(94 days)
The WALLSTENT® Biliary Endoprosthesis is intended for use in the treatment of biliary strictures produced by malignant neoplasms.
The Wallstent® Biliary Endoprosthesis is indicated for the palliation of malignant neoplasms in the biliary tree.
The WALLSTENT® Biliary Endoprosthesis is a self-expanding prosthesis constructed of biomedical superalloy and an elastomeric polymer. Smaller diameter models may utilize a radiopaque core. The prosthesis is a braided wire structure that may be covered with an elastomeric polymer in selected models. 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 (K993232) is a 510(k) premarket notification for a modified medical device delivery system, not an AI/ML powered device. Therefore, the questions related to AI/ML specific aspects (like training/test sets, ground truth methodology, expert consensus, MRMC studies, standalone performance) are not applicable.
The submission focuses on demonstrating substantial equivalence of a new delivery system for an existing product (WALLSTENT® Biliary Endoprosthesis). The acceptance criteria and the study to prove it are based on in vitro testing comparing the new delivery system to the predicate device's delivery system.
Here's an interpretation of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred from "substantially equivalent") | Reported Device Performance | Study Type |
|---|---|---|---|
| Deployment Forces | Comparable to current delivery systems | Demonstrated to be comparable | In vitro testing |
| Handling Characteristics | Comparable to current delivery systems | Demonstrated to be comparable | In vitro testing |
| Reduced Profile | Smaller French size than predicate device's delivery system | Achieved reduced profile | Design comparison |
Explanation:
The core acceptance criterion for this 510(k) is that the new Unistep™ Plus Delivery System with a reduced profile is "substantially equivalent" to the previously cleared Unistep™ Plus Delivery System (K964119). This substantial equivalence is specifically assessed in terms of deployment forces and handling characteristics. The reduced profile itself is a design change, and the 510(k) aims to show this change doesn't negatively impact performance.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the provided text. The document only mentions "results of in vitro testing."
- Data Provenance: In vitro testing. This means the testing was conducted in a laboratory environment, not on human or animal subjects. Details on the specific country of origin are not provided, but it would have been conducted by Boston Scientific Corporation.
- Retrospective or Prospective: Not applicable as it's in vitro testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- This question is not applicable. The "ground truth" for in vitro testing of a physical device is typically based on engineering specifications, industry standards, and measurable physical properties, not expert human interpretation in the way AI/ML ground truth is established.
4. Adjudication Method for the Test Set
- This question is not applicable. As it's in vitro testing, there would be no subjective adjudication of results by human experts in the way AI/ML studies require. Test results would be objectively measured and compared against predefined engineering tolerances or equivalence criteria.
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
- This question is not applicable. This is not an AI/ML device; it's a physical medical device delivery system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- This question is not applicable in the context of AI/ML ground truth. For this device, the "ground truth" for the in vitro testing would be the performance characteristics of the predicate delivery system (K964119) and established engineering/design specifications for safe and effective device function. The new delivery system's performance needed to fall within acceptable parameters defined by these benchmarks to be considered substantially equivalent.
8. The Sample Size for the Training Set
- This question is not applicable. This is not an AI/ML device, so there is no training set in the AI/ML sense.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable. As there is no AI/ML training set, there is no ground truth established for it.
§ 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.