(25 days)
The ReSolve® Biliary Locking 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 two suture holes and 17 to 18 drainage holes in the distal curve region. It is made from a biocompatible thermoplastic. A hydrophilic coating reduces entry site/catheter friction during placement. The components of the catheter allow initial placement using an over-the-wire technique. These include a metal stiffening cannula, flexible stiffening cannula, straightener, and repositioning tool. The pigtail straightener is provided to assist in feeding the guide wire through the catheter. 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 the catheter tip and 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.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: ReSolve® Biliary Locking Drainage Catheter
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes a "Special Premarket Notification 510(k)" for the ReSolve® Biliary Locking Drainage Catheter. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than presenting new clinical efficacy data. As such, the "acceptance criteria" are primarily related to safety and performance testing to ensure the device performs as intended and is safe for its stated use, and that these characteristics are substantially equivalent to the predicate device.
The document lists various tests performed, indicating that the device "met the pre-determined acceptance criteria applicable to the safety and efficacy of the device." However, it does not explicitly quantify the specific acceptance thresholds for each test. For example, it lists "Hub Leak" as a test but doesn't state "leakage must be less than X mL/hr."
Below is a table summarizing the tests performed and the general reported performance.
| Acceptance Criteria Category | Specific Test Performed | Reported Device Performance |
|---|---|---|
| Design Verification | Conditioning | Met pre-determined acceptance criteria |
| Dimensional | Met pre-determined acceptance criteria | |
| Drainage Hole Orientation | Met pre-determined acceptance criteria | |
| Marker Band/Hole Location | Met pre-determined acceptance criteria | |
| Tip Penetration | Met pre-determined acceptance criteria | |
| Hub Leak | Met pre-determined acceptance criteria | |
| Vacuum Test | Met pre-determined acceptance criteria | |
| Tubing Kink Test | Met pre-determined acceptance criteria | |
| Safety & Performance | Marker Band Adhesion | Met pre-determined acceptance criteria |
| Hub Tensile Testing | Met pre-determined acceptance criteria | |
| Tubing Tensile Testing | Met pre-determined acceptance criteria | |
| Material Durability Testing | Met pre-determined acceptance criteria | |
| Bile Exposure Testing | Met pre-determined acceptance criteria | |
| Stiffening Cannula Friction Test | Met pre-determined acceptance criteria | |
| Biocompatibility | Cytotoxicity | Met pre-determined acceptance criteria (per ISO 10993) |
| Irritation | Met pre-determined acceptance criteria (per ISO 10993) | |
| Acute Systemic Toxicity | Met pre-determined acceptance criteria (per ISO 10993) | |
| Pyrogenicity | Met pre-determined acceptance criteria (per USP 34 ) | |
| Chemical Characterization | Met pre-determined acceptance criteria (per ISO 10993) | |
| Ethylene Oxide Sterilization (Validation) | Met requirements of ISO 11135-1:2007 | |
| Ethylene Oxide Residuals | Met requirements of ISO 10993-7:2008 | |
| Sterile Barrier Systems | Accelerated Aging | Met requirements of ASTM F 1980-07:2007 |
| Shipping/Packaging | Performance Testing of Shipping Containers and Systems | Met requirements of ASTM D4169-09:2009 |
| Conditioning for Testing | Met requirements of ISO 2233:2000 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for each of the performance and safety tests listed. The data provenance is implied to be from internal testing conducted by Merit Medical Systems, Inc. There is no information regarding the country of origin of the data or whether the tests were retrospective or prospective, though device performance testing is typically prospective (i.e., conducted specifically for the submission).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to this submission. The "ground truth" concept, especially involving expert consensus or adjudication, is typically relevant for studies validating diagnostic algorithms (e.g., AI in radiology) where a human expert's judgment or a definitive diagnostic method is used as the reference standard. This document describes a 510(k) submission for a physical medical device (a catheter) based on performance testing and substantial equivalence, not a diagnostic algorithm. Therefore, no experts were used to establish "ground truth" in this context.
4. Adjudication Method for the Test Set
This section is not applicable for the same reasons as point 3. Adjudication methods like "2+1" or "3+1" are used in studies involving subjective assessments or disagreements among experts, which is not the case for the physical and biocompatibility tests described for this catheter.
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
This section is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic imaging devices or AI algorithms that assist human readers. The ReSolve® Biliary Locking Drainage Catheter is a physical therapeutic device, not an imaging device or an AI assistant. Therefore, no MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This section is not applicable. This refers to the standalone performance of an AI algorithm, which is not relevant for a physical medical device like a catheter.
7. The Type of Ground Truth Used
The "ground truth" in this context is established by objective engineering specifications, material standards, and biological safety standards. For example:
- Engineering Specifications: Dimensional tolerances, tensile strength requirements, leak rates, kink resistance, marker band adhesion force.
- Material Standards: Biocompatibility (cytotoxicity, irritation, systemic toxicity, pyrogenicity, chemical characterization) as defined by ISO 10993 series and USP 34.
- Sterilization and Packaging Standards: Requirements for ethylene oxide sterilization (ISO 11135-1), residuals (ISO 10993-7), accelerated aging of sterile barriers (ASTM F 1980-07), and shipping performance (ASTM D4169-09).
8. The Sample Size for the Training Set
This section is not applicable. There is no "training set" in the context of a physical medical device like this catheter. Training sets are used for machine learning or AI algorithms.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as point 8.
§ 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.