(71 days)
The Comfort Cup and Ear Tip accessories are for use with non-Grason Stadler (GSI) Audiometer, Otoacoustic Emission and Auditory Brainstem Response devices and are patient applied parts to support auditory evaluation studies.
The audiometer, otoacoustic emission (OAE) and auditory brainstem response (ABR) accessories addressed in this pre-market notification are Comfort Cup and Eartip. These devices are used to couple auditory stimulus into the ear or ear canal to support audiometer, OAE and ABR testing. Both devices connect to the audiometer, OAE and ABR devices through a sound conducting tube. The sound from the audiometer, OAE and ABR devices are conducted through the sound conducting tube to the ear in the application of the Comfort Cup or to the ear canal in the applications of the Eartip. The Comfort Cup and Eartip accessories are single patient use disposables.
The provided text does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.
This document is a 510(k) Pre-market Notification for the VIASYS Healthcare NeuroCare Group's Comfort Cup and Eartip Accessories. The primary purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics, and does not raise new questions of safety or effectiveness.
Therefore, I cannot populate the table or answer the questions as the required information is not present in the provided text. The document focuses on demonstrating substantial equivalence based on intended use and technological characteristics, rather than reporting on specific performance studies against defined acceptance criteria.
§ 874.1050 Audiometer.
(a)
Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.