ShaeferH

The ShaeferH Oral Appliance is a custom-fabricated, prescription intraoral mandibular advancement device for single-patient use during sleep. It is indicated for treatment of mild to moderate obstructive sleep apnea (OSA) and/or snoring in adult patients 18 years or older, functioning by positioning the mandible anteriorly to maintain upper airway patency.

The device is a passive, non-powered monoblock intraoral appliance with no electrical components, software, batteries, wireless technology, or active heating elements. It is fabricated from medical-grade thermoplastic polymer (EVA equivalent) with a thermo-responsive liner (ThermAcryl), features clinician-directed titration for mandibular positioning that differs in implementation from the predicate but serves the same functional purpose, and contains no articulated joints, detachable components, or user-actuated adjustment mechanisms.

Not stated in this summary. The document references ISO 13485 clauses for quality management system requirements but does not identify specific test methods, consensus standards (ISO, IEC, ASTM), or performance testing standards used for device evaluation.

The ShaeferH is substantially equivalent to the predicate device (Serena Sleep Block, K203606) because both are non-powered intraoral mandibular advancement devices with identical intended use, shared fundamental principle of operation relying on mechanical mandibular repositioning, equivalent materials, and similar design and function. The alternative clinician-directed titration mechanism does not alter the principle of operation, clinical function, or intended patient population, and the device introduces no new mechanical principles or novel structural features requiring additional testing.