(162 days)
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No
The summary does not mention AI, ML, or related terms, and the description focuses on hardware and software for attenuation correction in a gamma camera system.
No
The device is described as being used for "diagnostic imaging," specifically to "detect or image the distribution of radionuclides in the body or organ." It is intended to help diagnose conditions, not treat them.
Yes
The "Intended Use / Indications for Use" states its purpose is "To detect or image the distribution of radionuclides in the body or organ," and the "Device Description" explicitly says, "This device is intended to be used for diagnostic imaging of organs and lesions." Additionally, the "Intended User / Care Setting" mentions "Nuclear Medicine diagnostic examinations."
No
The device description explicitly states that the device includes adding hardware and software to a gamma camera system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "detect or image the distribution of radionuclides in the body or organ" using SPECT. This describes an in vivo (within the living body) diagnostic imaging procedure, not an in vitro (outside the living body) test.
- Device Description: The device is described as adding hardware and software to a gamma camera system for diagnostic imaging of organs and lesions. Gamma cameras are used for nuclear medicine imaging, which is an in vivo technique.
- Input Imaging Modality: The input is a "Gamma camera system," which is used for in vivo imaging.
IVD devices are typically used to examine specimens (like blood, urine, tissue) taken from the body to diagnose diseases or conditions. This device operates by detecting radiation emitted from within the patient's body.
N/A
Intended Use / Indications for Use
The Beacon system is a new option for non-uniform attenuation correction on the Axis or Irix gamma camera systems. This device is intended to be used for diagnostic imaging of organs and lesions. There is no change of intended use from that of the predicate device.
To detect or image the distribution of radionuclides in the body or organ, using the following technique(s): C. Tomographic imaging (SPECT) for non Positron emitter Energy Range (keV) 50-550
Product codes (comma separated list FDA assigned to the subject device)
90 KPS
Device Description
This device includes adding hardware and software to a gamma camera system.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Gamma camera system
Anatomical Site
Organs and lesions
Indicated Patient Age Range
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Intended User / Care Setting
Trained health care professionals who are responsible for Nuclear Medicine diagnostic examinations will operate the system.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
PICKER INTERNATIONAL 510(k) NOTICE
BEACON S SYSTEM
E: SUMMARY OF SAFETY AND EFFECTIVENESS
This is a summary of the information submitted by Picker International, Inc. to the Office of Device Evaluation (DRAERD) of the FDA as required by the Federal Food, Drug, and Cosmetic Act as amended on November 18, 1990 in section 807.92(c) for the Beacon system.
The Beacon system is a new option for non-uniform attenuation correction on the Axis or Irix gamma camera systems. This device is intended to be used for diagnostic imaging of organs and lesions. There is no change of intended use from that of the predicate device. This device includes adding hardware and software to a gamma camera system.
Functional specifications and operator's instructions (preliminary) are included in the attachments. Final documentation will be provided with productions units.
The Beacon system is substantially equivalent to legally marketed devices. Trained health care professionals who are responsible for Nuclear Medicine diagnostic examinations will operate the system. The Beacon system will be certified to electrical safety standards (IEC-601 or UL-544) by a third party organization prior to use on human patients. Labeling (Product Bulletin and Operator's Guide) will be provided to the user of the equipment.
This device will be developed to our quality system which includes design controls. The quality standard procedure OI 2300 "Program Planning and Control System" defines how an engineering project goes from concept to closure. This procedure complies with the FDA-OSR regulation and the ISO-9001 standard.
Picker has reviewed all known information and performed an investigation as to the causes of safety and effectiveness concerning the Beacon. In addition, all information contained in this 510(k) Notice is accurate and complete.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol in a circular fashion. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 6 1999
Norman J. Yager Manager, OA/Regulatory Picker International, Inc. Nuclear Medicine Division 595 Miner Road Highland Heights. Ohio 44143 Re:
Beacon-S Model 211060 Dated: February 26, 1999 Received: March 1, 1999 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS
Dear Mr. Yager:
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 vour 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 requlations,
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 requlation 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,
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
2
-16-
K983948 510(k) Number (if known): BEACON-S Device Name: ._
..............................................................................................................................................................................
Nuclear Medicine Device
Indication For Use: To detect or image the distribution of radionuclides in the body or organ, using the following tochnique(s).
| YES | NO | Energy Range (keV) | ||
|---|---|---|---|---|
| A. Planar imaging | X | |||
| B. | Whole body imaging | X | ||
| C. Tomographic imaging (SPECT) for non Positron emitter | X | 50-550 | ||
| D. Positron imaging by coincidence | X | |||
| E. | Po-itron imaging without coincidence | X | ||
| F. | Other indication(s) in the device label, but not included in above list | N.A. |
(Pliase do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
F'rescription Lise
(Per 21 CFR 801.109)
OR
Over-the-Counter Use
(Optional Formx 1-2-96)
(Division Sign-Of)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K983948