MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM by CORDIS CORP.

Cordis Catheter Sheath Introducers are intended for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.

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

AI/ML Overview

This document is a 510(k) premarket notification for the Cordis Brite Tip Catheter Sheath Introducer and does not contain information about acceptance criteria or a study proving the device meets them.

The document primarily focuses on demonstrating "substantial equivalence" to a predicate device, which is a regulatory pathway used when a new device is as safe and effective as an already legally marketed device. This pathway typically relies on demonstrating similar technological characteristics and intended use, rather than presenting a full study with acceptance criteria and performance metrics.

Therefore, I cannot extract the requested information as it is not present in the provided text.

Summary

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0CT 1 1998

Attachment 4

Summary of Safety and Effectiveness

General Provisions	Trade Name: Cordis Brite Tip Catheter Sheath IntroducerCommon/Classification Name: Catheter Introducer System
Name ofPredicateDevices	Cordis Brite Tip Catheter Sheath Introducer
Classification	Class II.
PerformanceStandards	Performance standards have not been established by the FDA under section 514 ofthe Food, Drug and Cosmetic Act.
Intended Useand DeviceDescription	Cordis Catheter Sheath Introducers are intended for use in arterial and venousprocedures 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. Theintroducer consists of a cannula of co-extruded polyethylene with barium sulfate, ahigh density polyethylene body, and polyurethane sideport extension.Theradiopaque 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 ofSubstantialEquivalence	The Brite Tip CSI's are substantially equivalent to the previously cleared Brite TipCSI's.

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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

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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

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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)

Regulation Number and Section

§ 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).