QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS)

K011572 · Digirad Corp. · KPS · Jun 15, 2001 · Radiology

Device Facts

• Record ID: K011572
• Device Name: QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS)
• Applicant: Digirad Corp.
• Product Code: KPS · Radiology
• Decision Date: Jun 15, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Quantitative Gated SPECT (QGS) and Quantitative Perfusion SPECT (QPS) programs are intended for use in the display and quantification of myocardial perfusion and functional parameters from cardiac SPECT data.

Device Story

QGS/QPS are standalone software applications for cardiac SPECT data analysis. Input: reconstructed tomographic slices of left ventricle from gated/non-gated cardiac SPECT studies. Operation: software processes slices to generate quantitative metrics and visual maps. QPS quantifies myocardial perfusion (defect extent/severity) using gender/isotope-specific normal limits; generates 2D/3D perfusion maps. QGS quantifies myocardial function (global/regional ejection fraction, wall thickening, left ventricular volume at end-diastole/end-systole); generates 2D/3D perfusion/thickening images. Used in clinical settings by healthcare providers to visualize cardiac data and assess myocardial health. Output: quantitative reports and 2D/3D images assist clinicians in evaluating perfusion defects and cardiac function, supporting diagnostic decision-making.

Clinical Evidence

Clinical validation conducted by Cedars-Sinai Medical Center; published in Journal of Nuclear Medicine, Vol. 41, No. 4, April 2000. Functionality tests confirmed software performance against specifications using standard Cedars-Sinai test cases.

Technological Characteristics

Standalone software applications; PC architecture; Microsoft Windows OS; third-party X-server software. Algorithms perform automated quantification of myocardial perfusion and function from SPECT tomographic slices.

Indications for Use

Indicated for display and quantification of myocardial perfusion and functional parameters from cardiac SPECT data in patients undergoing cardiac SPECT imaging.

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

• Digirad 2020tc SPECT Imaging System (K982855)
• QGS and QPS (SMV America) (K003358)

Submission Summary (Full Text)

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Digirad Corporation, Traditional [510(k)] Submission Digirad Corporation, Traditional [570(IS)] Buchasitative Perfusion SPEC

# Appendix F. 510(k) Summary

JUN 1 5 2001

#### 510(k) Summary 00

- 8.1 Identification:
- 8.1.1 Date of Application: May 18, 2001

## 8.1.2 Applicant's and Name and Address:

Corey Stewart Quality Control Manager Digirad Corporation 9350 Trade Place San Diego, CA 92126

# 8.1.3 Telephone and Fax Numbers of the Applicant

Telephone: (858) 537 - 2118 Fax: (858) 549 - 9789 Email: [e-mail]

- 8.1.4 Signature
Signature
Cory Stewart

Date 5/18/01

- 8.2 Device name and classification
- 8.2.1 Classification Code: 90 KPS
- 8.2.2 Panel Identification: Radiology
- 8.2.3 Proprietary Name: Quantitative Gated SPECT (QGS) Quantitative Perfusion SPECT (QPS)

RA

SK4G

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Digirad Corporation, Traditional [510(k)] Submission QGS (Quantitative Gated SPECT) and QPS (Quantitative Perfusion SPECT)

#### 8.2.4 Common Name:

Gamma Camera System

#### 8.2.5 Classification Name:

System. Emission Computed Tomography

#### 8.2.6 Classification Class:

Class II Product

#### 8.2.7 Substantial Equivalence

The proposed device and the predicate devices have the same indication for use and functionalities. The QGS and OPS proposed is the same application as the QGS and QPS sponsored by SMV America. The QGS and QPS proposed shall be analyzing the same data as the existing Digirad 2020tc SPECT Imaging System.

| Table 8.1 | Predicate devices | |
|-----------|-------------------|--|
|-----------|-------------------|--|

| | Existing Digirad<br>2020tc SPECT<br>Imaging System | QGS/QPS<br>Sponsor: SMV<br>America |
|------------------|----------------------------------------------------|------------------------------------|
| Product Code | 90 KPS | 90 KPS |
| 510(k)<br>Number | K982855 | K003358 |

#### 8.2.8 Device Description

The OGS/OPS programs are independent. standalone software applications developed by Cedars-Sinai Medical Center for the display and quantification of cardiac SPECT data. The programs will run on the computer systems with a PC architecture, the Microsoft® Windows® operating systems and a third party X-server software.

The QGS/QPS programs take reconstructed tomographic slices of the left ventricle generated from gated and/or non-gated cardiac SPECT studies and display the images along with automatically generated quantification.

QPS analyzes myocardial perfusion by quantifying defect extent and severity using gender and isotope-specific normal limits. 2D and 3D perfusion maps are automatically generated.

QGS analyzes myocardial function by quantifying global and regional ejection fraction, wall thickening, and left ventricular volume at end-diastole and end-systole. 2D and 3D images of perfusion and thickening are generated.

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#### 8.2.9 Intended Use

The Quantitative Gated SPECT (QGS) and Quantitative Perfusion SPECT (QPS) programs are intended for use in the display and quantification of myocardial perfusion and functional parameters from cardiac SPECT data.

### 8.2.10 Testing

Functionality tests were conducted to demonstrate that each software application functioned as per its specifications. Computer platform test was performed by running QGS and QPS programs on computer systems with proposed platform using a standard Cedars-Sinai test case. The test passed with the actual results matching the Cedars-Sinai results.

Clinical validation on QGS and OPS programs has been conducted by Cedars-Sinai Medical Center and published in the Journal of Nuclear Medicine, Vol. 41, No.4, April 2000.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like strokes. The bird is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 5 2001

Corey Stewart Quality Control Manager DIGIRAD Corporation 9350 Trade Place San Diego, CA 92126-6334 Re: K011572

QGS (Quantitative Gated SPECT) and QPS (Quantitative Perfusion SPECT) Dated: May 18, 2001 Received: May 21, 2001 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS

Dear Mr. Stewart:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the We'ne 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). 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 (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, to sadel additional controlly equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements to compry with the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding r mi reter will and really 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 807.97). Other general information on your chance, "Misolanding of received from the Division of Small Manufacturers 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 (s)

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## APPENDIX G. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K_011572

Device Name:

QGS (Quantitative Gated SPECT) and QPS (Quantitative Perfusion SPECT)

Indications For Use:

The Quantitative Gated SPECT (QGS) and Quantitative Perfusion SPECT (QPS) programs are intended for use in the display and quantification of myocardial perfusion and functional parameters from cardiac SPECT data.

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Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, Prescription Use and Radiological Devices 510(k) Number