(90 days)
No
The summary describes a physical component (collimators and cart) for a gamma camera and does not mention any software, algorithms, or processing that would indicate AI/ML.
No
The device is described as an accessory (collimators and cart) for a gamma camera, intended for obtaining nuclear medicine images. Its purpose is diagnostic imaging, not treatment.
Yes
The device is used to obtain Nuclear Medicine images, which are then used by medical professionals to diagnose diseases or conditions. The "Intended Use" explicitly states "To obtain Nuclear Medicine images... in the human body," which is a step in the diagnostic process.
No
The device description explicitly states it comprises "two high-energy collimators and a collimator cart," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is used to "obtain Nuclear Medicine images based on high-energy photons from an administered positron-emitting radioactive agent in the human body." This is an in vivo imaging process, meaning it involves imaging within the living body, not analyzing samples taken from the body.
- Input: The input is "high-energy photons from an administered positron-emitting radioactive agent" within the human body, not a biological specimen.
Therefore, the function and input of this device align with in vivo imaging rather than in vitro diagnostics.
N/A
Intended Use / Indications for Use
The VPC-94 collimators are designed for high-energy (511 KeV) NM imaging, with the Apex Varicam and Millennium VG Dual-Head Variable-Angle Gamma Cameras.
To obtain Nuclear Medicine images based on high-energy photons from an administered positron-emitting radioactive agent in the human body.
Product codes
KPS
Device Description
The VPC-94 high-energy (511 KeV) collimators and cart is an option for the Apex VariCam and Millennium VG gamma camera (K953801). It comprises two high-energy collimators and a collimator cart.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Nuclear Medicine images based on high-energy photons
Anatomical Site
human body.
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 VPC-94 option achieves its intended use.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench data and Clinical data show that the VPC-94 option achieves its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Dyna Camera 2C
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
Image /page/0/Picture/0 description: The image shows the text "JUL 1 3 1998" on the top left corner. Below the date, the word "ELGEMS" is written in a stylized font. The letter "G" in "ELGEMS" has a circular design element incorporated into it.
ELGEMS Ltd. • P.O. Box 170 • Tirat Hacarmel 30200 ISRAEL• TEL: 972-4-8310335/420 • FAX: 972-4-8310515
K98/352
9. 510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(h))
Device Name
VPC-94: High Energy (511 KeV) Collimator for Dual-Head Variable-Angle Gamma Camera.
Establishment Name and Registration Number of Submitter
ELGEMS Ltd.
Name: Registration Number: Corresponding Official:
9613299 Yair Friedman - VP, Quality and Regulatory Affairs ELGEMS Ltd. P.O. Box 170 Tirat Hacarmel 30200, ISRAEL
Device Classification
)
ﺎ .
Nuclear Medicine 90 123 KPS Panel Identification: Classification Code: (Radiology) Class II Product Classification Class:
Reason for 510(k) Submission
Modification of legally marketed device.
Identification of Legally Marketed Equivalent Devices
Dyna Camera 2C - no K number available, pre-amendment device. The Dyna Camera 2C is a single-head gamma camera. It can be equipped with the 615-211 High Energy Collimator, having an energy range of 44 - 525 KeV.
Device Description
The VPC-94 high-energy (511 KeV) collimators and cart is an option for the Apex VariCam and Millennium VG gamma camera (K953801). It comprises two high-energy collimators and a collimator cart.
Description of Change or Modification
The VPC-94 is equivalent to the Dyna Camera 2C 615-211 apart from the VPC-94 resolution, which is better at a comparable sensitivity, since two detector heads are used for the VariCam instead of one for the Dyna 2C.
Intended Use of Device
The VPC-94 collimators are designed for high-energy (511 KeV) NM imaging, with the Apex Varicam and Millennium VG Dual-Head Variable-Angle Gamma Cameras.
Summary of Studies
Bench data and Clinical data show that the VPC-94 option achieves its intended use.
Conclusion
In the opinion of ELGEMS Ltd., the VPC-94 is substantially equivalent to the Dyna Camera 2C 615-211 high-energy collimator. The VPC has the same intended use as the predicate device and no new safety or effectiveness concerns are raised.
1
Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized eagle with three lines representing its wings and body. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 3 1998
Yair Friedman VP. Quality and Regulatory Affairs Elgems Ltd. P.O. BOX 170 Tirat Hacarmel 30200 Israel
Re:
VPC-94 High Energy (511 KeV) Collimator for Dual-Head Variable-Angle Gamma Dated: April 9, 1998 Received: April 14, 1998 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS
Dear Mr. Friedman:
We have reviewed your Section 510/k) notification of intent to market the device referenced above and we have determined the device is substantially econvalent (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 (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 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 deving 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/dsmaldsmam.html".
Sincerely yours,
Kilian Yin
Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
CAKNOWN K981352 510(k) Number (if known): VPC-94: High Energy (511 KeV) Collimator for Device Name: Dual-Head Variable-Angle Gamma Camera
Indications For Use:
) --
) -
To obtain Nuclear Medicine images based on high-energy photons from an administered positron-emitting radioactive agent in the human body.
(Please do not write below this line - continue on another page if needed)
( Concurrence of CDRH, Office of Device Evaluation (ODE) )
Daniel A. Skym
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devic 8135c 510(k) Number
Prescription Use (Per 21 CFR 801.109)
Over-the-Counter Use OR