(12 days)
Not Found
No
The description focuses on automatic generation and calculation based on image processing techniques, without mentioning AI or ML algorithms.
No.
The device is a software application for the display and analysis of medical images and does not provide any therapeutic function.
Yes
The device is described as a software application that provides "analysis of gated short axis blood pool (red blood cells, RBC) SPECT datasets," and facilitates "Automatic calculation of left and right ventricular volumes and ejection fractions," with results to be "reviewed by qualified healthcare professionals." These functions directly support the interpretation of medical images to identify health conditions, which is characteristic of a diagnostic device.
Yes
The device is explicitly described as a "standalone software application" and its functionality is solely related to the display and analysis of existing SPECT datasets. There is no mention of accompanying hardware or control of hardware.
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) outside the body to provide information about a patient's health. This device analyzes medical images (SPECT scans) of the blood pool within the body.
- The intended use and device description clearly state that it processes and analyzes SPECT image data. It calculates volumes, ejection fractions, and displays images, all based on the visual information from the scan.
- There is no mention of analyzing any biological samples.
Therefore, this device falls under the category of medical imaging software or image processing software, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Quantitative Blood Pool SPECT (QBS) is a standalone software application for the display and analysis of gated short axis blood pool (red blood cells, RBC) SPECT datasets. The results provided by QBS should be reviewed by qualified healthcare professionals (e.g., radiologists, cardiologists, or general nuclear medicine physicians) trained in the use of medical imaging devices.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
Quantitative Blood Pool SPECT (QBS) is a standalone software application for the display and analysis of gated short axis blood pool (red blood cells, RBC) SPECT datasets. The results provided by QBS should be reviewed by qualified healthcare professionals (e.g., radiologists, cardiologists, or general nuclear medicine physicians) trained in the use of medical imaging devices. QBS provides the following functionality:
- Automatic generation of left and right ventricular endocardial surfaces and valve planes from three-dimensional (3D) gated short axis blood pool images.
- Automatic calculation of left and right ventricular volumes and ejection fractions.
- Two-dimensional (2D) image display using standard American College of Cardiology (ACC) cardiac SPECT conventions.
- 3D image display. Ability to combine isosurfaces extracted from the data with the calculated endocardial surfaces in various ways (endocardial borders displayed as wireframes, shaded surfaces or both).
- Ability to support manual identification of the left-ventricular (LV) region, to separate it from the right ventricle (RV) in cases where the automatic algorithm fails or returns unsatisfactory results.
- Ability to rotate, zoom and cine surfaces.
- Calculation and display of polar maps representing wall motion.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
SPECT
Anatomical Site
Blood pool (specifically left and right ventricles)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified healthcare professionals (e.g., radiologists, cardiologists, or general nuclear medicine physicians) trained in the use of medical imaging devices.
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)
Not Found
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
CONFIDENTIAL
ADMINISTRATIVE INFORMATION
AUG 0 6 2002
622412
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS I.
- ADAC Laboratories Submitted By: A. 540 Alder Drive Milpitas, California 95035
(408) 468-3051 Tel: Fax: (408) 468-3050
Coleen Coleman At address above
Contact Person:
- Quantitative Blood Pool SPECT (QBS) B. Device Trade Name: Nuclear Medicine Software Application Common Name: Image Processing System Classification Name: (Computer)
- C. Predicate Device(s):
| Manufacturer | Product Name | 510(k) No. |
|---|---|---|
| ELGEMS Ltd. | QPS/BPGS/MoCo Processing | |
| Applications for eNTEGRA™ | ||
| Workstation | K003264 |
-
D. Device Description:
Ouantitative Blood Pool SPECT (OBS) is a standalone software application for the display and analysis of gated short axis blood pool (red blood cells, RBC) SPECT datasets. The results provided by QBS should be reviewed by qualified healthcare professionals (e.g., radiologists, cardiologists, or general nuclear medicine physicians) trained in the use of medical imaging devices. QBS provides the following functionality: -
. Automatic generation of left and right ventricular endocardial surfaces and valve planes from three-dimensional (3D) gated short axis blood pool images.
-
. Automatic calculation of left and right ventricular volumes and ejection fractions.
-
Two-dimensional (2D) image display using standard American . College of Cardiology (ACC) cardiac SPECT conventions.
1
- 3D image display. Ability to combine isosurfaces extracted from the . data with the calculated endocardial surfaces in various ways (endocardial borders displayed as wireframes, shaded surfaces or both).
- Ability to support manual identification of the left-ventricular (LV) . region, to separate it from the right ventricle (RV) in cases where the automatic algorithm fails or returns unsatisfactory results.
- Ability to rotate, zoom and cine surfaces. ●
- Calculation and display of polar maps representing wall motion. .
- E. Indications for Use:
Ouantitative Blood Pool SPECT (QBS) is a standalone software application for the display and analysis of gated short axis blood pool (red blood cells, RBC) SPECT datasets. The results provided by QBS should be reviewed by qualified healthcare professionals (e.g., radiologists, cardiologists, or general nuclear medicine physicians) trained in the use of medical imaging devices.
- F. Technological Comparison:
The Quantitative Blood Pool SPECT (QBS) and the QPS/BPGS/MoCo Processing Applications for eNTEGRA Workstation (K003264) have similar indications for use and overall function and perform in a similar manner with respect to data display and analysis.
II. CONCLUSIONS
QBS is substantially equivalent to BPGS contained in the ELGEMS Ltd. OPS/BPGS/MoCo Processing Applications (K003264) previously cleared by FDA. OBS™ and BPGS (K003264) have the same indications for use and overall function and perform in a similar manner with respect to processing and display of short axis Blood Pool Gated SPECT imaging.
BPGS software application contained in the predicate device (K003264) is similar to the ADAC Quantitative Blood Pool SPECT (QBS). BPGS (K003264) and QBS both have automatic calculation of left and right ventricular volumes and ejection fractions, provide (3D) models, and have calculation and display of polar maps. QBS has similar indications for use and overall function and perform in a similar manner with respect to data display and analysis as the predicate device BPGS (K003264). Therefore, this premarket notification has demonstrated substantial equivalence as defined and understood in the Federal Food, Drug, & Cosmetic Act and its amendments.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The seal is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 0 6 2002
ADAC Laboratories % Michael Kwan, Ph.D. Office Coordinator Underwriters Laboratories, Inc. 1655 Scott Boulevard SANTA CLARA CA 95050-4169 Re: K022428
Trade/Device Name: Quantitative Blood Pool SPECT (OBS) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II
Product Code: 90 LLZ Dated: July 24, 2002 Received: July 25, 2002
Dear Dr. Kwan:
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 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:
| 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" (21 CFR Part 807.97). 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
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
Quantitative Blood Pool SPECT (QBS)
Sponsor Name:
ADAC Laboratories
Indications for Use:
Quantitative Blood Pool SPECT (QBS) is a standalone software application for the display and analysis of gated short axis blood pool (red blood cells, RBC) SPECT datasets. The results provided by QBS should be reviewed by qualified healthcare professionals (e.g., radiologists, cardiologists, or general nuclear medicine physicians) trained in the use of medical imaging devices.
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
(Division Sign-Off)
Division of Reproductive, Abdominal
and Radiological Devices
510(k) Number K022428
000012