(90 days)
No
The summary does not mention AI, ML, or related concepts, and the description focuses on hardware and software for attenuation correction and image registration, which are standard image processing techniques.
No.
The device is used to generate corrected images for diagnostic purposes (attenuation corrected emission images, registration of anatomical and physiological images) and not for treating or preventing a disease or condition.
No
The device is used to generate corrected images and facilitate localization, which are image processing tasks rather than diagnostic functions. The intended use focuses on image quality and registration, not on diagnosing conditions.
No
The device description explicitly states that the Hawkeye Option comprises "additional hardware and software," indicating it is not a software-only 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 the device is an addition to gamma cameras used to obtain and process emission images (NM images) and X-ray images. These are imaging modalities that capture information from the patient's body, not from samples taken from the body.
- Intended Use: The intended use is to obtain and register images for anatomical and physiological information, which is characteristic of medical imaging devices, not IVDs.
The device is a medical imaging device used for diagnostic purposes, but it operates by capturing images directly from the patient, not by analyzing samples in a laboratory setting.
N/A
Intended Use / Indications for Use
The intended use of the device is to produce attenuation-corrected NM images. The attenuation maps are also displayed with the NM images to facilitate the localization of the NM activity in the patient anatomy.
To obtain attenuation corrected emission images and to provide registration of anatomical and physiological images.
Product codes
90 KPS
Device Description
The Hawkeye Option is an addition to the Apex VariCam / Millennium VG gamma cameras (K953801). It comprises additional hardware and software to generate corrected NM images for non-uniform attenuation and to facilitate localization of the emission images in the patient anatomy.
The VariCam (K953801) gamma camera has been modified to accommodate for the Hawkeye transmission subsystem, by including an additional correction map for attenuation, obtained by an X-ray generation and detection system attached to the rotating frame of the gantry.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
NM images; X-ray
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
Not Found
Summary of Performance Studies
Bench and clinical data show that Hawkeye attenuation-corrected images are more uniform than NM images without attenuation correction. The images also demonstrate the localization capabilities of the Hawkeye.
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
510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 9. 807.87(h))
Device Name
13.00
Proprietary Device Name : Hawkeye Option for Dual-Head Variable Angle Gamma Camera.
Establishment Name and Registration Number of Submitter
| Name: | |
|---|---|
| Registration Number: | |
| Corresponding Official: |
ELGEMS Ltd. 9613299 Dan Laor ELGEMS Ltd. P.O. Box 170 Tirat Hacarmel 30200, ISRAEL
Device Classification
Classification Code: Panel Identification: Classification Name: Common Name: Classification Class:
90 KPS Radiology ECT system (per 21CFR 892.1200 ) Nuclear Medicine Imaging system Class II Product
Reason for 510(k) Submission
Modification of legally marketed device.
Identification of Legally Marketed Equivalent Devices
VTransACT option for the VariCam Gamma Camera - K980959 Advanced Analysis Software: Fusion/Registration and rCBF Autoradiographic Model - K941223/S1
Device Description
The Hawkeye Option is an addition to the Apex VariCam / Millennium VG gamma cameras (K953801). It comprises additional hardware and software to generate corrected NM images for non-uniform attenuation and to facilitate localization of the emission images in the patient anatomy.
Description of Change or Modification
The VariCam (K953801) gamma camera has been modified to accommodate for the Hawkeye transmission subsystem, by including an additional correction map for attenuation, obtained by an X-ray generation and detection system attached to the rotating frame of the gantry.
Intended Use of Device
The intended use of the device is to produce attenuation-corrected NM images. The attenuation maps are also displayed with the NM images to facilitate the localization of the NM activity in the patient anatomy.
1
Summary of Studies
-
- Sench and clinical data show that Hawkeye attenuation-corrected images are more uniform than NM images without attenuation correction. The images also demonstrate the localization capabilities of the Hawkeye.
Conclusion
In the opinion of ELGEMS Ltd., the Hawkeye is substantially equivalent in terms of safety and effectiveness to the VTransACT (K980959) for purposes of attenuation correction, and to the Advanced Analysis Software (K941223/S1) for purposes of facilitating localization of emission activity in the patient anatomy.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/15 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a person's profile.
AUG 26 1999
Quality and Regulatory Affairs
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re:
K991841 Hawkeve Option for Dual-Head Variable Angle Gamma Camera Requiatory Class: Il (two) Product Code: 90 KPS 21 CFR 892.1200 Dated: May 28, 1999 Received: May 28, 1999
Dear Mr. Laor:
Mr. Dan Laor
P.O. Box 170
ISRAEL
ELGMENS, Ltd.
Tirat Hacarmel 30200
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 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,
Dan Setiz
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
K991841 510(k) Number (if known): Hawkeye option for dual head variable angle gamma Device Name: camera
Indications For Use:
To obtain attenuation corrected emission images and to provide registration of anatomical and physiological images.
(Please do not write below this line - continue on another page if needed)
( Concurrence of CDRH, Office of Device Evaluation (ODE) )
Javid a. hayom
ivision Sign-Off) vision of Reproductive, Abdominal, ENT, and Radiological Devices 191841 510(k) Number
Prescription Use
(Per 21 CFR 801.109) ✓
OR Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________