(20 days)
The MaxAir™ Nasal Dilator is intended to be used to enhance the flow of air through the nose. The nasal dilator is designed to pull on the outer lateral wall of the nasal passage which in turn will reduce the resistance to air flow through the nasal passage during breathing. The MaxAir™ Nasal Dilator's uses include, but are not limited to persons with temporary symptoms of nasal congestion which may be caused by colds, deviated septums, allergic rhinitis, and alar and valve insufficiency. The reduction of resistance to air flow in the nasal passage can also reduce the onset of snoring due to restrictions to air flow through the nasal passages.
The MaxAir™ Nasal Dilator is designed to pull on the outer lateral wall of the nasal passage which in turn will reduce the resistance to air flow through the nasal passage during breathing.
The provided documents are a 510(k) clearance letter and an Indications for Use statement for the Maxair Nasal Dilator System. These documents confirm that the device has received FDA clearance, but they do not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot provide the requested information based on the input provided. The acceptance criteria and study details would typically be found in the 510(k) submission summary or a separate performance study report, which is not included here.
§ 874.3900 Nasal dilator.
(a)
Identification. A nasal dilator is a device intended to provide temporary relief from transient causes of breathing difficulties resulting from structural abnormalities and/or transient causes of nasal congestion associated with reduced nasal airflow. The device decreases airway resistance and increases nasal airflow. The external nasal dilator is constructed from one or more layers of material upon which a spring material is attached, with a skin adhesive applied to adhere to the skin of the nose; it acts with a pulling action to open the nares. The internal nasal dilator is constructed from metal or plastic and is placed inside the nostrils; it acts by pushing the nostrils open or by gently pressing on the columella.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.