GORE TRI-LOBE BALLOON CATHETER

K033670 · W. L. Gore & Associates, Inc. · DQY · May 5, 2004 · Cardiovascular

Device Facts

• Record ID: K033670
• Device Name: GORE TRI-LOBE BALLOON CATHETER
• Applicant: W. L. Gore & Associates, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: May 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Tri-Lobe Balloon Catheter is intended to assist in the dilatation of self-expanding endoprostheses in large diameter vessels.

Device Story

Dual lumen catheter with distal low-pressure compliant tri-lobe balloon; designed for use with 0.035" guidewire. Tri-lobe design allows limited blood flow during endoprosthesis touch-up. Features two 304 stainless steel markers for angiographic visualization and placement. Used by clinicians in cardiovascular procedures to ensure proper expansion of endoprostheses. Sterile, single-use device.

Clinical Evidence

Bench testing only. Device integrity testing was performed to verify performance against specified requirements; all results met requirements.

Technological Characteristics

Dual lumen catheter; low-pressure compliant tri-lobe balloon; 304 stainless steel radiopaque markers; compatible with 0.035" guidewire; sterile, single-use.

Indications for Use

Indicated for assisting in the dilatation of self-expanding endoprostheses in large diameter vessels.

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

• ANCURE® Iliac Balloon Catheter (K003495)
• Equalizer™ Balloon Catheter (K021721)
• LDOB Occlusion Balloon Catheter (K002286)

Submission Summary (Full Text)

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**MAY - 5 2004**

510(k) Premarket Notification

510(k) Summary of Substantial Equivalence

K033670

GORE Tri-Lobe Balloon Catheter

# 510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE

| Proprietary Name: | GORE Tri-Lobe Balloon Catheter |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | balloon catheter |
| Classification Name: | catheter, angioplasty, peripheral, transluminal,<br>percutaneous catheter |
| Device Classification: | Class II |
| Product Classification and Code: | 870.1250, DQY |
| Classification Panel: | Cardiovascular Devices |
| Establishment Registration Number: | 2025240 |
| Contact Person: | Brandon Hansen<br>Regulatory Affairs<br>Medical Products Division<br>WL Gore & Associates, Inc.<br>3450 West Kiltie Lane<br>Flagstaff, AZ 86002-0500<br>Telephone: [phone]<br>Facsimile: [phone]<br>E-mail: [e-mail] |

#### Performance Standards

Performance standards do not currently exist for these devices. None established under Section 514.

## Device Description

The GORE Tri-Lobe Balloon Catheter is a dual lumen catheter with a low pressure compliant balloon attached to the distal end of the catheter. The balloon is a tri-lobe design to allow for limited blood flow when used to touch up an endoprosthesis. The catheter is designed to be used with a 0.035" guidewire. Two 304 stainless steel markers provide angiographic visualization of the balloon length and facilitate intravascular placement of the balloon prior to inflation. The GORE Tri-Lobe Balloon Catheter is provided sterile for single-use.

Image /page/0/Picture/9 description: The image contains the Gore logo on the left and the word "Confidential" on the right. The Gore logo is a stylized design with the word "GORE" in bold letters. The word "Confidential" is written in a simple, sans-serif font. The image appears to be a stamp or watermark, indicating that the document is confidential.

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# Indication for Use

The Tri-Lobe Balloon Catheter is intended to assist in the dilatation of self-expanding endoprostheses in large diameter vessels.

# Substantially Equivalent Devices

In W. L. Gore & Associates Inc.'s opinion, the GORE Tri-Lobe Balloon Catheter is believed to be substantially equivalent to the following predicate devices currently in interstate commerce with respect to comparable features, materials of construction and intended use.

- ANCURE® Iliac Balloon Catheter (Guidant Cardiac & Vascular Surgery . (C&VS), Menlo Park, CA) - K003495
- Equalizer™ Balloon Catheter (Boston Scientific Corporation, Natick, MA) -. K021721
- LDOB Occlusion Balloon Catheter (COOK INCORPORATED, . Bloomington, IN) - K002286

Labeling, packaging and sterilization of the GORE Tri-Lobe Balloon Catheter is substantially equivalent to that of the predicate devices listed above.

## Summary of Studies

W. L. Gore & Associates, Inc. performed device integrity testing to support that the GORE Tri-Lobe Balloon Catheter will perform adequately when used according to the intended use. All device integrity test results for the GORE Tri-Lobe Balloon Catheter met specified requirements.

# Conclusion (Statement of Equivalence)

Through data and information presented, numerous similarities support a determination of substantial equivalence, and therefore market clearance of the W. L. Gore & Associates, Inc.'s GORE Tri-Lobe Balloon Catheter through this 510(k) Premarket Notification.

Image /page/1/Picture/14 description: The image contains the Gore logo on the left and the word "Confidential" on the right. The Gore logo is a stylized design with the word "GORE" in bold letters. The word "Confidential" is written in a simple, sans-serif font. The image appears to be a document header or watermark indicating the confidential nature of the document.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of a bird, which is likely an eagle, with its wings spread. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 5 2004

W. L. Gore and Associates, Inc. c/o Mr. Brandon Hansen Regulatory Affairs 3450 West Kiltie Lanc Flagstaff, AZ 86001

K033670 Rc:

Trade Name: Tri-Lobe Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Codc: DQY Dated: November 21, 2003 Received: November 24, 2003

Dear Mr. Hansen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to togens actment date of the Medical Device Amendments, or to commence prox to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, devices mat have been require approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not required to the general controls provisions of the Act. The 1 ou may, therefore, market the act include requirements for annual registration, listing of gencial controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your de vice is classified (600 a00 r0) als. Existing major regulations affecting your device can may be subject to basil adon't regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 -- Mr. Brandon Hansen

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that I Dr is issuates or wor device complies with other requirements of the Act that IDA has made a dolorimiation administered by other Federal agencies. You must of any redital statutes and regations and ancluding, but not limited to: registration and listing (21 Comply with an the Act 3 requirements,01); good manufacturing practice requirements as set CFK Part 807), labering (21 CFRT art 801), good if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro neviole (seting your device as described in your Section 510(k) This letter will anow you to begin mailwang your device of your device to a legally prematicated 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), please If you desire specific acrise 101 ) 594-4646. Also, please note the regulation entitled, Comaci the Office of Comparket notification" (21CFR Part 807.97). You may obtain Misorallums by reference to premanter to premainter the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Wh

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: GORE Tri-Lobe Balloon Catheter Catheter Cather Cather

Indications For Use:

..

The Tri-Lobe Balloon Catheter is intended to assist in the dilatation of self-expanding endoprostheses in large diameter vessels.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) Division of Cardiovascular Devices | |
|--------------------------------------------------------|---------|
| 510(k) Number | K033670 |

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