(29 days)
To provide septal support and reduce or prevent adhesions between the septum and lateral nasal wall following surgery.
The Custom Nasal Splints, constructed of medical grade flouroplastic (i.e. Teflor®) or medical grade silicone, are designed to be trimmed by the surgeon for custom applications. The splints provide septal support and reduce or prevent adhesions between the septum and lateral nasal wall following surgery. The splints are available in various thicknesses. The Custom Nasal Splint are supplied sterile, two splints per package, five packages per box.
The provided text describes Boston Medical Products' Custom Nasal Splints, their indications for use, and a 510(k) submission for market clearance. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, or adjudication methods.
The document is a US FDA 510(k) summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance study results against specific acceptance criteria.
Therefore, I cannot provide the requested information based on the input text. The text only confirms that the device is "constructed using well-established medical grade flouroplastic or medical grade silicone", and that it was deemed "substantially equivalent" to predicate devices, allowing it to proceed to market.
§ 874.4780 Intranasal splint.
(a)
Identification. An intranasal splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material.(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.