(43 days)
Olympus HX-20-1 Endoscopic Ligator "EndoLoop" has been designed to be used with Olympus endoscopes in delivering a MAJ-254 Ligation Loop(Standard) or MAJ-340 Ligation Loop (Small) designed to prevent or control bleeding following polypectompy of pedunculated polyps.
The Olympus HX-20-1 Endoscopic Ligator is intended to deliver a MAJ-254 Ligation Loop (Standard) or MAJ-340 Ligation Loop (Small ) to prevent or control bleeding following polypectomy of pedunculated polyps. The Olympus HX-20-1 Endoscopic Ligator "EndoLoop" is substantially equivalent in intended use to the Olympus HX-20-1 which has been cleared premarket notification with #K964661. The modification on this submission differs from previously cleared 510(k) HX-20-1 in the instruction manual with emergency treatments and warnings.
The provided text is a 510(k) summary for the Olympus HX-20-1 Endoscopic Ligator, a medical device. This document does not describe a study to prove the device meets acceptance criteria or contain performance data in the context of an AI/algorithm-driven device.
The 510(k) summary primarily focuses on establishing substantial equivalence to a predicate device (Olympus HX-20-1 Endoscopic Ligator, #K964667). Substantial equivalence is determined based on intended use, device description, and technological characteristics. The significant point in this submission is the modification of the instruction manual with emergency treatments and warnings, not changes to the device's fundamental function or a new performance study.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance because it is not present in the provided text. The document is for a medical device (endoscopic ligator), not an AI or algorithmic medical device, and the submission is about a minor modification and substantial equivalence, not a performance study.
§ 876.4400 Hemorrhoidal ligator.
(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.