(114 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 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 that 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 a medical device, the WALLSTENT® Tracheobronchial Endoprosthesis with Unistep™ Plus Delivery System. The primary purpose of this 510(k) is to introduce an alternate delivery system with a reduced profile (smaller diameter). The core endoprosthesis itself appears to be the same as the predicate device (K964121).
The study described focuses on demonstrating the substantial equivalence of this new delivery system to the existing one, not on proving the clinical efficacy or diagnostic accuracy of the stent itself.
Here's an analysis of the acceptance criteria and study data based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Goal of the Study) | Reported Device Performance (as per the 510(k) summary) |
|---|---|
| Deployment forces are comparable to the current delivery systems | "The alternate delivery system can be found substantially equivalent based on the results of in vitro testing that demonstrates the deployment forces... are comparable to the current delivery systems." |
| Handling characteristics are comparable to the current delivery systems | "The alternate delivery system can be found substantially equivalent based on the results of in vitro testing that demonstrates the ...handling characteristics are comparable to the current delivery systems." |
| Design is substantially equivalent to the predicate device | "Boston Scientific Corporation has demonstrated that the WALLSTENT® Tracheobronchial Endoprosthesis with Unistep™ Plus Delivery System with reduced profile for the delivery system is substantially equivalent based on design..." |
| Test results are substantially equivalent to the predicate device | "Boston Scientific Corporation has demonstrated that the WALLSTENT® Tracheobronchial Endoprosthesis with Unistep™ Plus Delivery System with reduced profile for the delivery system is substantially equivalent based on ...test results..." |
| Indications for use are substantially equivalent to the predicate device | "Boston Scientific Corporation has demonstrated that the WALLSTENT® Tracheobronchial Endoprosthesis with Unistep™ Plus Delivery System with reduced profile for the delivery system is substantially equivalent based on ...indications for use..." |
Summary of Device Performance: The 510(k) concludes that the new delivery system is substantially equivalent to the predicate device based on in vitro testing of deployment forces and handling characteristics, as well as design and indications for use.
2. Sample Size Used for the Test Set and the Data Provenance
The document mentions "in vitro testing" but does not specify the sample size for the test set. It also does not provide information on data provenance such as country of origin or whether it was retrospective or prospective, as it's an in vitro (benchtop) study, not a clinical study involving human patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable or provided in the document. The study described is in vitro testing of mechanical properties and handling, not a study requiring expert clinical judgment or ground truth establishment in a diagnostic sense.
4. Adjudication Method for the Test Set
This information is not applicable or provided. Since the study focuses on in vitro comparisons of mechanical properties like deployment forces and handling, there would be no need for an adjudication method as seen in clinical or diagnostic studies.
5. 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
No, an MRMC comparative effectiveness study was not done. This document describes the substantial equivalence of a medical device's delivery system, not an AI-powered diagnostic tool. Therefore, there is no AI assistance or human reader improvement to measure an effect size for.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This submission is for a physical medical device (stent and delivery system), not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this in vitro study would be the established mechanical performance and handling characteristics of the predicate delivery system. The new delivery system's performance metrics (deployment forces, handling) are compared against these known values to demonstrate "comparability." It's not clinical "ground truth" derived from pathology or outcomes.
8. The Sample Size for the Training Set
This information is not applicable or provided. This is not a machine learning or AI algorithm submission where training sets are relevant.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or provided. As above, there is no training set for a machine learning algorithm.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem is a stylized representation of an eagle, with three curved lines forming the body and wings. The logo is black and white.
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: K992510
K92510
Trade/Device Name: WALLSTENT® Tracheobronchial Endoprosthesis with Unistep™ Plus Delivery System Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis
Regulatory Class: III Product Code: JCT Dated: October 31, 1999 Received: November 3, 1999
Dear Ms. Byland:
This letter corrects our substantially equivalent letter of November 18, 1999.
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave ro roved your becaused the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the enactment date of 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, and Cosmedo Tect (110) that do neer equine general controls provisions of the Act. The general therefore, maintons of the Act include requirements for annual registration, listing of devices, condons provisions or actice, 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 or any I 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,
Herbert Lemmerus
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) | K992510 |
|---|---|
| Device Name | WALLSTENT® Tracheobronchial Endoprosthesis with Unistep™ Plus Delivery System |
| Indications For Use | The WALLSTENT® Tracheobronchial Endoprosthesis is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms. |
Prescription Use:_ X (Per 21 CFR §801 Subpart D) OR
Over-The-Counter Use: ر (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concerrence of CDRH, Office of Device Evaluation (ODE)
Hulda Gunn
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K992510
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Boston
Scientific
510(k) Summary K992510
| 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 26, 1999 |
| Date Prepared | July 14, 2006 |
| ProprietaryName(s) | WALLSTENT® Tracheobronchial Endoprosthesis withUnistep™ Plus Delivery System |
| Common Name | Tracheal Endoprosthesis |
| Product Code | JCT |
| Classification ofDevice | Class III, 21 CFR Part 878.3720 |
| Predicate Device | WALLSTENT®TracheobronchialEndoprosthesisK964121December 04, 1996 |
| 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 stent's purpose is toincrease or maintain the inner luminal diameter of thetracheobronchial passage. |
| DeviceDescriptioncont'd | The stent is placed by means of a delivery system. Thedelivery system is a coaxial tubing assembly that constrainsthe prosthesis until it is released in a controlled manner.The release of the stent is accomplished by retracting theouter sheath. The prosthesis is packaged constrained onthe delivery system ready for placement. The system issterile 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 | The purpose of this 510(k) is to allow an alternate deliverysystem. Compared to the present Unistep™ Plus DeliverySystem (K964121), this version of the Unistep™ PlusDelivery System has a reduced profile that is a smallerdiameter. |
| The alternate delivery system can be found substantiallyequivalent based on the results of in vitro testing thatdemonstrates the deployment forces and handlingcharacteristics are comparable to the current deliverysystems. | |
| Conclusion | In summary, Boston Scientific Corporation hasdemonstrated that the WALLSTENT® TracheobronchialEndoprosthesis with Unistep™ Plus Delivery System withreduced profile for the delivery system is substantiallyequivalent based on design, test results, and indications foruse to the predicate devices. |
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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.”