(186 days)
The Bridge Constant Biliary Stent System is indicated for use in the palliation of malignant neoplasm in the biliary tree.
The subject device is a single use only device with a stent mounted on an over-the-wire delivery system. The device is equipped with an A V100 balloon mounted on the distal portion of the catheter to facilitate the percutaneous delivery of the stent.
This is a 510(k) summary for a medical device that does not use AI, therefore, much of the requested information regarding AI-specific studies and performance metrics is not applicable.
Here's the information based on the provided text, with clarifications where direct AI-related data is absent:
Acceptance Criteria and Device Performance for Medtronic AVE Bridge Constant Biliary Stent System
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices (Bridge Extra Support (K991533) and Bridge Assurant (K011817)) rather than specific quantitative acceptance criteria for this device. The core acceptance criterion for this submission is that the device is substantially equivalent to the predicate devices and meets their established performance and safety profiles.
| Acceptance Criterion (Implicit for Substantial Equivalence) | Reported Device Performance (Summary of Equivalence) |
|---|---|
| Intended Use Equivalence: Indicated for the same purpose as predicate devices. | Indicated for use in the palliation of malignant neoplasm in the biliary tree, same as predicate devices. |
| Technological Characteristics Equivalence: Similar materials, design principles, and operational mechanisms to predicate devices, without raising new questions of safety or effectiveness. | Constructed of biocompatible materials; balloon expandable; features stents pre-mounted on a sheathless stent delivery system. Differences between the subject and predicate devices are stated as "not relevant to the ability of the subject device to palliate malignant neoplasms in the biliary tree." |
| Performance (In vitro/Preclinical) Equivalence: Safe and effective performance confirmed through testing. | Preclinical/in-vitro testing was conducted to confirm the safe and effective performance of this device as well as the biocompatibility of the device. |
| Biocompatibility: Device materials are biocompatible. | Device is constructed of biocompatible materials. Preclinical/in-vitro testing confirmed biocompatibility. |
| Sterilization: Provided sterile and not intended for reuse/resterilization. | Device is provided sterile and not intended for reuse or resterilization. |
2. Sample Size for the Test Set and Data Provenance
This 510(k) summary describes preclinical/in-vitro testing. It does not involve a "test set" of patient data or data provenance in the context of an AI study. The testing would have been conducted on the device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a medical device submission based on physical device testing and substantial equivalence, not an AI model requiring expert-established ground truth from a test set.
4. Adjudication Method for the Test Set
Not applicable for the reasons stated in point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is not an AI algorithm designed to assist human readers or perform diagnostic tasks. It is a physical medical device (biliary stent system).
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is not an AI algorithm.
7. Type of Ground Truth Used
For the preclinical/in-vitro testing, the "ground truth" would be established through engineering specifications, material standards, and validated testing protocols. For instance, burst pressure, tensile strength, radial force, and biocompatibility standards would serve as the ground truth against which the device performance is measured. It's not based on expert consensus, pathology, or outcomes data in the human patient context for this specific submission, but rather on physical and chemical performance standards.
8. Sample Size for the Training Set
Not applicable. This is not an AI device trained on a dataset.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI device.
§ 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.