(90 days)
The Dilon 2000 Digital Gamma Camera is intended to be used to measure and image the distribution of selected single photon emitting radioisotopes in the human body. The resulting images are intended to be reviewed by qualified medical personnel.
To detect or image the distribution of radionuclides in the body or organ, using the following technique(s).
A. Planar Imaging
Energy Range (keV): 100 to 200
The Dilon 2000 is a high resolution, small field of view, portable gamma camera designed for general use in imaging radio pharmaceuticals.
The primary components of the Dilon 2000 are:
Detector Head: contains a two dimensional array of scintillation crystals, an array of position sensitive photomultiplier tubes and signal amplification and discrimination electronics.
Gantry Arm: safely supports the detector as positioned by the technologist operating the camera. Counter balancing is provided to hold the detector in its last position.
Mobile Cabinet: Contains data acquisition electronics, image development computer and Segami Pegasus™ imaging software. The cabinet also contains power filtering, isolation and a high voltage power supply.
This submission is for a Dilon 2000 Gamma Camera. The document does not describe a study to prove the device meets acceptance criteria, but rather states that "Images and performance testing data were collected on a prototype camera. Image quality and camera usage is equivalent to that of the predicate devices."
Therefore, I cannot provide all the requested information, particularly regarding specific acceptance criteria metrics, sample sizes, expert qualifications, or comparative effectiveness studies, as these details are not present in the provided text.
Here's a summary of what can be extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria or provide a table of performance metrics. It generally states: "Image quality and camera usage is equivalent to that of the predicate devices."
2. Sample Size Used for the Test Set and Data Provenance:
Not specified in the provided text. The document only mentions "Images and performance testing data were collected on a prototype camera."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not specified in the provided text.
4. Adjudication Method for the Test Set:
Not specified in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study is not mentioned. The document focuses on demonstrating substantial equivalence to predicate devices, not on comparing human reader performance with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
This device is a gamma camera, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance as typically understood for AI-powered devices does not apply in this context. The device's performance inherently involves image acquisition, processing (by the system's software, Segami Pegasus™ imaging software), and then review by qualified medical personnel.
7. The Type of Ground Truth Used:
Not explicitly stated. Given that the device images the distribution of radioisotopes, the ground truth would typically be established through the physical properties of the radioisotopes and their known distribution patterns, potentially corroborated by other diagnostic methods, but this is not detailed in the provided text.
8. The Sample Size for the Training Set:
Not applicable or specified. This device is a gamma camera, not a machine learning algorithm that requires a separate training set in the conventional sense. The "training" here would relate to the design and calibration of the camera's components and software based on established physics and medical imaging principles.
9. How the Ground Truth for the Training Set Was Established:
Not applicable or specified, as this is a hardware device with associated software, not a machine learning model requiring a ground-truthed training set.
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Section E - 510(k) Summary
- General Information .
| A. | Submitted By: | Dilon Technologies Inc.12050 Jefferson Ave., Suite 250Newport News, VA 23606Tel: 757-269-4910Fax: 757-269-4912 |
|---|---|---|
| Contact Person: | Lee H. FairchildTel: 757-269-4910Fax: 757-269-4912Email: lfairchild@dilon.com | |
| B. | Device Trade Name:Common Name:Classification Name: | Dilon 2000Gamma Camera SystemScintillation (Gamma) Camera |
| C. | Predicate Devices: | ADAC Transcam (K924639) |
| D. | Device Description: |
The Dilon 2000 is a high resolution, small field of view, portable gamma camera designed for general use in imaging radio pharmaceuticals.
The primary components of the Dilon 2000 are:
Detector Head: contains a two dimensional array of scintillation crystals, an array of position sensitive photomultiplier tubes and signal amplification and discrimination electronics.
Gantry Arm: safely supports the detector as positioned by the technologist operating the camera. Counter balancing is provided to hold the detector in its last position.
Mobile Cabinet: Contains data acquisition electronics, image development computer and Segami Pegasus™ imaging software. The cabinet also contains power filtering, isolation and a high voltage power supply.
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D. Intended Use:
The Dilon 2000 Digital Gamma Camera is intended to be used to measure and image the distribution of selected single photon emitting radioisotopes in the human body. The resulting images are intended to be reviewed by qualified medical personnel.
- E. Substantial Equivalence:
The Dilon 2000 has the same indications for use as the predicate gamma cameras and employs equivalent gamma detection technology.
II. Testing
Images and performance testing data were collected on a prototype camera. Image quality and camera usage is equivalent to that of the predicate devices.
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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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 6 1999
Lee H. Fairchild Director of Product Marketing Dilon Technologies Inc. Applied Research Center 12050 Jefferson Ave., Suite 250 Newport News, VA 23606
Re:
K984466 Dilon 2000 Gamma Camera Dated: December 14, 1998 Received: December 16, 1998 Regulatory class: I 21 CFR 892.1100/Procode: 90 IYX
Dear Mr. Fairchild:
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 acturined the devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the manced production as noo more with the been reclassified in accordance with the provisions of the Mourdines Annoneneric 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 if your device is dazence (oo above) institutions affecting your device can be found in the Code of be days to udalland Controls. 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 regarding action. In addition, 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, the promotes and and which the titled, "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,
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
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510(k) Number (if known): K984466 Device Name: Dilon 2000
Nuclear Medicine Devices
Indications For Use: To detect or image the distribution of radionuclides in the body or organ, using the following technique(s).
| YES | NO | Energy Range (keV) | |
|---|---|---|---|
| A. Planar Imaging | X | 100 to 200 | |
| B. Whole body imaging | X | ||
| C. Tomographic imaging (SPECT) fornon Positron emitter | X | ||
| D. Positron imaging by coincidence | X | ||
| E. Positron imaging without coincidence | X | ||
| F. Other indication(s) in the device label,but not included in the above list | X |
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
sion Sign-Off)
sion of Reproductive, Abdominal, ENT,
ud Radiological Device
k) Number K984466
Prescription Use OR
(Per 21 CFR 801.109)
OR
Over-the-Counter Use
§ 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).