(70 days)
Not Found
No
The description focuses on hardware design (CdTe semiconductor detector) and standard image processing algorithms, with no mention of AI or ML.
No.
The MGC-500 is indicated for imaging and visualizing the distribution of radionuclides; it does not treat or cure any condition.
Yes
The device is a gamma camera, which is used in nuclear medicine to create images of the distribution of radionuclides in the human body. This imaging is used to diagnose various medical conditions.
No
The device description clearly states it is a nuclear medical imager incorporating a solid-state CdTe semiconductor detector, which is a hardware component for detecting gamma rays. While it mentions image processing software, the core function relies on physical detection hardware.
Based on the provided information, the Mini Gamma Camera MGC-500 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "imaging the distribution of radionuclides in the human body using planer imaging techniques." This describes an in vivo (within the living body) diagnostic imaging procedure, not an in vitro (outside the living body) test performed on biological samples.
- Device Description: The description reinforces this by explaining it "extracorporeally detects and visualizes the gamma ray emitted from an administered radiopharmaceutical." This is the core function of a nuclear medicine imaging device used on a patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside the body, which are hallmarks of IVD devices.
Therefore, the Mini Gamma Camera MGC-500 is a medical imaging device used for in vivo nuclear medicine procedures.
N/A
Intended Use / Indications for Use
The Mini Gamma Camera MGC-500 is indicated for use in imaging the distribution of radionuclides in the human body using planer imaging techniques. The MGC-500 may also be used intraoperatively if a protective sheath is used.
Product codes (comma separated list FDA assigned to the subject device)
90 IYX
Device Description
The Mini Gamma Camera, MGC500, is a nuclear medical imager (commonly known as a scintillation or gamma camera) that is smaller, lighter and more portable than the existing gamma cameras. The MGC500 is intended for use in nuclear medicine procedures, including intraoperative procedures. To collect such information, it extracorporeally detects and visualizes the gamma ray emitted from an administered radiopharmaceutical. While previous gamma cameras have consisted of a sodium iodide scintillating crystal and photomultiplier tube (PMT), the design of the MGC-500 incorporates a solid-state CdTe semiconductor detector. This allows the device to be smaller, lighter, and more portable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
nuclear medicine procedures
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)
The Mini Gamma Camera MGC-500 was tested to the specifications of the The Minn Surmance Standard for scintillation cameras. It was also tested to the requirements of the IEC-60601-1 for electrical safety.
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.
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
§ 892.1100 Scintillation (gamma) camera.
(a)
Identification. A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. 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 I (general controls).
0
510(k) Summary
Mini Gamma Camera MGC-500
Classification Name: Scintillation Camera 21 CFR 892.1100
Acrorad Company, Ltd. 13-23 Suzaki Gushikawa-shi Okinawa 904-2234 JAPAN
Phone: (+081) 98-934-8960 Fax: (+081) 98-934-8961
Contact: Mivoko Nishikawa, Prepared: March 4, 2004
LEGALLY MARKETED PREDICATE DEVICE A.
The MGC-500 is substantially equivalent to the Digirad 2020 Notebook Imager, which was cleared by FDA on May 28, 1997 as K961104. For characteristic of intraoperative use, the MGC-500 is also the substantially equivalent to the Neoprobe 1500/2000 radioisotope detector (K971320).
DEVICE DESCRIPTION B.
The Mini Gamma Camera, MGC500, is a nuclear medical imager (commonly known as a scintillation or gamma camera) that is smaller, lighter and more portable than the existing gamma cameras. The MGC500 is intended for use in nuclear medicine procedures, including intraoperative procedures. To collect such information, it extracorporeally detects and visualizes the gamma ray emitted from an administered radiopharmaceutical. While previous gamma cameras have consisted of a sodium iodide scintillating crystal and photomultiplier tube (PMT), the design of the MGC-500 incorporates a solid-state CdTe semiconductor detector. This allows the device to be smaller, lighter, and more portable.
C. INTENDED USE
The Mini Gamma Camera MGC-500 is indicated for use in imaging the distribution of radionuclides in the human body using planer imaging The MGC-500 may also be used intraoperatively if a techniques. protective sheath is used.
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SUBSTANTIAL EQUIVALENCE SUMMARY D.
The MGC-500 is a medical device, and it has the same indications for use The MOO on a mount as the legally marketed predicate devices. The and targer population as the onomical characteristics as the predicate MGC-300 Thas the Same toonnistics of the device are sufficiently precise that performance data are not required, but for others, performance data that performance auta are no. The performance data and descriptions in is provided in this oubmison will demonstrate that the MGC-500 is substantially equivalent1 to the predicate devices.
TECHNOLOGICAL CHARACTERISTICS E.
The proposed and predicate devices both use a detector head that converts The proposed and prodicate al signals. The predicate device uses a photor chergy into bloosonvert gamma photon energy into visible light scirithlauing oct oryotar to our of the sensed by photo diodes and converted into electrical signals. The proposed Acrorad device converts gamma photons directly into electrical signals through use of a CdTe detector.
The electrical signals generated by the incoming gamma photons are The Clection of Signale generations. Discriminators are used in hardware proportional to onorg proposed and predicate devices to limit acceptable of soltware in both proposed of the radiopharmaceutical being used for imaging. The location of a gamma detection event is determined used for imaging. The channel of the detector, and standard image by the fissal algorithms are used to present the image to the user.
TESTING F.
The Mini Gamma Camera MGC-500 was tested to the specifications of the The Minn Surmance Standard for scintillation cameras. It was also tested to the requirements of the IEC-60601-1 for electrical safety.
CONCLUSIONS G.
This pre-market notification has demonstrated Substantial Equivalence as rms pro mainer stood in Sections 513(f)(1) and 513(i)(1) of the Federal delined and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.
The meaning of the terms "substantial equivalence" and "substantially equivalent" as used in l this 510(k) is limited to the terms "oubstance in, and used by FDA in accordance with, Sections this STO(K) is limited to the trefy they they they the Federal Food, Drug, and Cosmetic Act.
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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 stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.
Public Health Service · ·
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 4 2004
Acrorad Company, Ltd. % T. Whit Athey, Ph.D. Senior Consultant The Health Policy Resources Group, LLC 2305 Gold Mine Road, Suite 200 BROOKEVILLE MD 20833-2233
Re: K040587
Trade/Device Name: Mini Gamma Camera MGC-500 Regulation Number: 21 CFR 892.1100 Regulation Name: Scintillation (gamma) Camera Regulatory Class: II Product Code: 90 IYX Dated: March 5, 2004 Received: March 5, 2004
Dear Dr. Athey:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act), 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Nancy C. Brigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Mini Gamma Camera MGC-500 Device Name:
Indications For Use:
The Mini Gamma Camera MGC-500 is indicated for use in imaging the distribution of radionuclides in the human body using planer imaging techniques. The MGC-500 may also be used intraoperatively if a protective sheath is used.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ﺳﮯ (Per 21 CFR 801.109)
ાર
Over-The-Counter Use
David A. Lyman
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Device 510(k) Number.
000059