SYSTEM, TOMOGRAPHY, COMPUTED EMISSION

K071503 · Syntermed, Inc. · KPS · Jul 26, 2007 · Radiology

Device Facts

• Record ID: K071503
• Device Name: SYSTEM, TOMOGRAPHY, COMPUTED EMISSION
• Applicant: Syntermed, Inc.
• Product Code: KPS · Radiology
• Decision Date: Jul 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

The Emory Cardiac Toolbox™ (CEqual®, EGS™) 3.1 software program should be used for the quantification of myocardial perfusion (CEqual®), for the display of wall motion and guantification of left-ventricular function parameters from gated Tc99m 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 mechanic dyssynchrony using phase anaylsys, and 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).

Device Story

Emory Cardiac Toolbox 3.1 is a software program for nuclear medicine computer systems; processes gated SPECT and PET myocardial perfusion studies. Inputs: SPECT/PET raw data; CT coronary angiography models. Processing: automated quantification of perfusion, ejection fraction, volumes, myocardial mass, transient ischemic dilatation, and cardiac mechanic dyssynchrony; generates tomograms via filtered backprojection (FBP) or iterative reconstruction (MLEM/OSEM); performs 3D alignment of coronary artery models onto left-ventricular epicardial surface. Outputs: visual scoring, prognostic information, expert system interpretation, 3D overlays, and quantitative functional parameters. Used in clinical settings by physicians to aid diagnostic interpretation; requires user verification of automated outputs. Benefits: provides quantitative data to assist physician in assessing myocardial function and perfusion; supports clinical decision-making by integrating functional metrics with visual analysis.

Clinical Evidence

Evidence includes phantom, animal, and clinical studies. SPECT reconstruction validated in 10 patients. Phase analysis for dyssynchrony validated in 90 normal patients and 75 prospective patients. Previous versions (2.0, 2.1, 2.6) validated via multicenter trials (n=80), in-house trials (n=217), and specific studies for Rb-82 (n=176), PET perfusion (n=90), N-13-ammonia (n=144), and 3D CT alignment (n=8).

Technological Characteristics

Software-based processing program; operates in IDL environment on nuclear medicine computer systems. Supports FBP and iterative (MLEM/OSEM) reconstruction. Features include automated quantification, 3D coronary overlay, and phase analysis for dyssynchrony. Connectivity: integrates with nuclear medicine systems and CT angiography data.

Indications for Use

Indicated for patients undergoing gated SPECT and PET myocardial perfusion studies requiring quantification of myocardial perfusion, left-ventricular function, wall motion, and cardiac mechanic dyssynchrony assessment.

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

• AutoSPECT Plus (K992317)
• GE Vivid 7 Diagnostic Ultrasound System with TSI (K031663)

Reference Devices

• Emory Cardiac Toolbox (CEqual®, EGS™) Version 2.0 (K992450)
• Emory Cardiac Toolbox Version 2.1 (K014033)

Submission Summary (Full Text)

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K07/503

JUL 26 2007

# ITEM I

# 510(k) SUMMARY

# Safety and Effectiveness

## 1. Medical Device Establishment:

Syntermed. Inc. Registration No. 1066019 Owner Operator I.D. 9041128 Device Regulation Number: 892.1200 Product Code: KPS Classification Panel: Radiology Voice: [phone], FAX: [phone] Contact person: Kenneth F. Van Train Address: Syntermed, Inc. Tower Place Center 3340 Peachtree Road, NE Suite 1800 Atlanta, GA 30326 Date Summary Prepared: May 30, 2007

#### 2. Medical Device:

Emory Cardiac Toolbox™ 3.1 - 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

#### 3. Medical Device Equivalence:

AutoSPECT Plus developed by ADAC Laboratories K992317 for Emory Reconstruction Toolbox (ERTb™) and GE Vivid 7 Diagnostic Ultrasound System with TSI developed by GE Medical Systems K031663 for Phase Analysis.

## 4. Device Description:

The Emory Cardiac Toolbox™ 3.1 is used to display gated wall motion and for quantifying parameters of left-ventricular perfusion and function from gated SPECT & PET myocardial perfusion studies. These parameters are: perfusion, ejection fraction, end-diastolic volume, end-systolic volume, myocardial mass, transient ischemic dilatation (TID), and cardiac mechanic dyssynchrony. In addition, the

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program offers the capability of providing the following diagnostic information: computer assisted visual scoring, prognostic information, expert system image interpretation, and patient specific 3D coronary overlay. 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 using either filtered backprojection (FBP) or iterative reconstruction (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, N-13-ammonia, FDG protocols, and user defined normal databases. This program was developed to run in the IDL operating system environment which can be executed on any nuclear medicine computer systems which supports IDL and the Aladdin (General Electric) software development environment. The program processes the studies automatically. however, user verification of output is required and manual processing capability is provided.

## 5. Intended Use and Potential Adverse Effect on Health:

The intended use of this program was to provide the physician with a program which would allow him to determine quantitative analysis of the myocardial perfusion, display wall motion and determine measurements of ejection fraction and ventricular volumes from his patients gated SPECT & PET myocardial perfusion study, obtain visual interpretation scores, prognostic information, expert system interpretation, for the 3D alignment of coronary artery models from CT cornary angiography onto the left ventricular 3D epicardial surface, for the assessment of cardiac mechanic dyssynchrony using phase analysis, and 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 (MLFM/QSEM). This program serves merely as a display and processing program to aid in the diagnostic interpretation of a patients' study. 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 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 Emoy Cardinc Toolbox™ (CEqual®, EGS™) Version 2.0, Ref. 510(k) #: K992450 and Version 2.1, Ref. 510(k) #: K014033). The accuracy for modifications in version 3.1 for SPECT reconstruction and for evaluation of cardiac mechanic dyssynchrony by phase analysis can be found in Item H (Testing & Validation) of this 510(k) submission. The physician should be aware of the accuracy when integrating the quantistive 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

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physician will utilize for his final interpretation. interpretation of the study lies with the physician.

The final responsibility for

## 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, and 2.6. 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™ 3.1 provides additional features for the assessment of cardiac mechanic dvssynchrony using phase anaylsys, and 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) which executes in the IDL operating system environment and we believe is substantially equivalent to AutoSPECT Plus developed by ADAC Laboratories K992317 for Emory Reconstruction Toolbox (ERTb™) and GE Vivid 7 Diagnostic Ultrasound System with TSI developed by GE Medical Systems K031663 for Phase Analysis. To our knowledge there have been no safety problems with the AutoSPECT Plus program which has been in the marketplace since October 1, 1999 and with GE Vivid 7 Diagnostic Ultrasound System with TSI which has been which has been in the marketplace since June 9. 2003.

## 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 and these results are listed in Item H. Testing & Validation. We contend that the method employed for the development and validation for the assessment of cardiac mechanic dyssynchrony using phase anaylsys, and for generation of the short axis, vertical, and horizontal long axis tomograms from the

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SPECT raw data using either filtered backprojection (FBP) or iterative SFLCT Taw data using oldior "Microa" Salac Toolbox™ 3.1, have proven its reconstraction (MELM/OOLM), Embly Other Statures in Emory Cardiac Salely and Cheoliverioos: The Spicition and phase analysis are substantially Toolbox - O.T TOP OF LOT Tor OF LOS Laboratories K992317 for Emory Reconstruction Toolbox (ERTb™) and GE Vivid 7 Diagnostic Ultrasound Emory Reconstrabiler Fronton (E Medical Systems K031663 for Phase Analysis Oystem with TOT doveloped a for marketing. The Emory Cardiac Toolbox™ 3.1 is intended for the same purpose along with the additional purpose of alignment Intended for the Same parpose analysis and raises no new issues of safety or effectiveness.

4

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Image /page/4/Picture/0 description: The image shows a logo with a circular border containing text. Inside the circle is a stylized graphic of three curved lines that resemble a bird in flight or abstract waves. The text around the circle reads "DEPARTMENT OF HEALTH & HUMAN SERVICES".

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Kenneth F. Van Train President Syntermed, Inc. 245 Owens Drive ANAHEIM CA 92808

Re: K071503

Trade/Device Name: Emory Cardiac Toolbox 3.1 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS and LLZ Dated: May 30, 2007 Received: June 5, 2007

#### Dear Mr. 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 indiver 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 Concercular Act (Act) that do not require approval of a premarket approval application (PMA) and COSII. therefore, market the device, subject to the general controls provisions of the Art, Tho may, 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 (Spocial Controls) or 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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oting Publio Shalth lating and Prop

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Page 2 -

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 CFR Part 807); labeling (21 CFR Part 801); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone]

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html

Sincerely yours.

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K071503 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Emory Cardiac Toolbox 3.1 Executing on Nuclear Medicine Computers Device Name:

Indications For Use:

The Emory Cardiac Toolbox™ (CEqual®, EGS™) 3.1 software program should be used for the quantification of myocardial perfusion (CEqual®), for the display of wall motion and guantification of left-ventricular function parameters from gated Tc99m 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 mechanic dyssynchrony using phase anaylsys, and 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).

## Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use** √
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Formal 1-2-96)

Helent lemer
Division Sign Off

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number _