CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM

K051549 · Digirad Corp. · KPS · Jul 13, 2005 · Radiology

Device Facts

• Record ID: K051549
• Device Name: CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM
• Applicant: Digirad Corp.
• Product Code: KPS · Radiology
• Decision Date: Jul 13, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

Cardius-1, Cardius-2, Cardius-3: 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. 2020tc SPECT Imaging System: The Digirad 2020tc SPECT Imaging system is intended for use in the generation of both planar and Single Photon Emission Computed Tomography (SPECT) clinical images in nuclear medicine applications. The Digirad SPECT Rotating Chair is used in conjunction with the Digirad 2020tc Imager™ to obtain SPECT images in patients who are seated in an upright position. Specifically, the 2020tc Imager™ is intended to image the distribution of radionuclides in the body by means of a photon radiation detector. In so doing, the system produces images depicting the anatomical distribution of radioisotopes within the human body for interpretation by authorized medical personnel.

Device Story

Cardius and 2020tc SPECT imaging systems; used in nuclear medicine for cardiac studies; planar and SPECT imaging. Device captures radionuclide distribution via photon radiation detector; produces images for interpretation by authorized medical personnel. Modifications include addition of Camera Center-of-Rotation (COR) quantitative check in data acquisition software and minor user interface updates. No hardware changes. Used in clinical settings; operated by trained medical staff. Output assists clinicians in diagnostic assessment of cardiac function and anatomy.

Clinical Evidence

Bench testing included comprehensive software verification and validation. Clinical imaging studies performed with modified and unmodified software confirmed that clinical image quality remained similar. All test results met pre-defined acceptance criteria.

Technological Characteristics

Solid-state SPECT imaging system. Software-based data acquisition with integrated Center-of-Rotation (COR) quantitative check. No hardware changes from predicate. Operates as a photon radiation detector for radionuclide imaging.

Indications for Use

Indicated for patients requiring nuclear medicine imaging, specifically planar and SPECT cardiac studies, to visualize the anatomical distribution of radioisotopes within the body.

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

• 2020tc SPECT Imaging System and the SPECTtour Chair (K982855)
• Cardius-1 and Cardius-2 SPECT Imaging System (K030085)

Submission Summary (Full Text)

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### Appendix 1: 510(k) Summary

Image /page/0/Picture/1 description: The image shows the word "K051549" in a handwritten style at the top. Below that is the logo for DIGIRAD, with the tagline "Leaders in Solid-State Imaging." The DIGIRAD logo includes a geometric design on the left side.

## A. Sponsor

Digirad Corporation 13950 Stowe Drive Poway, California 92064 Contact Person: Joel Tuckey Tel: [phone] Fax: [phone]

JUL 1 3 2005

#### Date Prepared: June 8, 2005 B.

#### C. Device Name

Trade Name: Cardius-1, Cardius-2, Cardius-3, 2020tc SPECT Imaging System Classification Name: System, Emission Tomography

#### D. Description of Changes

The changes to the Cardius and 2020tc cameras involve modifications to the data acquisition software used on the gamma cameras. The primary change to the data acquisition software involves the addition of a Camera Center-of-Rotation (COR) quantitative check. Additional minor changes were made to the User Interface screen. There were no hardware changes to the cameras.

#### ui Intended Use

The intended uses of the Cardius and 2020tc cameras have not changed. They are intended for use in the generation of cardiac studies, including planar and Single Photon Emission Computed Tomography (SPECT) studies, in nuclear medicine applications.

#### F. Cleared/Predicate Device

The proposed device bundle is substantially equivalent to the following cleared/predicate devices:

2020tc SPECT Imaging System and the SPECTtour Chair (SPECT Imaging System), (1) cleared on November 9, 1998 under 510(k) #K982855; and

Cardius-1 and Cardius-2 SPECT Imaging System, cleared on February 5, 2003 under (2) 510(k) #K030085.

#### G. Conclusions Drawn from Testing

Testing was performed with the Cardius and 2020tc cameras to demonstrate that the design outputs met the design inputs of the proposed acquisition software changes. Testing included comprehensive software verification and validation studies in addition to clinical imaging with modified and unmodified software. All software test results met pre-defined acceptance criteria. The quality of the clinical images produced with the modified software was similar to the quality of the images produced with the unmodified software.

13950 Stowe Drive t 858.726.1600 Poway, CA 92064-8803

f 858.726.1700 www.digirad.com

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 3 2005

Mr. Joel Tuckey Vice President Quality Digirad Corporation 13950 Stowe Drive POWAY CA 92064-8803 Re: K051549

Trade/Device Name: Cardius-1, Cardius-2, Cardius-3, 2020tc SPECT Imaging System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS

Dated: June 8, 2005 Received: June 13, 2005

Dear Mr. Tuckey:

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 (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, 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) I ms letter will anow you to ough tinding of substantial equivalence of your device to a legally prematics notification: "The station 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 If you dosire sportio as no of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Atoo, promother general information on your responsibilities under the Act from the 001:577: " Connell Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Nancy C. Hogdon

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 510(k) Number (if known): K051549 Device Name: Cardius-1, Cardius-2, Cardius-3, 2020tc SPECT Imaging System

Indications for Use:

Cardius-1, Cardius-2, Cardius-3:

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.

2020tc SPE.CT Imaging System:

The Digirad 2020tc SPECT Imaging system is intended for use in the generation of both planar and Single Photon Emission Computed Tomography (SPECT) clinical images in nuc ear medicine applications. The Digirad SPECT Rotating Chair is used in conjunction with the Digirad 2020tc Imager™ to obtain SPECT images in patients who are seated in an upright position.

Specifically, the 2020te Imager™ is intended to image the distribution of radionuclides in the body by means of a photon radiation detector. In so doing, the system produces images depicting the anatomical distribution of radioisotopes within the human body for interpretation by authorized medical personnel.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Civer-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C bradon

Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
\$104her K051549

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