(232 days)
This device is used for endoscopic removal of biliary stones and for contrast injection.
The subject extraction balloon is comprised of a latex balloon mounted at the distal end of a nylon catheter with three internal lumens. The balloon can be inflated to three sizes, 8.5 mm, 12 mm and 15 mm diameters. Radiopaque bands placed at the distal and proximal ends of the balloon provide fluoroscopic visualization of the balloon location. The catheter length is 275 cm with a diameter of 6.6 Fr. The three lumens corresponds to a balloon inflation port, a wire guide port and an injection port. The hubs on the respective lumens are color-coded white, purple, and gray. A stopcock is included at the proximal end of the balloon inflation port to control air movement into or out of the balloon.
Here's a breakdown of the requested information based on the provided document:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" for clinical performance that the device must meet (e.g., a specific success rate for stone removal). Instead, it focuses on demonstrating that the modified device performs as intended and is as safe and effective as its predicate.
The reported device performance is presented as a summary of non-clinical testing results.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Device performs as intended | - Balloon Diameter validation |
| - Balloon Deflation validation | |
| - Balloon Strength validation | |
| - Shelf Life Testing results | |
| - Packaging Validation results | |
| Biocompatible | - Biocompatibility testing conducted according to ISO 10993-1:2009 |
| Does not raise new safety/effectiveness questions | - Risk Analysis (DFMECA) completed, showing modifications do not raise new questions of safety or effectiveness. |
2. Sample Size for Test Set and Data Provenance
The document describes non-clinical (bench) testing and does not include any human clinical "test set" data. Therefore, information regarding human sample size, country of origin, or retrospective/prospective nature of a clinical test set is not applicable.
3. Number of Experts and Qualifications for Ground Truth of Test Set
Not applicable, as no human clinical test set data is presented. The "ground truth" for the non-clinical tests would be defined by engineering specifications and recognized testing standards.
4. Adjudication Method for the Test Set
Not applicable, as no human clinical test set data is presented.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done or reported in this document. The device is a physical medical device (an extraction balloon), not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
For the non-clinical testing, the "ground truth" was established by engineering specifications, design requirements, and recognized testing standards (e.g., ISO 10993-1 for biocompatibility).
8. Sample Size for the Training Set
Not applicable. As a physical medical device undergoing non-clinical validation, there is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for this type of device validation.
§ 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.