(182 days)
The ReSolve® Biliary Drainage Catheter with locking pigtail and hydrophilic coating is used for drainage of bile within the biliary system.
The ReSolve® Biliary Locking Drainage Catheter consists of single lumen tubing with 17 to 18 drainage holes (depending on the French size of the catheter) and a single dedicated suture hole. One of the drainage holes doubles as a suture hole. The tubing is made from a polyurethane material. A hydrophilic coating reduces entry site/catheter friction during placement. The catheter is offered in two drainage hole configurations. The RBC (long) configuration has a lesion gap (distance between the proximal pigtail and the distal shaft drainage hole) of 5 cm. The RBDC (standard) has a lesion gap of 2 cm. The components of the catheter allow initial placement using an over-the-wire technique. These include a metal stiffening cannula, flexible stiffening cannula, pigtail straightener and repositioning tool. The hubs of the flexible and metal stiffening cannula are color coded for catheter French size identification. The pigtail straightener is provided to assist in feeding the guide wire through the catheter. A dead end cap is included to prevent fluid from exiting the catheter after placement. Once the catheter position is established in the area to be drained, the pigtail is formed by retracting a suture which is looped from the hub to catheter tip then back to the hub. The hub incorporates a suture locking mechanism to retain the distal pigtail shape. It may be unlocked using the repositioning tool to allow repositioning or replacement of the catheter. A single radiopaque marker band is located proximal to the most proximal drainage hole to assist in accurate placement of the drainage holes in the biliary duct. In addition, the shaft of the catheter is printed with markings for the clinician to determine how deep the catheter is in the patient. The catheter is available in the same sizes 8.5F, 10F, 12F, and 14F with the same useable length, 40 cm, as the predicate device. The ReSolve® Biliary Locking Drainage Catheter is a single use device that is supplied sterile and non-pyrogenic. The device is marketed with the following components, depending on the product configuration: StayFIX® or Revolution™ catheter securement device.
The provided document is a 510(k) premarket notification for a medical device (ReSolve® Biliary Locking Drainage Catheter) and focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about a study proving the device meets specific acceptance criteria related to AI or algorithmic performance. The studies mentioned are primarily bench tests and biocompatibility tests for the physical device.
Therefore, most of the requested information regarding AI/algorithmic performance, such as sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies, cannot be extracted from this document.
However, I can provide what is available regarding the safety and performance tests performed on the physical device.
1. Table of acceptance criteria and the reported device performance:
The document lists various Safety & Performance Tests, implying that for each of these tests, specific acceptance criteria would have been met to deem the device safe and effective and substantially equivalent to the predicate. However, the specific quantitative acceptance criteria or the detailed reported performance results are not provided in this summary. The document only lists the types of tests conducted.
| Test Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Performance Testing - Bench | Cyclic Fatigue Testing | Not detailed in document (Implied to meet pre-defined criteria for substantial equivalence) |
| Material Improvement | Not detailed in document | |
| Chemical Testing | Not detailed in document | |
| Optical Density/Radio-detectability | Not detailed in document | |
| Curve Shape | Not detailed in document | |
| Visual Product Dimensions – Useable Length | Not detailed in document | |
| Product Dimensions – Marker Band to Pigtail Distance | Not detailed in document | |
| Product Dimensions – Distal Shaft Hole to Pigtail Distance | Not detailed in document | |
| Marker Band/Proximal Hole Location Punched Holes Orientation and Number of Holes Hydrophilic Coating Coverage/Adherence and Length Guidance Wire Passage Test Flow Testing Pigtail Pull Test Tip Penetration Test Cannula and Stiffener Insertion Test Tip Geometry Drainage Hole Tensile Test Catheter Collapse Tubing Kink Testing Hub Leak/Liquid Ingress Test Hub Tensile Test Marker Band Transition Ink Adherence 14F Metal and Plastic Stiffening Cannula Hub Tensile Test and Visual Inspection Pigtail Straightener Test | Not detailed in document (Implied to meet pre-defined criteria for substantial equivalence). Specific changes noted are: "drainage holes has been modified to standardize the gap between the pigtail and the shaft holes (RBC versus RBDC) across all French sizes with adjustment of the marker band location to account for this change. The geometry of the tip has been modified slightly to have a longer taper." | |
| Biocompatibility | Cytotoxicity Sensitization Irritation Acute Systemic Toxicity Pyrogenicity Genotoxicity Implantation Chemical Characterization | Not detailed in document (Implied to meet ISO 10993 requirements and pass tests as per USP sections and ). |
The document concludes that "Based on the indications for use, design, safety and performance testing, the subject ReSolve® Biliary Locking Drainage Catheter meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device, the ReSolve® Biliary Locking Drainage Catheter, K131832." This statement indicates that all safety and performance tests were successfully completed and the device performed as expected against established criteria (though not explicitly detailed).
Regarding the other points, the document is a 510(k) submission for a physical medical device and does not pertain to AI/algorithmic performance. Therefore, the following information is not available:
- Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as this is a physical device, not an AI algorithm. The performance tests mentioned are bench tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. "Ground truth" in this context would refer to defined physical or chemical properties, not expert-derived labels.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This device is not an AI for human reader assistance.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the physical device, "ground truth" refers to specifications, standards, and established metrics for physical and chemical properties and performance (e.g., tensile strength, leak rates, biocompatibility test results).
- The sample size for the training set: Not applicable (no AI training set).
- How the ground truth for the training set was established: Not applicable (no AI training set).
§ 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.