(28 days)
Used to ligate internal hemorrhoids.
The Wilson-Cook Modified Multiple Band Ligator is used to ligate internal hemorrhoids. This device is supplied non-sterile and intended for single use only. The modification of the predicate Wilson-Cook Multiple Band Ligator (K944220/A) consists of a change to the handle in order to accommodate single-hand operation through an anoscope. In addition, the modified device comes preloaded with the barrel attached to the tip of the handle. The predicate device is designed for attachment to the end of an endoscope, while the modified Multiple Band Ligator is used in conjunction with an anoscope. The barrel and bands of the modified device are identical to the barrel and bands of the Wilson-Cook Multiple Band Ligator in the choice of the production and the specifications of each. The trigger cord is comprised of the same materials, however the trigger cord is slightly shorter in length for the modified devices, as the modified device comes preloaded and is used with an anoscope. Loading catheter and irrigation adapter are not needed.
The provided text does not contain detailed information about specific acceptance criteria or a dedicated study with performance metrics for the Wilson-Cook Modified Multiple Band Ligator. Instead, it focuses on the device's substantial equivalence to a predicate device and the process of design control, risk analysis, and design verification.
However, based on the provided text, we can infer some general information about design verification and what the acceptance criteria would have been for a device like this, even if the specific outcomes aren't quantified.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document states: "All results obtained during our Design Verification met our predetermined acceptance criteria for this product line." This implies that acceptance criteria were established and met, but the specific criteria and the reported performance values are not provided in the text.
We can infer the types of criteria that would have been evaluated based on the description of the device modification and its function:
| Acceptance Criteria Category (Inferred) | Reported Device Performance (Not Quantified) |
|---|---|
| Functional Performance: | |
| - Ability to ligate hemorrhoids | Met predetermined criteria |
| - Single-hand operation through anoscope | Met predetermined criteria |
| - Trigger cord functionality | Met predetermined criteria |
| Dimensional Integrity: | |
| - Barrel dimensions | Met predetermined criteria |
| - Band specifications | Met predetermined criteria |
| - Trigger cord length | Met predetermined criteria |
| Material/Biocompatibility: | |
| - Biocompatibility of patient-contacting materials | Established through history and/or testing |
| Safety: | |
| - Freedom from defects causing harm | Risk analysis performed and controls in place |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document only mentions "Design Verification" and "dimensional and functional testing" without detailing the number of units tested.
- Data Provenance: Not specified, but generally, design verification testing for medical devices is conducted by the manufacturer (Wilson-Cook Medical Inc.) in a controlled environment. It is not a clinical study in this context, so concepts like "country of origin" for data are not applicable in the same way. The testing would be prospective in the sense that it's performed on the manufactured device models to ensure they meet specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided. "Ground truth" and expert consensus are terms typically used in clinical studies or studies evaluating diagnostic accuracy, especially for AI/ML devices. This document describes a modification to a physical medical device (a ligator) and its engineering-based design verification testing. The "ground truth" here is adherence to engineering specifications and functional performance.
4. Adjudication method for the test set:
This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert opinions, typically in clinical evaluations or image interpretation studies. For design verification of a physical device, the "adjudication" is essentially the comparison of test results against predefined engineering acceptance criteria by qualified technicians or engineers.
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 information is not applicable and not provided. This device is a manual surgical tool, not an AI-assisted diagnostic or therapeutic device. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided. This is a physical, manually operated medical device. There is no "algorithm" to be evaluated in a standalone manner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's verification is engineering specifications, functional requirements, and material properties. The device is tested to ensure it meets these predefined criteria. This is not derived from clinical outcomes, pathology, or expert consensus in the typical sense.
8. The sample size for the training set:
This information is not applicable and not provided. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
This information is not applicable and not provided. As there is no training set, this question is not relevant.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):
The document states that a Design Verification process was conducted. This involved:
- Risk Analysis: Identifying risks relative to performance requirements, including failure modes, effects, severity, potential causes, and rates of occurrence, along with design control elements to eliminate them.
- Dimensional Testing: Measuring the physical properties of the modified device (e.g., barrel, bands, trigger cord length) to ensure they conform to specifications.
- Functional Testing: Assessing the operational performance of the device, likely including its ability to ligate, the functionality of the trigger cord, and its compatibility with an anoscope for single-hand operation.
- Biocompatibility Assurance: Establishing biocompatibility through a history of patient-contacting materials and/or specific biocompatibility test results.
The key statement is: "All results obtained during our Design Verification met our predetermined acceptance criteria for this product line." This indicates that a study (the Design Verification process) was performed, and the device successfully fulfilled the established criteria, although the specific details of those criteria and quantitative performance results are not openly provided in this 510(k) summary. The study essentially confirmed that the modified device's design (including changes to the handle, preloaded barrel, and trigger cord length) maintained the same safety and effectiveness profile as the predicate device.
§ 876.4400 Hemorrhoidal ligator.
(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.