21 CFR 888.1150 — Arthroscopic Or Orthopedic Endoscopic Intraoperative Augmented Reality Video See-Through Display System

Orthopedic (OR) · Part 888 Subpart B—Diagnostic Devices · § 888.1150

Identification

SportSuite Vision Software is an arthroscopic or orthopedic endoscopic intraoperative augmented reality video see-through display system. It consists of augmented reality software on a head-mounted display that displays arthroscopic or endoscopic video and medical imaging during orthopedic surgery, specifically for femoroacetabular impingement and labral repair hip arthroscopy procedures. The device is intended to intraoperatively augment visualization with contextually relevant information and data, including that received from other devices.

Classification Rationale

FDA concludes that this device should be classified into Class II. This order classifies the device into Class II with the establishment of special controls, which provide reasonable assurance of the safety and effectiveness of the device type.

Product Codes