(75 days)
Vantage 2.0 ExSPECT
No
The description focuses on traditional image processing techniques (QA tools, iterative reconstruction for noise reduction) and does not mention AI or ML.
No
The device is described as a software program that provides quality assurance enhancements and noise reduction for nuclear medicine images, not as a device for direct treatment or diagnosis of a disease or condition.
No
The intended use of Vantage ExSPECT II is to "provide quality assurance enhancements to nuclear medicine images" and to "improve the consistency and usability" of another product. It provides "feedback regarding the quality of the acquired images" such as banding, truncation, and count levels, and helps reduce noise. This focus on improving image quality and consistency for other diagnostic images, rather than directly diagnosing a medical condition, indicates it's a quality assurance tool, not a diagnostic device itself.
Yes
The device is described as a "software program" and a "computer program" that is an "optional addition" to existing gamma camera systems. While it processes images from hardware, the device itself is presented as a software modification and enhancement to existing cleared systems, not a new hardware component.
Based on the provided information, Vantage ExSPECT II is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide quality assurance enhancements to nuclear medicine images acquired using the ADAC Gamma Camera Systems." This focuses on improving the quality and consistency of imaging data, not on analyzing biological samples (like blood, urine, tissue) to diagnose or monitor a disease or condition.
- Device Description: The description details a software program that processes and enhances nuclear medicine images. It mentions improving functional information and using anatomical information from external sources. This is consistent with image processing and analysis, not in vitro testing.
- Input Imaging Modality: The input is "Nuclear medicine images acquired using the ADAC Gamma Camera Systems." This is an imaging modality, not a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other components typically associated with in vitro diagnostics.
In summary, Vantage ExSPECT II is a software tool designed to improve the quality of nuclear medicine images, which falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Vantage ExSPECT II is intended to provide quality assurance enhancements to nuclear medicine images acquired using the ADAC Gamma Camera Systems.
Product codes
90 KPS
Device Description
Vantage ExSPECT II is a software program, which will be marketed as an optional addition to ADAC Laboratories Gamma Camera products. This is a modification of the Vantage 2.0 ExSPECT software package, cleared in 510k K971878.
Vantage ExSPECT II is a computer program that provides a patient's functional information, which is further improved by using the anatomical information, obtained using the external radioactive scanning line sources with special collimation to minimize patient exposure, and the acquisition electronics and software, cleared in 510k K943596 for Vantage 1.0.
Vantage ExSPECT II is a modification of Vantage 2.0 ExSPECT and is designed to provide the user with additional quality assurance (QA) to improve the consistency and usability of the Vantage 2.0 ExSPECT product. The Post Acquisition QA tool provides the user with feedback regarding the quality of the acquired images in that it alerts the user as to the level of any banding or truncation in the data as well as the level of counts acquired in each data set. The other improvement is two user-selectable iterative reconstruction methods for reducing the noise level in the transmission image.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Nuclear medicine images
Anatomical Site
Not Found
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
Images were processed using both the Post Acquisition QA tool and the transmission iterative reconstruction methods.
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Vantage 2.0 ExSPECT
Reference Device(s)
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.
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SEP - 1
| Vantage ExSPECT II |
|---|
| ADAC Laboratories |
| 510(k) Premarket Notification |
Appendix IX, 510(k) Summary of Safety and Effectiveness Data Page 1 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA
General Information I.
Submitted By: A.
ADAC Laboratories 540 Alder Drive Milpitas, CA 95035 Tel: (408) 468-3989 Fax: (408) 435-7427
Dennis W. Henkelman at address above Contact Person:
B. Device Trade Name: Vantage ExSPECT II Common Name: Gamma Camera Systems System, Emission Computed Tomography Classification Name:
C. Predicate Device: Vantage 2.0 ExSPECT
D. Device Description:
Vantage ExSPECT II is a software program, which will be marketed as an optional addition to ADAC Laboratories Gamma Camera products. This is a modification of the Vantage 2.0 ExSPECT software package, cleared in 510k K971878.
Vantage ExSPECT II is a computer program that provides a patient's functional information, which is further improved by using the anatomical information, obtained using the external radioactive scanning line sources with special collimation to minimize patient exposure, and the acquisition electronics and software, cleared in 510k K943596 for Vantage 1.0.
Vantage ExSPECT II is a modification of Vantage 2.0 ExSPECT and is designed to provide the user with additional quality assurance (QA) to improve the consistency and usability of the Vantage 2.0 ExSPECT product. The Post Acquisition QA tool provides the user with feedback regarding the quality of the acquired images in that it alerts the user as to the level of any banding or truncation in the data as well as the level of counts acquired in each data set. The other improvement is two
1
user-selectable iterative reconstruction methods for reducing the noise level in the transmission image.
-
E. Indications for Use:
Vantage ExSPECT II is intended to provide quality assurance enhancements to nuclear medicine images acquired using the ADAC Gamma Camera Systems. -
F. Technological Comparison:
The Vantage 2.0 ExSPECT and Vantage ExSPECT II devices have the same indications for use, source type and geometry, system hardware, operating principles, and emission reconstruction algorithm, with the exception of the Post Acquisition QA tool and minor modifications to the transmission reconstruction algorithm. -
II. Testing
Images were processed using both the Post Acquisition QA tool and the transmission iterative reconstruction methods.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP = 1 1999
Ms. Genine M. Grant Sr. Software Engineer ADAC Laboratories 540 Alder Drive Milpitas, CA 95035
Re: K992078
Vantage ExSPECT II Dated: June 18, 1999 Received: June 18, 1999 Product Code: 90 KPS Requlatory Class: Il (two) 21 CFR 892.1200
Dear Ms. Grant:
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 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, 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 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 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 concerning your device in 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 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/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, 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):
Vantage ExSPECT II Device Name:
ADAC Laboratories Sponsor Name:
Indications For Use:
Vantage ExSPECT II is intended to provide quality assurance enhancements to nuclear medicine images acquired using the ADAC Gamma Camera Systems.
Do Not Write Below This Line - Continue on Another Page if Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
David k. Skymm
(Division Sign-Off)
Division of Reproductive, Abdominal, EN and Radiological Device 510(k) Number
ખ Prescription Use Over-The-Counter Use 0
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