(452 days)
The cautery is a battery-powered medical device used in Ophthalmologic surgical procedures to cause blood vessels to constrict and produce blood loss and keep the surgical field clear. Use for controlling diffuse bleeding and sculpting woven grafts.
The cautery is a battery-powered medical device used in Ophthalmologic surgical procedures to cause blood vessels to constrict and produce blood loss and keep the surgical field clear.
I am sorry, but the provided text is a 510(k) clearance letter for a medical device (Disposable Battery Powered Cautery). It establishes substantial equivalence to a predicate device and provides regulatory information.
However, this document does not contain any information regarding acceptance criteria, device performance results, study design, sample sizes, ground truth establishment, or expert qualifications as requested in your prompt.
Therefore, I cannot extract the information required to answer your request.
§ 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.