(50 days)
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.
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.
The provided text is a 510(k) premarket notification summary for the WALLSTENT® Tracheobronchial Endoprosthesis, specifically addressing an alternate delivery system. This document primarily focuses on establishing substantial equivalence to a predicate device for this alternate delivery system, rather than providing detailed acceptance criteria and performance data for the endoprosthesis itself.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for the device (the endoprosthesis) is largely not present in the provided text. The document states that the alternate delivery system was found substantially equivalent based on in vitro test results demonstrating comparable deployment forces and handling characteristics to the current delivery system.
Here's a breakdown of what can be extracted about the alternate delivery system and what is missing regarding the endoprosthesis:
Information available regarding the alternate delivery system:
- Acceptance Criteria & Performance:
- Acceptance Criteria (Implicit): The alternate delivery system should have deployment forces and handling characteristics comparable to the predicate delivery system.
- Reported Device Performance: In vitro test results demonstrate that deployment forces and handling characteristics are comparable to the current delivery system.
- Study Type: In vitro testing.
Missing Information (or implicitly not applicable) for the alternate delivery system and entire device (endoprosthesis):
- A table of acceptance criteria and the reported device performance: While comparability is stated for the delivery system, specific quantifiable criteria and results are not provided for either the delivery system or the stent itself.
- Sample size used for the test set and the data provenance: Not specified for the in vitro tests of the alternate delivery system. No information for the endoprosthesis.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as the testing mentioned is in vitro for the delivery system, not involving expert interpretation of patient data.
- Adjudication method for the test set: Not applicable for in vitro testing of the delivery system.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical medical device (stent and delivery system), not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the delivery system, "ground truth" seems to be the performance of the predicate delivery system in in vitro tests. For the endoprosthesis itself, the document doesn't provide this detail.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.
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: 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 (OS) 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 Leenheer
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 X (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
Page 1 of 1
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K964121 p. lot'2
Image /page/3/Picture/1 description: The image shows the logo for Boston Scientific. The logo is in a bold, serif font. The word "Boston" is on the top line, and the word "Scientific" is on the bottom line. The logo is black and white.
510(K) SUMMARY K964121
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01545 Telephone: 508-683-4942 Fax: 508-683-5939
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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Image /page/4/Picture/0 description: The image contains the words "Boston Scientific" in a bold, serif font. The word "Boston" is stacked on top of the word "Scientific". The text is black and the background is white. The image appears to be a logo or branding element.
K76411 p. 20+2
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 Wallstent Tracheobronchial Encoprosticals will as 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 The purpose or unis J10(k) is to anow an accentate placement. This feature is presently partially deploy and then rocolisian and broad to 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 The attentiate don't by system our son 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.
§ 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.”