Integrity V500 (Integrity, Integrity with VEMP)

The Integrity V500 with VEMP is an auditory evoked response stimulator that measures vestibular function through Vestibular Evoked Myogenic Potential (VEMP) testing. It is a PC-based system intended to assist clinicians, audiologists, and ENT doctors in assessing vestibular disorders in school-age children through geriatric adults. The device measures muscle responses from acoustic or vibratory stimulation to evaluate conditions such as superior canal dehiscence and Ménière's disease.

The Integrity with VEMP uses the same PC-based hardware architecture as the reference device Integrity V500, consisting of a battery-operated VivoLink patient interface, bio-amplifier, transducers, and electrodes. Key differences from the reference device are software additions: a biofeedback EMG monitor displaying real-time muscular activity in visual form (color-coded ranges), and VEMP response normalization that scales recorded sweeps based on EMG energy to compensate for imbalanced muscle contraction between sides. Compared to the mains-powered predicate Eclipse with VEMP, the Integrity is battery-powered but shares similar electrode montages, stimulation parameters, and biofeedback functionality.

Not stated in this summary.

Substantial equivalence is established through three converging lines of evidence: (1) Clinical Study 1 demonstrated that latency and amplitude measurements from the Integrity VEMP (cVEMP and oVEMP) were consistent with published literature norms and showed good-to-excellent statistical reliability (ICC 0.63–0.95) compared to the predicate Eclipse with VEMP across multiple parameters. (2) Clinical Study 2 proved test-retest reliability and reproducibility in 67 subjects across two sites using air and bone conduction, with mean correlation values ≥0.92 and IQR values ≤0.12, matching or exceeding the industry-accepted standards cited from the Eclipse 510(k) (K162037). (3) Non-clinical testing confirmed the hardware shares no electrical safety or EMC differences from the reference Integrity V500, and software validation confirmed proper VEMP protocol function. The addition of biofeedback and normalization represents a functional improvement rather than a safety or effectiveness change, as these features facilitate rather than alter the underlying measurement mechanism.