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The DynaBite HOT Gastroenterology Biopsy Forceps used in endoscopic procedure for removing histological tissue samples from the inner walls of the intestines and for performing associated electrocautery. The subject device is intended to be used with a colonoscope, a connecting cable and a high-frequency electrical-current generator, manufactured by others.

The DynaBite HOT Biopsy Forceps is intended for uses in gastrointestinal endoscopic procedure for for removing a histological tissue samples from the inner walls of the intestines and for performing associated electrocautery.

The DynaBite HOT Gastroenterology Biopsy Forceps are manually operated, hand held, flexible, cable actuated, coated, monopolar, trans-rectal surgical instruments have diameters of either 2.2, or 3.3 millimeter and working lengths of 240 centimeter. Each forceps has a pair of double actuating, fenestrated cup jaws at the distal end. Both devices are used in endoscopic procedure for removing histological tissue samples from the inner walls of the intestines and for performing associated electrocautery. The subject device is intended to be used with a colonoscope, a connecting cable and a high-frequency electrical-current generator, manufactured by others. The distal jaws of the forceps are open and closed with a two bar linkage actuated by lateral motion of the proximal finger rings. Since the forceps are fabricated from electrically conductive stainless steels, the forceps may be used to transmit a high frequency wave form to the distal end of the forceps for electrocautery. A dielectric forceps coating and the endoscope electrically insulate the length of the forceps from unintended patient contact.

This 510(k) summary describes a medical device, the DynaBite HOT Gastroenterology Biopsy Forceps, and its substantial equivalence to previously marketed predicate devices. It does not contain information about an AI/ML powered device, nor does it present a study with acceptance criteria and device performance results as typically seen for AI/ML device submissions.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on regulatory approval based on technological equivalence to existing devices, rather than performance metrics from a specific study.

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