(30 days)
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.
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.
The provided text describes modifications to the software of existing SPECT imaging systems (Cardius and 2020tc cameras). The primary change involved adding a Camera Center-of-Rotation (COR) quantitative check and minor user interface adjustments. The core functionality and intended use of the devices remained unchanged.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pre-defined acceptance criteria for software test results | All software test results met pre-defined acceptance criteria. |
| Quality of clinical images with modified software | The quality of the clinical images produced with the modified software was similar to the quality of the images produced with the unmodified software. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "clinical imaging with modified and unmodified software." However, it does not specify the sample size used for this clinical imaging (the test set) or the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth, as it focuses on software verification and clinical image quality comparison.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method. It implies a comparison of image quality, but the process of this comparison (e.g., blinded review, consensus) is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done or reported. The study focused on demonstrating that the revised software did not degrade image quality or system performance compared to the previous version. It does not assess human reader improvement with AI assistance, as the changes are to the acquisition software, not an AI-assisted interpretation tool.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done
The primary change was the addition of a "Camera Center-of-Rotation (COR) quantitative check" and minor UI changes. This appears to be an internal technical algorithm within the acquisition software, not an independently evaluated "standalone" diagnostic algorithm. The testing described is more aligned with software verification and validation, ensuring the system's technical function, rather than diagnostic accuracy as a standalone AI. So, based on the information provided, a standalone study in the context of diagnostic AI performance was not done or reported.
7. The Type of Ground Truth Used
The most relevant "ground truth" implicitly used in this context would be the performance of the unmodified software/system as the benchmark for comparison. The goal was to demonstrate that the modified software produced "similar" quality images and met pre-defined technical acceptance criteria. There's no mention of external clinical ground truth like pathology or patient outcomes.
8. The Sample Size for the Training Set
This document describes software updates to an existing medical imaging system. It does not mention a training set in the context of machine learning. The changes are to data acquisition software, not an AI model that would typically require a training set.
9. How the Ground Truth for the Training Set was Established
As no training set is mentioned (see point 8), the method for establishing its ground truth is not applicable.
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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: (858) 726-1527 Fax: (858) 726-1700
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 (800) 638-2041 or (301) 443-6597 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
Pagc 1 of 1
§ 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.