(119 days)
The Ultraflex™ Tracheobronchial Stent System is intended for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
The Ultraflex™ Tracheobronchial Uncovered Stent System consists of a self-expanding nitinol stent preloaded onto a flexible delivery catheter. The stent is a permanent implant designed to provide intraluminal support to keep open the inner wall of the tracheobronchial tree. A suture is threaded through the stent loops at the proximal end of the stent, to aid in stent removal during the initial procedure in the event of incorrect placement. The stent is preloaded onto the delivery catheter via crocheting of the deployment suture around the stent onto the delivery catheter. The system is provided sterile.
The Ultraflex™ Tracheobronchial Stent is available with either a proximal or distal release system. The distal release system begins stent deployment from the lower (distal) end of the delivery catheter. The proximal release system begins stent deployment from the upper (proximal) end of the delivery catheter.
The delivery system accepts a 0.035 in (0.89 mm) or 0.038 in (0.97 mm) guidewire, and has two (2) radiopaque (RO) markers on the delivery system to facilitate fluoroscopic placement.
To deliver the stent, the stent delivery system is passed over the guidewire into the tracheobronchial lumen. The delivery catheter is advanced, so that the stent is in the appropriate implant position. This positioning step is conducted under fluoroscopy and/or by bronchoscopic visualization of the stent. The stent is deployed by holding the handle hub in the palm of one hand, and grasping the finger ring, that is attached to the deployment suture, with the other hand. By retracting the finger ring the suture crochet knots are unraveled in a circular manner along the length of the stent, gradually deploying the stent. This deployment technique is identical to the predicate Ultraflex stent. The deployed stent expands and creates a scaffold support to assist in maintaining lumen patency of the airway at the implant position.
The materials of the stent material, the delivery catheter and the deployment suture are identical to those of the predicate Ultraflex™ Tracheobronchial Stent System (K012883, K963241).
The retention suture material is identical to that of the predicate Ultraflex™ Esophageal NG Stent System (K091816). The wire knot adhesive and the retention suture knot adhesives have been changed to Ultraviolet (UV) cured adhesives with enhanced strength and shorter manufacturing curing times.
The provided text describes a 510(k) premarket notification for the Ultraflex™ Tracheobronchial Uncovered Stent System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device's absolute performance against specific acceptance criteria through a clinical study with human readers and ground truth.
Therefore, many of the requested categories for AI/ML device studies (sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, training sets) are not applicable to this submission.
However, based on the provided text, I can extract information related to the performance data and the conclusion of the study to demonstrate the device meets acceptance criteria by showing substantial equivalence to predicate devices.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria here are implicitly based on demonstrating that the new device is as safe, as effective, and performs as well as the predicate devices. The performance data presented demonstrates that the device met required specifications which are aligned with these criteria.
| Acceptance Criteria (Implicit from 510(k) Equivalence) | Reported Device Performance |
|---|---|
| Material Equivalence & Performance: New device materials, design, and manufacturing processes are substantially equivalent to predicate devices, and perform comparably regarding physical characteristics. | "The materials of the stent material, the delivery catheter and the deployment suture are identical to those of the predicate Ultraflex™ Tracheobronchial Stent System (K012883, K963241)." |
| "The retention suture material is identical to that of the predicate Ultraflex™ Esophageal NG Stent System (K091816)." | |
| "In-vitro and In-vivo testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." | |
| "Testing included but was not limited to: Dimensional, fatigue, compression, expansion, deployment accuracy, integrity." | |
| "Fatigue, compression, expansion, deployment accuracy and integrity testing were successfully conducted in simulated use bench models." | |
| Sterility: Device meets established sterility standards. | "Sterility was performed using Ethylene Oxide according ANSVAAMI 11135-1: 2007 with an Sterility Assurance Level of 10-6. Sterilization residuals comply with ANSI/AAMI 10993-7: 2008." |
| Biocompatibility: Device materials are biocompatible. | "Biocompatibility was confirmed via AAMI/ANSI/ISO 10993-1: 2009. Testing included cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, acute systemic toxicity, subacute toxicity - intravenous and intraperitoneal, genotoxicity - Ames assay and mouse lymphoma, and an intramuscular toxicity implant test." |
| Pyrogenicity: Device does not contain pyrogens. | "No detectable endotoxin was confirmed via Pyrogen testing conducted according to AAMI ST72 and USP 85 and USP 161." |
| Overall Safety & Effectiveness: Device is as safe, effective, and performs as well as predicate devices for its intended use. | "Boston Scientific Corporation has demonstrated that no significant differences exist between the proposed UltraflexTM Tracheobronchial Stent System and the predicate Ultraflex™ Tracheobronchial Stent System (K012883), the predicate UltraflexTM Esophageal NG Stent System (K091816), and the predicate Merit Medical Endotek Aero™ Tracheobronchial Stent System (K082284, K083625). Therefore, the Ultraflex™ Tracheobronchial Stent System is as safe, as effective and performs as well as the predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "In-vitro and In-vivo testing" and "simulated use bench models." It also states, "Testing was conducted on both the proposed sterile Ultraflex™ Tracheobronchial Stent and the non-sterile Aero™ Tracheobronchial Stent System." However, specific sample sizes (e.g., number of stents tested for each parameter) are not provided. The data provenance is internal testing performed by Boston Scientific Corporation. The nature of the tests (bench models, in-vitro/in-vivo) suggests a prospective, controlled testing environment rather than retrospective data from a specific country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a medical device submission, not an AI/ML algorithm study requiring human experts to establish ground truth for image or data interpretation. The "ground truth" for this device's performance is established by meeting engineering specifications and scientific standards in a lab setting, rather than expert consensus on clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML algorithm study that would involve adjudication of expert interpretations.
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
Not applicable. This is not an AI/ML algorithm that assists human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. As this device is a physical medical implant, the concept of "standalone algorithm performance" does not apply. The device's performance is inherently its function when implanted or used.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on documented engineering specifications, international standards (e.g., ANSVAAMI, AAMI/ANSI/ISO, USP), and established scientific testing methodologies (e.g., cytotoxicity tests, fatigue tests, pyrogen testing). Performance is measured against these objective criteria rather than subjective expert consensus, pathology, or clinical outcome data in the context of an AI/ML study.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set for an AI/ML algorithm was used.
§ 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.”