The Northwestern Gated Blood Pool SPECT (NUMUGAS™) software program is indicated to use for the display of wall motion and quantification of left ventricular functional parameters from gated Tc-99m Blood Pool SPECT studies.

Device Description

The Northwestern Gated Blood Pool SPECT™ (NUMUGAS™) is used to display gated wall motion and for quantifying parameters of left-ventricular function from gated blood pool SPECT studies. These parameters are: ejection fraction, end-diastolic volume, endsystolic volume, stroke volume, maximum and average emptying and filling rates, ejection and filling periods and times, and regional ejection fraction. This program was developed to run in the IDL operating system environment which can be executed on any nuclear medicine computer systems which supports the IDL software development environment. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.

AI/ML Overview

N/A

Summary

510(k) SUMMARY

APR 23 2002
K020300
ITEM I

Safety and Effectiveness

1. Medical Device Establishment:

Syntermed
Voice &FAX: (714) 281-1256
Contact person: Kenneth Van Train
Email: vantrain@syntermed.com
Date Summary Prepared: January 23, 2002

2. Medical Device:

Northwestern Gated Blood Pool SPECT™ (NUMUGAS™) - Software program used for the display of wall motion and quantification of left ventricular function parameters from gated Tc99m blood pool SPECT studies

3. Medical Device Equivalence:

Emory Cardiac Toolbox™ 2.0 Ref. 510(k) #: K992450.

4. Device Description:

The Northwestern Gated Blood Pool SPECT™ (NUMUGAS™) is used to display gated wall motion and for quantifying parameters of left-ventricular function from gated blood pool SPECT studies. These parameters are: ejection fraction, end-diastolic volume, end-systolic volume, stroke volume, maximum and average emptying and filling rates, ejection and filling periods and times, and regional ejection fraction. This program was developed to run in the IDL operating system environment which can be executed on any nuclear medicine computer systems which supports the IDL 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 display wall motion and determine measurements of ejection fraction and ventricular volumes from his patients gated blood pool SPECT study. This program serves merely as a display and processing program to aid in the diagnostic interpretation of a patient's study. It was not meant to replace or eliminate the standard visual analysis of

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the gated blood pool SPECT 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 program can be found in Item H, Testing & Validation and 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 programs marketed in the past which perform similar functions to those performed by the Northwestern Gated Blood Pool SPECT™ (NUMUGAS™) program. Every Nuclear Medicine manufacturer has programs that can calculate planar gated blood pool and several of them have programs for determining similar quantitative parameters of ejection fraction, end-diastolic volume, end-systolic volume, stroke volume, maximum and average emptying and filling rates, ejection and filling periods and times, and regional ejection fraction. NUMUGAS™ provides a program which executes in the IDL operating system environment and we believe is substantially equivalent to the Emory Cardiac Toolbox™ 2.0 Ref. 510(k) #: K992450. To our knowledge there have been no safety problems with the calculation of functional parameters from SPECT myocardial perfusion studies for the Emory Cardiac Toolbox™ program which has been in the marketplace for over three years.

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 in-house testing and clinical validation studies. Specific details and results concerning the validation of the Northwestern Gated Blood Pool SPECT™ program are listed in Item H, Testing & Validation. We contend that the method employed for the development and the final in-house validation results of this medical display software program, Northwestern Gated Blood Pool SPECT™, have proven its safety and effectiveness. In our opinion the Northwestern Gated Blood Pool SPECT™ is substantially equivalent to the Emory Cardiac Toolbox™ which has been cleared for marketing. The Northwestern Gated Blood Pool SPECT™ program is intended for the same purpose and raises no new issues of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

APR 23 2002

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

Re: K020300
Trade/Device Name: Northwestern Gated Blood Pool SPECT (NUMUGAS)
Regulation Number: 21 CFR 892.1200
Regulation Name: Emission computed tomography system
Regulatory Class: II
Product Code: 90 KPS
Dated: January 23, 2002
Received: January 29, 2002

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 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:

8xx.1xxx (301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx (301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx (301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx (301) 594-4654
Other (301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

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): K020300

Device Name: Northwestern Gated Blood Pool SPECT (NUMUGAS™)

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✓
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K020300

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.