(79 days)
No
The description focuses on traditional image processing techniques (attenuation correction, scatter correction, resolution recovery) and does not mention AI or ML.
No
The device is described as software that processes images to correct for attenuation effects and enhance image quality. It does not exert a therapeutic effect on the patient.
No
The device is described as software that enhances SPECT emission images by correcting for attenuation effects and other image quality issues. It produces images depicting anatomical density but does not interpret or diagnose conditions based on these images; rather, it improves the quality of pre-existing diagnostic images.
No
The device is described as a software program that is an optional addition to ADAC Laboratories Gamma Camera products and utilizes external radioactive scanning line sources, acquisition electronics, and software. While the core of the modification is software, it is explicitly tied to and relies on specific hardware components (Gamma Camera Systems, scanning line sources, acquisition electronics) for its function, making it a software component of a larger hardware/software system, not a standalone software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Vantage 2.0 ExSPECT system produces images depicting the anatomical density of a patient and enhances emission images acquired using a gamma camera. This involves imaging the patient directly using external radioactive sources and SPECT technology.
- No Sample Analysis: There is no mention of analyzing samples taken from the patient's body. The process is entirely focused on in-vivo imaging and image processing.
Therefore, the Vantage 2.0 ExSPECT system falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Vantage 2.0 ExSPECT option to the ADAC Gamma Camera Systems produces images which depict the anatomical density of a patient. The system is intended to provide an enhancement to the emission images acquired using the ADAC Gamma Camera Systems by correcting for attenuation effects in the patient.
Product codes
90 KPS
Device Description
Vantage 2.0 ExSPECT 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 1.0 software package, cleared in 510k K943596.
Vantage 2.0 ExSPECT 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 510k K943596 for Vantage 1.0.
The system uses the same imaging technique of Single Photon Emission Computed Tomography (SPECT) with attenuation correction, as in Vantage 1.0, but adds image quality enhancements by correcting for the Photopeak scatter, Downscatter, and Resolution Recovery (RR).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Single Photon Emission Computed Tomography (SPECT)
Anatomical Site
anatomical density of a patient
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
524 118 18
AUG - 8 1997
System, Emission Computed Tomography
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA
I. General Information
ADAC Laboratories Submitted By: A. 540 Alder Drive Milpitas, CA 95035 Tel: (408) 321-9100 Fax: (408) 321-9686 Dennis Henkelman at address above Contact Person: Vantage 2.0 ExSPECT B. Device Trade Name: Gamma Camera Systems Common Name:
-
C. Vantage 1.0 Predicate Device:
Classification Name: -
D. Device Description:
-
. '
Vantage 2.0 ExSPECT 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 1.0 software package, cleared in 510k K943596.
Vantage 2.0 ExSPECT 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 510k K943596 for Vantage 1.0.
The system uses the same imaging technique of Single Photon Emission Computed Tomography (SPECT) with attenuation correction, as in Vantage 1.0, but adds image quality enhancements by correcting for the Photopeak scatter, Downscatter, and Resolution Recovery (RR).
1
E. Indications for Use:
The Vantage 2.0 ExSPECT option to the ADAC Gamma Camera Systems produces images which depict the anatomical density of a patient. The system is intended to provide an enhancement to the emission images acquired using the ADAC Gamma Camera Systems by correcting for attenuation effects in the patient.
F. Technological Comparison:
The Vantage 1.0 and Vantage 2.0 ExSPECT 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 reconstruction algorithm to better account for resolution recovery and Photopeak and down scatter.
II. Testing
.
"
Images were acquired using the protocol outlined in the Vantage user manual.
2
Image /page/2/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 three stripes representing the three levels of government: federal, state, and local. The eagle is facing left and has its wings spread. The text "DEPARTMENT OF HEALTH & HUM" is arranged in a semi-circle around the left side of the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 8 1997
Dennis W. Henkelman Director, Regulatory Affairs and Quality Assurance ADAC Laboratories 540 Alder Drive Milpitas, California 95035
Dear Mr. Henkelman:
Re: K971878
Vantage 2.0 ExSPECT Gamma Camera Dated: May 19, 1997 Received: May 21, 1997 Regulatory Class: II 21 CFR 892.1200/Procode: 90 KPS
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 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 equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, 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 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/dsmamain.html".
Sincerely yours
h.J.Liau Yin
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
3
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Vantage 2.0 ExSPECT Device Name:
_ADAC Laboratories Sponsor Name:
Indications For Use:
:
The Vantage 2.0 ExSPECT option to the ADAC Gamma Camera Systems produces images which depict the anatomical density of a patient. The system is intended to provide an enhancement to the emission images acquired using the ADAC Gamma Camera Systems by correcting for attenuation effects in the patient.
Do Not Write Below This Line - Continue on Another Page if Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ro Phillips
Prescription Use Over-The-Counter Use 0
V
Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Do 510(k) Number