(205 days)
No
The summary describes a collimator, a passive component of a nuclear medicine imaging system, and does not mention any software or processing capabilities that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No
The device is described as a collimator for a nuclear medicine imaging system; its intended use is to detect or image the distribution of radionuclides, which is a diagnostic function, not a therapeutic one.
Yes
Explanation: The device is used "To detect or image the distribution of radionuclides in the body or in organ," which is a process to provide information used in diagnosing medical conditions.
No
The device description explicitly states "511 keV Collimator for TRIONIX Triad," which is a hardware component used in nuclear medicine imaging.
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 in organ." This describes an in vivo (within the living body) diagnostic procedure, not an in vitro (outside the living body) diagnostic procedure.
- Device Description: The device is a "511 keV Collimator for TRIONIX Triad." A collimator is a component of a nuclear medicine imaging system, which is used for in vivo imaging.
- Input Imaging Modality: The input imaging modality is "Nuclear Medicine," which is an in vivo imaging technique.
- Anatomical Site: The anatomical site is "body or in organ," further indicating an in vivo application.
IVD devices are typically used to examine specimens (like blood, urine, tissue) taken from the body to diagnose diseases or conditions. This device is used to image the distribution of substances within the body.
N/A
Intended Use / Indications for Use
To detect or image the distribution of radionuclides in the body or in organ, using the following technique(s).
A. Planar imaging: YES, Energy Range (keV): 511 keV
B. Whole body imaging: YES, Energy Range (keV): 511 keV
C. Tomographic imaging (SPECT) for non Positron emitter: YES, Energy Range (keV): 511 keV
D. Positron imaging by coincidence: NO
E. Positron imaging without coincidence: YES
F. Other indication(s) in the device label, but not included in above list: Could be used with 511 keV photo imaging and photons of smaller energy simultaneously (e.g. 140 keV and 511 keV)
Product codes
90 KPS
Device Description
511 keV Collimator for TRIONIX Triad; 511 keV collimator for T88; 511 keV Collimator for cardiac Triad (9" and 20")
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Nuclear Medicine Device
Anatomical Site
body or organ
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 9 1997
Ms. Daphne Reed Manager, Regulatory Affairs TRIONIX Research Laboratory, Inc. 8037 Bavaria Road .................. Twinsburg, OH 44087
Re: K964438
511 keV Collimator for TRIONIX Triad Dated: April 4, 1997 Received: April 8, 1997-Regulatory Class: II 21 CFR 892.1200/Procode: 90 KPS
Dear Ms. Reed:
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, 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 proctibitions against misforanding 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 in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 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 predication 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 vitto diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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/dsmamain.html".
Sincerely yours,
William Yu
Lilian 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
1
Response to Question 1 ATTACH ment 1
2 Page_1 . of
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
511 keV collimator for T88 (_K873775/A) Device Name: _________________________________________________________________________________________________________________________________________________________________
Nuclear Medicine Device
Indication For Use: To detect or image the distribution of radionuclides in the body or in organ, using the following technique(s).
| YES | NO | Energy Range (keV) | ||
|---|---|---|---|---|
| A. | Planar imaging | x | 511 keV | |
| B. | Whole body imaging | x | 511 keV | |
| C. | Tomographic imaging (SPECT) for non Positron emitter | x | 511 keV | |
| D. | Positron imaging by coincidence | x | ||
| E. | Positron imaging without coincidence | x | ||
| F. | Other indication(s) in the device label, but not included in above list | Could be used with 511 keV photo imaging and photons of smaller energy simultaneously (e.g. 140 keV and 511 keV) |
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) |
| OR | Over-the-Counter Use |
|---|---|
| ---- | ---------------------- |
| (Division Sign-Off) | |
|---|---|
| --------------------- | -- |
| (Division Sign-Off) | |
|---|---|
| Division | ductive, Abdominal, ENT, |
| a | al Devices |
| 510(k) Number | K964438 |
(Optional Rormat 1-2-96)
2
Page 2_ of _2
K964438 510(k) Number (if known):_ 511 keV Collimator for cardiac Triad (9" and 20") Devicc Name:_ (K920776)(K923345)
Nuclear Medicine Device
Indication 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 | 511 keV | |
| B. | Whole body imaging | X | 511 keV | |
| C. | Tomographic imaging (SPECT) for non Positron emitter | X | 511 keV | |
| D. | Positron imaging by coincidence | X | ||
| E. | Positron imaging without coincidence | X | ||
| F. | Other indication(s) in the device label, but not included in above list | Could be used with 511 keV | ||
| photon imaging and photons of | ||||
| smaller energy simultaneously | ||||
| (e.g 140 keV and 511 keV) |
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use L (Per 21 CFR 801.109)
| Division Sign Off | |
|---|---|
| OR | |
| Over-the-Counter Use |
(Division Sign-Off) Division a Penroductive, Abdominal, ENT, and i crogical Deyic
५ :
i Number
nat 1-2-96)