WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

K021901 · Boston Scientific Scimed, Inc. · JCT · Jul 9, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K021901
• Device Name: WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
• Applicant: Boston Scientific Scimed, Inc.
• Product Code: JCT · General, Plastic Surgery
• Decision Date: Jul 9, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Self-expanding tracheobronchial endoprosthesis; metallic superalloy monofilament wire stent with radiopaque core; braided polyester (PET) graft material bonded to exterior. Delivered via coaxial Unistep Plus Delivery System; exterior tube constrains stent; interior tube features holding sleeve/stent cup for partial deployment and re-constrainment. Radiopaque markers facilitate fluoroscopic visualization during placement. Used by physicians in clinical settings to maintain airway patency in patients with malignant strictures. Device provides mechanical support to airway; prevents occlusion by tumor growth.

Clinical Evidence

Bench testing only. Testing included catheter length, crossing profile, deployment/re-constrainment forces, stent graft securement, tensile testing of various assembly points, deployed stent graft outer diameter, accelerated aging, and biocompatibility. All results confirmed the modified delivery system meets specifications.

Technological Characteristics

Metallic superalloy monofilament wire stent with radiopaque core; braided polyester (PET) graft. Coaxial delivery system (9F-12F). Radiopaque marker bands for imaging. Self-expanding. Sterilized device. No software/algorithm.

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

• WALLGRAFT® Tracheobronchial Endoprosthesis with Unistep™ Delivery System (K000001)
• WALLGRAFT® Tracheobronchial Endoprosthesis with Unistep™ Plus Delivery System (K003100)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract image of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.

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: K021901

Trade/Device Name: Wallgraft® Tracheobronchial Endoprosthesis with Unistep Plus Delivery System

Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis Regulatory Class: II Product Code: JCT Dated: June 7, 2002 Received: June 10, 2002

Dear Ms. Byland:

This letter corrects our substantially equivalent letter of July 9, 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 - 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 vours.

Herbert Lehman

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) | K021901 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | WALLGRAFT® Tracheobronchial Endoprosthesis with Unistep™ Plus Delivery System |
| Indications For Use | The WALLGRAFT® Tracheobronchial Endoprosthesis is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms. |

Prescription Use:_____________________________________________________________________________________________________________________________________________________________ × (Per 21 CFR §801 Subpart D) OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Huld Lume

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

**510(k) Number** \$\underline{K_{02}(90)}\$

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K021901 p. lot 3

# 510(k) Summary

| 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 | June 7, 2002 | | |
| Date Prepared | July 14, 2006 | | |
| Proprietary<br>Name(s) | WALLGRAFT® Tracheobronchial Endoprosthesis with<br>Unistep™ Plus Delivery System | | |
| Common Name | Tracheal Endoprosthesis | | |
| Product Code | JCT | | |
| Classification of<br>Device | Class II, 21 CFR Part 878.3720 | | |
| Predicate Device | WALLGRAFT®<br>Tracheobronchial<br>Endoprosthesis<br>with Unistep™<br>Delivery System | K000001 | June 5, 2005 |
| | WALLGRAFT®<br>Tracheobronchial<br>Endoprosthesis<br>with Unistep™<br>Delivery System | K003100 | December 20, 2000 |

:

B

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

### Device Description

The Wallgraft Endoprosthesis with Unistep Plus Delivery System is available in the models indicated in the table below.

A brief description of the stent graft and delivery system components follow.

| Stent Graft<br>Diameter | Stent Graft Length | Delivery System<br>Profile |
|-------------------------|----------------------------|----------------------------|
| 6.0 mm | 20 mm, 30 mm, 50 mm, 70 mm | 9F |
| 7.0 mm | 20 mm, 30 mm, 50 mm, 70 mm | 9F |
| 8.0 mm | 20 mm, 30 mm, 50 mm, 70 mm | 9F |
| 9.0 mm | 20 mm, 30 mm, 50 mm, 70 mm | 10F |
| 10.0 mm | 20 mm, 30 mm, 50 mm, 70 mm | 10F |
| 12.0 mm | 30 mm, 50 mm, 70 mm | 11F |
| 14.0 mm | 50 mm, 70 mm | 12F |

Stent Graft Description

The Wallgraft Endoprosthesis (stent graft) consists of a metallic stent comprised of biomedical superalloy monofilament wire with a radiopaque core, braided in a tubular mesh configuration. A platinum nickel micro-cable is incorporated into the stent to enhance radiopacity of the device. A graft material comprised of braided polyester varn (PET) is adhesively bonded to the outside of the metallic stent. This design configuration results in a stent graft that is flexible, compliant, and self-expanding with the barrier characteristics of a tubular graft.

#### Delivery System Description

The Unistep Plus Delivery System consists of a coaxial tube system. The exterior tube serves to constrain the stent graft over the interior tube until retracted during deployment. The coaxial tubes have the capability of re-constraining the stent graft after partial deployment. A holding sleeve and stent cup, attached to the interior tube, aid in the re-constraining process.

Radiopaque marker bands situated adjacent to the proximal and distal ends of the stent graft facilitate imaging during deployment. A radiopaque marker band located on the exterior tube and a limit marker band on the interior tube function as deployment limit markers. Re-constrainment is possible up to the point where the exterior tube marker band is proximally retracted to the location of the interior tube limit marker.

The interior tube of the coaxial system contains a central lumen which will accommodate a 0.035" guide wire. The delivery system will be available in a single working length of 90 cm.

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021901 p. 3 of 3

| Intended Use | The WALLGRAFT® Tracheobronchial Endoprosthesis is<br>indicated for use in the treatment of tracheobronchial<br>strictures produced by malignant neoplasms. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics | The modified 9 F - 11 F Unistep Plus Delivery System of the<br>6 mm to 12 mm Wallgraft Endoprosthesis will be<br>manufactured in a substantially equivalent manner to the<br>currently marketed 12 F delivery system of the 14 mm<br>Wallgraft Tracheobronchial Endoprosthesis with Unistep<br>Plus Delivery System, cleared to market under K003100,<br>December 20, 2000. |
| Performance<br>Testing | Testing was conducted to verify that the modified 9 F - 11 F<br>delivery system met product specifications. The following<br>testing was performed:<br>Total Catheter Length Catheter Crossing Profile Deployment Force Reconstrainment Force Stent Graft Securement Hub to Stainless Steel Tube Tensile Distal Tip Tensile Inner Member Assembly Tensile Valve Body to Exterior Tube Tensile Deployed Stent Graft OD Post Accelerated Aging Testing Biocompatibility All test results verified that the modified 9 F - 11 F delivery<br>system is adequate for its intended use. The modified<br>device is considered substantially equivalent to the currently<br>marketed 9 F - 11 F delivery system (K000001) and the 12<br>F delivery system (K003100). |
| Conclusion | In summary, Boston Scientific Corporation has<br>demonstrated that the WALLGRAFT® Tracheobronchial<br>Endoprosthesis with Unistep™ Plus Delivery System is<br>substantially equivalent based on design, test results, and<br>indications for use to the predicate devices. |