(77 days)
The Mentor® Gemini™ Hemostatic Eraser™ is used to achieve episcleral and or intraocular hemostasis utilizing diathermy.
The MENTOR® GEMINI™ HEMOSTATIC ERASER™ is a hand-held bipolar probe used for coagulation which consists of (a) a handle and (b) a disposable tip (electrode). The handle transfers RF energy to the disposable tip via a unique electrical contact system located in the internal cavity of the handle. After a single use, the Tip is intended to be disposed of in a safe and cost effective manner. The handle is intended to be used 1-50 times before discarding.
This 510(k) summary explicitly states: "The determination of substantial equivalence is not based on an assessment of any performance data, clinical or non-clinical." This means the submission does not contain information about acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested information from the provided text. The device's substantial equivalence was determined based on its similarity in indications, design, and features to a predicate device, not on specific performance data or clinical studies.
§ 886.4115 Thermal cautery unit.
(a)
Identification. A thermal cautery unit is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by heat conducted through a wire tip.(b)
Classification. Class II.