(204 days)
Not Found
No
The summary describes a physical medical device (angiographic catheter) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is used for diagnostic purposes (delivery of contrast medium for imaging selected sites in the vascular system), not for treating a disease or condition.
No
The device is used for the delivery of contrast medium, which aids in imaging, but it does not perform any diagnostic function itself. It is a tool for a separate diagnostic procedure.
No
The device description clearly states it is a physical catheter, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of radiopaque contrast medium to selected sites in the vascular system. This is an in vivo procedure, meaning it's performed within a living organism.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases or other conditions. This device does not perform such tests.
- Device Description: The description focuses on the physical characteristics of a catheter used for delivering substances into the body.
Therefore, the Cordis 5 F and 6 F Infiniti® Angiographic Catheters are medical devices used for a therapeutic or diagnostic procedure performed within the body, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Cordis 5 F and 6 F Infiniti® Angiographic Catheters are indicated for the delivery of radiopaque contrast medium to selected sites in the vascular system.
Cordis Angiographic Catheters are designed to deliver radiopaque contrast medium to selected sites in the vascular system.
Product codes
DOO
Device Description
The catheters included in this submission are 5 F and 6 F in diameter with a braided proximal shaft and a variety of tip configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
00-00034
PREMARKET NOTIFICATION 510(k) Cordis Corporation Infiniti® Angiographic Catheters Modification
SEP 30 1997
SUMMARY OF SAFETY AND EFFECTIVENESS
General Provisions l.
Common or Usual Name: Angiographic Catheter Proprietary Name: Cordis 5 F Infiniti® Angiographic Catheter Cordis 6 F Infiniti® Angiographic Catheter
11. Name of Predicate Devices
4 F Infiniti® Angiographic Catheter, K960975, April 02, 1996 6 F Paragon (Infiniti® ) Angiographic Catheter, K921310/A, Sept. 17, 1992
III. Classification
Class II
IV. Performance Standards
Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act.
V. Intended Use and Device Description
The Cordis 5 F and 6 F Infiniti® Angiographic Catheters are indicated for the delivery of radiopaque contrast medium to selected sites in the vascular system.
The catheters included in this submission are 5 F and 6 F in diameter with a braided proximal shaft and a variety of tip configurations.
VI. Biocompatibility
All appropriate biocompatibility tests were previously performed on the materials used for the 5 F and 6 F Infiniti® Angiographic Catheters. No new tests were performed, since all materials had been successfully tested on previously concurred devices.
1
PREMARKET NOTIFICATION 510(k) Cordis Corporation Infiniti® Angiographic Catheters Modification
VII. Summary of Substantial Equivalence
The Cordis 5 F and 6 F Infiniti® Angiographic Catheters are similar in design, construction, indication for use, and performance characteristics to other commercially angiographic catheters.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
SEP 3 0 1997
Elena S. Juqo, M.D. Cordis Corporation P.O. Box 025700 Miami, Florida 33102-5700
K970854 Re:
5 Fr and 6 Fr Infiniti® Angiographic Catheters Requlatory Class: II (two) Product Code: DOO Dated: July 2, 1997 Received: July 3, 1997
Dear Dr. Jugo:
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, Druq, 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 II (Special Controls) or 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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 regulations.
3
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) 594-4648. 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,
Thomas J. Callahon
Thomas J. Cal ahan Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
00-0.0053
PREMARKET NOTIFICATION 510(k) Cordis Corporation Infiniti® Angiographic Catheters Modification
510(k) Number (if known): ___________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
Cordis Angiographic Catheters are designed to deliver radiopaque contrast medium to selected sites in the vascular system.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ta. Re
(Division Sign-Off) (Division Sign-Olt)
Division of Cardiovascular, Respiratory,
Division of Cardiovascular, Respiratory, Division of Given and Neurological Devices
510(k) Number .
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)