MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM

K983023 · Cordis Corp. · DYB · Oct 1, 1998 · Cardiovascular

Device Facts

• Record ID: K983023
• Device Name: MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
• Applicant: Cordis Corp.
• Product Code: DYB · Cardiovascular
• Decision Date: Oct 1, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

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

Device Story

System consists of introducer, mini-guidewire, and vessel dilator; used for percutaneous access in arterial and venous procedures. Introducer features co-extruded polyethylene cannula with barium sulfate, high-density polyethylene body, and polyurethane sideport extension; radiopaque tip composed of tungsten, polyethylene, and zinc stearate. Device facilitates insertion of intravascular devices into vasculature. Operated by clinicians in clinical settings. Provides access point for interventional procedures; benefits patient by enabling minimally invasive vascular access.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: co-extruded polyethylene with barium sulfate, high-density polyethylene, polyurethane, tungsten, zinc stearate. Form factor: 4-9 French diameter, 3-120 cm length. Includes .035"-.038" mini-guidewire. Radiopaque tip. Non-powered, mechanical device.

Indications for Use

Indicated for patients undergoing arterial and venous procedures requiring percutaneous introduction of intravascular devices.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Cordis Brite Tip Catheter Sheath Introducer

Submission Summary (Full Text)

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0CT 1 1998

## Attachment 4

## Summary of Safety and Effectiveness

| General Provisions | Trade Name: Cordis Brite Tip Catheter Sheath Introducer<br>Common/Classification Name: Catheter Introducer System |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of<br>Predicate<br>Devices | Cordis Brite Tip Catheter Sheath Introducer |
| Classification | Class II. |
| Performance<br>Standards | Performance standards have not been established by the FDA under section 514 of<br>the Food, Drug and Cosmetic Act. |
| Intended Use<br>and Device<br>Description | Cordis Catheter Sheath Introducers are intended for use in arterial and venous<br>procedures requiring percutaneous introduction of intravascular devices.<br>The device description of the Brite Tip CSI is as follows.<br>The system consists of an introducer, a mini-guidewire, and a vessel dilator. The<br>introducer consists of a cannula of co-extruded polyethylene with barium sulfate, a<br>high density polyethylene body, and polyurethane sideport extension.<br>The<br>radiopaque tip is made of a blend of tungsten, polyethylene, and zinc stearate.<br>• 4 - 9 French<br>• 3 - 120 cm length<br>• .035" - 038′ mini guidewire |
| Biocompatibility | All materials used in the Brite Tip CSI's are biocompatible. |
| Summary of<br>Substantial<br>Equivalence | The Brite Tip CSI's are substantially equivalent to the previously cleared Brite Tip<br>CSI'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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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. |

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