OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System
Perimeter Medical Imaging AI, Inc.The OTIS 2.1 Optical Coherence Tomography System is a medical imaging device that provides high-resolution, two-dimensional, cross-sectional real-time images of excised human tissue microstructures. It uses non-ionizing optical radiation to create detailed subsurface images, aiding clinicians in evaluating tissue samples. The device automates image acquisition and review, allowing users to identify and annotate regions of interest efficiently, supporting clinical decision-making and improving visualization during tissue evaluation.
Intended Use
The OTIS 2.1 Optical Coherence Tomography System is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization, with image review manipulation software for identifying and annotating regions of interest.
Technology
The device uses optical coherence tomography (OCT) involving a super luminescent diode light source with a center wavelength of 1325 ± 15 μm to produce high-resolution subsurface images of excised tissue. It employs an interferometer to measure backscattered light and generates images by detecting changes in the optical properties of the tissue such as scattering, absorption, and refraction. The device includes automated scanning and image acquisition with a touch screen interface, and design improvements to optimize image acquisition, processing, and user experience, without changing the fundamental technology from its predicate device OTIS 2.0.
Performance
The OTIS 2.1 device underwent verification and validation testing under Perimeter's Design Control procedures, using the same protocols as its predicate device OTIS 2.0. Testing included biocompatibility per ISO 10993 standards, laser safety, electromagnetic compatibility, and basic safety tests. These demonstrated that the device met its design input requirements, fulfilled intended use, and was safe and effective for its intended environment.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/7/2020
2 months - 2
FDA Approval
2/25/2021
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