(28 days)
The Skater® Biliary Drainage Catheter is indicated for percutaneous biliary drainage.
The Skater® Biliary Drainage Catheter is a polyurethane catheter with SLIP-COAT™, a lubricious hydrophilic coating.. The catheter comes in a pigtail-loop, locking-type, end configuration with drainage holes. The catheters are provided in 8 French, 10 French, and 12 French sizes with a length of 40 cm. Accessories include a metal stiffening cannula, a plastic stiffening cannula, and a standard luer locking hub.
This document is a 510(k) Summary for the Skater® Biliary Drainage Catheter, detailing its regulatory submission to the FDA. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a performance study with detailed acceptance criteria and expert reviews in the way typically found for AI/ML-driven diagnostic devices.
Therefore, the requested information, particularly regarding specific acceptance criteria, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment in the context of a performance study, is largely not present in this document. The document describes product characteristics and safety/performance testing, which are manufacturing and preclinical assessments, not clinical performance studies for diagnostic accuracy.
Here's a breakdown of what can be gleaned from the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from "Safety and Performance" Section) | Reported Device Performance |
|---|---|
| Comparability to predicate device | "[A]ll data gathered demonstrates that the Skater® Biliary Drainage Catheter is comparable to the predicate devices." |
| Dimensional Inspection | Tested and presumably met internal specifications. |
| Process Performance Qualification | Tested and presumably met internal specifications. |
| Biocompatibility | Tested and presumably met biocompatibility standards. |
| Aging (Shelf-life) | Tested and presumably met stability standards. |
| LAL (Limulus Amebocyte Lysate - Endotoxin test) | Tested and presumably met endotoxin limits. |
| Bioburden (Sterilization) | Tested and presumably met sterilization standards. |
| EO/EC Residual (Ethylene Oxide/Epichlorohydrin - Sterilization residuals) | Tested and presumably met residual limits. |
| In vitro bench tests for safety and effectiveness | "The results of in vitro bench tests and biocompatibility testing demonstrate the safety and effectiveness of the Skater® Biliary Drainage Catheter." |
2. Sample size used for the test set and the data provenance
- Not explicitly stated for a clinical performance study. The document refers to "in vitro bench tests" and "biocompatibility testing," which are typically laboratory-based assessments, not clinical trials with human subjects or large datasets. No specific sample sizes for these tests are provided.
- Data Provenance: Not applicable in the context of a clinical performance study. The tests mentioned are laboratory/bench tests, not trials with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This information is relevant for diagnostic accuracy studies involving expert human review of images or data to establish a ground truth. The document describes bench and biocompatibility testing, which do not involve expert human interpretation for ground truth.
4. Adjudication method
- Not applicable. Adjudication methods (e.g., 2+1, 3+1) are for resolving discrepancies in expert human interpretation, which is not described as part of the testing here.
5. 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
- No. This type of study is for evaluating AI-assisted diagnostic performance. The Skater® Biliary Drainage Catheter is a medical device (catheter) and not an AI-powered diagnostic tool, so an MRMC study is not relevant to its regulatory submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This concept is for AI algorithms. The device itself is a physical medical instrument.
7. The type of ground truth used
- Benchmarking/Standard Measurements: For dimensional inspection, LAL, bioburden, EO/EC residual, and potentially other in vitro tests, the "ground truth" would be established by industry standards, validated measurement methods, and predefined acceptance limits (e.g., a specific dimension, a maximum endotoxin level, sterility).
- Biocompatibility Standards: For biocompatibility, the ground truth is established by recognized international standards (e.g., ISO 10993 series) and specific in vitro/in vivo tests designed to evaluate potential adverse biological reactions.
8. The sample size for the training set
- Not applicable. There is no "training set" for this type of medical device submission, as it does not involve machine learning or AI models. The device is evaluated through engineering, chemical, and biological testing, not by training an algorithm.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, this question is not relevant.
In summary: This 510(k) submission confirms that the Skater® Biliary Drainage Catheter underwent various safety and performance tests (dimensional, process, biocompatibility, aging, LAL, bioburden, EO/EC residual) and was found comparable to its predicate devices. However, it does not involve the type of clinical performance study details (e.g., test set, expert review, AI accuracy metrics) that would be pertinent to AI/ML diagnostic tools.
§ 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.