VIABAHN ENDOPROSTHESIS

K013648 · W. L. Gore & Associates, Inc. · JCT · Jan 8, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K013648
• Device Name: VIABAHN ENDOPROSTHESIS
• Applicant: W. L. Gore & Associates, Inc.
• Product Code: JCT · General, Plastic Surgery
• Decision Date: Jan 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GORE VIABAHN® Endoprosthesis is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.

Device Story

The GORE VIABAHN® Endoprosthesis is a self-expanding, implantable device designed to treat tracheobronchial strictures caused by malignant neoplasms. It consists of a fluoropolymeric tube reinforced with an external nitinol structure. The device is compressed and secured onto a catheter delivery system, which includes radiopaque markers to facilitate placement and is compatible with guidewires. It is intended for use by clinicians to restore airway patency in the tracheobronchial tract. By providing structural support to the airway, the device helps alleviate obstruction, potentially improving patient breathing and quality of life.

Clinical Evidence

Bench testing only.

Technological Characteristics

Self-expanding endoprosthesis; fluoropolymeric tube with external nitinol structure; catheter delivery system with radiopaque markers; compatible with guidewires.

Indications for Use

Indicated for patients with tracheobronchial strictures caused by malignant neoplasms.

Regulatory Classification

Identification

The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.

Special Controls

The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”

Predicate Devices

• Ultraflex™ Tracheobronchial Stent System
• WALLSTENT® Tracheobronchial Endoprosthesis
• aSpire Covered Stent and Delivery Catheter

Submission Summary (Full Text)

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

NOV 3 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

W.L. Gore & Associates, Inc. % Mr. Timothy W. Capehart Regulatory Affairs Associate 3450 West Kiltie Lane P.O. Box 2400 Flagstaff, Arizona 86003

Re: K013648

Trade/Device Name: The GORE VIABAHN® Endoprosthesis Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis Regulatory Class: II Product Code: JCT Dated: November 2, 2001 Received: November 5, 2001

Dear Mr. Capehart:

This letter corrects our substantially equivalent letter of January 8, 2002.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 -- Mr. Timothy W. Capehart

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, 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

Fuh Pete Thurn

Mark N. Melkerson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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#### K013648 510(k) Number (if known) :

The GORE VIABAHN® Endoprosthesis Device Name :

Indications for Use:

The GORE VIABAHN® Endoprosthesis is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.

# (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Restorative, Prescription (Per 21 CFR and Neuro

510(k) Num

Over the Counter Use _________________________________________________________________________________________________________________________________________________________

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013648 p. 1 of 2

#### XI. Summary of Safety and Effectiveness

Page 1 of 2

#### Applicant:

W.L. Gore & Associates, Inc. 3450 West. Kiltie Lane P.O. Box 500 Flagstaff, AZ 86002-0500

# Contact

Timothy W Capehart

### Date Prepared

November 1, 2001 Rev: August 28, 2006

## Trade or Proprietary Name

VIABAHN™ Endoprosthesis

#### Common or Usual Name

Tracheal Endoprosthesis

#### Classification Name

Tracheal Prosthesis

#### Device Predicates

Ultraflex™ Tracheobronchial Stent System, WALLSTENT® Tracheobronchial Endoprosthesis, aSpire Covered Stent and Delivery Catheter

#### Device Description

The VIABAHN™ Endoprosthesis is a self-expanding implantable endoprosthesis that is compressed and secured on the distal end of a catheter delivery system. The catheter delivery system provides a means for implanting the endoprosthesis at a target location

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# Summary of Safety and Effectiveness

Page 2 of 2

#### Device Description (cont'd)

within the tracheobronchial tract. The endoprosthesis consists of a fluoropolymeric tube with a nitinol structure located over its external surface. The catheter delivery system is configured with radiopaque markers and is designed for use with guidewires.

### Statement of Intended Use

The VIABAHN™ Endoprosthesis is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.

### Substantial Equivalence

A variety of tests, assessments, and comparisons demonstrate that the VIABAHN™ Endoprosthesis is substantially equivalent to the cited predicates in terms of composition, design, intended use, and performance attributes.