Luer-Split MAJ-2092

The Luer-Split MAJ-2092 is a reusable endoscope accessory that attaches to the instrument channel port of Olympus endoscopes. It enables simultaneous irrigation and insertion of EndoTherapy accessories by splitting the channel into separate irrigation and accessory ports. The device is single-use after cleaning and reprocessing per the manufacturer's instructions.

The subject device is a reusable, multi-patient adapter with a biopsy valve to resist backflow, compatible with a specific instrument diameter range, and featuring a particular arm shape on the adapter body. The predicate device is single-use without a separate backflow valve. Performance testing confirmed these technological differences do not raise new safety or effectiveness concerns.

Not stated in this summary.

Both devices share the same fundamental intended use of gaining access to the endoscope working channel. While the subject device is reusable with a backflow valve and the predicate is single-use without one, the differences in wording and design do not describe a new disease, condition, or patient population. Verification and validation testing including flow rate, durability, human factors, reprocessing, and biocompatibility demonstrated that these technological differences do not adversely affect device performance, establishing substantial equivalence to the predicate.