WALLSTENT ENDOPROSTHESIS

K982184 · Boston Scientific Scimed, Inc. · JCT · Jul 21, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K982184
• Device Name: WALLSTENT ENDOPROSTHESIS
• Applicant: Boston Scientific Scimed, Inc.
• Product Code: JCT · General, Plastic Surgery
• Decision Date: Jul 21, 1998
• Decision: SESE
• Submission Type: Special
• 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. The WALLSTENT® Enteral Endoprosthesis is indicated for palliation of duodenal strictures caused by malignant neoplasms. The WALLSTENT® Endoprosthesis is indicated for use in the treatment of biliary strictures produced by malignant neoplasms. The WALLSTENT® Enteral Endoprosthesis is indicated for palliative treatment of colonic strictures caused by malignant neoplasms. The WALLSTENT® Esophageal Prosthesis is indicated for palliative treatment of esophageal strictures produced by malignant neoplasms.

Device Story

WALLSTENT® Endoprosthesis is a self-expanding stent; constructed of braided biomedical superalloy wire; some models feature polymeric covering or radiopaque core. Stent maintains or increases luminal diameter in anatomical passages. Delivered via coaxial tubing assembly; outer tube retraction releases stent in controlled manner. Used in clinical settings for palliative treatment of malignant strictures. Device provides mechanical support to keep passages open, improving patient quality of life by alleviating obstruction symptoms. This specific submission updates labeling regarding MRI compatibility; no changes to device design, materials, or clinical function.

Clinical Evidence

No clinical data provided. Submission relies on bench testing and information supporting the labeling change for MRI compatibility.

Technological Characteristics

Self-expanding stent; braided biomedical superalloy wire; optional polymeric covering; optional radiopaque core. Coaxial delivery system. Mechanical expansion principle. No software or electronic components.

Indications for Use

Indicated for patients with malignant neoplasms causing strictures in the tracheobronchial tree, esophagus, duodenum, colon, or biliary tract. Also indicated for tracheoesophageal fistulas.

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 (12-30 mm) (K980163)
• WALLSTENT® Enteral Endoprosthesis (Duodenal) (K980113)
• WALLSTENT® Tracheobronchial Endoprosthesis (5-10 mm) (K964121)
• WALLSTENT® Biliary (8-10 mm) (K964119)
• WALLSTENT® Biliary (12 mm) (K961262)
• WALLSTENT® Enteral Endoprosthesis (K954290)
• WALLSTENT® Esophageal (K940396)
• WALLSTENT® Tracheobronchial Prosthesis (K934116)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image is a black and white seal for the Department of Health and Human Services, USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the top half of the circle. In the center of the seal is an abstract image of an eagle with three heads.

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: K982184

Trade/Device Name: WALLSTENT® Tracheobronchial Endoprosthesis Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis Regulatory Class: II Product Code: JCT, MUM, MOR, FGE, ESW Dated: June 18, 1998 Received: June 22, 1998

Dear Ms. Byland:

This letter corrects our substantially equivalent letter of July 21, 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

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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 Statement

| 510(k) Number<br>(if known) | K982184 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | WALLSTENT® Tracheobronchial Endoprosthesis |
| Indications For Use | The WALLSTENT® Tracheobronchial Endoprosthesis is<br>indicated for use in the treatment of tracheobronchial<br>strictures produced by malignant neoplasms. |

Prescription Use:_ X (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)

Hulu Lumm

Division of General, Restorative, and Neurological Devices

**510(k) Number** k982184

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510(k) Number (if known):

Device Name: WALLSTENT® Enteral Endoprosthesis

Indications For Use:

The WALLSTENT® Enteral Endoprosthesis is indicated for palliation of duodenal strictures caused by malignant neoplasms.

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

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

| Concurrence of CDRH/Office of Device Evaluation (ODE) | |
|-------------------------------------------------------|-------------------|
| | |
| (Division Sign-Off) | |
| Division of General, Restorative, | |
| and Neurological Devices | Page 1 of _______ |
| 510(k) Number | K982184 |

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:

Indications For Use:

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

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

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------------------------------|-------------------|
| (Division Sign-Off) Division of General, Restorative, and Neurological Devices | Page 1 of _______ |
| 510(k) Number | K982184 |

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510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The WALLSTENT® Enteral Endoprosthesis is indicated for palliative treatment of colonic strictures caused by malignant neoplasms.

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

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|------------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of General, Restorative, and Neurological Devices | |
| Page 1 of | |
| 510(k) Number | K982184 |

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510(k) Number (if known):

Device Name: WALLSTENT® Esophageal Endoprosthesis

Indications For Use:

The WALLSTENT® Esophageal Prosthesis is indicated for palliative treatment of esophageal strictures produced by malignant neoplasms.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices do not remove this line
510(k) Number K982184 0. Page 1 of ***_***

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982184 p. 1 of 3

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# 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 | July 13, 1998 | | | |
| Date Prepared | July 14, 2006 | | | |
| Proprietary<br>Name(s) | WALLSTENT®<br>Tracheo-<br>bronchial<br>Endoprosthesis | WALLSTENT®<br>Enteral<br>Endoprosthesis | WALLSTENT®<br>Biliary<br>Endoprosthesis | WALLSTENT®<br>Esophageal<br>Endoprosthesis |
| Common Name | Tracheal<br>Endoprosthesis | Esophageal<br>Endoprosthesis | Biliary Stent | Esophageal<br>Endoprosthesis |
| Product Code | JCT | MUM and<br>MQR | FGE | ESW |
| Classification of<br>Device | Class III<br>21 CFR Part<br>878.3720 | Class III<br>21 CFR Part<br>878.3610 | Class II<br>21 CFR Part<br>876.5010 | Class III<br>21 CFR Part<br>878.3610 |

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lc982184 p.20t'3

| Predicate Device | | | |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|------------------|
| 1 | WALLSTENT®<br>Tracheobronchial<br>Endoprosthesis<br>(12-30 mm) | K980163 | March 13, 1998 |
| 2 | WALLSTENT®<br>Enteral<br>Endoprosthesis<br>(Duodenal) | K980113 | April 3, 1998 |
| 3 | WALLSTENT®<br>Tracheobronchial<br>Endoprosthesis<br>(5-10 mm) | K964121 | December 4, 1996 |
| 4 | WALLSTENT®<br>Biliary (8-10 mm)<br>(Endoscopic and<br>Transhepatic) | K964119 | April 28, 1997 |
| 5 | WALLSTENT®<br>Biliary (12 mm)<br>(Endoscopic and<br>Transhepatic) | K961262 | May 16, 1996 |
| 6 | WALLSTENT®<br>Enteral<br>Endoprosthesis | K954290 | July 10, 1996 |
| 7 | WALLSTENT®<br>Esophageal | K940396 | October 2, 1994 |
| 8 | WALLSTENT®<br>Tracheobronchial<br>Prosthesis | K934116 | June 2, 1994 |
| Device<br>Description | The WALLSTENT® Tracheobronchial Endoprosthesis is a self-<br>expanding prosthesis constructed of braided wire of biomedical<br>superalloy, in some cases partially covered by a polymeric covering.<br>Some models include a radiopaque core. The stent's purpose is to<br>maintain or increase the luminal diameter of the passage in which it is<br>implanted.<br>The stent is placed by means of a delivery system, which is a coaxial<br>tubing assembly that constrains the prosthesis until it is released in a<br>controlled manner by retraction of the outer tube. | | |

:

1

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K982184 p. 3 of 3

| Indications for<br>Use | 1. | The WALLSTENT® Tracheobronchial<br>Endoprosthesis is indicated for use in the treatment<br>of tracheobronchial strictures produced by malignant<br>neoplasms. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 2. | Palliative treatment of colonic and duodenal<br>strictures caused by malignant neoplasms. |
| | 3. | The WALLSTENT® Tracheobronchial<br>Endoprosthesis is indicated for use in the treatment<br>of tracheobronchial strictures produced by malignant<br>neoplasms. |
| | 4. | Treatment of biliary strictures produced by malignant<br>neoplasms. |
| | 5. | Treatment of biliary strictures produced by malignant<br>neoplasms. |
| | 6. | Palliative treatment of colonic strictures caused by<br>malignant neoplasms. |
| | 7. | Treatment of esophageal strictures and<br>tracheoesophageal fistulas produced by malignant<br>neoplasms. |
| | 8. | The WALLSTENT® Tracheobronchial<br>Endoprosthesis is indicated for use in the treatment<br>of tracheobronchial strictures produced by malignant<br>neoplasms. |
| Technological<br>Characteristics | This premarket notification deals solely with addition of a<br>claim to MRI safety. The design of the product is<br>unchanged. | |
| Conclusion | The devices are unchanged and there are no changes to<br>safety and efficacy.<br>The purpose of this 510(k) notification is to present<br>information supporting a labeling change indicating a level<br>of MRI compatibility consistent with current and proposed<br>practices. | |