(421 days)
Used to maintain patency of malignant esophageal strictures and/or to seal tracheoesophageal fistula.
The Esophageal Z-Stent with Dua Anti-Reflux Valve is a nonsterile, disposable device, used to maintain patency of malignant esophageal strictures and/or to seal tracheoesophageal fistula. The product line includes Coated Metal Expandable stents in varying lengths and components to facilitate stent delivery.
The provided text describes a 510(k) premarket notification for a medical device modification, specifically the Esophageal Z-Stent with Dua Anti-Reflux Valve (K011591). It outlines the device description, intended use, classification, and substantial equivalence to predicate devices. However, the document does not contain a detailed study description with specific acceptance criteria and detailed performance results in the format requested.
The document mentions that "visual, dimensional and functional testing to ensure the performance and design integrity of this product line was conducted. All results obtained during our Design Verification and Validation met our predetermined acceptance criteria for this product line." However, it does not provide the specific "predetermined acceptance criteria" or the "results obtained" in a quantitative or qualitative manner that would allow for a table of performance vs. acceptance criteria.
Therefore, I cannot fill out the requested table or provide specific details for points 1-9 as the information is not present in the provided text. The submission focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics, materials, and intended use, rather than presenting a standalone clinical or performance study with detailed acceptance criteria and performance metrics.
Specifically, the following information is not available in the provided text:
- A table of acceptance criteria and the reported device performance: While it states that "All results obtained during our Design Verification and Validation met our predetermined acceptance criteria," the document does not list these criteria or the specific results.
- Sample size used for the test set and the data provenance: No information on a specific test set, its size, or origin is provided.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable as a specific test set is not detailed.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No such study is mentioned. The device is not an AI/imaging device where MRMC studies are typically performed.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
- The type of ground truth used: Not applicable, as no clinical study with a ground truth assessment is described.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
The document emphasizes a design control, risk analysis, and design verification/validation process, stating that these activities were conducted according to internal procedures and 21 CFR § 820.30. This process confirmed the device's performance requirements and identified/mitigated risks. The biocompatibility was established through "an extensive history of use in similar patient contacting medical devices and as applicable biocompatibility test results," but no specifics are given.
In summary, the provided document is a regulatory submission demonstrating substantial equivalence, not a detailed performance study with quantifiable acceptance criteria and results.
§ 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.”