(31 days)
The Ultraflex™ Esophageal NG Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and, for occlusion of concurrent esophageal fistula (for covered stents only).
The Ultraflex™ Esophageal NG Stent System (non-covered) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only.
The Covered Ultraflex™ Esophageal NG Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only, and occlusion of concurrent esophageal fistula.
The proposed Ultraflex™ Esophageal NG Stent System consists of a self-expanding metal stent preloaded on a flexible delivery catheter. The stent is offered either bare or covered and with either a proximal release or distal release delivery system.
The stent may be placed flouroscopically using radiopaque markers as a guide or endoscopically using the visual marker on the delivery catheter. To deploy the stent, hold the handle hub in the palm of one hand, and grasp the finger ring with the other hand. As the finger ring is retracted, the suture crochet knots are unraveled in a circular manner along the length of the stent, gradually deploying the stent. When the stent is completely released, the delivery catheter is removed.
This section describes the performance data and acceptance criteria for the Ultraflex™ Esophageal NG Stent System.
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Technological Characteristics | The technological characteristics of the proposed device are unchanged from the predicate device, except for: |
- A modified crochet suture pattern on the delivery catheter to create a 10mm "visual marker" (for proximal release product codes only).
- Modified suture material threaded around the circumference of each stent end. |
| Impact on Device Performance | These modifications have not impacted the device performance as demonstrated by bench testing. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a numerical value for a "test set" in the context of clinical data. The performance was demonstrated through "bench testing."
- Data Provenance: The document implies that the "bench testing" was conducted internally by Boston Scientific Corporation. The data provenance is presumed to be internal laboratory testing rather than human subject data with country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for this submission was based on engineering bench testing, not expert clinical interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical adjudication method was used for this bench testing.
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 submission pertains to a medical device (stent system) and its mechanical performance, not an AI or imaging diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm. Bench testing was performed on the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" was established through bench testing to assess the mechanical and functional characteristics of the device, primarily focused on ensuring that the stated modifications did not negatively impact performance compared to the predicate device. This would likely involve measurements of physical properties, deployment mechanics, and other relevant engineering parameters.
8. The sample size for the training set:
- Not applicable. This submission describes bench testing for a physical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set was used.
§ 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.”