CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM

K974448 · Cordis Corp. · DYB · Feb 6, 1998 · Cardiovascular

Device Facts

• Record ID: K974448
• Device Name: CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
• Applicant: Cordis Corp.
• Product Code: DYB · Cardiovascular
• Decision Date: Feb 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended 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.

Device Story

Brite Tip Catheter Sheath Introducer System provides vascular access for intravascular devices; facilitates percutaneous entry into arterial and venous systems. Device includes sheath with sideport for fluid infusion and blood withdrawal; maintains hemostasis during catheter introduction. Used by clinicians in clinical settings; provides conduit for diagnostic or interventional catheters. Benefits include simplified vascular access and maintenance of hemostasis during procedures.

Clinical Evidence

No clinical data; bench testing only. Biocompatibility established via reference to previously tested materials on predicate devices.

Technological Characteristics

Catheter sheath introducer system; includes valve for hemostasis and sideport for fluid management. Materials previously cleared for biocompatibility. No electronic or software components.

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

• Brite Tip® Catheter Sheath Introducer System (K971608)

Submission Summary (Full Text)

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00-00026 K974448

# PREMARKET NOTIFICATION 510(k)
Cordis, a Johnson and Johnson company
Brite Tip® Catheter Sheath Introducer
(Modification K971608)

FEB 6 1998

## SUMMARY OF SAFETY AND EFFECTIVENESS

### I. General Provisions

Common or Usual Name: Catheter Sheath Introducer or Sheath Introducer System.
Proprietary Name: Cordis Brite Tip® Catheter Sheath Introducer System.

### II. Name of Predicate Device

Brite Tip® Catheter Sheath Introducer System, K971608.

### III. Classification

Class II

### IV. 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Rockville MD 20857

# FEB 6 1998

Ms. Ariel MacTavish
Sr. Regulatory Affairs Associate
Cordis Corporation
P.O. Box 025700
Miami, FL 33102-5700

Re: K974448
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 regulations affecting your device can be found in the Code of Federal Regulations, 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 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 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.

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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" (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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular, Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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00-00051

# PREMARKET NOTIFICATION 510(k)

## Cordis Corporation

## Brite Tip® Catheter Sheath Introducer

510(k) Number (if known): K974448

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 IS NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)


Prescription Use ☑ (Per 21 CFR 801.109) OR Over-The-Counter Use