(50 days)
The MERIT ENDOTEK™ EndoMAXX™ Fully Covered Esophageal Stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and for occlusion of esophageal fistulae.
The MERIT ENDOTEK™ EndoMAXX Fully Covered Esophageal Stent is comprised of two components: the radiopaque self-expanding Nitinol stent and the deployment catheter. The stent is completely covered with a biocompatible silicone membrane. The stent expansion results from the physical properties of the metal and the proprietary geometry. The stent is designed with a larger diameter at the distal and proximal ends to reduce the possibility of migration. The overall stent geometry is designed to minimize foreshortening upon expansion, thus facilitating improvement in deployment accuracy. The proximal and distal ends of the stent are threaded with a suture intended for use in proximal and distal repositioning of the stent. The stent is deployed with a dedicated deployment catheter. The deployment catheter consists of two coaxial sheaths attached to a deployment handle. The handle permits one-handed positioning and deployment via a trigger mechanism. The exterior sheath serves to constrain the stent until the sheath is retracted during deployment. A radiopaque tip and marker on the inner shaft proximal to the stent aid the operator in determining stent position to the deployment threshold. Once deployment is initiated, the stent cannot be reconstrained. The stent can be repositioned proximally until the first deployment trigger is deployed for a two deployment trigger device or until the second deployment trigger is deployed for a three deployment trigger device. The inner tube of the coaxial sheath catheter contains a central lumen that will accommodate a 0.035" (0.89mm) guide wire. This feature is designed to allow safe guidance of the deployment catheter to the intended implant site while minimizing the risk of esophageal injury from the deployment catheter tip.
The Merit Medical Systems, Inc. EndoMAXX™ Fully Covered Esophageal Stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and for occlusion of esophageal fistulae. The device was found substantially equivalent to the ALIMAXX-ES™ Esophageal Stent.
1. A table of acceptance criteria and the reported device performance:
The document lists numerous tests that were successfully conducted, indicating the device met the established acceptance criteria for each without providing specific quantitative values for acceptance criteria or specific performance beyond "successfully completed."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical/Physical Testing | |
| Deployment | Successfully completed |
| Expansion Force | Successfully completed |
| Compression Force | Successfully completed |
| Dimensional | Successfully completed |
| Corrosion | Successfully completed |
| Tensile Strength | Successfully completed |
| Guidewire compatibility | Successfully completed |
| Distal Tip Insertion | Successfully completed |
| Stent foreshortening | Successfully completed |
| Deployment Catheter Profile | Successfully completed |
| Deployment Trigger Stroke | Successfully completed |
| Trigger safety | Successfully completed |
| Stent Deployment Force | Successfully completed |
| Stent Repositioning after partial deployment | Successfully completed |
| Deployment Accuracy | Successfully completed |
| Stent repositioning, after full deployment | Successfully completed |
| Stent expansion and condition after deployment | Successfully completed |
| System integrity | Successfully completed |
| Radius of leading stent struts | Successfully completed |
| Stent Springback after purse stringing suture | Successfully completed |
| Compression Force Pre-fatigue | Successfully completed |
| Expansion Force Pre-fatigue | Successfully completed |
| Stent in-fold distance | Successfully completed |
| Stent in-fold force | Successfully completed |
| Stent flexibility | Successfully completed |
| Suture cutting with forceps | Successfully completed |
| Suture tensile | Successfully completed |
| Stent Fatigue | Successfully completed |
| Cover Integrity after Fatigue | Successfully completed |
| Stent Springback after Fatigue (dimensional) | Successfully completed |
| Compression Force after Fatigue | Successfully completed |
| Expansion Force after Fatigue | Successfully completed |
| Stent Tensile | Successfully completed |
| First trigger to floater tensile | Successfully completed |
| Floater to internal connector tensile | Successfully completed |
| Second trigger to internal connector tensile | Successfully completed |
| For 3-trigger device, 1st trigger to second trigger tensile | Successfully completed |
| Handle to outer support tensile | Successfully completed |
| Handle to metal hypotube and inner shaft bond tensile | Successfully completed |
| Outer shaft to internal connector bond tensile | Successfully completed |
| Outer shaft tensile | Successfully completed |
| Pod to outer shaft tensile | Successfully completed |
| Tip to inner sheath bond | Successfully completed |
| Stent Anti-migration Strut Height | Successfully completed |
| Biocompatibility Testing | |
| Cytotoxicity | Successfully completed |
| Sensitization | Successfully completed |
| Implantation | Successfully completed |
| Sub-Chronic Toxicity | Successfully completed |
| Visibility & Compatibility | |
| Visualize stent with fluoroscopy | Successfully completed |
| Fluoroscopic visibility of deployment catheter | Successfully completed |
| MR Compatibility | Successfully completed |
| Packaging & Sterilization | |
| Packaging Condition | Successfully completed |
| Packaging performance (after accelerated aging and simulated shipping/handling) | Successfully completed |
2. Sample size used for the test set and the data provenance:
The document is a 510(k) summary and primarily focuses on non-clinical testing. It does not provide details on sample sizes for clinical test sets as clinical trials are typically not required for 510(k) applications demonstrating substantial equivalence. The tests performed are engineering and benchtop tests, therefore, information regarding data provenance (e.g., country of origin of the data, retrospective or prospective) is not applicable in the context of clinical data.
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):
This information is not applicable. The study described is not a clinical study involving diagnosis or interpretation by experts to establish ground truth. It is a series of non-clinical, benchtop and laboratory tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as the study involves non-clinical testing rather than clinical data requiring adjudication.
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:
No MRMC comparative effectiveness study was done. This 510(k) summary describes non-clinical testing for a medical device (esophageal stent) and does not involve AI assistance or human reader studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical medical implant (esophageal stent), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical tests conducted, the "ground truth" refers to the established engineering specifications, material properties, and biological safety standards (e.g., ASTM, ISO, USP standards) against which the device's performance was measured. For example:
- Mechanical/Physical Tests: Ground truth is defined by the requirements of the specific ASTM standards (e.g., mechanical strength, deployment forces, corrosion resistance) and internal specifications for device dimensions and functionality.
- Biocompatibility Tests: Ground truth is established by the requirements of ISO 10993 standards for cytotoxicity, sensitization, and implantation effects.
8. The sample size for the training set:
This information is not applicable. The study describes non-clinical performance and safety testing of a physical medical device, not the training of an algorithm or AI model.
9. How the ground truth for the training set was established:
This information is not applicable for the reasons stated in point 8.
§ 878.3610 Esophageal prosthesis.
(a)
Identification. An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal 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.”