(90 days)
Used to endoscopically ligate esophageal varices at or above the gastroesophagea1 junction or to ligate internal hemorrhoids.
The Wilson-Cook 10 Shot Multi-Band Ligator consists of a friction fit adapter for attachment to the distal tip of an endoscope, a barrel preloaded with ten (10) ligation bands, a trigger cord and handle for band deployment, an irrigation adapter and a loading catheter. This device is designed for attachment to the end of an endoscope for ligating esophageal varices or hemorrhoids. Once assembled and attached the endoscope is advanced to the desired banding site and individual bands are deployed via manipulation of the deployment handle and trigger cord. The multi-band feature allows for serial ligations, which reduces the need to remove the endoscope for reloading. This device is supplied non-sterile and is intended for single use only.
This submission focuses on establishing substantial equivalence to a predicate device rather than meeting specific performance acceptance criteria through a dedicated study. Therefore, many of the requested elements (like sample size for test/training sets, expert qualifications, and MRMC studies) are not applicable or explicitly stated in this type of submission.
Here's a breakdown based on the provided text:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) submission does not specify numerical "acceptance criteria" in the traditional sense (e.g., a specific percentage success rate, accuracy, etc.) nor does it report specific quantitative device performance against such criteria. Instead, it aims to demonstrate substantial equivalence to a predicate device by comparing design, materials, and intended use, and by confirming adequate functional testing.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (as stated in the submission) |
|---|---|
| Intended Use: Match predicate device's intended use (ligation of esophageal varices or internal hemorrhoids). | Matches Predicate: "Used to endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids." (Same as predicate) |
| Components: Similar components and functionality, with a difference in number of bands. | Similar Components: Non-Patient Contacting Loading Catheter, Irrigation Adapter, Trigger Cord, Deployment Handle. Difference: 10 Ligation Bands vs. 6 in predicate. |
| Patient Contacting Materials: Identical to predicate device. | Identical Materials: Friction Fit Adapter (Polyurethane), Barrel (Polycarbonate), Trigger Cord (Vectran), Bands (Latex Rubber). |
| Method of Use: Identical to predicate device. | Identical Method: "Friction Fit adapter and barrel with ligation bands mounted to the distal tip of the endoscope. Band release from the barrel accomplished by trigger cord and deployment handle." |
| Biocompatibility: Established for patient-contacting materials. | "Biocompatibility has been established for the patient contacting materials through a history of use in other similar medical devices and as applicable biocompatibility test results." |
| Functional Testing: Results comparable to predicate device. | "This product line has been subjected to functional testing as appropriate for this modification. All results were comparable to results obtained for the predicate device hence establishing the safety and effectiveness for this product line extension." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The submission refers to "functional testing" but does not provide details on the number of tests performed or the sample size of devices used in this testing.
- Data Provenance: Not specified. The context suggests internal testing by the manufacturer (Wilson-Cook Medical Inc.) to demonstrate comparability with their own predicate device. It is a retrospective comparison to the results of the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This type of premarket notification for substantial equivalence does not typically involve external experts establishing ground truth for a test set in the way an AI/diagnostic device study would. The assessment is primarily based on engineering and materials comparison, and functional testing to confirm the device operates as intended and is comparable to the predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. There is no indication of a test set requiring adjudication in this submission.
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
- No. An MRMC study was not conducted as this is a medical device for therapeutic intervention (ligation), not a diagnostic or AI-powered device involving "human readers" or "AI assistance."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI algorithm; it's a mechanical/manual device. Therefore, standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Functional Comparability to Predicate Device: The "ground truth" or basis for acceptance is primarily the established safety and effectiveness of the existing predicate device. The new device's functional performance, materials, and intended use are compared to this known predicate. Biocompatibility relies on "history of use in other similar medical devices" and "applicable biocompatibility test results" (which are not detailed here).
8. The sample size for the training set
- Not Applicable. This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI model, this question is not relevant to this submission.
§ 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.