VIATORR ENDOPROSTHESIS

K024178 · W. L. Gore & Associates, Inc. · JCT · Mar 7, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K024178
• Device Name: VIATORR ENDOPROSTHESIS
• Applicant: W. L. Gore & Associates, Inc.
• Product Code: JCT · General, Plastic Surgery
• Decision Date: Mar 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

VIATORR Endoprosthesis is a self-expanding, implantable stent designed to treat tracheobronchial strictures caused by malignant neoplasms. The device consists of a fluoropolymeric tube reinforced with an external nitinol structure and radiopaque markers. It is delivered via a catheter system, which is also equipped with radiopaque markers and designed for use with guidewires. The physician navigates the catheter to the target location within the tracheobronchial tract to deploy the stent. By expanding against the airway wall, the stent maintains patency in strictured areas, potentially improving patient breathing and quality of life. The device is intended for clinical use by physicians.

Clinical Evidence

No clinical data provided; substantial equivalence is supported by bench testing, assessments, and comparisons to predicate devices.

Technological Characteristics

Self-expanding implantable endoprosthesis; fluoropolymeric tube with external nitinol structure; includes radiopaque markers. Delivered via catheter system compatible with guidewires. Mechanical expansion mechanism.

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

• VIABAHN Endoprosthesis
• Ultraflex Tracheobronchial Stent System
• WALLGRAFT Tracheobronchial Endoprosthesis with Unistep Plus Delivery System

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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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: K024178

Trade/Device Name: VIATORR® Endoprosthesis Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis Regulatory Class: II Product Code: JCT Dated: December 16, 2002 Received: December 18, 2002

Dear Mr. Capehart:

This letter corrects our substantially equivalent letter of March 7, 2003.

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,

Mark N. Melk

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

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510(k) Number (if known) :

## K024178

Device Name :

VIATORR® Endoprosthesis

Indications for Use:

The VIATORR® 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)

V Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) Division of General, Restorative Counter Use _________________________________________________________________________________________________________________________________ and Neurological Devices

510(k) Number

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024178 p. 1 of 2

W.L. Gore & Associates, Inc. December 2002

VIATORR Endoprosthesis Premarket Notification

## Premarket Notification Summary

- 1. Applicant Name, Address:
W.L. Gore & Associates, Inc. 3450 W. Kiltie Lane P.O. Box 500 Flagstaff. AZ 86002-0500

Contact Person:

Date of Summary:

December 16, 2002 Revised August 28, 2006

Tracheobronchial stent

Timothy W Capehart

[phone]

- Tracheal prosthesis Classification Name: 2.
Common or Usual Name:

VIATORR™ Endoprosthesis Trade or Proprietary Name:

- Device Predicates: VIABAHN™ Endoprosthesis, Ultraflex™ 3. Tracheobronchial Stent System, and WALLGRAFT® Tracheobronchial Endoprosthesis with Unistep Plus Delivery System.
- Device Description: The VIATORR Endoprosthesis is a self-expanding 4. 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 within the tracheobronchial tract. The endoprosthesis consists of a fluoropolymeric tube with a nitinol structure located over its external surface and radiopaque markers. The catheter delivery system is configured with radiopaque markers and is designed for use with guidewires.

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Ko241178 p. 2 of 2

W.L. Gore & Associates, Inc. December 2002

VIATORR Endoprosthesis Premarket Notification

- Intended Use: The VIATORR Endoprosthesis is indicated for the 5. treatment of tracheobronchial strictures produced by malignant neoplasms.
- Substantial Equivalence: A variety of tests, assessments, and 6. comparisons demonstrate that the VIATORR Endoprosthesis is substantially equivalent to the cited predicates in terms of composition, design, intended use, and performance attributes.