(89 days)
No
The summary does not mention AI, ML, or related terms, and the description focuses on hardware and software for attenuation correction without suggesting advanced learning algorithms.
No
The device is described as an attenuation correction system for a gamma camera, used to generate corrected PET images. Its purpose is to improve image quality for diagnostic purposes, not to directly treat a disease or condition.
Yes
The device aids in obtaining attenuation-corrected PET images, which are used to generate diagnostic images. While it performs a correction and isn't a primary image acquisition device, its function is integral to improving the quality of images used for diagnosis.
No
The device description explicitly states it comprises "additional hardware and software".
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to obtain attenuation corrected Positron Emission Tomography (PET) images. This is a process performed on images generated from a medical imaging device (a Gamma Camera), not on biological samples (like blood, urine, or tissue) to diagnose a condition.
- Device Description: The device is described as an addition to a gamma camera to generate corrected PET images. This further reinforces its role in image processing and enhancement, not in analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting specific analytes, or providing diagnostic information based on the analysis of biological materials.
Therefore, this device falls under the category of a medical imaging accessory or image processing system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To obtain attenuation corrected Positron Emission Tomography (PET) images, by a Gamma Camera.
Product codes
90 IYX, 90 KPS
Device Description
The CoDe AC attenuation correction system is an addition to the Apex VariCam and Millennium VG gamma cameras (K953801). It comprises additional hardware and software to generate corrected Positron Emission Tomography images for non-uniform attenuation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Positron Emission Tomography (PET) 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
Not Found
Summary of Performance Studies
Bench data and Clinical data show that the CoDe AC option for the VariCam delivers more uniform images than regular coincidence imaging system without attenuation correction. Comparison to VTransACT images shows no significant difference.
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
S Ltd. • P.O. Box 170 • Tirat Hacarmel 30200 ISRAEL• 972-4-8563660 • FAX: 972-4-8577662
510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(h))
Device Name
CoDe AC: Attenuation Correction System for the VariCam Gamma Camera.
Establishment Name and Registration Number of Submitter
ELGEMS Ltd. Name: 9613299 Registration Number: Corresponding Official: Dan Laor ELGEMS Ltd. P.O. Box 170
Tirat Hacarmel 30200, ISRAEL
Device Classification
Classification Code: 90 IYX Panel Identification: Nuclear Medicine Classification Class: Class II Product
Reason for 510(k) Submission Modification of legally marketed device.
Identification of Legally Marketed Equivalent Devices
VTransACT option for the Apex VariCam (Millenium VG Gamma Camera) -K980659
Device Description
The CoDe AC attenuation correction system is an addition to the Apex VariCam and Millennium VG gamma cameras (K953801). It comprises additional hardware and software to generate corrected Positron Emission Tomography images for non-uniform attenuation.
Description of Change or Modification
The VariCam (K953801) gamma camera has been modified to accommodate for the CoDe AC attenuation correction system, by including an additional correction map for attenuation, obtained by one line of shielded point sources inserted in the septa collimator of the camera. This map is used to create an attenuation-corrected image.
Intended Use of Device
The intended use of the device is to produce attenuation-corrected PET images, even when attenuation coefficients are not uniform over the FOV.
Summary of Studies
Bench data and Clinical data show that the CoDe AC option for the VariCam delivers more uniform images than regular coincidence imaging system without attenuation correction. Comparison to VTransACT images shows no significant difference.
Summary of the Safety
The CoDe AC sealed and shielded source is activated manually, with no need of electro-mechanical shutter. The source exposure is done only during the transmission
1
ELGEM.
ELGEMS Ltd. • P.O. Box 170 • Tirat Hacarmel 30200 ISRAEL. TEL: 972-4-8563660 • FAX: 972-4-8577662
scan in a sequential transmission acquisition. A self-powered LED indicates continuously the status of the sources. The source is well collimated to the opposite detector FOV only. The CoDe AC option is an integral part of the septa collimator and no motion of the device is needed during the scan.
Conclusion
In the opinion of ELGEMS Ltd., the CoDe AC is substantially equivalent in terms of safety and effectiveness to the VTransACT option. The CoDe AC has the same intended use as the predicate device and no new safety or effectiveness concerns are raised.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/2/Picture/2 description: The image shows a partial view of a seal or emblem, featuring a stylized graphic of three overlapping, curved lines resembling a stylized human figure or abstract design. To the left of the graphic, a portion of text is visible, arranged vertically and curved to follow the shape of the emblem. The text appears to be part of the words "DEPARTMENT OF HEALTH &".
MAR - 7 2000
Lan Laor VP-Quality and Regulatory Affairs ELGEMS Ltd. P.O. Box 170 Tirat Hacarmel 30200 ISRAEL
Re:
K994167 CoDe AC: Attenuation Correction System for Dual-Head Variable Angle Gamma Camera with the Coincidence Option (CoDe) Dated: August 1, 1999 Received: December 9, 1999 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS
Dear Mr. Laor:
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 vour 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlatory 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 vour 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) 594-4591. 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" (21CFR 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,
Daniel G. Schultz, M.D. Captain, USPHS Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
3
510(k) Number (if known): UNKNOWN K994167
Device Name: CoDe AC : Attenuation Correction System for Dual-Head Variable Angle Gamma Camera with the Coincidence Option (CoDe).
Indication For Use:
To obtain attenuation corrected Positron Emission Tomography (PET) images, by a Gamma Camera.
(Please do not write below this line- continue on another page if needed)
(Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K994167
Prescription Use Or Over-the-Counter Use (Per 21 CFR 801.109)