(147 days)
EPIC-MCD, UGM 240H, GE ADVANCE
Not Found
No
The description focuses on traditional image processing techniques for attenuation correction based on physical principles (density and transmission of gamma rays). There is no mention of AI or ML algorithms for image reconstruction or analysis.
No.
The device is used to produce images of biodistribution of positron-emitting radioisotopes and correct for attenuation effects, which are diagnostic functions, not therapeutic.
Yes
The device "produces images of biodistribution of positron-emitting radioisotopes previously administered to the human body." Imaging the biodistribution of radioisotopes is a diagnostic function, as it helps in identifying and characterizing diseases. Furthermore, the description mentions that the system "provides an enhancement to the emission images acquired... by correcting for attenuation effects," which improves the diagnostic quality of the images.
No
The device description explicitly states it is an "optional addition to the ADAC EPIC-MCD Gamma Camera System" and describes the use of an "external source" for gamma rays, indicating it is a hardware modification or addition to an existing hardware system, not a standalone software 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 ADAC MCD-AC system works by detecting gamma ray emissions from radioisotopes previously administered to the human body. It then processes these emissions to create images of the biodistribution of the radioisotopes within the body. This is an in vivo process (occurring within the living organism), not an in vitro process (occurring outside the living organism).
- Intended Use: The intended use is to produce images of the biodistribution of radioisotopes and correct for attenuation effects within the human body. This directly relates to imaging the internal state of the patient, not analyzing samples taken from the patient.
Therefore, the ADAC MCD-AC system falls under the category of medical imaging devices used for in vivo procedures, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The MCD-AC option to the ADAC Gamma Camera Systems produces images which depict the anatomical density of a patient. The system is intended to provide an enhancement to the emission images acquired using the ADAC MCD Gamma Camera System by correcting for attenuation effects in the patient.
ADAC MCD-AC option to ADAC Dual Head Emission Tomographic System produces images of biodistribution of positron-emitting radioisotopes previously administered to the human body. The system is intended to provide an enhancement to the emission images acquired using the ADAC MCD System by correcting for attenuation effects in the human body.
Product codes (comma separated list FDA assigned to the subject device)
90 KPS
Device Description
MCD-AC is a system that will be marketed as an optional addition to the ADAC EPIC-MCD Gamma Camera System (e.g., Vertex+, any other ADAC camera in a dual-head configuration which can take 180° images). MCD-AC is short for Molecular Coincidence Defection Attenuation Correction, and is a modification to the EPIC-MCD system, cleared in 510k K952684.
The MCD-AC uses the same principle of coincidence imaging used by the EPIC-MCD, but adds the image quality enhancing feature of attenuation correction. When a radioactive material is administered to a patient and the resulting gamma ray emission detected, attenuation is observed due to the internal parts (e.g., bones, breast tissue, etc.) of the patient. The resulting image is then an underestimation of the actual image, due to the presence of bone or tissue in the pathway of the emission radiation.
When an image is generated representing the density of the patient, it is possible to compensate for the attenuation effects, since the attenuation of gamma rays are largely proportional to the density. Such an image can be obtained by sending a known flux of gamma rays from an external source, through the patient at different angles, registering what fraction is transmitted through the patient, and then reconstructing these projections to form an attenuation image (attenuation map). The count density in this image is inversely proportional to the density of the patient and can be used in the reconstruction of the emission image to compensate for gamma ray attenuation.
Mentions image processing
Yes
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A study was conducted to demonstrate the single source attenuation correction technique on MCD cameras. Images were obtained using phantoms and humans. The quality of the images produced was similar to the quality of images produced by the predicate devices.
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.
EPIC-MCD, UGM 240H, GE ADVANCE
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.
Not Found
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
OCT 2 3 1997
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
ADAC Laboratories Submitted By: A. 540 Alder Drive Milpitas, CA 95035 Tel: (408) 321-9100 Fax: (408) 321-9686 Contact Person: Dennis Henkelman at address above MCD-AC E. Device Trade Name: Gamma Camera Systems Common Name: Classification Name: System, Emission Computed Tomography C. Vantage 1.0 Predicate Device: EPIC-MCD UGM 240H GE ADVANCE
D. Device Description:
MCD-AC is a system that will be marketed as an optional addition to the ADAC EPIC-MCD Gamma Camera System (e.g., Vertex+, any other ADAC camera in a dual-head configuration which can take 180° images). MCD-AC is short for Molecular Coincidence Defection Attenuation Correction, and is a modification to the EPIC-MCD system, cleared in 510k K952684.
The MCD-AC uses the same principle of coincidence imaging used by the EPIC-MCD, but adds the image quality enhancing feature of attenuation correction. When a radioactive material is administered to a patient and the resulting gamma ray emission detected, attenuation is observed due to the internal parts (e.g., bones, breast tissue, etc.) of the patient. The resulting image is then an underestimation of the actual image, due to the presence of bone or tissue in the pathway of the emission radiation.
When an image is generated representing the density of the patient, it is possible to compensate for the attenuation effects, since the attenuation of gamma rays
1
are largely proportional to the density. Such an image can be obtained by sending a known flux of gamma rays from an external source, through the patient at different angles, registering what fraction is transmitted through the patient, and then reconstructing these projections to form an attenuation image (attenuation map). The count density in this image is inversely proportional to the density of the patient and can be used in the reconstruction of the emission image to compensate for gamma ray attenuation.
-
E. Indications for Use:
The MCD-AC option to the ADAC Gamma Camera Systems produces images which depict the anatomical density of a patient. The system is intended to provide an enhancement to the emission images acquired using the ADAC MCD Gamma Camera System by correcting for attenuation effects in the patient. -
F. Technological Comparison:
MCD-AC is similar to Vantage in that both devices correct for patient attenuation by use of radioactive sources to create attenuation maps. In both devices, the data is combined from attenuation maps with emission data to correct for attenuation due to bones, tissues, etc. within the patient. The algorithms used to perform this attenuation correction are similar. The reconstruction algorithm used for MCD-AC is the same as the algorithm used for EPIC-MCD with the exception that the MCD-AC algorithm is a modification to the EPIC-MCD algorithm to implement attenuation correction for MCD images.
The source type for the MCD-AC (Cs-137) is different from the source type for the Vantage (Gd-153) because it has been chosen to provide the appropriate attenuation for 511 KeV gamma rays. The source geometry is also different. MCD-AC uses a point source, while Vantage uses a line source. However, when the point source is translated along the patient, the computer views it as a line source.
II. Testing
A study was conducted to demonstrate the single source attenuation correction technique on MCD cameras. Images were obtained using phantoms and humans. The quality of the images produced was similar to the quality of images produced by the predicate devices.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 3 1997
Dennis W. Henkelman, R.A.C. Director, Regulatory Affairs and Quality Assurance ADAC Laboratories 540 Alder Drive Milpitas, CA 95035
Re: K971980
MCD-AC Attenuation Correction for SPECT Camera Dated: September 19, 1997 Received: September 22, 1997 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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranion.
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 requirement, 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 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 yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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/dsmamain.html".
Sincerely yours,
h.J. lian Yin
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
Revised August 8, 1997
K971980 510(k) Number (if known): Device Name: MCD-AC
ADAC Laboratories Sponsor Name:
Indications For Use:
ADAC MCD-AC option to ADAC Dual Head Emission Tomographic System produces images of biodistribution of positron-emitting radioisotopes previously administered to the human body. The system is intended to provide an enhancement to the emission images acquired using the ADAC MCD System by correcting for attenuation effects 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)
Uhvid C. Stymm
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device
Radiological Devices
510(k) Number K971980
Prescription Use $\sqrt{ }$
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _