21 CFR 886.1600 — Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device
Ophthalmic (OP) · Part 886 Subpart B—Diagnostic Devices · § 886.1600
Identification
A home monitoring ophthalmic imaging device is a prescription self-imaging device that incorporates imaging system hardware and automated image processing and analysis to enable patients at home to provide measurements that are intended for use by a physician for monitoring ophthalmic diseases or conditions in between regularly scheduled assessments. The Notal Vision Home Optical Coherence Tomography (OCT) System is an AI-based home use device indicated for visualization of intraretinal and subretinal hypo-reflective spaces in a 10 by 10-degrees area centered on the point of fixation of eyes diagnosed with neovascular age-related macular degeneration (NV-AMD), providing segmentation and estimation of the volume of these spaces.
Classification Rationale
Class II (special controls). The device is granted under the De Novo process, with risks mitigated by general controls and the identified special controls.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| SAX | Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device | 2 | 1 | SaMD |
Special Controls
SAX — Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device
In combination with the general controls of the FD&C Act, the home monitoring ophthalmic imaging device is subject to the following special controls:
De Novo Order DEN230043
