(25 days)
Not Found
No
The summary describes an updated version of OSEM reconstruction software, which is a standard iterative image reconstruction technique in SPECT imaging and does not inherently involve AI/ML. There is no mention of AI, ML, or related terms in the document.
No.
The device is described as an "Imaging System" intended for generating "cardiac studies" and "clinical images" by depicting the "anatomical distribution of radioisotopes within the human body for interpretation by authorized medical personnel." This indicates a diagnostic rather than a therapeutic purpose.
Yes
The device is intended for use in the generation of cardiac studies, including planar and SPECT studies, which produce images depicting the anatomical distribution of radioisotopes for interpretation by authorized medical personnel. This process generates information that aids in diagnosing medical conditions.
No
The device description explicitly states the change involves an updated version of reconstruction software to process studies acquired with imaging systems (Cardius and 2020tc SPECT Imaging Systems), which are hardware devices. The software is a component of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for generating cardiac studies (planar and SPECT) in nuclear medicine applications by imaging the distribution of radionuclides in the body. This involves imaging the patient directly, not analyzing samples taken from the body.
- Device Description: The description focuses on the imaging system and software for processing images acquired from the patient.
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. This device does not perform such tests.
The device is a medical imaging system used for in-vivo (within the living body) imaging.
N/A
Intended Use / Indications for Use
Cardius-1, Cardius-2, Cardius-3, Cardius 1 XPO, Cardius 3 XPO, Cardius 3 XPO Imaging Systems:
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.
Product codes (comma separated list FDA assigned to the subject device)
KPS
Device Description
The proposed change involves an updated version of nSPEED™ (3D-OSEM) reconstruction software to process cardiac SPECT studies acquired with non-parallel hole collimators, using half time and/or half count densities. With the updated software, cardiac SPECT studies acquired with both parallel hole and non-parallel hole collimators, using half time and/or half count densities, can be processed.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Single Photon Emission Computed Tomography (SPECT)
Anatomical Site
cardiac; human body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
authorized medical personnel
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
Digirad testing performed with cardiac phantom images and via a multicenter evaluation with data from over 450 patient images acquired with parallel hole and non-parallel hole collimators using Digirad imaging systems.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Digirad testing showed that preferred time and/or count data processed with previously cleared 2D-OSEM reconstruction technique and half time and/or half count density data processed with nSPEED®™ produce equivalent image quality and very good quantitative correlation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K982855, K030085, K051549, K052430, K070542
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K08 2368
SEP 1 2 2008
Appendix 2: 510(k) Summary
Sponsor A.
Digirad Corporation 13950 Stowe Drive Poway, California 92064 Contact Person: Joel Tuckey Tel: (858) 726-1527 Fax: (858) 726-1700
B. Date Prepared: August 15, 2008
C. Device Name
Trade Name: Cardius-1, Cardius-2, Cardius-3. Cardius 1 XPO, Cardius 2 XPO, Cardius 3 XPO, and 2020tc SPECT Imaging System Classification Name: System, Emission Tomography
D. Description of Changes
The proposed change involves an updated version of nSPEED™ (3D-OSEM) reconstruction software to process cardiac SPECT studies acquired with non-parallel hole collimators, using half time and/or half count densities. With the updated software, cardiac SPECT studies acquired with both parallel hole and non-parallel hole collimators, using half time and/or half count densities, can be processed.
E. Intended Use
The intended uses of the Cardius series and 2020tc cameras have not changed, and are summarized in the "Indications for Use" form included with this submission.
F. Cleared/Predicate Device
The proposed change is a modification to the following Digirad cleared devices:
- (1) 2020tc SPECT Imaging System and the SPECTour Chair (SPECT Imaging System), cleared on November 9, 1998 under 510(k) #K982855; and
- (2) Cardius-1 and Cardius-2 SPECT Imaging System cleared on February 5, 2003 under 510(k) #K030085.
- (3) Cardius-1, Cardius-2, Cardius-3, and 2020tc SPECT Imaging Systems cleared on July 13, 2005 under 510(k) #K051549
- (4) Cardius-1, Cardius-2, Cardius-3, and 2020tc SPECT Imaging Systems cleared on October 4, 2005 under 510(k) #K052430
- Cardius 1 XPO, Cardius 2 XPO, Cardius 3 XPO, and 2020tc SPECT Imaging (5) Systems cleared on March 23, 2007 under 510(k) #K070542
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G. Conclusions Drawn from Testing
Digirad testing performed with cardiac phantom images and via a multicenter evaluation with data from over 450 patient images acquired with parallel hole and non-parallel hole collimators using Digirad imaging systems show that preferred* time and/or count data processed with previously cleared 2D-OSEM reconstruction technique and half time and/or half count density data processed with nSPEED®™ produce equivalent image quality and very good quantitative correlation.
*Preferred time and count refers to times per stop and count density published in the ASNC 2008 Imaging Guidelines.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 2 2008
Mr. Joel Tuckey Vice President Quality Digirad Corporation 13950 Stowc Drive POWAY CA 92064-8803
Re: K082368
Trade/Device Name: Cardius-1, Cardius-2, Cardius-3, Cardius 1 XPO, Cardius 2 XPO, Cardius 3 XPO, and 2020tc SPECT Imaging Systems Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: August 15, 2008 Received: August 18, 2008
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 (PMA), 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.
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Page 2
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 to proceed to the market.
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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jaque In Whang
Joyce M. Whang, Ph.D. Acting 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): TBD Device Name: Cardius-1, Cardius-2, Cardius-3, Cardius 1 XPO, Cardius 2 XPO, Cardius 3 XPO, and 2020tc SPECT Imaging Systems
Indications for Use:
Cardius-1, Cardius-2, Cardius-3, Cardius 1 XPO, Cardius 3 XPO, Cardius 3 XPO Imaging Systems:
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.
Prescription Use _ V _________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR Over-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 Devic
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K082368
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