(81 days)
No
The summary describes a system for attenuation correction using hardware and software to generate a correction map, which is a standard image processing technique in SPECT, not indicative of AI/ML. There are no mentions of AI, ML, or related concepts, nor descriptions of training or test sets typically associated with AI/ML development.
No.
The device is used to improve the quality of emission SPECT images by attenuation correction, not to treat a disease or condition.
No
The device is used to improve the quality of SPECT images through attenuation correction, not to diagnose a medical condition. It enhances the imaging quality for diagnostic purposes performed by another device.
No
The device description explicitly states that the system "comprises additional hardware and software".
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 MG ATC system is an add-on to a gamma camera used for emission SPECT imaging. This is an in vivo imaging technique, meaning it involves imaging the body directly, not analyzing samples taken from the body.
- Intended Use: The intended use is to improve the quality of SPECT images by correcting for attenuation, which is a physical phenomenon that affects the signals detected by the camera within the body.
Therefore, the MG ATC system falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The intended use of the device is to produce attenuation-corrected NM images, even when attenuation coefficients are not uniform over the FOV.
MG ATC is indicated to improve the quality of emission SPECT images obtained on the Millennium MG dual head camera by attenuation correction.
Product codes (comma separated list FDA assigned to the subject device)
90 KPS
Device Description
The MG ATC attenuation correction system is an optional addition to the Millennium MG gamma camera (K962738). It comprises additional hardware and software to generate a correction map and corrected NM images for non-uniform attenuation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Gamma Camera
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
Bench data and Clinical data show that the MG ATC option delivers better uniformed images than regular SPECT without attenuation correction.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench data and Clinical data show that the MG ATC option delivers better uniformed images than regular SPECT without attenuation correction. Comparison to V TransACT images shows no significant difference.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the word "ELGEMS" in a stylized font. The letters are in bold, and the "G" is larger than the other letters. There is a curved line that starts at the top of the "G" and goes around to the bottom of the "G", creating a loop.
ELGEMS Ltd. • P.O. Box 170 • Tirat Hacarmel 30200 ISRAEL• TEL: 972-4-8310335/420 • FAX: 972-4-8310515
9. 510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(b)
Device Name
:
AUG 23
MG ATC: Attenuation Correction System for Dual-Head Variable-Angle Gamma Camera.
Establishment Name and Registration Number of Submitter
ELGEMS Ltd.
Name: Registration Number: Corresponding Official:
9613299 Laor Dan ELGEMS Ltd. P.O. Box 170 Tirat Hacarmel 30200, ISRAEL
Device Classification
Classification Code: 90 KPS Classification Class: Class II Product Panel Identification: Radiology
Reason for 510(k) Submission
Modification of legally marketed device.
Identification of Legally Marketed Equivalent Devices
V TransACT: Attenuation Correction System for Dual-Head Variable-Angle Gamma Camera - K980959.
Device Description
The MG ATC attenuation correction system is an optional addition to the Millennium MG gamma camera (K962738). It comprises additional hardware and software to generate a correction map and corrected NM images for non-uniform attenuation.
Description of Change or Modification
The Millennium MG gamma camera (K962738) gamma camera has been modified to accommodate for the MG ATC attenuation correction system, by including an additional correction map for attenuation, obtained by two scanning line sources attached to the heads supports 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 NM images, even when attenuation coefficients are not uniform over the FOV.
Summary of Studies
Bench data and Clinical data show that the MG ATC option delivers better uniformed images than regular SPECT without attenuation correction. Comparison to V TransACT images shows no significant difference.
1
$\mathcal{ELGEMS}$
ELGEMS Ltd. • P.O. Box 170 • Tirat Hacarmel 30200 ISRAEL• TEL: 972-4-8310335/420 • FAX: 972-4-8310515
Conclusion
加法规划。
In the opinion of ELGEMS Ltd., the MG ATC is substantially equivalent in terms of safety and effectiveness to the V TransACT option for the Varicam (K980959). The MG ATC has the same intended use as the predicate device and no new safety or effectiveness concerns are raised.
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with three lines extending from the head, possibly representing ideas or communication.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Dan Laor Quality and Requlatory Affairs ELGMENS, Ltd. P.O. Box 170 Tirat Hacarmel 30200
Re:
K991896 MG ATC: Attenuation Correction System for Dual-Head Variable-Angle Gamma Camera Requlatory Class: II (two) Product Code: 90 KPS 21 CFR 892.1200 Dated: June 1, 1999 Received: June 3, 1999
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 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,
CART David C. Stahl, M.D.
APT 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
510(k) Number (if known): DEVICE NAME: MG ATC: Attenuation correction system for dualhead variable-angle Gamma Camera
INDICATION FOR USE: MG ATC is indicated to improve the quality of emission SPECT images obtained on the Millennium MG dual head camera by attenuation correction. : : :
(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 | K991896 |
| Prescription Use | ✓ OR Over-the-Counter Use ______ |
| (Per 21 CFR 801.109) |