The WALLSTENT® Tracheobronchial Endoprosthesis is a self-expanding prosthesis constructed of braided wire of biomedical superalloy, in some cases partially covered by a polymeric covering. Some models include a radiopaque core. The stent's purpose is to maintain or increase the luminal diameter of the passage in which it is implanted. The stent is placed by means of a delivery system, which is a coaxial tubing assembly that constrains the prosthesis until it is released in a controlled manner by retraction of the outer tube.

AI/ML Overview

This document is a 510(k) premarket notification correction letter for multiple Boston Scientific WALLSTENT® Endoprosthesis devices. It does not contain information about acceptance criteria or a study demonstrating the device meets such criteria because it's focused on establishing substantial equivalence to previously cleared devices and adding an MRI safety claim.

Therefore, the requested information cannot be extracted from the provided text. The document's purpose is regulatory clearance based on substantial equivalence, not performance evaluation against specific acceptance criteria.

Summary

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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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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(if known)	K982184
Device Name	WALLSTENT® Tracheobronchial Endoprosthesis
Indications For Use	The WALLSTENT® Tracheobronchial Endoprosthesis isindicated for use in the treatment of tracheobronchialstrictures 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

Image /page/7/Picture/1 description: The image shows the words "Boston Scientific" stacked on top of each other. The words are in a bold, serif font. The word "Boston" is on the top line, and the word "Scientific" is on the bottom line. The text is black and the background is white.

510(k) Summary

Submitter'sName andAddress	Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311
Contact Nameand Information	Angela BylandManager, Regulatory AffairsPhone: 763-494-2887Fax: 763-494-2981e-mail: bylanda@bsci.com
Original DatePrepared	July 13, 1998
Date Prepared	July 14, 2006
ProprietaryName(s)	WALLSTENT®Tracheo-bronchialEndoprosthesis	WALLSTENT®EnteralEndoprosthesis	WALLSTENT®BiliaryEndoprosthesis	WALLSTENT®EsophagealEndoprosthesis
Common Name	TrachealEndoprosthesis	EsophagealEndoprosthesis	Biliary Stent	EsophagealEndoprosthesis
Product Code	JCT	MUM andMQR	FGE	ESW
Classification ofDevice	Class III21 CFR Part878.3720	Class III21 CFR Part878.3610	Class II21 CFR Part876.5010	Class III21 CFR Part878.3610

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lc982184 p.20t'3

Predicate Device
1	WALLSTENT®TracheobronchialEndoprosthesis(12-30 mm)	K980163	March 13, 1998
2	WALLSTENT®EnteralEndoprosthesis(Duodenal)	K980113	April 3, 1998
3	WALLSTENT®TracheobronchialEndoprosthesis(5-10 mm)	K964121	December 4, 1996
4	WALLSTENT®Biliary (8-10 mm)(Endoscopic andTranshepatic)	K964119	April 28, 1997
5	WALLSTENT®Biliary (12 mm)(Endoscopic andTranshepatic)	K961262	May 16, 1996
6	WALLSTENT®EnteralEndoprosthesis	K954290	July 10, 1996
7	WALLSTENT®Esophageal	K940396	October 2, 1994
8	WALLSTENT®TracheobronchialProsthesis	K934116	June 2, 1994
DeviceDescription	The WALLSTENT® Tracheobronchial Endoprosthesis is a self-expanding prosthesis constructed of braided wire of biomedicalsuperalloy, in some cases partially covered by a polymeric covering.Some models include a radiopaque core. The stent's purpose is tomaintain or increase the luminal diameter of the passage in which it isimplanted.The stent is placed by means of a delivery system, which is a coaxialtubing assembly that constrains the prosthesis until it is released in acontrolled manner by retraction of the outer tube.

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K982184 p. 3 of 3

Indications forUse	1.	The WALLSTENT® TracheobronchialEndoprosthesis is indicated for use in the treatmentof tracheobronchial strictures produced by malignantneoplasms.
	2.	Palliative treatment of colonic and duodenalstrictures caused by malignant neoplasms.
	3.	The WALLSTENT® TracheobronchialEndoprosthesis is indicated for use in the treatmentof tracheobronchial strictures produced by malignantneoplasms.
	4.	Treatment of biliary strictures produced by malignantneoplasms.
	5.	Treatment of biliary strictures produced by malignantneoplasms.
	6.	Palliative treatment of colonic strictures caused bymalignant neoplasms.
	7.	Treatment of esophageal strictures andtracheoesophageal fistulas produced by malignantneoplasms.
	8.	The WALLSTENT® TracheobronchialEndoprosthesis is indicated for use in the treatmentof tracheobronchial strictures produced by malignantneoplasms.
TechnologicalCharacteristics	This premarket notification deals solely with addition of aclaim to MRI safety. The design of the product isunchanged.
Conclusion	The devices are unchanged and there are no changes tosafety and efficacy.The purpose of this 510(k) notification is to presentinformation supporting a labeling change indicating a levelof MRI compatibility consistent with current and proposedpractices.

Regulation Number and Section

§ 878.3720 Tracheal prosthesis.

(a)
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.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”