(31 days)
Not Found
Not Found
No
The summary describes a standard catheter sheath introducer with no mention of AI or ML capabilities, image processing, or performance studies related to algorithmic analysis.
No
The device is described as an introducer for percutaneous introduction of intravascular devices, which facilitates a procedure but does not inherently provide therapy itself.
No
The device is described as an introducer for percutaneous introduction of intravascular devices, which is an interventional/surgical tool rather than a diagnostic one. Its purpose is to facilitate access for other devices, not to diagnose a condition.
No
The device description clearly outlines physical components (introducer, mini-guidewire, vessel dilator) made of various materials, indicating it is a hardware device, not software-only.
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 a procedural purpose, not for testing samples outside the body to diagnose a condition.
- Device Description: The description details a physical device (introducer, guidewire, dilator) designed to facilitate access to blood vessels. This is consistent with a surgical or interventional tool, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any diagnostic testing function.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is purely procedural.
N/A
Intended Use / Indications for Use
Cordis Catheter Sheath Introducers are intended for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
Product codes
DYB
Device Description
The system consists of an introducer, a mini-guidewire, and a vessel dilator. The introducer consists of a cannula of co-extruded polyethylene with barium sulfate, a high density polyethylene body, and polyurethane sideport extension. The radiopaque tip is made of a blend of tungsten, polyethylene, and zinc stearate.
• 4 - 9 French
• 3 - 120 cm length
• .035" - 038′ mini guidewire
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Arterial and venous
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)
Cordis Brite Tip Catheter Sheath Introducer
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
:
0CT 1 1998
Attachment 4
Summary of Safety and Effectiveness
| General Provisions | Trade Name: Cordis Brite Tip Catheter Sheath Introducer
Common/Classification Name: Catheter Introducer System |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of
Predicate
Devices | Cordis Brite Tip Catheter Sheath Introducer |
| Classification | Class II. |
| Performance
Standards | Performance standards have not been established by the FDA under section 514 of
the Food, Drug and Cosmetic Act. |
| Intended Use
and Device
Description | Cordis Catheter Sheath Introducers are intended for use in arterial and venous
procedures requiring percutaneous introduction of intravascular devices.
The device description of the Brite Tip CSI is as follows.
The system consists of an introducer, a mini-guidewire, and a vessel dilator. The
introducer consists of a cannula of co-extruded polyethylene with barium sulfate, a
high density polyethylene body, and polyurethane sideport extension.
The
radiopaque tip is made of a blend of tungsten, polyethylene, and zinc stearate.
• 4 - 9 French
• 3 - 120 cm length
• .035" - 038′ mini guidewire |
| Biocompatibility | All materials used in the Brite Tip CSI's are biocompatible. |
| Summary of
Substantial
Equivalence | The Brite Tip CSI's are substantially equivalent to the previously cleared Brite Tip
CSI's. |
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines that resemble a ribbon or wave. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 1998
Ms. Ariel MacTavish Sr. Requlatory Affairs Associate Cordis Corporation 14201 N.W. 60th Avenue Miami Lakes, FL 33014
Re: K983023 Trade Name: Cordis Brite Tip Catheter Sheath Introducer Regulatory Class: II Product Code: DYB Dated: September 22, 1998 Received: September 23, 1998
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 legally marketed predicate 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 Requlations, 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 (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will yerify 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
2
Page 2 - Ms. Ariel MacTavish
for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Attachment 2
Indications for Use Statement
| 510(k) Number (if known) | |
|---|---|
| Device Name | Brite Tip Catheter Sheath Introducer |
| 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 IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE) ్లో
స్టేషన్ స్టేషన్ Prescription Use _ Over-The-Counter Use_ OR (Per 21 CFR 801.109)