(81 days)
Not Found
No
The summary describes image processing software for a gamma camera, but there is no mention of AI, ML, or related concepts. The description focuses on simultaneous acquisition of multiple isotopes and transmission images, which are standard nuclear medicine techniques.
No
The device is described as a software program that produces nuclear medicine images, which is diagnostic in nature, not therapeutic.
No
The device is described as software that produces nuclear medicine images and does not mention analysis or interpretation of these images for diagnostic purposes. Its intended use is to produce images, not to diagnose conditions.
No
The device is described as an optional addition to ADAC Laboratories Gamma Camera products and is a software program that produces nuclear medicine images. While it is software, it is explicitly tied to and modifies the functionality of a hardware gamma camera system, making it a component of a larger hardware/software system, not a standalone software-only medical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "produce images of two emission isotopes simultaneously while also acquiring a transmission image." This describes an in vivo imaging process, where radioactive isotopes are administered to a patient and detected by a gamma camera to create images of internal organs or processes.
- Device Description: The device is a "software program" that "produces nuclear medicine images." Nuclear medicine imaging is an in vivo diagnostic technique.
- Input Imaging Modality: The input is from a "Gamma Camera," which is used for in vivo nuclear medicine imaging.
IVDs, on the other hand, are used to examine specimens (like blood, urine, or tissue) outside of the body to obtain information about a patient's health.
Therefore, the Vantage 3.0 InSynch™ is a software component for an in vivo diagnostic imaging system, not an IVD.
N/A
Intended Use / Indications for Use
The Vantage 3.0 InSynch ™ option to the ADAC Gamma Camera Systems is intended to produce images of two emission isotopes simultaneously while also acquiring a transmission image.
Product codes
90 KPS
Device Description
Vantage 3.0 InSynch™ 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 3.0 InSynch™ is a computer program that produces nuclear medicine images of two isotopes acquired simultaneously, corresponding to specific energy levels and a transmission image from external radioactive scanning line sources. Vantage 3.0 InSynch™ is an extension of Vantage 2.0 ExSPECT which acquires a single isotope image with the transmission image produced by the external radioactive scanning line sources.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Nuclear Medicine images / Gamma Camera Systems
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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
A study was conducted to demonstrate that Vantage 3.0 InSynch™ provides comparable images using simultaneous dual-isotope scanning to sequential dualisotope scanning. The quality of the images produced was similar to the quality of images produced by the predicate device.
Key Metrics
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
| Vantage 3.0 InSynch™ |
|---|
| 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
I. General Information
Submitted By: A.
ADAC Laboratories 540 Alder Drive Milpitas, CA 95035 Tel: (408) 321-9100 Fax: (408) 321-9686
Contact Person:
Dennis Henkelman at address above
- Vantage 3.0 InSynch™ Device Trade Name: B. Gamma Camera Systems Common Name: System, Emission Computed Tomography Classification Name:
- Vantage 2.0 ExSPECT C. Predicate Device:
- Device Description: D.
Vantage 3.0 InSynch™ 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 3.0 InSynch™ is a computer program that produces nuclear medicine
images of two isotopes acquired simultaneously, corresponding to specific energy levels and a transmission image from external radioactive scanning line sources. Vantage 3.0 InSynch™ is an extension of Vantage 2.0 ExSPECT which acquires a single isotope image with the transmission image produced by the external radioactive scanning line sources.
1
Indications for Use: E.
The Vantage 3.0 InSynch ™ option to the ADAC Gamma Camera Systems is intended to produce images of two emission isotopes simultaneously while also acquiring a transmission image.
F. Technological Comparison:
The Vantage 3.0 InSynch™ and Vantage 2.0 ExSPECT devices have the same source type, source strength, source geometry, system hardware, and operating principles. Whereas the Vantage 2.0 ExSPECT device was intended for the acquisition and reconstruction of a single emission isotope in addition to a line source, the Vantage 3.0 InSynch™ is intended for the acquisition of dual isotopes simultaneously.
II. Testing
A study was conducted to demonstrate that Vantage 3.0 InSynch™ provides comparable images using simultaneous dual-isotope scanning to sequential dualisotope scanning. The quality of the images produced was similar to the quality of images produced by the predicate device.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure embracing a bird, which is meant to represent the department's mission of protecting the health of all Americans and providing essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 1998
Dennis W. Henkelman Director, Regulatory Affairs and Quality Affairs ADAC Laboratories 540 Alder Drive Milpitas, CA 95035
Re:
K981291 Vantage 3.0 InSynch™M Dated: April 8, 1998 Received: April 9, 1998 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 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 II (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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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/odrh/dsma/dsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Throa 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 3.0 InSynch™ Device Name:
ADAC Laboratories Sponsor Name:
Indications for Use
The Vantage 3.0 InSynch ™ option to the ADAC Gamma Camera Systems is intended to produce images of two emission isotopes simultaneously while also acquiring a transmission image.
Do Not Write Below This Line - Continue on Another Page if Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
David H. Slyman
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number
ਲ Prescription Use Over-The-Counter Use 0