(97 days)
The WALLSTENT® Tracheobronchial Endoprosthesis is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
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 versions to allow physicians to select the most appropriate model based on their preference and individual patient condition. The stent's 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 released 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.
The provided text describes a 510(k) premarket notification for the WALLSTENT® Tracheobronchial Endoprosthesis, which is a medical device. This document is a regulatory submission for market clearance and does not contain acceptance criteria or a study that proves the device meets specific performance criteria in the way an AI/ML device submission would.
The document details the device's description, indications for use, and a comparison to predicate devices to demonstrate substantial equivalence, a key concept in 510(k) submissions. It mentions modifications to existing stents (increasing wire diameter and/or number of wires to standardize relative radial force), suggesting that some testing or design changes occurred, but it doesn't provide performance metrics or the details of a study with acceptance criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance because it is not present in the provided text. The submission is focused on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study against predefined acceptance criteria.
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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health and Human Services - USA. The seal features an abstract image of an eagle with its wings spread. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is 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: K961296
Trade/Device Name: WALLSTENT® Tracheobronchial Endoprosthesis Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis Regulatory Class: III Product Code: JCT Dated: March 29, 1996 Received: April 4, 1996
Dear Ms. Byland:
This letter corrects our substantially equivalent letter of July 10, 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 (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,
Hubert Lenoir
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) | K961296 |
|---|---|
| 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: × (Per 21 CFR §801 Subpart D)
ﻟﺘ
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)
Hulut Lewy
(Division S ign-Off Division of General, Restorative, and Neurological Devices
510(k) Number K961294
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962296 p. 1 of 2
Image /page/3/Picture/1 description: The image shows the logo for Boston Scientific. The logo is in a bold, serif typeface. The word "Boston" is on the top line, and the word "Scientific" is on the bottom line. The logo is in black and 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 | March 29, 1996 | ||
| Date Prepared | July 14, 2006 | ||
| ProprietaryName(s) | WALLSTENT® Tracheobronchial Endoprosthesis | ||
| Common Name | Tracheal Endoprosthesis | ||
| Product Code | JCT | ||
| Classification ofDevice | Class III, 21 CFR Part 878.3720 | ||
| Predicate Device | WALLSTENT®TracheobronchialProsthesis | K934116 | June 2, 1994 |
| WALLSTENT®TracheobronchialEndoprosthesis | K945494 | March 3, 1995 | |
| DeviceDescription | The WALLSTENT® Tracheobronchial Endoprosthesis is aself-expanding prosthesis constructed of biomedicalsuperalloy and an elastomeric polymer. Smaller diametermodels may utilize a radiopaque core. The prosthesis is abraided wire structure which may be covered with anelastomeric polymer in selected models. The outward radialforce along with the ends of the device serve to stabilize theprosthesis after implanted. The prosthesis is offered incovered and uncovered versions to allow physicians toselect the most appropriate model based on theirpreference and individual patient condition. The stent'spurpose is to increase or maintain the inner luminaldiameter of the tracheobronchial passage. |
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961296 p. 2 of 2
| DeviceDescriptioncont'd | The stent is placed by means of a delivery system. Thedelivery system is a coaxial tubing assembly whichconstrains the prosthesis until it is released in a controlledmanner. The release of the stent is accomplished byretracting the outer sheath. The prosthesis is packagedconstrained on the delivery system ready for placement.The system is sterile and intended for single use only. |
|---|---|
| Indications forUse | The WALLSTENT® Tracheobronchial Endoprosthesis isindicated for use in the treatment of tracheobronchialstrictures produced by malignant neoplasms. |
| TechnologicalCharacteristics | This premarket notification deals with modification to the 12and 14 mm stents to standardize the relative radial force.This was accomplished by increasing the wire diameterand/or number of wires used to fabricate the stent. |
| Conclusion | In summary, Boston Scientific Corporation hasdemonstrated that the predicate devices and theWALLSTENT® Tracheobronchial Endoprosthesis aresubstantially equivalent based on design, materials,methods of fabrication and indications for use. |
Carlos Concession
:
i
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§ 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.”