(31 days)
The Medtronic AVE Bridge™ Stent is intended to maintain patency of a bile duct which is occluded by a malignant tumor.
The Medtronic AVE Bridge™ Stent System (Hi-Flex) -- Biliary Indication is intended to maintain patency of a biliary duct which is occluded by a malignant tumor.
The Bridge™ Stent consists of a balloon expandable intralumenal stent premounted onto the balloon of an over-the-wire delivery catheter. Radiopaque markers are imbedded on the inner shaft (at each end of the stent) to aid in the placement of the stent during fluoroscopy. The delivery system is compatible with 0.035" guidewires and has a useable length of 75 cm or 120 cm. The device is provided in a sterile package. Size range: 6.0 to 10.0 mm Diameters; 20mm, 40mm, 60mm Lengths.
Based on the provided text, the Medtronic AVE Stent Delivery System is a medical device, and the document describes its 510(k) submission. However, the text does not contain a study that proves the device meets specific acceptance criteria in the format typically used for AI/software devices.
This document is a 510(k) summary for a physical medical device (a stent delivery system), not a software or AI-based device. The "performance testing" described is for comparing physical characteristics of the stent and its delivery system to a predicate device, focusing on substantial equivalence.
Therefore, I cannot provide the requested information in the format of AI-related acceptance criteria and study details because the document does not describe such a study for an AI/software device.
Instead, I can extract the information relevant to this physical medical device's performance testing and conclusions regarding substantial equivalence:
Acceptance Criteria and Device Performance (for a physical medical device, not AI/software):
| Performance Measure/Characteristic | Purpose of Testing | Reported Device Performance/Conclusion |
|---|---|---|
| (Not explicitly stated as "acceptance criteria") | To compare the stent/delivery system of the subject device and the predicate device. The data will support a premarket notification for the Medtronic AVE Stent Delivery System - For Use In Biliary Indication. | Subject Device (Medtronic AVE Bridge™ Stent) was found to be substantially equivalent to the predicate device (Peripheral AVE Stent Delivery System). The flexible Bridge™ Stent was previously found substantially equivalent in K983008 (approved Nov 25, 1998). Performance testing specifically aimed to highlight any differences and confirm this equivalence. |
| Specific Tests Conducted: | ||
| • Balloon Deflation Time | To compare the stent/delivery system of the subject device and the predicate device. | (Implicitly found comparable/equivalent to predicate, as overall conclusion is substantial equivalence) |
| • Crossing Profile | To compare the stent/delivery system of the subject device and the predicate device. | (Implicitly found comparable/equivalent to predicate, as overall conclusion is substantial equivalence) |
| • Stent Free Area | To compare the stent dimensional data for the subject device and the predicate device. | (Implicitly found comparable/equivalent to predicate, as overall conclusion is substantial equivalence) |
| • Stent Length | To compare the stent dimensional data for the subject device and the predicate device. | (Implicitly found comparable/equivalent to predicate, as overall conclusion is substantial equivalence) |
| • Stent Recoil | To compare the stent dimensional data for the subject device and the predicate device. | (Implicitly found comparable/equivalent to predicate, as overall conclusion is substantial equivalence) |
| Biocompatibility | To ensure the materials used are safe for human contact. | Passed all biocompatibility tests. |
| Sterilization | To ensure the device is sterile when provided. | Validated to a Sterility Assurance Level (SAL) of 10-6. Labeled pyrogen free; LAL testing performed daily as product release criteria. (Note: not "performance" in the same sense as stent function, but a critical quality characteristic) |
Explanation for AI/Software-Specific Questions (Not Applicable to this Document):
The following points refer to information typically found in submissions for AI/software devices. Since this document is for a physical medical device, these details are not present in the provided text.
- Sample sized used for the test set and the data provenance: Not applicable. The document describes physical testing, not a dataset for an AI model.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI model is not relevant here. The ground truth for the physical tests would be measured physical properties.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to expert consensus in AI model validation.
- 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 is for AI-assisted diagnostic tools.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithm performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the physical tests, the "ground truth" is typically the measured physical properties of the device components and comparisons against engineering specifications or predicate device performance.
- The sample size for the training set: Not applicable. No AI model is described.
- How the ground truth for the training set was established: Not applicable. No AI model is described.
In summary, the provided document describes a 510(k) submission for a physical stent delivery system, where "performance testing" focuses on establishing substantial equivalence to a predicate device based on physical and material characteristics, biocompatibility, and sterility, rather than the validation of an AI or software algorithm.
§ 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.