(25 days)
Not Found
No
The summary describes automated quantification and analysis based on predefined algorithms and normal limits, without mentioning AI or ML techniques. The validation studies are based on functionality tests and clinical validation from 2000, which predates the widespread use of AI/ML in medical imaging.
No
The device is a software application intended for the display and quantification of myocardial perfusion and functional parameters from cardiac SPECT data, which is for diagnostic purposes, not therapeutic intervention.
Yes
The device aids in the quantification of myocardial perfusion and functional parameters, which are used to display and assess the condition of the heart, indicating a diagnostic purpose.
Yes
The device description explicitly states that the QGS/QPS programs are "independent, standalone software applications" and describes their function as processing and displaying data from cardiac SPECT studies on standard computer systems. There is no mention of accompanying hardware developed or included with the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine things outside the living body.
- Device Function: The QGS/QPS programs analyze and quantify data from cardiac SPECT studies. SPECT (Single-Photon Emission Computed Tomography) is an in vivo imaging technique where a radioactive tracer is injected into the patient, and the device detects the emitted radiation from within the body.
- Input Data: The input data is reconstructed tomographic slices from cardiac SPECT studies, which are images derived from the in vivo distribution of a tracer.
Therefore, since the device processes data from an in vivo imaging modality (SPECT) and does not analyze samples taken from the body, it does not fit the definition of an In Vitro Diagnostic device. It is a medical image analysis software.
N/A
Intended Use / Indications for Use
The Quantitative Gated SPECT (QGS) and Quantitative Perfusion SPECT (QPS) programs are intended for use in the display and quantification of myocardial perfusion and functional parameters from cardiac SPECT data.
Product codes (comma separated list FDA assigned to the subject device)
90 KPS
Device Description
The OGS/OPS programs are independent. standalone software applications developed by Cedars-Sinai Medical Center for the display and quantification of cardiac SPECT data. The programs will run on the computer systems with a PC architecture, the Microsoft® Windows® operating systems and a third party X-server software.
The QGS/QPS programs take reconstructed tomographic slices of the left ventricle generated from gated and/or non-gated cardiac SPECT studies and display the images along with automatically generated quantification.
QPS analyzes myocardial perfusion by quantifying defect extent and severity using gender and isotope-specific normal limits. 2D and 3D perfusion maps are automatically generated.
QGS analyzes myocardial function by quantifying global and regional ejection fraction, wall thickening, and left ventricular volume at end-diastole and end-systole. 2D and 3D images of perfusion and thickening are generated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
SPECT
Anatomical Site
myocardial / cardiac / left ventricle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Functionality tests were conducted to demonstrate that each software application functioned as per its specifications. Computer platform test was performed by running QGS and QPS programs on computer systems with proposed platform using a standard Cedars-Sinai test case. The test passed with the actual results matching the Cedars-Sinai results.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical validation on QGS and OPS programs has been conducted by Cedars-Sinai Medical Center and published in the Journal of Nuclear Medicine, Vol. 41, No.4, April 2000.
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.
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
Digirad Corporation, Traditional [510(k)] Submission Digirad Corporation, Traditional [570(IS)] Buchasitative Perfusion SPEC
Appendix F. 510(k) Summary
JUN 1 5 2001
510(k) Summary 00
- 8.1 Identification:
- 8.1.1 Date of Application: May 18, 2001
8.1.2 Applicant's and Name and Address:
Corey Stewart Quality Control Manager Digirad Corporation 9350 Trade Place San Diego, CA 92126
8.1.3 Telephone and Fax Numbers of the Applicant
Telephone: (858) 537 - 2118 Fax: (858) 549 - 9789 Email: cstewart@digirad.com
- 8.1.4 Signature
Signature
Cory Stewart
Date 5/18/01
- 8.2 Device name and classification
- 8.2.1 Classification Code: 90 KPS
- 8.2.2 Panel Identification: Radiology
- 8.2.3 Proprietary Name: Quantitative Gated SPECT (QGS) Quantitative Perfusion SPECT (QPS)
RA
SK4G
1
Digirad Corporation, Traditional [510(k)] Submission QGS (Quantitative Gated SPECT) and QPS (Quantitative Perfusion SPECT)
8.2.4 Common Name:
Gamma Camera System
8.2.5 Classification Name:
System. Emission Computed Tomography
8.2.6 Classification Class:
Class II Product
8.2.7 Substantial Equivalence
The proposed device and the predicate devices have the same indication for use and functionalities. The QGS and OPS proposed is the same application as the QGS and QPS sponsored by SMV America. The QGS and QPS proposed shall be analyzing the same data as the existing Digirad 2020tc SPECT Imaging System.
| Table 8.1 | Predicate devices | |
|---|---|---|
| ----------- | ------------------- | -- |
| | Existing Digirad
2020tc SPECT
Imaging System | QGS/QPS
Sponsor: SMV
America |
|------------------|----------------------------------------------------|------------------------------------|
| Product Code | 90 KPS | 90 KPS |
| 510(k)
Number | K982855 | K003358 |
8.2.8 Device Description
The OGS/OPS programs are independent. standalone software applications developed by Cedars-Sinai Medical Center for the display and quantification of cardiac SPECT data. The programs will run on the computer systems with a PC architecture, the Microsoft® Windows® operating systems and a third party X-server software.
The QGS/QPS programs take reconstructed tomographic slices of the left ventricle generated from gated and/or non-gated cardiac SPECT studies and display the images along with automatically generated quantification.
QPS analyzes myocardial perfusion by quantifying defect extent and severity using gender and isotope-specific normal limits. 2D and 3D perfusion maps are automatically generated.
QGS analyzes myocardial function by quantifying global and regional ejection fraction, wall thickening, and left ventricular volume at end-diastole and end-systole. 2D and 3D images of perfusion and thickening are generated.
2
8.2.9 Intended Use
The Quantitative Gated SPECT (QGS) and Quantitative Perfusion SPECT (QPS) programs are intended for use in the display and quantification of myocardial perfusion and functional parameters from cardiac SPECT data.
8.2.10 Testing
Functionality tests were conducted to demonstrate that each software application functioned as per its specifications. Computer platform test was performed by running QGS and QPS programs on computer systems with proposed platform using a standard Cedars-Sinai test case. The test passed with the actual results matching the Cedars-Sinai results.
Clinical validation on QGS and OPS programs has been conducted by Cedars-Sinai Medical Center and published in the Journal of Nuclear Medicine, Vol. 41, No.4, April 2000.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like strokes. The bird is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 5 2001
Corey Stewart Quality Control Manager DIGIRAD Corporation 9350 Trade Place San Diego, CA 92126-6334 Re: K011572
QGS (Quantitative Gated SPECT) and QPS (Quantitative Perfusion SPECT) Dated: May 18, 2001 Received: May 21, 2001 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS
Dear Mr. Stewart:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the We'ne 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). 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 (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, to sadel additional controlly equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements to compry with the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding r mi reter will and really 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. 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 807.97). Other general information on your chance, "Misolanding of received from the Division of Small Manufacturers 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 vours.
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 (s)
4
APPENDIX G. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K_011572
Device Name:
QGS (Quantitative Gated SPECT) and QPS (Quantitative Perfusion SPECT)
Indications For Use:
The Quantitative Gated SPECT (QGS) and Quantitative Perfusion SPECT (QPS) programs are intended for use in the display and quantification of myocardial perfusion and functional parameters from cardiac SPECT data.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, Prescription Use and Radiological Devices 510(k) Number