(29 days)
The Bard® LUMINEXX™ 6 Fr Biliary Stent and Delivery System is indicated for use in the treatment of biliary strictures resulting from malignant neoplasms.
The Bard® LUMINEXX™ 6 Fr Biliary Stent and Delivery System is a stenting system designed to maintain the patency of biliary ducts obstructed by malignant neoplasms. The device includes the self-expanding Bard® LUMINEXX™ Biliary Stent pre-loaded on a unique delivery system. This 6 Fr delivery system is compatible with a 6 Fr introducer and accepts a .035" guidewire. The stent is available in various diameters and lengths. The delivery system is available in lengths of 80cm and 135cm.
Here's an analysis of the provided text regarding the Bard® LUMINEXX™ 6 Fr Biliary Stent and Delivery System, focusing on acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maintain patency of biliary ducts obstructed by malignant neoplasms (Intended Use) | Indicated for use in the treatment of biliary strictures resulting from malignant neoplasms. |
| Functionality comparable to predicate device | Bench data indicates comparability to the predicate device. |
| Compatibility with 6 Fr introducer | Compatible with a 6 Fr introducer |
| Accepts a .035" guidewire | Accepts a .035" guidewire |
| Self-expanding mechanism | Stent is self-expanding |
| Radiopacity | Tantalum discs on each end of the stent provide enhanced radiopacity |
Note: The document provided is a 510(k) summary for a medical device seeking substantial equivalence to a predicate device. It does not explicitly state numerical acceptance criteria (e.g., "stent patency rate of X%"). Instead, the "acceptance criteria" are inferred from the intended use and the comparison to the predicate device. The primary performance claim is comparability to the predicate device through "bench data."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document only mentions "Bench data." This typically implies laboratory testing on a non-clinical sample, not patient data.
- Data Provenance: Not specified. Given it's "bench data," there isn't a country of origin in the clinical sense. It's retrospective in the sense that the testing has already occurred.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not provided. "Bench data" refers to laboratory or mechanical testing, which does not typically involve experts establishing a ground truth in the same way clinical studies do (e.g., radiologists reviewing images). The comparability assessment would likely be done by engineers or technicians.
4. Adjudication Method for the Test Set
- This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for subjective assessments like image interpretation. "Bench data" would involve objective measurements and comparisons, not adjudication by multiple readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. The document explicitly states "Bench data indicate that the Bard® LUMINEXX™ 6 Fr Biliary Stent and Delivery System is comparable to the predicate device." This refers to non-clinical, laboratory testing, not a clinical study involving human readers or patient outcomes, especially not one evaluating the improvement of human readers with AI assistance (as this is an actual physical stent, not an AI diagnostic tool).
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This device is a physical medical implant (a stent), not an AI algorithm or diagnostic tool. Therefore, a standalone performance study in the context of AI is irrelevant.
7. Type of Ground Truth Used
-
The "ground truth" for the bench data would likely be established physical properties and performance metrics of the predicate device, against which the new device's performance was measured. This could include:
- Radial force
- Flexibility
- Migration resistance
- Deployment accuracy
- Radiopacity measurements
- Material properties (e.g., tensile strength, fatigue life)
-
This is not "expert consensus," "pathology," or "outcomes data" in the clinical sense.
8. Sample Size for the Training Set
- Not applicable. This device is a stent, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, no training set is relevant for this type of 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.