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.

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.
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. .

AI/ML Overview

The provided text describes a 510(k) summary for the Quantitative Blood Pool SPECT (QBS) device. It asserts substantial equivalence to a predicate device but does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets them. The document focuses on regulatory compliance based on similarity to a previously cleared device rather than detailed performance reporting against pre-defined metrics.

Therefore, much of the requested information regarding acceptance criteria and performance data is not explicitly available in the provided text. Based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly list acceptance criteria or provide specific quantitative performance metrics for the QBS device. It primarily states that the QBS performs "in a similar manner" to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance:

Not specified in the provided text. The document refers to "data display and analysis" but does not detail a test set or its characteristics.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not specified in the provided text.

4. Adjudication Method:

Not specified in the provided text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not mentioned in the provided text.

6. Standalone Performance Study:

A standalone study in the sense of demonstrating algorithm performance via concrete metrics is not explicitly reported. The device itself is described as a "standalone software application," but this refers to its operational independence, not a performance study methodology. The document establishes substantial equivalence by comparing the QBS device's functionality to the predicate device, stating they "have similar indications for use and overall function and perform in a similar manner with respect to data display and analysis."

7. Type of Ground Truth Used:

Not specified in the provided text for any performance evaluation. The document mentions that "The results provided by QBS should be reviewed by qualified healthcare professionals (e.g., radiologists, cardiologists, or general nuclear medicine physicians)," implying human review as the ultimate arbiter, but it doesn't detail how ground truth was established for testing the QBS software itself.

8. Sample Size for the Training Set:

Not specified in the provided text. This document focuses on a 510(k) submission, which often relies on demonstrating equivalence rather than providing detailed algorithm training and testing data.

9. How the Ground Truth for the Training Set Was Established:

Not specified in the provided text.

Summary

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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 ProcessingApplications 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.

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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.

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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.

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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):

K022428

Device Name:

Quantitative Blood Pool SPECT (QBS)

Sponsor Name:

ADAC Laboratories

Indications for Use:

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

Regulation Number and Section

§ 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).