(70 days)
Not Found
No
The summary describes a standard angiography catheter for delivering contrast medium and makes no mention of AI or ML capabilities, image processing, or performance studies related to algorithmic analysis.
No
The device is described as a catheter used to deliver contrast medium for diagnostic imaging (angiography), rather than for treating a disease or condition.
No
The device is used to deliver contrast medium for imaging, not to diagnose a condition itself. Its function is interventional, aiding in visualization rather than providing diagnostic information from its own operation.
No
The device description clearly states it is a physical catheter with a radiopaque body and tip, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver radiopaque contrast medium to selected sites in the vascular system." This describes a device used within the body for a diagnostic imaging procedure, not a device used to test samples outside the body (which is the definition of an IVD).
- Device Description: The description of a "single lumen catheter with a radiopaque body and tip" is consistent with a device used for angiography, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, the Cordis Angiography Catheters described are medical devices used for diagnostic imaging procedures, but they are not IVDs.
N/A
Intended Use / Indications for Use
The Cordis 4 F and 5 F Nylex™ Angiography Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vasculature.
Cordis Angiography Catheters are designed to deliver radiopaque contrast medium to selected sites in the vascular system.
Product codes
DQO
Device Description
The catheters included in this submission are single lumen catheters with a radiopaque body and tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vasculature / 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
00-00033
PREMARKET NOTIFICATION 510(k) Cordis Corporation 4 F and 5 F Nylex™ Angiography Catheters Modification
JUL | 4 1997 SUMMARY OF SAFETY AND EFFECTIVENESS
- General Provisions 1.
Common or Usual Name: Diagnostic and Intravascular Catheter and Percutaneous Catheter
Proprietary Name: Cordis 4 F Nylex™ Angiography Catheter and Cordis 5 F Nylex™ Angiography Catheter
-
Name of Predicate Devices 11.
Cordis Corporation 4 F Nylex™ Angiography Catheter (K962759) Cordis Corporation 5 F Nylex™ Angiography Catheter (K930479) Cordis Corporation Envoy™ and Vista Brite Tip™ Guiding Catheter (K962362) -
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 4 F and 5 F Nylex™ Angiography Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vasculature.
The catheters included in this submission are single lumen catheters with a radiopaque body and tip.
- VI. Biocompatibility
All appropriate biocompatibility tests have been performed on the materials used for the modified 4 F and 5 F Nylex™ Angiography Catheters.
1
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PREMARKET NOTIFICATION 510(k) Cordis Corporation 4 F and 5 F Nylex™ Angiography Catheters Modification
Summary of Substantial Equivalence VII.
The Cordis F 4 and F 5 Nylex™ Angiography Catheters are similar in design, construction, indication for use and performance characteristics to other commercially available angiography catheters.
A statement of substantial equivalence to another product is required by 21CFR 807.87, and relates only to whether the present product can be marketed without prior reclassification or clinical approval. The present submission is therefore not related to the coverage of any patent, and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the Commissioner of the FDA has stated, " .. a determination of substantial equivalence under the federal Food, Drug, and Cosmetic Act relates to the fact that the product can lawfully be marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatever on the resolution of patent infringement suits" 42 Fed. Reg. 42,520, et seg. (1977)
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a white circle with a stylized caduceus symbol inside, which is a staff with two snakes coiled around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Elena S. Jugo, M.D. Manager, Regulatory and Clinical Affairs Cordis Corporation P.O. Box 025700 Miami, Florida 33102-5700
JUL 1 4 1997
Re: K971646 4 Fr and 5 Fr Nylex™ Angiography Catheters Regulatory Class: II (two) Product Code: DQO Dated: May 2, 1997 Received: May 5, 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, 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 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 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 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), přease 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. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
PREMARKET NOTIFICATION 510(k) Cordis Corporation 4 F and 5 F Nylex™ Angiography Catheters Modification
00-00055
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: 4 E and 5 E Nylex TM Angiography Catheters_________
Indications for Use:
Cordis Angiography 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)
ThAK
(Division Sign-On
Division of Caronwascular Respiratory,
and Neurological Devices 71146
510(k) Number -
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use