WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM

K992510 · Boston Scientific Corp · JCT · Nov 18, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K992510
• Device Name: WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM
• Applicant: Boston Scientific Corp
• Product Code: JCT · General, Plastic Surgery
• Decision Date: Nov 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The WALLSTENT® Tracheobronchial Endoprosthesis is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

Device Story

Self-expanding braided wire prosthesis; constructed of biomedical superalloy and elastomeric polymer; maintains inner luminal diameter of tracheobronchial passage. Delivered via coaxial tubing assembly; outer sheath retraction releases stent. Used by physicians in clinical settings to treat malignant strictures. Stent provides outward radial force for stabilization. Benefits include improved airway patency. Device is sterile, single-use.

Clinical Evidence

Bench testing only; in vitro testing demonstrated that deployment forces and handling characteristics of the reduced-profile delivery system are comparable to the predicate device.

Technological Characteristics

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

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

• WALLSTENT® Tracheobronchial Endoprosthesis (K964121)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 3 2006

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

Re: K992510

K92510
Trade/Device Name: WALLSTENT® Tracheobronchial Endoprosthesis with Unistep™ Plus Delivery System Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis

Regulatory Class: III Product Code: JCT Dated: October 31, 1999 Received: November 3, 1999

Dear Ms. Byland:

This letter corrects our substantially equivalent letter of November 18, 1999.

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave ro roved your becaused the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the enactment date of 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, and Cosmedo Tect (110) that do neer equine general controls provisions of the Act. The general therefore, maintons of the Act include requirements for annual registration, listing of devices, condons provisions or actice, 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 or any I 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 – 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,

Herbert Lemmerus

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

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## Indications for Use Statement

| 510(k) Number (if known) | K992510 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | WALLSTENT® Tracheobronchial Endoprosthesis with Unistep™ Plus Delivery System |
| Indications For Use | The WALLSTENT® Tracheobronchial Endoprosthesis is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms. |

Prescription Use:_ X (Per 21 CFR §801 Subpart D) OR

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

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

Concerrence of CDRH, Office of Device Evaluation (ODE)

Hulda Gunn

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

**510(k) Number** K992510

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K992510

**Boston**
Scientific

## 510(k) Summary K992510

| Submitter's<br>Name and<br>Address | Boston Scientific Corporation<br>One Scimed Place<br>Maple Grove, MN 55311 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name<br>and Information | Angela Byland<br>Manager, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| Original Date<br>Prepared | July 26, 1999 |
| Date Prepared | July 14, 2006 |
| Proprietary<br>Name(s) | WALLSTENT® Tracheobronchial Endoprosthesis with<br>Unistep™ Plus Delivery System |
| Common Name | Tracheal Endoprosthesis |
| Product Code | JCT |
| Classification of<br>Device | Class III, 21 CFR Part 878.3720 |
| Predicate Device | WALLSTENT®<br>Tracheobronchial<br>Endoprosthesis<br>K964121<br>December 04, 1996 |
| Device<br>Description | The WALLSTENT® Tracheobronchial Endoprosthesis is a<br>self-expanding prosthesis constructed of biomedical<br>superalloy and an elastomeric polymer. Smaller diameter<br>models may utilize a radiopaque core. The prosthesis is a<br>braided wire structure which may be covered with an<br>elastomeric polymer in selected models. The outward radial<br>force along with the ends of the device serve to stabilize the<br>prosthesis after implanted. The stent's purpose is to<br>increase or maintain the inner luminal diameter of the<br>tracheobronchial passage. |
| Device<br>Description<br>cont'd | The stent is placed by means of a delivery system. The<br>delivery system is a coaxial tubing assembly that constrains<br>the prosthesis until it is released in a controlled manner.<br>The release of the stent is accomplished by retracting the<br>outer sheath. The prosthesis is packaged constrained on<br>the delivery system ready for placement. The system is<br>sterile and intended for single use only. |
| Indications for<br>Use | The WALLSTENT® Tracheobronchial Endoprosthesis is<br>indicated for use in the treatment of tracheobronchial<br>strictures produced by malignant neoplasms. |
| Technological<br>Characteristics | The purpose of this 510(k) is to allow an alternate delivery<br>system. Compared to the present Unistep™ Plus Delivery<br>System (K964121), this version of the Unistep™ Plus<br>Delivery System has a reduced profile that is a smaller<br>diameter. |
| | The alternate delivery system can be found substantially<br>equivalent based on the results of <i>in vitro</i> testing that<br>demonstrates the deployment forces and handling<br>characteristics are comparable to the current delivery<br>systems. |
| Conclusion | In summary, Boston Scientific Corporation has<br>demonstrated that the WALLSTENT® Tracheobronchial<br>Endoprosthesis with Unistep™ Plus Delivery System with<br>reduced profile for the delivery system is substantially<br>equivalent based on design, test results, and indications for<br>use to the predicate devices. |

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