(233 days)
The WALLSTENT™ RP Endoprosthesis and WALLSTENT™ Endoprosthesis Tracheobronchial are indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
The WALLSTENT RP Endoprosthesis Tracheobronchial and WALLSTENT Endoprosthesis Tracheobronchial are comprised of two components: The implantable metallic stent and the UNISTEP Plus delivery system. The stent is composed of biomedical superalloy wire, braided in a tubular mesh configuration. This design configuration results in a stent that is flexible, compliant, and self-expanding. The delivery system consists in part of coaxial tubes. The exterior tube serves to constrain the stent until retracted during delivery. Radiopaque marker bands situated on the interior and exterior tubes aid in imaging during deployment. Small stent sizes (5mm-12mm) may have a radiopaque core to improve radiopacity. The interior tube of the coaxial system contains a central lumen that accommodates a 0.035 in (0.89mm) guidewire.
This document describes the regulatory clearance for the WALLSTENT™ RP Endoprosthesis Tracheobronchial and WALLSTENT™ Endoprosthesis Tracheobronchial. This is a medical device, specifically a self-expanding stent used to treat tracheobronchial strictures caused by malignant neoplasms.
The submission is a 510(k) premarket notification, which means the manufacturer is demonstrating that the device is substantially equivalent to a legally marketed predicate device. Therefore, the "study" described is primarily focused on demonstrating this substantial equivalence, particularly regarding MRI compatibility, rather than a clinical study evaluating the device's efficacy against clinical acceptance criteria in a human population.
Given the nature of the document (a 510(k) summary), many of the requested details about acceptance criteria for device performance, ground truth establishment, expert adjudication, multi-reader multi-case studies, and training set information are not directly applicable or available. The study in question is a non-clinical bench test study for MR compatibility.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present specific quantitative acceptance criteria for clinical performance (e.g., success rates, complication rates) or an AI model's performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device and safety, particularly regarding MR compatibility.
| Acceptance Criteria (General Principle for 510(k)) | Reported Device Performance (Summary of Non-Clinical Test) |
|---|---|
| Substantial Equivalence to Predicate Device (WALLSTENT™ Tracheobronchial Endoprosthesis K992510) | "The proposed WALLSTENT RP Endoprosthesis Tracheobronchial and WALLSTENT Endoprosthesis Tracheobronchial is substantially equivalent to the existing Wallstent Endoprosthesis Tracheobronchial cleared by FDA under premarket notification K992510 (November 18, 1999). WALLSTENT RP Endoprosthesis Tracheobronchial and WALLSTENT Endoprosthesis Tracheobronchial has the same intended use, scientific technology, design, sterilization method, and packaging as the applicable predicate device. The only difference is to the MR Safety labeling information within the Directions for Use." |
| Safety and Compatibility in the Magnetic Resonance (MR) Environment | "Bench testing in accordance with FDA guidance document Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, dated December 11, 2014) to support labeling as MR Conditional. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the device testing." |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical bench testing. Therefore, the concept of a "test set" in the context of patient data or clinical images does not apply. The "sample size" would refer to the number of physical devices or components tested in the lab. This specific number is not explicitly stated in the provided text, but the testing was for MR compatibility. The data provenance is from bench testing conducted by Boston Scientific Corporation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The study is non-clinical bench testing for MR compatibility, not a study involving medical images needing expert interpretation.
4. Adjudication Method for the Test Set
Not applicable. This was a non-clinical bench test, not a study involving human interpretation or adjudication of medical data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This document describes a 510(k) submission for a physical medical device, not an AI or imaging software. The study performed was non-clinical bench testing for MR compatibility.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI or algorithm-based device.
7. The Type of Ground Truth Used
For the MR compatibility testing, the "ground truth" would be established by physical measurements and adherence to the FDA guidance document "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment." This involves objective physical testing for parameters such as magnetically induced displacement force, torque, and heating, and assessment of image artifact.
8. The Sample Size for the Training Set
Not applicable. This is not an AI or algorithm-based device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this type of device submission.
§ 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.”