(15 days)
The MediSISS Reprocessed Hot Biopsy Forceps and accessories are intended to be used endoscopically to obtain tissue specimens, remove polyps, and cauterize tissue.
Not Found
I am sorry, but based on the text provided, I cannot fulfill your request. The document is a 510(k) clearance letter from the FDA for reprocessed hot biopsy forceps, along with a list of substantially equivalent devices and indications for use. It does not contain any information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, ground truth establishment, or any comparative effectiveness studies as you have requested.
The letter primarily confirms that the reprocessed devices are substantially equivalent to legally marketed predicate devices and have met the regulatory requirements for medical devices.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).