(73 days)
Not Found
No
The document describes a standard catheter sheath introducer and does not mention any AI or ML components or functionalities.
No
The device is described as an introducer system for percutaneous introduction of intravascular devices, providing vascular access and maintaining hemostasis. It facilitates procedures rather than directly treating a condition or disease.
No
The device is described as an introducer system for percutaneous introduction of intravascular devices and does not mention any diagnostic capabilities.
No
The device description clearly describes a physical catheter sheath introducer system, which is a hardware device. There is no mention of software as the primary or sole 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 "percutaneous introduction of intravascular devices" in arterial and venous procedures. This describes a device used within the body for accessing blood vessels, not a device used to test samples outside the body.
- Device Description: The description reinforces this by stating it provides "vascular access" and allows for "infusion of fluids" and "withdrawal of blood" through a sideport. These are actions performed directly on the patient's circulatory system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) to diagnose a condition, monitor treatment, or screen for diseases. The device's function is purely procedural for accessing the vasculature.
Therefore, this device falls under the category of a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The line extensions for Brite Tip® Catheter Sheath Introducer System is indicated for use in arterial and venous procedures requiring percutaneous introduction of catheters and other intravascular devices.
As with other currently marketed Cordis CSIs mentioned in this submission, these devices provide vascular access for various intravascular devices through the valve while simultaneously maintaining hemostasis. Infusion of fluids into the vasculature and withdrawal of blood from the vasculature are possible using the sheath sideport.
Product codes
74 DYB
Device Description
The modified Cordis Brite Tip® Catheter Sheath Introducer System is similar in design, constructions, indication for use, and performance characteristics to other commercially available sheath introducers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
00-00026 K9174448
PREMARKET NOTIFICATION 510(k) Cordis, a Johnson and Johnson company Brite Tip® Catheter Sheath Introducer (Modification K971608)
6 1008 구 3
SUMMARY OF SAFETY AND EFFECTIVENESS
General Provisions l.
Common or Usual Name: Catheter Sheath Introducer or Sheath Introducer System. Proprietary Name: Cordis Brite Tip® Catheter Sheath Introducer System.
.. Name of Predicate Device
Brite Tip® Catheter Sheath Introducer System, K971608.
III. Classification
Class II
N. 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 line extensions for Brite Tip® Catheter Sheath Introducer System is indicated for use in arterial and venous procedures requiring percutaneous introduction of catheters and other intravascular devices.
As with other currently marketed Cordis CSIs mentioned in this submission, these devices provide vascular access for various intravascular devices through the valve while simultaneously maintaining hemostasis. Infusion of fluids into the vasculature and withdrawal of blood from the vasculature are possible using the sheath sideport.
VI. Biocompatibility
All materials used in the line extensions for Cordis Brite Tip® Catheter Sheath Introducer System had been successfully tested on previously concurred devices. Since all appropriate biocompatibility tests were previously performed on these materials, testing was not repeated.
VII. Summary of Substantial Equivalence
The modified Cordis Brite Tip® Catheter Sheath Introducer System is similar in design, constructions, indication for use, and performance characteristics to other commercially available sheath introducers.
1
Rockville MD 20857
First e 1998
Ms, Ariel MacTavish Sr. Requlatory Affairs Associate Cordis Corporation P.O. Box 025700 Miami, FL 33102-5700
K974448 Re: Brite Tip® Catheter Sheath Introducer System Regulatory Class: II (two) Product Code: 74 DYB Dated: November 24, 1997 Received: November 25, 1997
Dear Ms. MacTavish:
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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 Failure to comply with the GMP regulation may result in assumptions. requlatory 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.
2
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 requlation 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. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
00-00051
PREMARKET NOTIFICATION 510(k) Cordis Corporation Brite Tip® Catheter Sheath Introducer
510(k) Number (if known):
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications for Use:
Cordis Catheter Sheath Introducers are intended for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
T.A.V.
(D. Off)
[ ardiovascular, Respiratory,
2. :ical Devices K974448
5. Number
Prescription Use
(Per 21 CFR 801.109)
1
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________