EMORY CARDIAC TOOLBOX 2.1 EXECUTING ON NUCLEAR MEDICINE COMPUTERS

K014033 · Syntermed, Inc. · KPS · Feb 22, 2002 · Radiology

Device Facts

• Record ID: K014033
• Device Name: EMORY CARDIAC TOOLBOX 2.1 EXECUTING ON NUCLEAR MEDICINE COMPUTERS
• Applicant: Syntermed, Inc.
• Product Code: KPS · Radiology
• Decision Date: Feb 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: Software as a Medical Device

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Left-ventricular perfusion	—	—	—	In-house trial validations: 217 patients. Multicenter trial validation: 80 patients. Computer assisted visual scoring: 20 patients. Prognosis: 504 patients. Expert system: 461 patients. Coronary fusion: 9 patients. Rb-82 normal limits: 176 patients. PET tools for perfusion-metabolism match-mismatch: 90 patients.	—	—	—
Left-ventricular function	—	—	—	In-house trial validations: 217 patients. Multicenter trial validation: 80 patients. Computer assisted visual scoring: 20 patients. Prognosis: 504 patients. Expert system: 461 patients. Coronary fusion: 9 patients. Rb-82 normal limits: 176 patients. PET tools for perfusion-metabolism match-mismatch: 90 patients.	—	—	—

Indications for Use

The Emory Cardiac Tool Box™ (CEquar®, EGS™) 2.1 software program should be used for the quantification of left-ventricular function parameters and for the display of wall motion and the results of the SPECT & PET myocardial perfusion studies.

Device Story

Emory Cardiac Tool Box™ 2.1 is a software program for nuclear medicine computer systems; processes gated SPECT and PET myocardial perfusion studies. Inputs: gated SPECT/PET image data. Processing: automated quantification of left-ventricular function (ejection fraction, volumes, mass, TID) and wall motion; includes computer-assisted visual scoring, prognostic information, expert system interpretation, and 3D coronary overlay. Output: quantitative metrics and visual displays for physician review. Used in clinical settings by physicians to aid diagnostic interpretation; requires user verification of automated results. Does not replace standard visual analysis; physician integrates output with patient history, EKG, and other diagnostic data to make final clinical decisions. Benefits: provides standardized quantitative analysis to assist in diagnostic and prognostic assessment of myocardial perfusion and function.

Clinical Evidence

Effectiveness established via phantom studies, computer simulations, and clinical trials. Functional parameter calculations validated in 217 patients. Multicenter trial included 80 patients. Additional evaluations: computer-assisted visual scoring (n=20), prognosis (n=504), expert system (n=461), coronary fusion (n=9). Rb-82 normal limits validated (n=176). PET tools for perfusion-metabolism match-mismatch validated (n=90).

Technological Characteristics

Software-based processing and display program. Operates within IDL environment on nuclear medicine computer systems supporting IDL and Aladdin (GE) software development environment. Features automated processing with manual override capability. Algorithms include expert system interpretation, visual scoring, and 3D coronary overlay.

Indications for Use

Indicated for patients undergoing gated SPECT and PET myocardial perfusion studies to quantify left-ventricular function parameters (perfusion, ejection fraction, end-diastolic volume, end-systolic volume, myocardial mass, transient ischemic dilatation) and display wall motion.

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 Tool Box™ (CEqual®, EGS™) Version 2.0 (K992450)

Submission Summary (Full Text)

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KO/40 33

# ITEM G

## FEB 2 2 2002

# 510(k) SUMMARY

# Safety and Effectiveness

#### 1. Medical Device Establishment:

Syntermed, Inc. Registration No. 1066019 Owner Operator I.D. 9041128 Voice/FAX: [phone] Contact person: Kenneth F. Van Train Date Summary Prepared: December 4, 2001

## 2. Medical Device:

Emory Cardiac Tool Box™ 2.1 - Display and Processing program for gated SPECT & PET myocardial perfusion studies executing on nuclear medicine computer systems.

## 3. Medical Device Equivalence:

Emory Cardiac Tool Box™ (CEqual®, EGS™) Version 2.0, Ref. 510(k) #: K992450,

### 4. Device Description:

The Emory Cardiac Tool Box™ 2.1 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 and transient ischemic dilatation (TID). In addition, the 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. 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

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patients gated SPECT & PET myocardial perfusion study, obtain visual interpretation scores, prognostic information, expert system interpretation, and coronary overlay onto 3D perfusion images. 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 in the days 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 tomographic integroe 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 (See Item F, Testing & Validation for Emory Cardiac Tool Box™ (CEqual®) EGS™) Version 2.0, Ref. 510(k) #: K992450) and the accuracy for version 2.1 can be found in Item F (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. 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™ 2.1 provides a program which executes in the IDL operating system environment and we believe is substantially equivalent to our previous version of the Emory Cardiac Tool Box™ 2.0 (CEqual®, EGS™), K992450. To our knowledge there have been no safety problems with the Emory Cardiac Tool Box™ 2.0 (CEqual®, EGS™) program which has been in the marketplace for twentynine months.

### 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 program 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. Specific details and results concerning the validation of the Emory Cardiac Tool Box™ 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) are listed in Item F, Testing & Validation. We contend that the method employed for the development and validation of the Rb-82 and PET tools for analysis of

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metabolism and perfusion of this medical display software program, Emory Cardiac Tool Box™ 2.1, have proven its safety and effectiveness. In our opinion the Emory Cardiac Tool Box™ 2.1 is substantially equivalent to our previous version of the Emory Cardiac Tool Box™ 2.0 (CEqual®, EGS™) which has been cleared for marketing. The Emory Cardiac Tool Box™ 2.1 is intended for the same purpose and raises no new issues of safety or effectiveness.

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Image /page/3/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem is a stylized representation of a bird or a wing-like shape, composed of three curved lines that suggest movement or flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 2 2002

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

Re: K014033

Trade/Device Name: Emory Cardiac Toolbox™ 2.1 Executing on Nuclear Medicine Computers Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: December 4, 2001 Received: December 7, 2001

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 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 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.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nredicate 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:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html.

Sincerely vours.

Nancy C. Brogdon

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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Page 1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:____Emory Cardiac-Toolbox 2.1-Executing on Nuclear Medicine Computers

Indications For Use:

The Emory Cardiac Tool Box™ (CEquar®, EGS™) 2.1 software program should be The Emory Cardiac Tool Box = (OEqual + EUG = and for the display of wall motion and used for the quantification of left-ventricular (Ocquar ) and really of the results of the results of the SPECT & PET
quantification of left-ventricular function parameters f myocardial perfusion studies (EGS™): .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

| 510(k) Number | K017033 |
|---------------|---------|
|---------------|---------|

| Prescription Use (Per 21 CFR 801.109) | <div style="display:inline-block; vertical-align:middle;">✓</div> | OR | Over-The-Counter Use ______ |
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