(108 days)
The Skater® Biliary Drainage Catheter is indicated for percutaneous biliary drainage.
The Skater® Biliary Drainage Catheter is made from hydrophilic coated polyurethane. 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.
The provided text describes a 510(k) submission for the "Skater® Biliary Drainage Catheter" and focuses on demonstrating its substantial equivalence to a predicate device, rather than proving it meets specific acceptance criteria through a clinical study or performance goals set for a new, non-inferiority claim.
Here's a breakdown based on the information provided, highlighting what is present and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria/Performance Goals: The document does not explicitly state quantitative "acceptance criteria" or performance goals in terms of specific metrics (e.g., accuracy, sensitivity, specificity, or success rates) for the device's clinical function. Instead, it aims to demonstrate substantial equivalence to a predicate device.
Reported Device Performance:
The document does describe the types of tests performed.
| Criterion/Test Type | Reported Device Performance (Skater® Biliary Drainage Catheter) |
|---|---|
| Functional Testing | All data demonstrates comparability to the predicate device. |
| Leakage Testing | All data demonstrates comparability to the predicate device. |
| Catheter Body Tensile Strength and Elongation | All data demonstrates comparability to the predicate device. |
| Physical Dimensions | All data demonstrates comparability to the predicate device. |
| Catheter Body to Hub Tensile Strength | All data demonstrates comparability to the predicate device. |
| Biocompatibility Testing | Demonstrates safety and effectiveness. |
| Overall Safety and Effectiveness | Demonstrated through in vitro bench tests and biocompatibility testing; believed to be substantially equivalent to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "in vitro bench tests" but does not specify sample sizes for these tests. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective) as it pertains to clinical performance data, because no clinical performance study is described. The tests conducted appear to be laboratory-based engineering and material property tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided. The device comparison is based on bench testing and material characteristics, not on interpretations by medical experts for clinical ground truth.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. As no expert-based ground truth establishment or clinical performance study is detailed, no adjudication method would have been used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not done. This type of study is commonly used for diagnostic accuracy of image-based AI devices, which is not the nature of this device. The submission is for a medical catheter, and the evidence provided focuses on physical and material characteristics compared to a predicate device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone study was not done. This is also relevant for AI/software devices, which this catheter is not. The performance evaluation is for the physical device itself.
7. Type of Ground Truth Used
The "ground truth" for the tests performed (functional, leakage, tensile strength, physical dimensions) would have been the engineering specifications and established testing standards for medical devices of this type, as well as comparison against the performance of the predicate device. It is not based on expert consensus, pathology, or outcomes data, as these are typically used for clinical performance evaluations.
8. Sample Size for the Training Set
This information is not applicable and not provided. This device is a physical catheter, not an AI or machine learning algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the same reason as point 8.
Summary of the Study:
The study described is a series of in vitro bench tests and biocompatibility testing designed to demonstrate that the "Skater® Biliary Drainage Catheter" is substantially equivalent to the "Boston Scientific Corporation, Flexima™ Biliary Catheter (K023870)" predicate device. The tests covered functional performance, leakage, tensile strength and elongation of the catheter body, physical dimensions, and catheter body to hub tensile strength. The conclusion is that the new device performs "comparably" to the predicate in these areas, and that the combined results of these tests and biocompatibility testing demonstrate its safety and effectiveness. The report does not involve clinical trials, expert reviews of clinical cases, or AI performance metrics.
§ 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.