(97 days)
The FLUENCY® Plus Tracheobronchial Stent Graft is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms or in benign strictures after all alternative therapies have been exhausted.
The FLUENCY® Plus Tracheobronchial Stent Graft is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
The FLUENCY® Plus Tracheobronchial Stent Graft includes a self-expanding Nitinol stent encapsulated with carbon-impregnated ePTFE pre-loaded on a flexible "pull-back" delivery system. It is a single use prosthetic device designed to maintain the patency of the tracheobronchial tree in patients with tracheobronchial strictures. Highly radiopaque tantalum markers on the stent graft ends facilitate stent graft placement. The FLUENCY® Plus Tracheobronchial Stent Graft is available in various lengths and diameters. It is preloaded into various size delivery catheters, depending on the size of the stent graft and is available in various delivery system lengths.
The acceptance criteria for the FLUENCY® Plus Tracheobronchial Stent Graft are described and the study that proves the device meets them is detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
The provided documentation does not specify numerical acceptance criteria for the device's performance. Instead, it states that the device was evaluated based on the "Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses. April 28, 1998." and that "All test results confirm the modified device to be substantially equivalent to the predicate device." The "Conclusions" section reiterates that "The FLUENCY® Plus Tracheobronchial Stent Graft met all the predetermined performance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."
The primary changes described for the FLUENCY® Plus are:
- Modification of the inner catheter tip.
- Modification to the outer catheter material and configuration.
The reported device performance improvements due to these changes are:
- Reduced deployment force.
- Reduced risk of tip entanglement during withdrawal of the delivery system.
- More precise stent graft placement during deployment.
- More delivery system length options for physicians.
The document assesses substantial equivalence, meaning the new device performs at least as well as the predicate device (FLUENCY® Tracheobronchial Stent Graft (K031041)) in terms of safety and effectiveness, based on non-clinical data.
Based on the provided text, a direct table of acceptance criteria with specific numerical values for performance metrics cannot be generated as these are not explicitly stated. The acceptance criteria are implicitly defined by conformance to the specified FDA guidance and the demonstration of substantial equivalence to the predicate device in terms of design verification and validation.
Implied Acceptance Criteria and Reported Performance:
| Acceptance Criteria Category | Specific Criteria (Implicitly from Guidance & Equivalence) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Reduced deployment force compared to predicate device. | Achieved reduced deployment force. |
| Reduced risk of tip entanglement during withdrawal. | Achieved reduced risk of tip entanglement. | |
| Deployment Accuracy | More precise stent graft placement. | Achieved more precise placement. |
| Delivery System Options | Availability of more delivery system length options. | Achieved more delivery system length options. |
| Biocompatibility | Maintained biocompatibility (same as predicate). | Maintained substantial equivalence in material aspects. |
| Sterilization | Maintained sterilization method (same as predicate). | Maintained substantial equivalence in sterilization. |
| Overall Equivalence | Substantial equivalence to predicate device in safety and effectiveness. | Met all predetermined performance criteria and is substantially equivalent. |
2. Sample Size for the Test Set and Data Provenance
The document describes non-clinical performance data which involved design verification and validation. It does not refer to a "test set" in the context of patient data or clinical images. The data provenance is from non-clinical laboratory testing conducted by the manufacturer, Bard Peripheral Vascular, Inc., in the USA (Tempe, AZ). The studies are retrospective in the sense that they are laboratory tests performed on the device prototypes and not prospective clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the studies described are non-clinical (laboratory testing) and do not involve human-interpreted test sets. No expert-established ground truth related to clinical outcomes or image interpretation is mentioned.
4. Adjudication Method for the Test Set
This information is not applicable as the studies described are non-clinical and do not involve a test set requiring adjudication by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not performed, or at least not described in the provided documentation. The submission focuses on non-clinical performance and substantial equivalence based on engineering and material changes.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
This question is not applicable as the device is a physical medical implant (stent graft) with a delivery system, not an algorithm or AI-based system.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical performance studies would be based on engineering specifications, material properties, and physical measurements obtained during design verification and validation tests. These tests are implicitly assessing the device's conformance to its design intent and performance characteristics relative to the predicate device and relevant standards/guidance.
8. Sample Size for the Training Set
This information is not applicable as the device is a physical medical implant and not an AI/algorithm-based system that requires a training set. The "training" for such a device would be its iterative design, prototyping, and testing phases.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the device is a physical medical implant and not an AI/algorithm-based system.
§ 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.”