(27 days)
Digirad 2020tc SPECT Imaging System, ADAC Forte
Not Found
No
The summary describes a standard nuclear imaging system with image acquisition and processing capabilities, but there is no mention of AI, ML, or related technologies.
No
The device is described as an imaging system used to generate cardiac studies, not to treat or cure a disease or condition.
Yes
The device is intended for "generation of cardiac studies, including planar and Single Photon Emission Computed Tomography (SPECT) studies," which are performed for diagnostic purposes in nuclear medicine. Its function is to "acquire" images for these studies, indicating it's used to gather information for diagnosis.
No
The device description explicitly states it includes hardware components such as a gantry, detectors, and a patient imaging chair, in addition to the acquisition/processing station. The performance studies also mention hardware verification and validation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Cardius Function: The Cardius device is an imaging system that uses nuclear medicine techniques (SPECT and planar imaging) to visualize the heart within the patient's body. It does not analyze samples taken from the patient.
The description clearly states its purpose is to generate cardiac studies using imaging modalities, not to perform laboratory tests on biological specimens.
N/A
Intended Use / Indications for 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.
Product codes
90 KPS
Device Description
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).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Single Photon Emission Computed Tomography (SPECT)
Anatomical Site
Cardiac
Indicated Patient Age Range
Not Found
Intended User / Care Setting
nuclear medicine applications
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Digirad 2020tc SPECT Imaging System, ADAC Forte
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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: (858) 537-2118 Fax: (858) 549-9789
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).
1
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.
2
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.
3
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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.
4
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