CARDIUS-1 AND CARDIS-2

K030085 · Digirad Corp. · KPS · Feb 5, 2003 · Radiology

Device Facts

• Record ID: K030085
• Device Name: CARDIUS-1 AND CARDIS-2
• Applicant: Digirad Corp.
• Product Code: KPS · Radiology
• Decision Date: Feb 5, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

The Cardius product models are intended for use in the generation of cardiac studies, including planar and Single Photon Emission Computed Tomography (SPECT) studies, in nuclear medicine applications.

Device Story

Cardius-1 (single-detector) and Cardius-2 (dual-detector) are open-gantry, upright-seated cardiac nuclear imaging systems. Device includes gantry, detectors, acquisition/processing station, and mechanized patient imaging chair for loading and cardiac centering. System performs static, dynamic, and gated/non-gated SPECT (circular orbit) and planar studies. Operated by nuclear medicine personnel in clinical settings. Output consists of cardiac images used by physicians to assess cardiac function and pathology. Benefits include specialized cardiac positioning and imaging capabilities.

Clinical Evidence

Bench testing included hardware, software, and electrical safety verification. Clinical imaging testing performed to compare image quality against predicate devices; results met pre-defined acceptance criteria.

Technological Characteristics

Open-gantry, upright-seated SPECT system. Single-detector (Cardius-1) or dual-detector (Cardius-2) configurations. Includes mechanized patient imaging chair. Supports circular orbit SPECT and planar acquisition. Software-based acquisition and processing station.

Indications for Use

Indicated for patients requiring cardiac nuclear medicine imaging, specifically planar and SPECT studies.

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
• ADAC Forte (cardiac applications only)

Submission Summary (Full Text)

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# APPENDIX 1. 510(k) SUMMARY

A. Sponsor

FEB 0 5 2003

Digirad Corporation 9350 Trade Place San Diego, California 92126-6334 Contact Person: Corey Stewart Tel: [phone] Fax: [phone]

# Date Prepared: 1/06/03 B.

### C. Device Name

Trade Name: Cardius-1, Cardius-2

Classification Name: System, Emission Tomography

#### Device Description D.

The Cardius model cameras are gantry (open gantry, upright seated) devices designed for single- (Cardius-1) or dual-detector (Cardius-2) cardiac nuclear imaging studies. The device includes an acquisition/processing station, a gantry, one or two detectors, and a gantrymounted patient imaging chair. The patient imaging chair is mechanized to accommodate patient loading and cardiac centering in the detector field of view.

The imaging chair motion control allows for acquisition of Cardiac SPECT and planar studies, including static, dynamic, gated/non-gated SPECT (circular orbit only).

#### E. Intended Use

The Cardius-1 and Cardius-2 are intended for use in the generation of cardiac studies, including planar and Single Photon Emission Computed Tomography (SPECT) studies, in nuclear medicine applications.

#### ட். Predicate Device

The Cardius systems are substantially equivalent in design and intended use to the Digirad 2020tc SPECT Imaging System and the ADAC Forte (cardiac applications only).

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# G. Summary of Substantial Equivalence

The Cardius -1 and Cardius- 2 devices are substantially equivalent to the predicate devices in intended use, physical characteristics, performance specifications and safety characteristics.

# H. Testing

Comprehensive verification and validation testing was performed with the Cardius-1 and Cardius-2 devices including; hardware, software, electrical safety, and clinical imaging All test results met pre-defined acceptance criteria. The quality of the clinical images produced were similar to the quality of the images produced by the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure, with three profiles overlapping to create a sense of depth and community.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Corey Stewart Ouality Assurance Manager

Re: K030085

FEB 0 5 2003

Trade/Device Name: Cardius-1 and Cardius-2 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: January 7, 2003 Received: January 9, 2003

Dear Mr. Stewart:

Digirad Corporation

SAN DIEGO CA 92126-6334

9350 Trade Place

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 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

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. Brogdon

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

Enclosure

Page 2

to proceed to the market.

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# APPENDIX 2. INDICATION FOR USE STATEMENT

510(k) Number (if known): K 030085

Device Name:

Cardius-1, Cardius-2

Indications for Use:

The Cardius product models are intended for use in the generation of cardiac studies, including planar and Single Photon Emission Computed Tomography (SPECT) studies, in nuclear medicine applications.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR Over-the-Counter Use

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K030085