OTSCneo System Set (100.03n-14n, 100.27n-31n)

The OTSCneo System Set is an over-the-scope clip application device used during flexible endoscopy in the gastrointestinal tract. It consists of a memory-shape alloy clip mounted on a transparent plastic cap that attaches to an endoscope tip. The device is indicated for hemostasis of mucosal/submucosal defects, bleeding ulcers, and polyps; closure of GI tract perforations; and marking of lesions. Target tissue is drawn into the cap using endoscopic instruments or suction, then the clip is deployed via a manual thread mechanism.

The device features a transparent clip-bearing cap with a silicon spout that fits to endoscope tips and incorporates a manual, thread-based application mechanism. Technical differences from the predicate were identified in design details, but performance bench testing—including endoscope compatibility, application forces, and mechanical properties evaluation—showed these differences have precedent in other cleared reference devices and do not raise different safety or effectiveness questions.

Not stated in this summary.

The subject device is substantially equivalent to the predicate devices (OTSC System Set, stentfix OTSC System Set, and BARS Set) based on identical intended use and performance. Although technical differences exist, performance bench testing data demonstrate the device performs safely and effectively with the same fundamental design approach: a transparent clip-bearing cap with silicon spout and manual thread-based application mechanism. The differences have precedent in other cleared devices and do not raise different questions of safety and effectiveness.