(102 days)
This device is 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 Disposable Hemostasis Clip is a sterile, single use device that consists of a metal clip that detaches from the introducer to maintain approximation of tissue to achieve hemostasis in the gastrointestinal tract. The device is compatible with endoscopes with a minimum accessory channel of 2.8 mm. The Disposable Hemostasis Clip is 230 cm long. The deployed clip portion of the Disposable Hemostasis Clip is stainless steel and nitinol while the introducer is nylon, stainless steel and nitinol.
The provided text describes a 510(k) summary for a medical device called the "Disposable Hemostasis Clip" by Wilson-Cook Medical, Inc. / Cook Endoscopy. Based on the provided information, I will answer your questions.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly detailed in the provided document beyond the general statement that the device met "performance requirements to fulfill the intended use." The document indicates the device's performance through non-clinical bench testing, demonstrating its substantial equivalence to predicate devices for its intended use.
| Acceptance Criteria (Inferred from regulatory context and intended use) | Reported Device Performance |
|---|---|
| Ability to fulfill intended use for endoscopic clip placement. | Met performance requirements through non-clinical bench testing to fulfill intended use. |
| Hemostasis for mucosal/submucosal defects less than 3 cm. | Substantially equivalent to currently cleared predicate devices for this indication. |
| Hemostasis for bleeding ulcers. | Substantially equivalent to currently cleared predicate devices for this indication. |
| Hemostasis for arteries less than 2 mm. | Substantially equivalent to currently cleared predicate devices for this indication. |
| Hemostasis for polyps less than 1.5 cm in diameter. | Substantially equivalent to currently cleared predicate devices for this indication. |
| Compatibility with endoscopes with a minimum accessory channel of 2.8 mm. | Device description states compatibility. |
| Device length of 230 cm. | Device description states length. |
| MR Conditional per ASMT F2503. | The deployed clip portion of the device is MR Conditional per ASMT F2503. |
| Detachment of metal clip from introducer. | Device description states "consists of a metal clip that detaches from the introducer to maintain approximation of tissue to achieve hemostasis." |
| Maintenance of tissue approximation. | Device description states "consists of a metal clip that detaches from the introducer to maintain approximation of tissue to achieve hemostasis." |
| Sterile, single-use. | Device description states "sterile, single use device." |
| Not intended for repair of GI tract lumenal perforations. | This is a limitation of the device's intended use and not a performance criterion to be met, but rather a boundary of its application. |
2. Sample Size Used for the Test Set and the Data Provenance
The document states "Performance testing consisting of non-clinical bench testing demonstrates that the Disposable Hemostasis Clip met the performance requirements to fulfill the intended use of the device." However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be non-clinical, implying laboratory or simulated environments rather than human patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not provided in the document. The performance testing was non-clinical bench testing, which typically does not involve human expert adjudication for ground truth in the same way clinical studies with medical images or diagnoses might.
4. Adjudication Method for the Test Set
As the performance testing was non-clinical bench testing, an adjudication method in the context of human expert review (e.g., 2+1, 3+1) is not applicable and therefore not mentioned in this document.
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
A Multi Reader Multi Case (MRMC) comparative effectiveness study is not mentioned in the document. This device is a mechanical hemostasis clip, not an AI-powered diagnostic or assistive tool, so an MRMC study comparing human reader performance with and without AI assistance would not be relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This question is not applicable as the device is a medical instrument (hemostasis clip), not an algorithm or AI system. Therefore, standalone algorithm performance is not a concept that applies to this device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Given that the testing was "non-clinical bench testing," the ground truth likely involved physical measurements and objective criteria based on pre-defined engineering specifications and intended functionality (e.g., clip strength, deployment success, tissue approximation force against a simulated target). Clinical ground truth (like pathology or patient outcomes) would not be generated in non-clinical bench testing.
8. The Sample Size for the Training Set
This information is not provided and is not relevant for this type of medical device's performance testing described. Training sets are typically associated with machine learning or AI models, which is not the case here.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no mention of a training set or machine learning in the context of this device's regulatory review.
§ 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.