(90 days)
Used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal/submucosal defects less than 3 cm in the upper GI tract, bleeding ulcers, arteries less than 2 mm, and polyps less than 1.5 cm in diameter in the GI tract. This device is not intended for the repair of GI tract lumenal perforations.
The Wilson-Cook Endoscopic Clipping Device is comprised of an introducer with a locking handle and one (1) pre-loaded clip. The introducer is used to deploy the clip and is not left in the patient. The clip is left in the patient to accomplish hemostasis.
The provided text describes the Wilson-Cook Endoscopic Clipping Device and its 510(k) submission for premarket notification. The document focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics typically seen for AI/ML devices or novel technologies requiring extensive clinical trials.
Based on the provided information, here's an analysis:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" in the way a performance study for an AI algorithm would. Instead, the basis for approval is "substantial equivalence" to a predicate device. The performance is described qualitatively.
| Criterion Type | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Intended Use | To be substantially equivalent to the predicate device's intended use. | "Used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal/submucosal defects less than 3 cm in the upper GI tract, bleeding ulcers, arteries less than 2 mm, and polyps less than 1.5 cm in diameter in the GI tract. This device is not intended for the repair of GI tract lumenal perforations." (This is identical to the predicate device's intended use, with the exception of the predicate's mention of "anchoring to affix jejunal feeding tubes," which is notably absent from the subject device's intended use.) |
| Design | To be substantially equivalent to the predicate device's design. | "The Wilson-Cook Endoscopic Clipping Device is substantially equivalent to the referenced predicate device with respect to design..." |
| Materials of Construction | To be substantially equivalent to the predicate device's materials. | "The Wilson-Cook Endoscopic Clipping Device is substantially equivalent to the referenced predicate device with respect to ... materials of construction..." |
| Safety and Effectiveness | To perform in accordance with its intended use and be safe and effective. | "The Wilson-Cook Endoscopic Clipping Device underwent simulated use testing and biocompatibility testing. Test results provide reasonable assurance the device will perform in accordance with its intended use." |
"Being similar to predicate devices with respect to intended use and technology, and having test results that indicate the device will perform in accordance with its intended use, the Wilson-Cook Endoscopic Clipping Device meets the requirements for 510(k) substantial equivalence." |
| Sterility | Sterile, Disposable (consistent with predicate) | "Sterile, Disposable" |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "simulated use testing and biocompatibility testing," but does not provide any specific sample sizes or details about the test set used for these studies. There is no information on data provenance (e.g., country of origin, retrospective/prospective). This type of information is typically not included in a 510(k) summary focused on substantial equivalence for a mechanical device unless human clinical data was explicitly required, which it wasn't here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as the device is a mechanical clipping device, not a diagnostic AI/ML device that requires expert-established ground truth for interpretation. The "ground truth" for this device would be its functional performance (e.g., successful clip deployment, hemostatic ability in a model) rather than a clinical interpretation. The document does not mention any expert review in this context.
4. Adjudication Method for the Test Set
This is not applicable for the same reasons as #3. There is no mention of an adjudication method as there's no diagnostic output or interpretation requiring consensus among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improve with AI vs without AI assistance
This is not applicable. The device is a physical endoscopic clipping device, not an AI or imaging device involving human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance would be based on engineering performance specifications and simulated use testing (e.g., successful deployment, clip closing force, material integrity, biocompatibility). It is implied that the device met these engineering and material standards, which are considered sufficient for demonstrating substantial equivalence based on the "simulated use testing and biocompatibility testing" mentioned. No pathology or outcomes data is explicitly detailed in this summary.
8. The Sample Size for the Training Set
This is not applicable. This is a mechanical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as #8.
§ 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.