SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)

The SleeveLUX 24 and 16 Anoscope/Proctoscope are class II self-illuminating, single-use disposable instruments used to diagnose and treat conditions in the anal canal and lower rectum, such as 1st, 2nd, and 3rd degree hemorrhoids. The device comprises a main body tube, sleeve, trocar, handle, and LED module that allow clinicians to visualize and treat lower rectal pathology.

Both the predicate device and SleeveLUX are composed of the same material (polycarbonate) and are used for examination of the anal canal with integrated light sources. Both have the same intended use and require trained professionals to operate. The SleeveLUX has a similar shelf life of 3 years (compared to 5 years for the predicate).

Not stated in this summary.

The devices are substantially equivalent because they are composed of the same material (polycarbonate), both are used in examination of the anal canal with integrated light sources, both have the same intended use, and both require trained professionals to operate. Mechanical testing confirmed the device has suitable mechanical properties and no issues with cytotoxicity, irritation, or sensitization.