(89 days)
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No
The document describes a standard angiographic x-ray imaging system and does not mention any AI or ML components or capabilities.
No
The device is an angiographic x-ray imaging system used for diagnosis and imaging, not for treating a disease or condition.
Yes
The device is described as an "Angiographic x-ray imaging system" used for "cardiac catheterization procedures." Angiography and x-ray imaging are diagnostic modalities used to visualize internal structures for the purpose of diagnosis. The system's application in "reducing the time necessary for complex adult cardiac catheterization studies" and its value in "pediatric cardiology" by allowing "reduced use of contrast material" further indicate its role in obtaining visual information for diagnostic purposes, rather than direct treatment.
No
The device description explicitly states it is an "Angiographic x-ray imaging 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:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Unicath SP Biplane System is an imaging system that uses X-rays to visualize the heart and coronary arteries. It does not perform tests on biological samples.
- Intended Use: The intended use describes the device as an "Angiographic x-ray imaging system" for "cardiac catheterization procedures." This involves direct imaging of the body, not analysis of samples.
Therefore, the Unicath SP Biplane System falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Unicath SP Biplane System is an Angiographic x-ray imaging system designed for those cardiac catheterization procedures requiring two simultaneous images of the heart and/or coronary arteries. Such systems are used to reduce the time necessary for complex adult cardiac catheterization studies, but they are particularly valuable in pediatric cardiology where biplane imaging allows reduced use of contrast material due to the need for fewer injections. This is a great advantage since contrast causes significant discomfort in children and carries with it an increased health risk for them. The System is designed to be operated by professional medical personnel only.
Product codes
90 JAA, 90 IZI
Device Description
Unicath SP BI-Plane (models M269 & M289 combined)
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Angiographic x-ray
Anatomical Site
Heart and/or coronary arteries
Indicated Patient Age Range
Adult, pediatric
Intended User / Care Setting
professional medical personnel
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, facing right. The eagle is composed of three curved lines that suggest movement and flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 29 1997
Wayne V. Loomer Director, Quality Assurance and Regulatory Affairs 300 Foster St. Littleton, MA 01460
Re: K973744
Unicath SP BI-Plane (models M269 & M289 combined) Dated: September 29, 1997 Received: October 1, 1997 Regulatory class: II 21 CFR 892.1650/Procode: 90 JAA 21 CFR 892.1600/Procode: 90 IZI
Dear Mr. Loomer:
We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent 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, 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 misbranion.
If your device is classified (see above) into either class II (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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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, 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 vours.
h.J.Liau Yu
Lillian 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
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510(k) Number (if known): K973744
Device Name: _ Unicath SP BI-Plane
Indications For Use:
The Unicath SP Biplane System is an Angiographic x-ray imaging system designed for those cardiac catheterization procedures requiring two simultaneous images of the heart and/or coronary arteries. Such systems are used to reduce the time necessary for complex adult cardiac catheterization studies, but they are particularly valuable in pediatric cardiology where biplane imaging allows reduced use of contrast material due to the need for fewer injections. This is a great advantage since contrast causes significant discomfort in children and carries with it an increased health risk for them. The System is designed to be operated by professional medical personnel only.
(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)
ા કરર
OR
Over-The-Counter Use
(Optional Format 1-2-96) .....
William
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K973744