(77 days)
No
The document describes standard image processing techniques (SPECT with attenuation correction) and quality assurance tools. There is no mention of AI, ML, or related concepts.
No
Explanation: The device is intended to provide quality assurance enhancements to nuclear medicine images and uses image acquisition techniques; it does not directly treat or prevent a disease or condition.
Yes
Explanation: The device, Vantage 2.5, is software that enhances nuclear medicine images acquired using gamma camera systems. Nuclear medicine imaging, specifically SPECT, is a diagnostic imaging technique used to diagnose and assess various medical conditions by visualizing the functional processes within the body. By providing "quality assurance enhancements to nuclear medicine images," the device directly contributes to the quality and reliability of images used for diagnostic purposes.
No
The device is described as a software program that is an "optional addition to ADAC Laboratories Gamma Camera products." It also mentions using "acquisition electronics and software" and relies on the "same imaging technique of Single Photon Emission Computed Tomography (SPECT)." While the submission focuses on the software, its function is intrinsically tied to and dependent on the hardware of the Gamma Camera system for image acquisition and processing, making it a component of a larger hardware/software system, not a standalone software-only medical device.
Based on the provided information, Vantage 2.5 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- Vantage 2.5's Function: Vantage 2.5 is a software program that processes and enhances nuclear medicine images acquired using a gamma camera. It deals with in vivo imaging (imaging within the living body) using radioactive tracers, not in vitro analysis of specimens.
- Intended Use: The intended use describes quality assurance enhancements to nuclear medicine images and scatter correction capabilities. This is related to the imaging process itself, not the analysis of biological samples.
- Device Description: The description clearly states it's a software program for gamma camera products and uses SPECT imaging techniques.
Therefore, Vantage 2.5 falls under the category of medical imaging software, not an IVD.
N/A
Intended Use / Indications for Use
Vantage 2.5 is a software program, which will be marketed as an addition to ADAC Laboratories Gamma Camera products. This is a modification of the Vantage 2.0 ExSPECT software package, cleared in 510k K971878.
Vantage 2.5 is intended to provide quality assurance enhancements to nuclear medicine images acquired using the gold Gama Camera Systems. It includes scatter correction capability for
Product codes
90 KPS
Device Description
Vantage 2.5 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 510(k) K971878.
Vantage 2.5 is a computer program that provides a patient's anatomical information using the external radioactive scanning line sources with special collimation to minimize patient exposure, and the acquisition electronics and software, cleared in 510(k) K943596 for Vantage 1.0 and in 510(k) K971878 for Vantage 2.0 ExSPECT.
The system uses the same imaging technique of Single Photon Emission Computed Tomography (SPECT) with attenuation correction, as in Vantage 2.0 ExSPECT, but adds Quality Assurance (QA) Tools by using Pre-Scan, Automatic Energy Window Checking and Transmission QA Reference.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Single Photon Emission Computed Tomography (SPECT)
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 acquired using the protocol outlined in the Vantage user manual.
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
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.
0
JUL 26 1999
| Vantage 2.5 | |
|---|---|
| ADAC Laboratories | |
| 510(k) Premarket Notification |
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA
I. General Information
- ADAC Laboratories A. Submitted by: 540 Alder Drive Milpitas, California 95035 Tel: (408) 468-3989 Fax: (408) 435-7427 Dennis W. Henkelman at address above Contact Person: Vantage 2.5 B. Device Trade Name: Gamma Camera Systems Common Name: System, Emission Computed Tomography Classification Name:
- C. Vantage 2.0 Predicate Device:
- D. Device Description:
Vantage 2.5 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 510(k) K971878.
Vantage 2.5 is a computer program that provides a patient's anatomical information using the external radioactive scanning line sources with special collimation to minimize patient exposure, and the acquisition electronics and software, cleared in 510(k) K943596 for Vantage 1.0 and in 510(k) K971878 for Vantage 2.0 ExSPECT.
The system uses the same imaging technique of Single Photon Emission Computed Tomography (SPECT) with attenuation correction, as in Vantage 2.0 ExSPECT, but adds Quality Assurance (QA) Tools by using Pre-Scan, Automatic Energy Window Checking and Transmission QA Reference.
- E. Indications for Use:
Vantage 2.5 is a software program, which will be marketed as an addition to ADAC Laboratories Gamma Camera products. This is a modification of the Vantage 2.0 ExSPECT software package, cleared in 510k K971878.
1
- F. Technological Comparison:
The Vantage 2.0 ExSPECT and Vantage 2.5 devices have the same indications for use, source type and geometry, system hardware, operating principles, and reconstruction algorithms, with the exception of minor modifications to the acquisition software.
II. Testing
Images were acquired using the protocol outlined in the Vantage user manual.
2
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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a person with their arms outstretched.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 26 1999
Dennis W. Henkelman, R.A.C. Director, Regulatory Affairs & Quality Assurance ADAC Laboratories 540 Alder Drive Milipitas. California 95035
Re: K991607
Vantage 2.5 Gamma Camera System Dated: May 7, 1999 Received; May 10, 1999 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 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 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 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
3
Page
K991607 SIO(k) NUMBER (IF KNOWN): _
Vantage 2.5 DEVICE NAME:
INDICATIONS FOR USE:
Vantage 2.5 is intended to provide quality assurance enhancements to nuclear medicine images acquired using the gold Gama Camera Systems.
scatter correction capability for It includes scatter correction capability for
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use (Optional Format 1-2-96
David L. Segerson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological D 510(k) Number