(71 days)
ADAC CEQUAL, Sopha Sophy NXT
Not Found
No
The summary describes automated image processing and quantification techniques but does not mention AI or ML.
No
The device is a software application for reviewing and quantifying Cardiac SPECT data, providing information for physicians to assess heart functionality and analyze myocardial defects. It aids in diagnosis and assessment, but does not provide treatment or therapy.
Yes
The device processes Cardiac SPECT data to quantify cardiac function, identify defects, and generate various maps (perfusion, wall thickening, wall motion, regional ejection fraction) which physicians use to assess the anatomical and physiological functionality of the heart and analyze the presence of myocardial defects. This directly aids in the diagnosis of heart conditions.
Yes
The device description explicitly states that AutoQUANT, QPS, and QGS are "software applications" designed for the review and quantification of Cardiac SPECT data. There is no mention of accompanying hardware components being part of the device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples (like blood, urine, tissue) to provide information about a patient's health. The description clearly states that this device processes and quantifies Cardiac SPECT data, which are medical images.
- The intended use and device description focus on image processing and analysis of the heart's structure and function based on SPECT scans. This is a form of medical imaging analysis, not laboratory testing of biological specimens.
- There is no mention of analyzing any biological samples.
Therefore, this device falls under the category of medical imaging software, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The AutoQUANT , Quantitative Perfusion SPECT (QPS), and Quantitative Gated SPECT (QGS) applications are intended to enable a fully automated review and quantification of Cardiac SPECT data.
Product codes
90 KPS
Device Description
AutoQUANT is a software application designed to enable a fully automated, comprehensive review and quantification of Cardiac SPECT data within a suite of applications. AutoQUANT can operate as an independent single application or can be integrated into an application containing Quantitative Perfusion SPECT (QPS) and/or Quantitative Gated SPECT (QGS). AutoQUANT provides a tool to review and quantify all types of Cardiac SPECT data sets (perfusion and/or gated) to determine the location, orientation, and anatomical extent of the left ventricle of the heart, to construct 3D contour maps of the heart, and to calculate the heart volume (for the left ventricular wall), the lung/heart ratio, and transient ischemic dilation (TID). Physicians use this information to assess the anatomical and physiological functionality of the heart and analyze the presence of myocardial defects through comprehensive imaging modalities.
Quantitative Perfusion SPECT (QPS) is a software application designed for the review and quantification of myocardial perfusion SPECT short axis data. QPS can operate as an independent single application or as an embedded function packaged with AutoQUANT. Using the QPS application, myocardial rest and stress short axis projections (standard and gated Cardiac SPECT) can be reviewed and compared, the extent and volume of cardiac defects can be calculated, and 3D and 2D perfusion maps can be generated. The QPS application can also be used to create a user-definable Normal database (with definable normal limits) for review, quantification, and comparison.
Quantitative Gated SPECT (QGS) is a software application designed to view and analyze processed SPECT short axis or gated short axis data sets. QGS can operate as an independent single application or as an embedded function packaged with AutoQUANT. Using the QGS application, myocardial gated short axis projections can be reviewed and compared, the extent and severity of cardiac defects can be calculated, and 3D and 2D wall thickening, wall motion and regional ejection fraction maps can be generated. The application can be used to display the left ventricular endocardial and epicardial surfaces; polar maps indicating perfusion, wall thickening, wall motion, and regional ejection fraction: standard cardiac SPECT short axis and horizontal slices; and 3D cardiac surfaces and volumes from gated SPECT data. When using gated SPECT data, the left ventricular volume and left ventricular ejection fraction (LVEF) can be automatically calculated or regions may be manually specified for calculation. When using non-gated short axis SPECT data, the left ventricular volume can be calculated automatically or manually.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Cardiac SPECT data (perfusion and/or gated), myocardial perfusion SPECT short axis data (standard and gated Cardiac SPECT), SPECT short axis or gated short axis data sets.
Anatomical Site
Left ventricle of the heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians
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
Testing was conducted to demonstrate that each software application functioned as per its specifications. All tests passed with the actual results matching the expected results.
Key Metrics
Not Found
Predicate Device(s)
ADAC CEQUAL, Sopha Sophy NXT
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
| AutoQUANT, Quantitative Perfusion SPECT (QPS), & Quantitative Gated SPECT (QGS) |
|---|
| ADAC Laboratories |
| 510(k) Premarket Notification |
| Appendix VIII, 510(k) Summary of Safety and Effectiveness Data |
|---|
| Page 1 of 3 |
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA
- I. General Information
A. Submitted By:
ADAC Laboratories 540 Alder Drive Milpitas, CA 95035 Tel: (408) 321-9100 Fax: (408) 321-9686
Contact Person:
Dennis Henkelman at address above
AutoOUANT Device Trade Name: B. Quantitative Perfusion SPECT (QPS) Quantitative Gated SPECT (QGS) Gamma Camera System Common Name: System, Emission Computed Tomography Classification Name:
| C. Predicate Device: | ADAC CEQUAL®
Sopha Sophy NXT |
| ---------------------- | --------------------------------- |
|---|
Device Description: D.
AutoQUANT is a software application designed to enable a fully automated, comprehensive review and quantification of Cardiac SPECT data within a suite of applications. AutoQUANT can operate as an independent single application or can be integrated into an application containing Quantitative Perfusion SPECT (QPS) and/or Quantitative Gated SPECT (QGS). AutoQUANT provides a tool to review and quantify all types of Cardiac SPECT data sets (perfusion and/or gated) to determine the location, orientation, and anatomical extent of the left ventricle of the heart, to construct 3D contour maps of the heart, and to calculate the heart volume (for the left ventricular wall), the lung/heart ratio, and transient ischemic dilation (TID). Physicians use this information to assess the anatomical and physiological functionality of the heart and analyze the presence of myocardial defects through comprehensive imaging modalities.
1
Quantitative Perfusion SPECT (QPS) is a software application designed for the review and quantification of myocardial perfusion SPECT short axis data. QPS can operate as an independent single application or as an embedded function packaged with AutoQUANT. Using the QPS application, myocardial rest and stress short axis projections (standard and gated Cardiac SPECT) can be reviewed and compared, the extent and volume of cardiac defects can be calculated, and 3D and 2D perfusion maps can be generated. The QPS application can also be used to create a user-definable Normal database (with definable normal limits) for review, quantification, and comparison.
Quantitative Gated SPECT (QGS) is a software application designed to view and analyze processed SPECT short axis or gated short axis data sets. QGS can operate as an independent single application or as an embedded function packaged with AutoQUANT. Using the QGS application, myocardial gated short axis projections can be reviewed and compared, the extent and severity of cardiac defects can be calculated, and 3D and 2D wall thickening, wall motion and regional ejection fraction maps can be generated. The application can be used to display the left ventricular endocardial and epicardial surfaces; polar maps indicating perfusion, wall thickening, wall motion, and regional ejection fraction: standard cardiac SPECT short axis and horizontal slices; and 3D cardiac surfaces and volumes from gated SPECT data. When using gated SPECT data, the left ventricular volume and left ventricular ejection fraction (LVEF) can be automatically calculated or regions may be manually specified for calculation. When using non-gated short axis SPECT data, the left ventricular volume can be calculated automatically or manually.
-
E. Indications for Use:
The AutoQUANT , Quantitative Perfusion SPECT (QPS), and Quantitative Gated SPECT (QGS) applications are intended to enable a fully automated review and quantification of Cardiac SPECT data. -
F. Technological Comparison:
The AutoQUANT, OPS, QGS, ADAC CEQUAL, and Sopha Sophy NXT Cardiac Software applications have similar indications for use and utilize the same type of data sets for analysis and calculation of data. The ADAC QPS, OGS, CEQUAL, and Sophy NXT Cardiac Software perform the same calculations and analyses on the data sets.
2
II. Testing
Testing was conducted to demonstrate that each software application functioned as per its specifications. All tests passed with the actual results matching the expected results.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black and white, and the text is also in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 1998 MAY
Dennis W. Henkelman Director, Regulatory Affairs and Quality Assurance ADAC Laboratories 540 Alder Drive Milpitas, CA 95035
Re:
K980715 AutoQUANT (Gamma Camera System) Dated: February 23, 1998 Received: February 24, 1998 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS
Dear Mr. Henkelman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (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 895. A substantially equivalion 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 concerning your device in the Federal Register. Thease 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsmaldsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: AutoQUANT Quantitative Perfusion SPECT (QPS) Quantitative Gated SPECT (QGS)
ADAC Laboratories Sponsor Name:
Indications for Use
The AutoQUANT, Quantitative Perfusion SPECT (QPS), and Quantitative Gated SPECT (QGS) applications are intended to enable a fully automated review and quantification of Cardiac SPECT data.
Do Not Write Below This Line - Continue on Another Page if Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Over-The-Counter Use
David H. Segerson
(Division Sign-Off)
Division of Reproductive, Abdominal, EN and Radiological Dev 510(k) Number