WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH PERMALUME COVERING

K980163 · Boston Scientific Scimed, Inc. · JCT · Mar 13, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K980163
• Device Name: WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH PERMALUME COVERING
• Applicant: Boston Scientific Scimed, Inc.
• Product Code: JCT · General, Plastic Surgery
• Decision Date: Mar 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Wallstent Tracheobronchial Endoprosthesis is intended for us in the treatment of tracheobronchial strictures produced by malignant neoplasms. The Wallstent Tracheobronchial Endoprosthesis with Permalume Covering is indicated for use in the treatment of tracheobronchial strictures or fistulas produced by malignant neoplasms.

Device Story

Self-expanding braided wire prosthesis; constructed of biomedical superalloy and elastomeric polymer; optional Permalume elastomeric polymer covering; radiopaque core in smaller diameters. Stent maintains or increases inner luminal diameter of tracheobronchial passage; radial force and ends stabilize device post-implantation. Delivered via coaxial Unistep Plus delivery system; system constrains prosthesis until release via outer sheath retraction. Allows partial deployment and re-constraint for precise placement. Sterile; single-use. Used by physicians in clinical settings to treat malignant airway obstructions.

Clinical Evidence

Bench testing only. Substantial equivalence supported by in vitro and in vivo deployment testing demonstrating comparable deployment forces and handling characteristics to predicate delivery systems.

Technological Characteristics

Self-expanding braided wire prosthesis; biomedical superalloy and elastomeric polymer construction; radiopaque core in smaller models. Coaxial tubing delivery system; allows partial deployment and re-constraint. Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for patients with tracheobronchial strictures or fistulas 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

• Wallstent Tracheobronchial Prosthesis with Unistep Delivery System (K934116)
• Wallstent Tracheobronchial Prosthesis with Unistep Plus Delivery System (K964121)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Boston Scientific Corporation % Ms. Angela Byland Manager, Regulatory Affairs Cardiovascular Two Scimed Place Maple Grove, Minnesota 55311-1566

Re: K980163

Trade/Device Name: WALLSTENT® Tracheobronchial Prosthesis and Wallstent Tracheobronchial Endoprosthesis with Permalume covering Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis Regulatory Class: II Product Code: JCT Dated: January 15, 1998 Received: January 16, 1998

Dear Ms. Byland:

This letter corrects our substantially equivalent letter of March 13, 1998.

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

{1}------------------------------------------------

Page 2 - Ms. Angela Byland

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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known): K980163

Device Name:

Wallstent® Tracheobronchial Prosthesis and Wallstent Tracheobronchial Endoprosthesis with Permalume covering

Indications for Use:

The Wallstent Tracheobronchial Endoprosthesis is intended for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

The Wallstent Tracheobronchial Endoprosthesis with Permalume® Covering is intended for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Helmut Leuer

(Division Sign-( Division of General, Restore . and Neurological Devices

Page 1 of 1

**510(k) Number** k98 0163

{3}------------------------------------------------

K980163 p. lot 2

Image /page/3/Picture/1 description: The image shows the logo for Boston Scientific. The logo is in a bold, serif font. The word "Boston" is on the top line, and the word "Scientific" is on the bottom line. The logo is black and white.

## 510(K) SUMMARY K980163

#### 1. Submitter:

Boston Scientific Corporation 100 Boston Scientific Wav Marlborough, MA 01545 Telephone: [phone] Fax: [phone]

Contact: Kathleen Morahan Director Regulatory Affairs Original Date Prepared: January 12, 1998 Revision Date: July 14, 2006

#### 2. Device:

Trade Name: Wallstent® Tracheobronchial Endoprosthesis with Unistep Plus Delivery System Common Name: Tracheal Prosthesis Classification Name: Tracheal Prosthesis Regulation Number: 878.3720 Product Code: JCT Classification: Class II

Trade Name: Wallstent Tracheobronchial Endoprosthesis with Permalume Covering and Unistep Plus Delivery System Common Name: Tracheal Prosthesis Classification Name: Tracheal Prosthesis Regulation Number: 878.3720 Product Code: JCT Classification: Class II

#### 3. Predicate Device:

Boston Scientific Corporation's Wallstent Tracheobronchial Prosthesis with Unistep Delivery System, K934116

Boston Scientific Corporation's Wallstent Tracheobronchial Prosthesis with Unistep Plus Delivery System, K964121

#### 4. Device Description:

The Wallstent Tracheobronchial Endoprosthesis is a self-expanding prosthesis constructed of biomedical superalloy and an elastomeric polymer. Smaller diameter models may utilize a radiopaque core. The prosthesis is a braided wire structure which may be covered with an elastomeric polymer in selected models. The outward radial force along with the ends of the

{4}------------------------------------------------

K980163 p. 2 of 2

Image /page/4/Picture/1 description: The image shows the logo for Boston Scientific. The text "Boston" is stacked on top of the text "Scientific". The font is a serif font and the text is black.

device serve to stabilize the prosthesis after implanted. The prosthesis is offered in covered and uncovered version to allow physicians to select the most appropriate models based on their preference and individual patient condition. The stents purpose is to increase or maintain the inner luminal diameter of the tracheobronchial passage.

The stent is placed by means of a delivery system. The delivery system is a coaxial tubing assembly which constrains the prosthesis until it is release in a controlled manner. The release of the stent is accomplished by retracting the outer sheath. The prosthesis is packaged constrained on the delivery system ready for placement. The system is sterile and intended for single use only.

#### 5. Intended Use:

The Wallstent Tracheobronchial Endoprosthesis is intended for us in the treatment of tracheobronchial strictures produced by malignant neoplasms.

The Wallstent Tracheobronchial Endoprosthesis with Permalume Covering is indicated for use in the treatment of tracheobronchial strictures or fistulas produced by malignant neoplasms.

### 6. Technological Characteristics:

The purpose of this 510(k) us to allow an alternate delivery system. Compared to the Unistep Delivery System (K934116), the Unisten Plus delivery system allows the user to partially deploy and then reconstrain the stent to facilitate placement. This feature is presently available in the Wallstent Tracheobronchial Endoprosthesis with Unistep Plus Delivery System (K964121). Compared to the present Unistep Plus Delivery System (K964121), the modified system has different materials for the outer and inner tubing.

### 7. Performance Data:

The alternate delivery system can be found substantially equivalent based on results of in vitro and in vivo deployment testing which demonstrate that deployment forces and handling characteristics are comparable to the current delivery system.

#### 8. Conclusion:

Boston Scientific Corporation has demonstrated that the Wallstent Tracheobronchial Endoprosthesis with Unistep Plus Delivery System, Wallstent Tracheobronchial Endoprosthesis with Permalume Covering and Unistep Plus Delivery System with modified delivery system is substantially equivalent based on design, test results, and indications for use to the predicate devices.