21 CFR 874.4775 — Ear, Nose, And Throat Image Analyzer
Ear, Nose, Throat (EN) · Part 874 Subpart E—Surgical Devices · § 874.4775
Identification
Tyto Insights for Eardrum Bulging Detection is an over-the-counter web-based AI-enabled software analytics device intended to automatically detect the bulging of the eardrum in Oroscopic video recordings acquired by the compatible electronic otoscope, as identified in the product labeling, in patients aged 6 months and older. The device is not intended for diagnosis. A healthcare provider's advice is required to understand the meaning of the Tyto Insights for Eardrum Bulging Detection result. Healthcare providers should consider the device result in conjunction with otoscopic recordings and other relevant patient data. The device is not intended to detect other abnormal otoscopic findings.
Classification Rationale
FDA has determined that, for the previously stated indications for use, the Tyto Insights for Eardrum Bulging Detection can be classified in class II with the establishment of special controls for class II. FDA believes that class II (special) controls provide reasonable assurance of the safety and effectiveness of the device type.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| SHL | Ear, Nose, And Throat Image Analyzer | 2 | 1 | SaMD |
Special Controls
SHL — Ear, Nose, And Throat Image Analyzer
In combination with the general controls of the FD&C Act, the ear, nose, and throat image analyzer is subject to the following special controls: (1) Clinical performance testing must demonstrate the accuracy and precision of the device output to demonstrate that the device performs as intended under anticipated conditions of use in the intended patient population for the stated indications for use. (2) Human factors/usability testing must demonstrate that the user can correctly use the device, based solely on reading the directions for use. (3) Software verification, validation, and hazard analysis must be performed. (4) Labeling must include: (i) Hardware compatibility information; (ii) A warning that the device is not intended to be used independently for diagnosis; and (iii) A summary of the clinical performance testing conducted with the device, including the study endpoints and statistical confidence intervals.
De Novo Order DEN250014
