(79 days)
A Rhinomanometer is a medical instrument, intended to measure nasal airway pressure up to 5 centimeters H2O. (500Pa) and air flow up to 1000 ml/s. (2001 a) and in the now ap to roove. which is useful to the physician in studying the nasal decongestion of the nasal This is a not it as re procedures, before and after surgical procedures, responses to medications, presence or absence of polyps, deviated septums, enlarged adenoids, etc.
The RhinoStream Rhinomanometer module is designed to objectively and quickly measure and quantify a dynamic measure of the patient ability breath through the nasal airway passages.
The provided text describes a 510(k) summary for the RhinoStream Rhinomanometer and its substantial equivalency comparison to a predicate device. However, it does not contain information about acceptance criteria, specific studies, or performance metrics in a way that allows for the detailed breakdown requested.
The document focuses on:
- Device Description and Intended Use: Explains what the RhinoStream Rhinomanometer does.
- Substantial Equivalency Comparison: Compares the RhinoStream to the Mercury Medical Rhinomanometer based on device description, indications, and technological characteristics (e.g., pressure and airflow measurement ranges, software, data storage).
- FDA Clearance Letter: Confirms the device's 510(k) clearance based on substantial equivalence.
- Indications for Use Statement: Reiterates the intended use in a regulatory format.
The absence of performance data, study designs, sample sizes, and expert review details is typical for a 510(k) summary, which primarily emphasizes substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical performance studies for novel claims.
Therefore, I cannot provide the requested information in the structured table and points as the input document does not contain that level of detail.
§ 868.1800 Rhinoanemometer.
(a)
Identification. A rhinoanemometer is a device used to quantify the amount of nasal congestion by measuring the airflow through, and differential pressure across, a patient's nasal passages.(b)
Classification. Class II (performance standards).