(60 days)
Used for endoscopic removal of biliary stones, pancreatic stones, and foreign bodies.
The Wilson-Cook Mini Basket Extraction Basket is a sterile, single use device used through the accessory channel of endoscopes. The device consists of basket, catheter, and handle components. The basket component is constructed of monofilament metal wires and a helical design. The catheter is 200 cm in total length with a working length of 182 cm and 5 Fr diameter. The catheter is composed of Polytetrafluoroethylene (PTFE). The handle is a pin-vice design composed of polycarbonate with an acetal side arm fitting. The device is not compatible with any mechanical lithotripter.
This document describes a 510(k) premarket notification for a medical device called the "Wilson-Cook Mini Basket Extraction Basket" (K182381). This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval) application.
Therefore, the information provided in this document is not a study that proves the device meets specific acceptance criteria in the way a clinical trial would for an AI/algorithm-based device. Instead, it demonstrates the device's technical performance and equivalence to a predicate device.
Given this context, I will address your request by interpreting "acceptance criteria" as the performance tests conducted to establish equivalence and "proof" as the results of those non-clinical tests. Since this is a physical medical device and not an AI or algorithm-based product, many of your specific questions regarding AI-related performance measures (e.g., sample size for AI test sets, number of experts for ground truth, MRMC studies) are not applicable.
Here's an adaptation of your requested information based on the provided document:
Device Name: Wilson-Cook Mini Basket Extraction Basket
FDA 510(k) Number: K182381
Device Type: Biliary Catheter and Accessories (Physical Medical Device, not AI/Algorithm)
1. Table of Acceptance Criteria and Reported Device Performance
For this physical medical device, "acceptance criteria" are implied by the successful completion of the listed performance tests, which are standard for such devices to demonstrate functionality and safety in comparison to a predicate. The document states that these tests "confirmed that the subject device performs as intended."
| Acceptance Criteria (Implied by Test Type) | Reported Device Performance |
|---|---|
| Stone and Foreign Body Capture (Demonstrate ability to capture intended targets) | Testing was conducted and confirmed the basic performance of the device as intended. |
| Tensile Strength (Ensure device withstands forces during use without breaking) | Testing was conducted and confirmed the basic performance of the device as intended. |
| Functional Performance (Overall performance of basket, catheter, handle components) | Testing was conducted and confirmed the basic performance of the device as intended. |
| Shelf Life (Maintain performance over time) | Testing was conducted and confirmed the basic performance of the device as intended. |
| Biocompatibility (Safety of materials in contact with body) | Performed in accordance with FDA Guidance ISO 10993-1 and ISO 10993-1:2009. (Implies satisfactory results as part of clearance). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes (e.g., number of devices, number of stones tested) for each non-clinical test. This level of detail is typically found within the full 510(k) submission, not the summary letter.
- Data Provenance: The studies were conducted by Wilson-Cook Medical, Inc. / Cook Endoscopy. These are non-clinical (benchtop/laboratory) tests, not human studies. The data provenance is internal to the manufacturer's testing facilities. It is inherently "retrospective" in the sense that the testing was completed before the submission.
3. Number of Experts and Qualifications for Ground Truth
- This question is not applicable as this is a physical medical device submission, not an AI/algorithm device requiring expert human readers to establish ground truth for image interpretation or similar AI-specific performance metrics. Performance was assessed through engineering and material science tests.
4. Adjudication Method for the Test Set
- This question is not applicable as this is a physical medical device submission. Adjudication methods like 2+1 or 3+1 are used for expert consensus on challenging cases, primarily in clinical studies involving interpretation (e.g., radiology for AI). The tests performed here are objective engineering tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. MRMC studies are used to evaluate the comparative effectiveness of different diagnostic methods, typically involving human readers interpreting images, possibly with AI assistance. This submission is for a physical device used for stone extraction, not an AI diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the Loop) Performance
- Not applicable. This section relates to AI/algorithm performance. The Wilson-Cook Mini Basket is a physical device that is used by a human endoscopist. There is no "algorithm only" performance for this type of product.
7. Type of Ground Truth Used
- The "ground truth" for the non-clinical tests would be defined by engineering specifications, material properties, and physical standards for stone capture, tensile strength, and functional operation. For example, a successful "stone capture" test would be defined by the physical retention of the stone within the basket under specified conditions, rather than a clinical outcome or expert diagnosis. Biocompatibility used established ISO standards.
8. Sample Size for the Training Set
- Not applicable. This question pertains to AI/machine learning models which require training data. This is a physical medical device. Manufacturing processes and design iterations occur, but there isn't a "training set" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, this pertains to AI/machine learning. For a physical device, functional parameters and material specifications are validated through established engineering and quality control procedures during design and manufacturing.
§ 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.