(86 days)
The Schneider WALLSTENT® Biliary Endoprosthesis is indicated for use in the treatment of biliary strictures produced by malignant neoplasms.
The WALLSTENT® Biliary Endoprosthesis is a self-expanding prosthesis constructed of biomedical superalloy and an elastomeric polymer. The prosthesis is a braided wire structure. The outward radial force along with the ends of the device serve to stabilize the prosthesis after implanted. The stent's purpose is to increase or maintain the inner lumen diameter of the biliary duct.
The stent is placed by means of a delivery system. The delivery system is a coaxial tubing assembly that constrains the prosthesis until it is released in a controlled manner. The release of the stent is accomplished by retracting the outer sheath. The prosthesis is packaged constrained on the delivery system ready for placement. The system is sterile and intended for single use only.
This document is a 510(k) summary for a medical device called the WALLSTENT® Biliary Transhepatic Endoprosthesis with Unistep™ Plus Delivery System. It describes the device, its intended use, and argues for its substantial equivalence to previously marketed devices.
However, the provided text does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria.
Specifically, the following information is missing or not applicable based on the provided text:
- A table of acceptance criteria and the reported device performance: This document only describes the device and its proposed modifications, but does not present specific performance metrics or acceptance criteria for those metrics.
- Sample size used for the test set and the data provenance: No information about a "test set" or its sample size is provided. The document mentions "in vitro and in vivo deployment testing" but gives no details about the size or nature of these tests.
- Number of experts used to establish the ground truth... and qualifications: Not applicable, as there's no mention of a ground truth being established by experts for performance evaluation.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not indicated. The document focuses on regulatory approval based on substantial equivalence, not comparative effectiveness.
- 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 AI algorithm.
- The type of ground truth used: Not applicable, as no performance study with ground truth is detailed.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device that would require a "training set."
- How the ground truth for the training set was established: Not applicable.
Summary of what is present:
The document describes a modified delivery system for an existing WALLSTENT® Biliary Endoprosthesis. The claim for substantial equivalence is based on:
- In vitro and in vivo deployment testing: These tests were performed to demonstrate that "deployment forces and handling characteristics are comparable to the current delivery systems." No specific results, sample sizes, or acceptance criteria for these tests are provided in this summary.
- Comparison to predicate devices: The modified system is compared to existing WALLSTENT® models (K923993, K961262, K964119) and the WALLSTENT® Tracheobronchial Endoprosthesis (K980163) for material changes.
In conclusion, the provided text serves as a regulatory submission (510(k) Summary) and focuses on demonstrating substantial equivalence to predicate devices, rather than detailing a study against specific acceptance criteria for performance.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.