograms from the SPECT raw data either filtered backprojection (FBP) or iterative reconstruction using (MLEM/OSEM). The Emory Cardiac Toolbox can be used with any of the following Myocardial SPECT Protocols: Same Day and Two Day Sestamibi, Dual-Isotope (Tc-99m/Tl-201), Tetrofosmin, and Thallium, Rubidium-82, Rubidium-82 with CTbased attenuation correction, N-13-ammonia, FDG protocols, and user defined normal databases. This program was developed to run in the .NET operating system environment which can be executed on any PC, any nuclear medicine computer system, or through a web browser. In addition, the program can be used for the decision support in interpretation and automatic structured reporting of the study. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Emory Cardiac Toolbox v3.1 K071503, Emory Cardiac Toolbox v2.0 K992450, COR Analyzer developed by Rcadia K110071, CORRIDOR 4DM V2010 developed by INVIA K101279, Coronary Flow Reserve (CFR) Quantification (cfrQuant) developed by University of Texas Medical School at Houston K113754

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

Unknown
The document mentions "expert system image interpretation" and "decision support in interpretation," which could potentially involve AI/ML, but the summary does not explicitly state the use of AI, DNN, or ML. The description of performance studies also doesn't provide details typical of AI/ML model validation (e.g., training/test sets, specific AI/ML metrics).

Therapeutic

No
The device is described as a software program for the quantification and display of myocardial perfusion and left-ventricular function parameters from medical imaging studies. It provides diagnostic information and decision support, but it does not directly treat or prevent diseases.

Diagnostic

Yes

The primary function of the device, as described in the "Intended Use / Indications for Use" and "Device Description" sections, is to quantify myocardial perfusion, display wall motion, quantify left-ventricular function parameters, assess cardiac mechanical dyssynchrony, and provide various diagnostic information such as computer-assisted visual scoring, prognostic information, and expert system image interpretation. These functions are all aimed at aiding in the diagnosis of cardiac conditions.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states it is a "software program" and details its functions related to processing and analyzing medical images and data. There is no mention of accompanying hardware components being part of the device itself.

IVD (In Vitro Diagnostic)

Based on the provided information, the Emory Cardiac Toolbox™ 4.0 software program is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that the software processes medical images (SPECT, PET, CT) of the heart and its function. It does not analyze biological samples like blood, urine, or tissue.
The software provides quantitative analysis and decision support based on imaging data. While this information is used to aid in diagnosis and treatment decisions, it is derived from imaging modalities, not from the direct examination of biological specimens.

The Emory Cardiac Toolbox™ 4.0 is a medical device software that falls under the category of image processing and analysis software used in nuclear medicine and cardiology. It is intended to assist trained medical professionals in interpreting imaging studies and quantifying cardiac parameters.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

KPS

Device Description

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

SPECT, PET, CT

Anatomical Site

Myocardium / Left Ventricle

Indicated Patient Age Range

Not Found

Intended User / Care Setting

The product is intended for use by trained nuclear technicians and nuclear medicine or nuclear cardiology physicians.

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 effectiveness of the initial program, Emory Cardiac Toolbox™ 2.0. has been established in phantom and computer simulations studies, in-house trial validations which included an evaluation of left ventricular functional parameter calculations in 217 patients, and in a multicenter trial validation consisting of 80 patients. In addition, the computer assisted visual scoring, prognosis, expert system, and coronary fusion algorithms were successfully evaluated in 20, 504, 461, and 9 patients respectively. Additional validation of the Emory Cardiac Toolbox™ 2.1 program for development and validation of Rb-82 normal limits (n=176) and validation of PET tools for assessment of perfusion - metabolism match-mismatch (n=90) were successfully completed. Validation for the Emory Cardiac Toolbox™ 2.6 program included development and validation of N-13-ammonia normal limits (n= 144) and validation of the alignment method for 3D CT coronary artery onto the left ventricular 3D epicardial surface using phantom and patient studies (n = 8). Validation for the Emory Cardiac Toolbox™ 3.1 program included development (phantom, animal, and patients n=4) and prospective validation of SPECT reconstruction in 10 patients and for phase analysis which included development in 90 normal patients and prospective validation in 75 additional patients. Validation for the Emory Cardiac Toolbox™ 4.0 program included 301 patients used to validate the accuracy in deriving similar values for 14 perfusion, function and dyssynchrony variables from IDL to .NET conversion which demonstrated an accuracy greater than 99%, the coronary blood flow validation was conducted in 44 patient studies, and the decision support validation was conducted in 126 studies.

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

Emory Cardiac Toolbox™ 4.0: accuracy greater than 99% for 14 perfusion, function, and dyssynchrony variables (IDL to .NET conversion).

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

K123646

FEB 2 2 2013

510(k) SUMMARY

Safety and Effectiveness

Medical Device Establishment:

Syntermed, Inc. Registration No. 1066019 Owner Operator I.D. 9041128 Device Requlation Number: 892.1200 Product Code: KPS Classification Panel: Radiology Voice: (888) 263-4446 ext 102, FAX: (714) 281-1290 Contact person: Kenneth F. Van Train Address: Syntermed, Inc. 130 Wieuca Road Suite 108 Atlanta, GA 30342 Date Summary Prepared: November 15, 2012

Medical Device:

Emory Cardiac Toolbox™ 4.0 - Display and Processing program for gated SPECT & PET myocardial perfusion studies executing on nuclear medicine computer systems and Windows PC's.

Classification Name - System, Tomography, Computed, Emission

Medical Device Equivalence:

vww.syntermed.com · Office: 888.263.4446 · Fax: 888.216.7511

Emory Cardiac Toolbox v3.1 K071503, Emory Cardiac Toolbox v2.0 K992450 (PERFEX), COR Analyzer developed by Rcadia K110071, CORRIDOR 4DM V2010 developed by INVIA K101279, and Coronary Flow Reserve (CFR) Quantification (cfrQuant) developed by University of Texas Medical School at Houston K113754.

Device Description:

Nuclear is evolving. We're evolving with you.

· 130 West Wieuca Road · Suite 108

5. Intended Use and Potential Adverse Effect on Health:

The Emory Cardiac Toolbox™ 4.0 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™), for the 3D alignment of coronary artery models from CT coronary angiography onto the left ventricular 3D epicardial surface, 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 backproiection (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.

The interpretation provided by LVX is intended to assist a trained physician to analyze nuclear cardiology images. It was not meant to replace or eliminate the standard visual analysis of the gated SPECT & PET study. The physician should integrate all of the patients' clinical and diagnostic information, i.e. patients' history, stress and/or rest EKG, quality control images, visual interpretation of the gated tomographic images, and quantitative and decision support interpretative results, prior to making his final interpretation. This comprehensive processing technique (as with all diagnostic imaging) is not perfect, and will be associated with some false positive and false negative results. The expected accuracy of the initial program can be found in the multicenter trial results listed in the article by Vansant

et al Emory Cardiac Toolbox™ (CEquar®, EGS™) Version 2.0, Ref. 510(k) #: K992450 and Version 2.1, Ref. 510(k) #: K014033). The accuracy for modifications in version 4.0 for analysis of coronary blood flow, coronary flow reserve and for evaluation of the decision support system (LVX) in comparison to PERFEX results can be found in Item H (Testing & Validation) of this 510(k) submission. The physician should be aware of the accuracy when integrating the quantitative results for his final interpretation. Therefore, this program has no direct 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 interpretation of the study lies with the physician.

6. Marketing History:

There have been several medical device gated SPECT programs marketed in the past which perform similar functions to those performed by the Emory Cardiac Tool Box™ 2.0, 2.1, 2.6 and 3.1. These programs are all used for the purpose of displaying wall motion and deriving functional parameters for the diagnostic interpretation by a physician. The Emory Cardiac Tool Box™ 4.0 provides additional features for the analysis of coronary blood flow, and for the decision support in interpretation (LVX) and automatic structured reporting of the SPECT and PET study and we believe is substantially equivalent to Emory Cardiac Toolbox v3.1 K071503 for conversion from IDL to NET; Emory Cardiac Toolbox v2.0 K992450 and COR Analyzer developed by Rcadia K110071 for decision support; and CORRIDOR 4DM V2010 developed by INVIA K101279 and Coronary Flow Reserve (CFR) Quantification (cfrQuant) developed by University of Texas Medical School at Houston K113754 for mvocardial blood flow and coronary flow reserve. To our knowledge there have been no safety problems with the COR Analyzer decision support system which has been in the marketplace since January 31, 2011 and with CORRIDOR which has been marketed since August 4, 2010 or Coronary Flow Reserve (CFR) Quantification (cfrQuant) marketed since July 19, 2012.

7. Conclusions:

The safety of this program has been determined through the various stages of software development which included the initial design, coding, debugging, testing, and validation. The effectiveness of the initial program, Emory Cardiac Toolbox™ 2.0. has been established in phantom and computer simulations studies, in-house trial validations which included an evaluation of left ventricular functional parameter calculations in 217 patients, and in a multicenter trial validation consisting of 80 patients. In addition, the computer assisted visual scoring, prognosis, expert system, and coronary fusion algorithms were successfully evaluated in 20, 504, 461, and 9 patients respectively. Additional validation of the Emory Cardiac Toolbox™ 2.1 program for development and validation of Rb-82 normal limits (n=176) and validation of PET tools for assessment of perfusion - metabolism match-mismatch (n=90) were successfully completed. Validation for the Emory Cardiac Toolbox™ 2.6 program included development and validation of N-13ammonia normal limits (n= 144) and validation of the alignment method for 3D CT coronary artery onto the left ventricular 3D epicardial surface using phantom and

patient studies (n = 8). Validation for the Emory Cardiac Toolbox™ 3.1 program included development (phantom, animal, and patients n=4) and prospective validation of SPECT reconstruction in 10 patients and for phase analysis which included development in 90 normal patients and prospective validation in 75 additional patients. Validation for the Emory Cardiac Toolbox™ 4.0 program included 301 patients used to validate the accuracy in deriving similar values for 14 perfusion, function and dyssynchrony variables from IDL to .NET conversion which demonstrated an accuracy greater than 99%, the coronary blood flow validation was conducted in 44 patient studies, and the decision support validation was conducted in 126 studies and these results are listed in Item H, Testing & Validation. We contend that the method employed for the development and validation for the conversion from IDL to .NET operating system, the analysis of coronary blood flow and coronary flow reserve, and the decision support for interpretation of SPECT and PET data have proven its safety and effectiveness. In our opinion the additional features in Emory Cardiac Toolbox™ 4.0 for decision support for interpretation and coronary blood flow analysis are substantially equivalent to Emory Cardiac Toolbox v2.0 K992450 (PERFEX) and Rcadia's COR Analyzer K110071 for decision support (LVX) and INVIA's CORRIDOR 4DM V2010 K101279 and Coronary Flow Reserve (CFR) Quantification (cfrQuant) developed by University of Texas Medical School at Houston K113754 for coronary blood flow analysis which have all been cleared for marketing. The Emory Cardiac Toolbox™ 4.0 is intended for the same purpose as Emory Cardiac Toolbox™ 3.1 along with the additional purpose of decision support for interpretation, coronary blood flow, and coronary flow reserve analysis and raises no new issues of safety or effectiveness.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

February 22, 2013

Syntermed, Inc. Kenneth F. Van Train, Ph.D. President, 130 Wieuca Road Suite 108 Atlanta, GA 30342

Re: K123646

Emory Cardiac Toolbox 4.0 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computerized Tomography Regulatory Class: Class II Product Code: KPS Dated: November 16, 2012 Received: November 27, 2012

Dear Dr. 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. 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.

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 requirements, including, but not limited to: registration and listing (21

Page 2 - [Contact Person's Name]

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Michael Hara

Janine M. Morris Director Division Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number: K123646

Device Name:_Emory Cardiac Toolbox™ 4.0

Indications For Use:

The product is intended for use by trained nuclear technicians and nuclear medicine or nuclear cardiology physicians. The clinician remains ultimately responsible for the final interpretation and diagnosis based on standard practices and visual interpretation of all SPECT and PET data.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Michi FDA'Hara

(Division Sign C

Page 1 of

Division of Radiotogical Hea

Office of In Vitro Diagnostics and Radiological He

510(k) L.123646