(137 days)
The Merit ENDOTEK AEROmini™ Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
The MERIT ENDOTEK AEROmini Tracheobronchial Stent System is comprised of two components: the radiopaque self-expanding nitinol stent and the delivery system. The stent is completely covered with a biocompatible polvurethane membrane. The stent expansion results from the physical properties of the metal and the proprietary geometry. The overall stent geometry is designed to maintain a constant length over the entire range of possible diameters. As a result of this unique design the stent has virtually no foreshortening, thus facilitating the selection of the appropriate stent length. The stent is deployed endoscopically with a dedicated delivery system with or without the aid of fluoroscopic imaging. The delivery system consists of two coaxial sheaths. The exterior sheath serves to constrain the stent until the sheath is retracted during deployment. The stent remains constrained by the delivery system until the trigger is pulled beyond the white deployment threshold mark located between the trigger and hand grip. This feature allows for repositioning of the stent proximally. A radiopaque tip and marker on the inner shaft aid the operator in determining stent position in relation to the deployment threshold mark, where repositioning or en bloc withdrawal is no longer possible. The inner sheath of the delivery system contains a central lumen that will accommodate a 0.035" guide wire. This feature is designed to allow guidance of the delivery system to the intended implant site while minimizing the risk of airway injury from the delivery system tip.
The stent and delivery system are provided sterile using ethylene oxide (EO) process.
This document describes a 510(k) premarket notification for the AEROmini Tracheobronchial Stent System, manufactured by Merit Medical Systems, Inc. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (K140382) to allow the device to be marketed.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly numerical targets in the provided text. Instead, the document states that the device "met the standards' established acceptance criteria applicable to the substantial equivalence of the device" and "met the predetermined acceptance criteria applicable to the performance of the device" for various tests. The general acceptance criterion is demonstrating that the new AEROmini device, with its new sizes and a new delivery system, performs equivalently to the predicate device and national/international standards without raising new questions of safety or effectiveness.
Below is a table summarizing the types of tests conducted (representing the indirectly stated acceptance criteria categories) and the reported device performance. No specific numerical thresholds or performance metrics are provided in this summary.
| Acceptance Criteria Category (Test Type) | Reported Device Performance |
|---|---|
| Mechanical Performance (Stent) | |
| Deployment Testing | Successfully conducted. |
| Expansion Force Testing | Successfully conducted. |
| Compression Force Testing | Successfully conducted. |
| Dimensional Testing | Successfully conducted. |
| Tensile Strength Tests | Successfully conducted. |
| Stent Expansion & Condition After Deployment | Successfully completed. |
| Stent Foreshortening | Successfully completed. |
| Stent Dimensions | Successfully completed. |
| Migration & Removal Force | Successfully completed. |
| AM-Strut Height | Successfully completed. |
| Stent Compression | Successfully completed. |
| Stent Expansion | Successfully completed. |
| Suture Purse String | Successfully completed. |
| Stent Dimensions Post Suture Purse String – 12F and 16F only | Successfully completed. |
| Suture Tensile Strength | Successfully completed. |
| Stent Tensile | Successfully completed. |
| Stent Fatigue | Successfully completed. |
| Cover Integrity After Fatigue | Successfully completed. (Implies cover remained intact and functional) |
| Coating Integrity After Fatigue | Successfully completed. (Implies coating remained intact and functional) |
| Stent Spring Back After Fatigue | Successfully completed. |
| Compression Force After Fatigue | Successfully completed. |
| Expansion Force After Fatigue | Successfully completed. |
| Mechanical Performance (Delivery System) | |
| Guide Wire Compatibility | Successfully completed. |
| Delivery Device Working Length | Successfully completed. |
| Delivery Device Stent Pod OD | Successfully completed. |
| Delivery Device Shaft OD - 7.9F | Successfully completed. |
| Trigger Stroke | Successfully completed. |
| Insertion Force | Successfully completed. |
| Deployment Force | Successfully completed. |
| Distal Tip Insertion & Flexibility/Kink Resistance | Successfully completed. |
| Repositioning | Successfully completed. (Within the defined limits before the deployment threshold mark) |
| Delivery System Deployment Accuracy | Successfully completed. |
| System Integrity | Successfully completed. |
| Delivery System Tensile Strength Tests- 7.9 F only | Successfully completed. |
| Imaging Compatibility | |
| Fluoroscopic Visibility of Deployment Catheter | Successfully completed. |
| Endoscopic Visibility of Deployment Catheter | Successfully completed. |
| MR Compatibility (Magnetically Induced Displacement Force, RF Heating, Torque, Image Artifacts) | Successfully conducted according to ASTM standards, implying the device is safe and its presence does not unduly affect MR imaging. |
| Biocompatibility | |
| Cytotoxicity (for new 7.9F delivery system) | Successfully completed. |
| Sensitization (for new 7.9F delivery system) | Successfully completed. |
| Irritation (for new 7.9F delivery system) | Successfully completed. |
| Material Mediated Pyrogenicity (for new 7.9F delivery system) | Successfully completed. |
| Biocompatibility (general, for new 7.9F delivery system materials) | Successfully conducted according to ISO 10993 series and FDA guidance. |
| Sterilization & Packaging | |
| Sterilization (Ethylene Oxide Process) | Successfully conducted according to ISO 11135:2014, implying sterility is maintained. |
| Packaging Performance (Performance Testing of Shipping, Conditioning) | Successfully conducted according to ASTM D4169-16, ISO 2233:2000, and ISO 11607-1:2006, implying package integrity and sterility maintenance. |
| Seal Peel Strength | Successfully completed. |
| Visual Inspection | Successfully completed. |
| Bubble Emission | Successfully completed. (Implies package integrity) |
| Clinical/Procedural Compatibility | |
| Atraumatic Tip | Successfully completed. |
| Compatibility with 2.8mm working channel | Successfully completed. |
| Compatibility with Olympus BF-1TH190 Rotary Scope | Successfully completed. |
2. Sample size used for the test set and the data provenance:
The document does not specify the sample sizes used for each individual test. It lists a "battery of tests" that were performed based on recognized performance standards and guidance. The provenance of the data (e.g., country of origin) is not mentioned beyond the fact that it was conducted by the manufacturer, Merit Medical Systems, Inc., for a U.S. FDA submission. The nature of these tests (mechanical, biocompatibility, sterilization, etc.) implies laboratory or bench testing rather than human clinical data. Therefore, it is not retrospective or prospective in the clinical trial sense.
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 and not provided in the document. The "ground truth" for these engineering and materials tests is established by adhering to widely accepted international and national standards (e.g., ISO, ASTM, FDA guidance) and their specified methodologies, rather than expert consensus on individual cases. The manufacturers' internal experts and testing personnel would perform these tests and interpret the results against the standard criteria.
4. Adjudication method for the test set:
This is not applicable as the tests are primarily objective measurements against defined standards, not subjective interpretations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The device described, the AEROmini Tracheobronchial Stent System, is a physical medical device (a stent and its delivery system), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is a physical stent system, not an algorithm.
7. The type of ground truth used:
The "ground truth" for the performance evaluations is based on adherence to:
- Recognized Performance Standards: e.g., ISO 11135:2014, ASTM D4169-16, ASTM F2052-15, ISO 10993 series.
- FDA Guidance: Specifically, "Guidance for the Content of Premarket Notifications for Esophageal and Tracheal Prostheses, April 28, 1998" and "Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, May 1, 1995."
- Internal specifications and risk analysis: "Performance testing was conducted based on the risk analysis."
These documents and standards define acceptable methods, materials properties, and performance limits for such devices.
8. The sample size for the training set:
This is not applicable. The device is a physical medical device and does not involve AI algorithms that require training sets.
9. How the ground truth for the training set was established:
This is not applicable.
§ 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.”