WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS

K964121 · Boston Scientific Scimed, Inc. · JCT · Dec 4, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K964121
• Device Name: WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
• Applicant: Boston Scientific Scimed, Inc.
• Product Code: JCT · General, Plastic Surgery
• Decision Date: Dec 4, 1996
• Decision: ST
• 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 stent; constructed of biomedical superalloy and elastomeric polymer; optional Permalume covering. Stent maintains luminal diameter of tracheobronchial passage. Delivered via coaxial tubing assembly; outer sheath retraction releases stent. Delivery system allows partial deployment and re-constraint for precise placement. Used by physicians in clinical settings to treat malignant airway obstructions. Stent provides radial force for stabilization. Single-use, sterile device.

Clinical Evidence

Bench testing only. In vitro and in vivo deployment testing performed to compare handling characteristics and deployment forces against the predicate delivery system.

Technological Characteristics

Self-expanding braided wire stent; biomedical superalloy; elastomeric polymer (Permalume). Coaxial tubing delivery system. Sterile, single-use. Mechanical deployment via sheath retraction.

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 (K934116)
• Wallstent Tracheobronchial Prosthesis (K945494)
• Wallstent Tracheobronchial Prosthesis (K961296)

Reference Devices

• Esophageal delivery system (K940396)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
NOV - 3 2006
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: K964121
Trade/Device Name: WALLSTENT® Tracheobronchial Endoprosthesis
Regulation Number: 21 CFR 878.3720
Regulation Name: Tracheal prosthesis
Regulatory Class: II
Product Code: JCT
Dated: October 14, 1996
Received: October 15, 1996

Dear Ms. Byland:

This letter corrects our substantially equivalent letter of December 4, 1996.

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 – 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

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# Indications for Use

510(k) Number (if known): K964121

Device Name: Wallstent® Tracheobronchial Endoprosthesis

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 or fistulas 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)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K964121

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K964121 p. 10+2

# Boston Scientific

510(K) SUMMARY
K964121

## 1. Submitter:

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

Contact: Kathleen Morahan
Director Regulatory Affairs
Original Date Prepared: September 26, 1996
Revision Date: July 14, 2006

## 2. Device:

Trade Name: Wallstent® Tracheobronchial Endoprosthesis
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, K934116
Boston Scientific Corporation’s Wallstent Tracheobronchial Prosthesis, K945494
Boston Scientific Corporation’s Wallstent Tracheobronchial Prosthesis, K961296

## 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 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.

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K9641d1 p. 20+2

# Boston Scientific

## 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) is to allow an alternate delivery system which allows the user to partially deploy and then reconstrain the stent to facilitate placement. This feature is presently available in the Esophageal delivery system (K940396). (The Classic™ delivery system which is used with covered stents is not part of this submission.)

## 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 believes the alternate delivery system is substantially equivalent based on design, test results and indications for use.