ENVY GUIDING CATHETER

K990726 · Cook, Inc. · DQY · Apr 2, 1999 · Cardiovascular

Device Facts

• Record ID: K990726
• Device Name: ENVY GUIDING CATHETER
• Applicant: Cook, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Apr 2, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

Used for the delivery of PTCA balloons and other various types of interventional cardiology devices. They are intended for use by physicians trained and experienced in PTCA and interventional cardiology techniques. Not intended for cerebral vascular use.

Device Story

Envy Guiding Catheter is an intravascular diagnostic catheter used in interventional cardiology. It facilitates delivery of PTCA balloons and other interventional devices to target sites. The device consists of an inner layer of nylon tubing with stainless steel braiding, laminated with an outer TFE layer, and finished with a hydrophilic coating for lubricity. It is available in 4.0, 7.0, and 8.0 French sizes. An optional inner polyethylene catheter, tapered to an .038-inch endhole, assists in introducing the guiding catheter over a wire guide or through a sheath. The device is operated by trained physicians in a clinical setting. It provides a pathway for interventional tools, aiding in the performance of cardiology procedures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on identical design, materials, and indications to the predicate device.

Technological Characteristics

Materials: inner nylon tubing, stainless steel braiding, outer TFE tubing, hydrophilic coating. Sizes: 4.0, 7.0, 8.0 French. Construction: multi-layer laminate. No energy source or software components.

Indications for Use

Indicated for use by physicians trained in PTCA and interventional cardiology for the delivery of PTCA balloons and other interventional cardiology devices. Contraindicated for cerebral vascular use.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Envy™ Guiding Catheter, 6.0 French (K974774)

Submission Summary (Full Text)

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APR 2 1995

K990726

Special 510(k) Premarket Notification EnvyTM Guiding Catheter COOK INCORPORATED

510(k) Summary 0

| Submitted By: | April Lavender, RAC<br>Vice President, Regulatory Affairs<br>COOK INCORPORATED<br>925 South Curry Pike<br>P.O. Box 489<br>Bloomington, IN 47402<br>[phone] |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|

## Device:

| Trade Name: | Envy™ Guiding Catheter | | |
|-------------------------------|-------------------------------------|--|--|
| Proposed Classification Name: | Catheter, Intravascular, Diagnostic | | |
| | 21 CFR Part 876.1200 (74DO) | | |

## Predicate Devices:

The Envy™ Guiding Catheter, 4.0, 7.0 and 8.0 French, has the same intended use, materials of construction, and technological characteristics as the Envy™ Guiding Catheter, 6.0 French.

## Device Description:

The Envy™ Guiding Catheter is manufactured using an inner layer of nylon tubing with stainless steel braiding and laminated with an outer layer of TFE tubing. This tubing is coated with a hydrophilic coating to enhance lubricity. This catheter is available in 4.0, 7.0 and 8.0 French outer diameter, various lengths and various curves to accommodate interventional cardiology procedures.

| French Size | Inside diameter |
|-------------|-----------------|
| 4.0 | .040-inch |
| 7.0 | .078-inch |
| 8.0 | .092-inch |

This device can also be used with an inner catheter used for introduction. The inner catheter is manufactured using polyethylene tubing tapered to an .038-inch endhole with a hydrophilic coated distal tip. The length of the inner catheter corresponds to the guiding catheter length. The inner catheter is designed to introduce the guiding catheter over an 0.038-inch wire guide or through an appropriately sized sheath introducer.

17

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Special 510(k) Premarket Notification EnvyTM Guiding Catheter COOK INCORPORATED

#### D 510(k) Summary

# Substantial Equivalence:

The Envy™ Guiding Catheter, 4.0, 7.0 and 8.0 French, is similar to many devices in commercial distribution for delivery of PTCA balloons and other various types of interventional cardiology devices. It is identical to the currently marketed Envy™ Guiding Catheter, 6.0 French, in overall configuration and indications. The Envy™ Guiding Catheter, 6.0 French, was cleared for commercial distribution on October 16, 1998, D.C.#K974774. The identical indications for use and technological characteristics of the Envy™ Guiding Catheter supports a determination of substantial equivalency.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the Department of Health & Human Services logo and the date April 2, 1999. The logo is a stylized image of three human profiles. The text is in a simple, sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. April Lavender, RAC Vice President Requlatory Affairs Cook Incorporated 925 South Curry Pike P.O. Box 489 Bloomington, IN 47402

Re : K990726 Envy™ Guiding Catheter, 4.0, 7.0 and 8.0 French Regulatory Class: II (Two) Product Code: 74 DQY Dated: March 3, 1999 Received: March 5, 1999

Dear Ms. Lavender:

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 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 In addition, FDA may publish further regulatory action. 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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# Page 2 - Ms. April Lavender, RAC

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding described in your srown promazion and 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 [phone]. Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" Other general information on your (21CFR 807.97). 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. Callahan

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

Enclosure

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510(k) Number (if known):_

Device Name:

Envy™ Guiding Catheter

Indications for Use:

Used for the delivery of PTCA balloons and other various types of interventional cardiology devices. They are intended for use by physicians trained and experienced in PTCA and interventional cardiology techniques. Not intended for cerebral vascular use.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|-------------------------|
| Prescription Use<br>(Per 21 CFR 801.109) | OR Over-the-Counter Use |

for TJC
(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number