(78 days)
HORIZONS POLYPECTOMY SNARES ARE INTENDED TO ELECTROSURGICALLY REMOVE POLYPS IN THE GI TRACT UNDER ENDOSCOPIC VISUALIZATION
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I am sorry, but this document contains no information about acceptance criteria or the study that proves whether the device meets those criteria. It is a 510(k) clearance letter for a medical device (Horizons Polypectomy Snares), indicating that the device has been deemed substantially equivalent to a legally marketed predicate device.
The letter confirms that the device can be marketed but does not include details on:
* Acceptance criteria for device performance
* Specific study data or methodology
* Sample sizes used
* Ground truth establishment
* Expert qualifications
* Adjudication methods
* Details of multi-reader multi-case (MRMC) comparative effectiveness studies
* Standalone algorithm performance studies
* Training set information
§ 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).