(56 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 produced by malignant neoplasms.
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 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.
This 510(k) premarket notification (K980163) for the WALLSTENT® Tracheobronchial Prosthesis and Wallstent Tracheobronchial Endoprosthesis with Permalume covering does not contain detailed acceptance criteria or a comprehensive study report with specific performance metrics suitable for a table. The document is primarily a summary demonstrating substantial equivalence to previously cleared predicate devices, focusing on an alternate delivery system.
Therefore, many of the requested details cannot be extracted directly from this submission.
Here's a breakdown of what can be inferred or stated based on the provided text, and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Deployment forces comparable to current delivery system. | "demonstrate that deployment forces ... are comparable to the current delivery system." |
| Handling characteristics comparable to current delivery system. | "demonstrate that ... handling characteristics are comparable to the current delivery system." |
| — (No mention of clinical efficacy or safety metrics as this is not a de novo or PMA submission) | — (No quantitative performance metrics like sensitivity, specificity, accuracy, or clinical outcomes are provided for the device itself or its clinical application.) |
Explanation: The "Performance Data" section explicitly states that the alternate delivery system was found substantially equivalent based on in vitro and in vivo deployment testing which demonstrated comparable deployment forces and handling characteristics to the current delivery system. These are the only mentioned performance criteria from the document.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document only mentions "in vitro and in vivo deployment testing" without detailing the number of tests, devices, or animal subjects (if applicable for in vivo).
- Data Provenance: Not specified. It's an internal study conducted by Boston Scientific Corporation, likely in their research and development facilities. It does not mention country of origin or whether it was retrospective or prospective in a clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/not specified. For in vitro and in vivo deployment testing assessing physical characteristics, "ground truth" would typically come from calibrated measurement equipment and engineering standards, rather than expert consensus on diagnostic images or clinical outcomes.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication method for the test set
- Adjudication Method: Not applicable/not specified. This type of method is usually relevant for studies involving human interpretation (e.g., radiology reads) or clinical endpoints that require review panels. For engineering performance testing, the results are typically objectively measured.
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
- MRMC Study: No. This is not an AI/imaging device. It's a medical implantable device (stent) and its delivery system.
- Effect Size of AI: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used
- Type of Ground Truth: For the "deployment forces" and "handling characteristics," the ground truth would have been established through objective engineering measurements using calibrated equipment and established test protocols. This is not "expert consensus," "pathology," or "outcomes data" in the clinical sense. It's physical property measurement.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set" in that context. The development and testing would involve engineering design, prototyping, and iterative testing.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. As there is no training set in the AI sense, there's no ground truth established for it. The ground truth for the product's engineering specifications would be derived from design requirements, material properties, and manufacturing standards.
In summary: The provided 510(k) focuses on demonstrating that a modified delivery system for an existing medical device (tracheobronchial stent) maintains comparable performance to predicate delivery systems based on engineering tests of deployment forces and handling. It is not a clinical study of a diagnostic device or AI algorithm, and therefore many of the requested details about acceptance criteria, ground truth, and study design are not present in this type of regulatory submission summary.
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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 consists of a stylized eagle with three lines representing its body and wings. 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
Boston Scientific Corporation % Ms. Angela Byland Manager, Regulatory Affairs Cardiovascular Two Scimed Place Maple Grove, Minnesota 55311-1566
Re: K980163
Trade/Device Name: WALLSTENT® Tracheobronchial Prosthesis and Wallstent Tracheobronchial Endoprosthesis with Permalume covering Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis Regulatory Class: II Product Code: JCT Dated: January 15, 1998 Received: January 16, 1998
Dear Ms. Byland:
This letter corrects our substantially equivalent letter of March 13, 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
510(k) Number (if known): K980163
Device Name:
Wallstent® Tracheobronchial Prosthesis and Wallstent Tracheobronchial Endoprosthesis with Permalume covering
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 produced by malignant neoplasms.
Prescription Use × (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)
Helmut Leuer
(Division Sign-( Division of General, Restore . and Neurological Devices
Page 1 of 1
510(k) Number k98 0163
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K980163 p. lot 2
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510(K) SUMMARY K980163
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Wav Marlborough, MA 01545 Telephone: 508-683-4942 Fax: 508-683-5939
Contact: Kathleen Morahan Director Regulatory Affairs Original Date Prepared: January 12, 1998 Revision Date: July 14, 2006
2. Device:
Trade Name: Wallstent® Tracheobronchial Endoprosthesis with Unistep Plus Delivery System Common Name: Tracheal Prosthesis Classification Name: Tracheal Prosthesis Regulation Number: 878.3720 Product Code: JCT Classification: Class II
Trade Name: Wallstent Tracheobronchial Endoprosthesis with Permalume Covering and Unistep Plus Delivery System 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 with Unistep Delivery System, K934116
Boston Scientific Corporation's Wallstent Tracheobronchial Prosthesis with Unistep Plus Delivery System, K964121
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
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K980163 p. 2 of 2
Image /page/4/Picture/1 description: The image shows the logo for Boston Scientific. The text "Boston" is stacked on top of the text "Scientific". The font is a serif font and the text is black.
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.
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 treatment of tracheobronchial strictures or fistulas produced by malignant neoplasms.
6. Technological Characteristics:
The purpose of this 510(k) us to allow an alternate delivery system. Compared to the Unistep Delivery System (K934116), the Unisten Plus delivery system allows the user to partially deploy and then reconstrain the stent to facilitate placement. This feature is presently available in the Wallstent Tracheobronchial Endoprosthesis with Unistep Plus Delivery System (K964121). Compared to the present Unistep Plus Delivery System (K964121), the modified system has different materials for the outer and inner tubing.
7. Performance Data:
The alternate delivery system can be found substantially equivalent based on results of in vitro and in vivo deployment testing which demonstrate that deployment forces and handling characteristics are comparable to the current delivery system.
8. Conclusion:
Boston Scientific Corporation has demonstrated that the Wallstent Tracheobronchial Endoprosthesis with Unistep Plus Delivery System, Wallstent Tracheobronchial Endoprosthesis with Permalume Covering and Unistep Plus Delivery System with modified delivery system is substantially equivalent based on design, test results, and indications for use to the predicate devices.
§ 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.”