(470 days)
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Not Found
No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or specific AI/ML-driven features. The description focuses on the core functionality of a standard fluoroscopic X-ray system.
No
The device is described as an image-intensified fluoroscopic X-ray system used for diagnostic imaging and interventional procedures, which are typically for diagnosis or for guiding therapeutic interventions, but not therapeutic in themselves.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "used for diagnostic imaging".
No
The device description explicitly states it is an "Image-intensified fluoroscopic X-ray system," which is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as an "Image-intensified fluoroscopic X-ray system" used for "diagnostic imaging and interventional procedures." These procedures involve imaging the inside of the body using X-rays, which is an in vivo (within the living body) process.
- Device Description: The description confirms it's an "Image-intensified fluoroscopic X-ray system," reinforcing its function as an imaging device used on a living patient.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. The provided information does not mention any analysis of biological samples.
Therefore, the Trinias is an in vivo diagnostic and interventional imaging system, not an IVD.
N/A
Intended Use / Indications for Use
- The Trinias is an Image-intensified fluoroscopic X-ray system, which is used for diagnostic imaging and interventional procedures as described in 21 CFR 892.1650.
- The Trinias is intended to be used for cardiac angiography, abdominal angiography, abdominal angiography, peripheral angiography, rolational angiography, multi-purpose angiography and whole body radiographic filluoroscopic procedures.
- The Trinias is intended to be used for interventional procedures such as invasive cardiology and interventional neuroradiology.
Product codes (comma separated list FDA assigned to the subject device)
OWB, JAA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Image-intensified fluoroscopic X-ray
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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.
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).
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§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 26, 2014
SHIMADZU Corporation % Mr. Don Karle Manager, Customer Service Shimadzu Medical Systems 20101 South Vermont Avenue TORRANCE CA 90202-1328
Re: K123508
Trade/Device Name: Trinias Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA Dated: February 7, 2014 Received: February 12, 2014
Dear Mr. Karle:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class 11 (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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Page 2-Mr. Karle
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Sm. 7)
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K123508
Device Name Trinias
Indications for Use (Describe)
-
The Trinias is an Image-intensified fluoroscopic X-ray system, which is used for diagnostic imaging and interventional procedures as described in 21 CFR 892.1650.
-
The Trinias is intended to be used for cardiac angiography, abdominal angiography, abdominal angiography, peripheral angiography, rolational angiography, multi-purpose angiography and whole body radiographic filluoroscopic procedures.
. The Trinias is intended to be used for interventional procedures such as invasive cardiology and interventional neuroradiology.
Type of Use (Select one or both, as applicable)
Z Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED,
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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FORM FDA 3881 (9/13)
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