(51 days)
The Quantum TTC Biliary Balloon Dilator is used to dilate strictures of the biliary tree.
The subject balloon dilator is a 3 cm polyethylene terephthalate (PET) balloon mounted at the distal end of pebax catheter. The balloon can be inflated to single size diameters of 4, 6, 8, or 10 mm. The catheter is available in lengths of 180 cm or 320 cm with a 6.8-5.5 Fr diameter.
This is a 510(k) summary for the Quantum TTC Biliary Balloon Dilator. It describes device performance through non-clinical testing rather than clinical study. Therefore, several aspects of your request, such as sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types related to a clinical study, are not applicable or cannot be extracted from this document.
Here's the information that can be extracted or inferred from the provided document regarding acceptance criteria and performance:
1. A table of acceptance criteria and the reported device performance
The document lists various non-clinical tests performed to demonstrate device performance. The specific acceptance criteria (e.g., "balloon must burst above X psi") are not explicitly stated with numerical values; only the categories of tests are provided. However, the conclusion states that these tests confirm the device performs as intended and adequately address risks, implying that acceptance criteria for each test were met.
| Acceptance Criteria Category (Test Performed) | Reported Device Performance |
|---|---|
| Balloon Diameter and Length | Performed as intended |
| Distensibility | Performed as intended |
| Balloon Burst Strength | Performed as intended |
| Tensile Testing of the Device Joint Components | Performed as intended |
| Radiopacity Testing | Performed as intended |
| Dimensional Testing Through Simulated Use | Performed as intended |
| Shelf Life Testing | Performed as intended |
| Packaging Validation | Performed as intended |
| Biocompatibility Testing | Passed according to ISO 10993-1 |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. This document reports on non-clinical (engineering and laboratory) testing rather than a clinical study with human subjects. The "test set" would refer to the number of devices or components tested, which is not specified.
- Data Provenance: The testing was conducted internally by the manufacturer (Wilson-Cook Medical, Inc.) as part of their design verification and validation process. This is internal testing, not data from a specific country or retrospective/prospective clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of clinical studies, refers to the confirmed diagnosis or outcome used to evaluate a device's accuracy. This document describes non-clinical engineering tests. The "ground truth" for these tests would be established by engineering specifications and standards, not expert clinical consensus.
4. Adjudication method for the test set
Not applicable. Adjudication methods like '2+1' are used in clinical studies to resolve discrepancies among experts. This is not relevant for non-clinical engineering tests.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. This document focuses on non-clinical performance to confirm substantial equivalence through engineering tests.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical instrument (a balloon dilator), not an algorithm or AI-based device. Therefore, the concept of "standalone performance" in the context of algorithms does not apply. The device's performance is inherently "standalone" in that it performs its physical function (dilation).
7. The type of ground truth used
For the non-clinical tests described, the "ground truth" implicitly refers to engineering specifications, design requirements, and relevant international standards (e.g., ISO 10993-1 for biocompatibility). The device's performance was compared against these predefined physical and material property requirements.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set 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.