(57 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms in medical imaging.
No
The device is described as generating real-time fluoroscopic images, which is a diagnostic function, not a therapeutic one.
Yes
The device is used to generate "real time fluoroscopic images in patients where medically indicated," which implies its use in diagnosing medical conditions by visualizing internal structures.
No
The device description explicitly states "VASCO scanning beam digital x-ray System," indicating it includes hardware components for generating x-ray images.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for generating real-time fluoroscopic images in patients. This indicates the device is used directly on a living organism for diagnostic purposes, which is characteristic of an in vivo diagnostic device, not an in vitro diagnostic device.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, outside of the body. This device does not operate on such samples.
- Device Description: The description "VASCO SYSTEM" and the input modality "digital x-ray" further support that this is an imaging system used on a patient, not a laboratory test.
Therefore, the Cardiac Mariners, Inc. VASCO scanning beam digital x-ray System is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cardiac Mariners, Inc. VASCO scanning beam digital x-ray System is intended for use in generating real time fluoroscopic images in patients where medically indicated.
Product codes
90 JAA
Device Description
VASCO scanning beam digital x-ray System
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Rockville MD 20850
Food and Drug Administration 9200 Corporate Boulevard
Image /page/0/Picture/2 description: The image shows a partial view of the Department of Health & Human Services logo. The logo includes the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of three abstract human figures, possibly representing individuals or families, with flowing lines suggesting movement or connection.
SEP 0008
E. Bruce Floyd Regulatory Afairs/Quality Assurance Cardiac Mariners, Inc. 120-B Albright Way Los Gatos, California 95030
Re:
K982345 Vasco Scanning Beam Dated: June 26, 1998 Received: July 6, 1998 Regulatory Class: II 21 CFR 892.1650/Procode 90 JAA
Dear Mr. Floyd:
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 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 your 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 (OS) 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 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 question 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/cdrb/dsmaldsmamain.html".
Sincerely yours,
Killian Yin, Ph.D.
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
Enclosure
1
Statement of Intended Use Cardiac Mariners, Inc.
VASCO SYSTEM
The Cardiac Mariners, Inc. VASCO scanning beam digital x-ray System is THE Ourdlations, mor in generating real time fluoroscopic images in patients where medically indicated.
Gind le. Segem
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number
PRESCRIPTION USE ✓
(PER 21 CFR 801.109)
Cardiac Mariners, Inc. 120-B Albright Way Los Gatos, CA 95030 Tel: (408) 379-6600