Search Results

The HX-5/6-1 Clip Fixing Devices are intended to be used with an Olympus endoscope for the purpose of:
(1) endoscopic marking,
(2) hemostasis for
(a) mucosal/sub-mucosal defects <3cm,
(b) bleeding ulcers,
(c) arteries <2mm,
(d) polyps <1.5cm in diameter,
(e) diverticula in the colon,
(3) as a method for endoscopic closure of
(a) mucosal/sub-mucosal defects <3cm,
(b) polyps <1.5cm in diameter,
(c) diverticula in the colon,
(d) fistulas <20mm that can be treated conservatively.

Not Found

The provided text is a 510(k) summary for the Olympus HX-5/6-1 Endoscopic Clipping Device. While it describes the device's intended use and provides a comparison to predicate devices, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance studies.

Therefore, I cannot extract the requested information from the given text.

The document discusses:

• Device Name: Rotatable Clip Fixing Devices HX-5/6-1
• Manufacturer: Olympus Optical Co., Ltd.
• Regulation Number: 21 CFR 876.4400 (Hemorrhoidal Ligator, Class II)
• Intended Use: Endoscopic marking, hemostasis (for mucosal/sub-mucosal defects, bleeding ulcers, arteries <2mm, polyps <1.5cm, diverticula in the colon), and as an aid to clip closure of GI tract perforations <20mm that can be treated conservatively.
• Predicate Devices: HX-5/6-1 Endoscopic Clipping Device #K963160 and Olympus HX-5/6 Endoscopic Clipping Device #K990687.

The document is primarily a regulatory filing (510(k) summary) demonstrating substantial equivalence to previously marketed devices rather than a detailed report of performance testing against specific acceptance criteria.

Ask a specific question about this device