CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM

K984500 · Cordis Corp. · DYB · Dec 23, 1998 · Cardiovascular

Device Facts

• Record ID: K984500
• Device Name: CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
• Applicant: Cordis Corp.
• Product Code: DYB · Cardiovascular
• Decision Date: Dec 23, 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

The Cordis Brite Tip Catheter Sheath Introducer is a system used for percutaneous access to the vascular system. It consists of an introducer cannula, a vessel dilator, and a mini-guidewire. The device is used by clinicians in clinical settings to facilitate the introduction of other intravascular devices into the arterial or venous system. The cannula is constructed from co-extruded polyethylene with barium sulfate, a high-density polyethylene body, and a polyurethane sideport extension. The radiopaque tip is a blend of tungsten, polyethylene, and zinc stearate. The system is available in sizes ranging from 4 to 11 French and lengths from 3 to 120 cm, with .035" to .038" mini-guidewires.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material characteristics.

Technological Characteristics

System includes introducer cannula (co-extruded polyethylene with barium sulfate, high-density polyethylene body, polyurethane sideport), vessel dilator, and mini-guidewire. Radiopaque tip composed of tungsten, polyethylene, and zinc stearate. Sizes: 4-11 French; lengths: 3-120 cm; guidewire diameters: .035"-.038". Biocompatible materials. Non-powered, mechanical device.

Indications for Use

Indicated for patients undergoing arterial or 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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## Attachment 4

## Summary of Safety and Effectiveness

| General<br>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. The<br>radiopaque tip is made of a blend of tungsten, polyethylene, and zinc stearate.<br>• 4 - 11 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

DEC 2 3 1998

Ms. Ariel MacTavish Sr. Requlatory Affairs Associates Cordis Corporation 14420 N.W. 60th Avenue Miami Lakes, FL 33014

Re: K984500 Cordis Brite Tip Catheter Sheath Introducer System Trade Name: Requlatory Class: II Product Code: DYB Dated: December 14, 1998 Received: December 17, 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 leqally 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the qeneral controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood 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 A substantially equivalent determination assumes compliance with 895. 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 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 Reqister. Please note: this response to your premarket notification submission does not affect any obligation

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Page 2 - Ms. Ariel MacTavish

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.

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 [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. Allelshan

Thomas J. Callal 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)

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(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices Hygysod 510(k) Number_

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use_