AUTOQUANT PLUS

K040326 · Adac Laboratories · KPS · Feb 25, 2004 · Radiology

Device Facts

• Record ID: K040326
• Device Name: AUTOQUANT PLUS
• Applicant: Adac Laboratories
• Product Code: KPS · Radiology
• Decision Date: Feb 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

AutoQUANT® Plus applications are intended to enable an automated display, review, and quantification of Nuclear Medicine Cardiology medical images and datasets. AutoQUANT® Plus may be used in multiple settings including the hospital, clinic, doctors office, or remotely via dial up. The results provided should be reviewed by qualified healthcare professionals (e.g., radiologists, cardiologists, or general nuclear medicine physicians) trained in the use of medical imaging devices.

Device Story

AutoQUANT® Plus is a software suite for processing/reviewing Cardiac SPECT and blood pool SPECT datasets. Inputs include gated/perfusion SPECT images. The device performs automated LV extraction, segmentation, and quantification; calculates heart volume, lung/heart ratio, transient ischemic dilation (TID), ventricular volumes, and ejection fractions. It generates 3D contour maps, polar maps of wall motion/parametric values (FFH amplitude/phase), and cine loops. Used in hospitals/clinics/remote settings by physicians to assess cardiac anatomy/physiology and myocardial defects. Output is displayed for physician review to support clinical decision-making. Includes an automated report generation (ARG) feature for PDF/text reports to reduce transcription errors. QBS component allows manual intervention for LV/RV separation if automatic segmentation fails.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological comparison and intended use similarity to previously cleared predicate devices.

Technological Characteristics

Software-based application suite for Cardiac SPECT data processing. Features automated segmentation, 3D contour mapping, and volumetric quantification. Includes report generation module. Operates on standard medical imaging hardware. No specific materials or energy sources defined as it is a software-only device.

Indications for Use

Indicated for use by qualified healthcare professionals (radiologists, cardiologists, nuclear medicine physicians) to display, review, and quantify Nuclear Medicine Cardiology images and datasets in clinical or remote settings.

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

• AutoQUANT® (K980715)
• Quantitative Blood Pool SPECT (QBS) (K022428)

Submission Summary (Full Text)

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# FEB 2 5 2004

### 510(k) SUMMARY SAFETY AND EFFECTIVENESS

| A. Submitted By: | ADAC Laboratories<br>540 Alder Dr.<br>Milpitas, CA 95035 | |
|--------------------------|----------------------------------------------------------------------|------------|
| | Contact: Joy M. Sacmar<br>Tel: [phone]<br>Fax: [phone] | |
| B. Device Trade Name: | AutoQUANT® Plus | |
| Common Name: | Gamma Camera Systems | |
| Classification Name: | Emission Computed Tomography System | |
| Device Class: | 21 CFR 892.1200, Class II | |
| Product Code: | 90 KPS | |
| C. Date prepared: | January 12, 2004 | |
| D. Predicate Device (s): | | |
| Manufacturer | Product Name | 510(k) No. |
| ADAC Laboratories | AutoQUANT® | K980715 |
| ADAC Laboratories | Quantitative Blood Pool SPECT (QBS) | K022428 |

#### E. Intended Use:

ADAC Laboratories

AutoQUANT® Plus applications are intended to enable an automated display, review, and quantification of Nuclear Medicine Cardiology medical images and datasets. AutoOUANT® Plus may be used in multiple settings including the hospital, clinic, doctors office, or remotely via dial up. The results provided should be reviewed by qualified healthcare professionals (e.g., radiologists, cardiologists, or general nuclear medicine physicians) trained in the use of medical imaging devices.

#### F. Device Description:

AutoQUANT® Plus is a suite of applications for the processing and review of Cardiac SPECT and blood pool SPECT datasets. AutoQUANT® Plus is composed of the following applications: AutoQUANT® (K980715) [AutoQUANT integrates 2 functionalities, Quantitative Perfusion SPECT (QPS) and Quantitative Gated SPECT (QGS) into a single application for LV (Left Ventricle) extraction and analysis], Quantitative Blood Pool SPECT (QBS) (K022428), and optionally QARG (for reporting purposes). Previously, the marketing clearance for QBS (K022428) was scparate and is now being combined with the AutoOUANT Plus 510(k) being submitted.

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AutoQUANT® is a software application designed to enable an automated, comprehensive review and quantification of Cardiac SPECT data. AutoQUANT® integrates 2 functionalities, Quantitative Perfusion SPECT (OPS) and Quantitative Gated SPECT (QGS) into a single application for LV (Left Ventricle) extraction and analysis. AutoQUANT® provides a tool to review and quantify all types of Cardiac SPECT data sets (perfusion and/or gated) to determine the location, orientation, and anatomical extent of the left ventricle of the heart, to construct 3D contour maps of the heart, and to calculate the heart volume (for the left ventricular wall), the lung/heart ratio, and transient ischemic dilation (TID). Physicians use this information to assess the anatomical and physiological functionality of the heart and analyze the presence of myocardial defects through comprehensive imaging modalities.

Also included in AutoQUANT Plus is Quantitative Blood Pool SPECT (QBS). OBS is an interactive standalone software application for the automatic segmentation and quantification of gated short axis blood pool (red blood cells, RBC) SPECT. The application can be used for automatic generation of left and right ventricular endocardial surfaces and valve planes from three-dimensional (3D) gated short axis blood pool images; automatic calculation of left and right ventricular volumes and ejection fractions; calculation and display of polar maps representing wall motion and parametric values (FFH amplitude and phase); two-dimensional (2D) image display using standard American College of Cardiology (ACC) cardiac SPECT conventions; and 3D image display. It also provides the following functionalities: ability to combine isosurfaces extracted from the data with the calculated endocardial surfaces in various ways (endocardial borders displayed as wireframes, shaded surfaces, both, or parametric); ability to map parametric values (First Fourier Harmonic (FFH) amplitude and phase) on the surfaces; ability to display parametric images (FFH amplitude and phase) for gated planar, gated raw projections and gated short axis images; ability to display cine loops of the original images; ability to generate count-based quantitative values using the automatically- and semi automatically-computed surfaces as ROIs and user-selectable thresholds; ability to generate and display phase histograms for FFH phase images and to display the mean and standard deviation of the peaks corresponding to atrial and ventricular voxels. After ventricular segmentation, a phase histogram for each ventricle is also computed and displayed; and ability to display normalized images for all gated images (i.e., images that do not exhibit count drop-off caused by arrhythmia). In addition, QBS supports manual identification of the left-ventricular (LV) region, to separate it from the right ventricle (RV) in cases where the automatic algorithm fails or returns unsatisfactory results; ability to generate filling rates from interpolated time-volume curves; and the ability to rotate, zoom, and cine surfaces.

In addition, an automatic report generation (ARG) feature has been added to AutoQUANT® Plus. This option in AutoOUANT produces consistent PDF (or text) reports based on a series of form elements within AutoQUANT . The tool consists of an additional window within AutoQUANT and does not alter any quantitative values. This is designed to reduce transcription errors and automate workflow. A separate QARG application allows searching and management of the ARG database, which requires all data to be manually entered. There are no algorithmic functions within the ARG/QARG feature.

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#### Technological Comparison: G.

The AutoQUANT®Plus and predicate AutoQUANT®/QBS Software Applications have similar indications for use and utilize the same type of data sets for analysis and calculation of data.

#### Conclusion: H.

11:00 :

AutoQUANT® Plus is substantially equivalent to the following predicate devices, AutoQUANT® (K980715) and QBS (K022428) based on similar intended use and technological comparison.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 5 2004

ADAC Laboratories % Ms. Denise Leung Klinker Reviewer Underwriters Laboratories, Inc. 1655 Scott Boulevard SANTA CLARA CA 95050-4169 Re: K040326 Trade/Device Name: AutoQUANT® Plus Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS

Dated: January 21, 2004 Received: February 10, 2004

Dear Ms. Klinker:

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 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.

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 (OS) 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 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 the 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" (21CFR Part 807.97) you may obtain. 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 yours,

Nancy C. Brogden

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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# INDICATIONS FOR USE STATEMENT

K040326 510 (k) NUMBER (IF KNOWN):

DEVICE NAME:

AutoQUANT® Plus

SPONSOR NAME:

ADAC Laboratories

## INDICATIONS FOR USE:

AutoQUANT® Plus applications are intended to enable an automated display, review, and quantification of Nuclear Medicine Cardiology medical images and datasels. AutoQUANT® Plus may be used in my tiple settings including the hospital, clinic, doctors office, or remotely via dial up. The results provided should be reviewed by qualified healthcare professionals (e.g., radiologists, cardiologists, or general nuclear medicine physicians) trained in the use of medical imaging devices.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

OR

Over-The-Counter-Use (Optional Format 1-2-96)

David A. Legner

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

000013