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The ASA Oral Appliances are intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older.

The American Sleep Association (ASA) Oral Appliances include three devices: the ASA Herbst and Herbst/Hilsen Hybrid devices. All are removable, intraoral devices which reposition the mandible and each is custom-fabricated to individual patient specifications. The devices are comprised of thermoformed polymer splints (copolyester or EVA) which are connected bilaterally via a stainless steel telescoping Herbst mechanism, reclosable fasteners or both.

This document is a 510(k) premarket notification for the American Sleep Association (ASA) Oral Appliances. It establishes substantial equivalence to predicate devices, but does not contain any study data or acceptance criteria for device performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and study results. The FDA's determination of substantial equivalence (SE) in this case is based on a comparison of technological characteristics and intended use to previously cleared devices, not on new clinical performance data for the ASA Oral Appliances themselves.

The document states:

• "In comparison to the predicate devices, the ASA Oral Appliances Conclusion: have the same intended use and the same technological characteristics and so do not raise new questions of safety and effectiveness."
• "Therefore the ASA Herbst and Herbst/Hilsen Hybrid devices can be found substantially equivalent to the predicate devices."

This indicates that no dedicated performance study was required for this 510(k) clearance based on the comparison to predicate devices: Removable Acrylic Herbst (K070327), Hilsen Anti-Snoring Device (K963591), and Silent Nite® sl (K972424).

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