rTOP
roclub GmbHrTOP is a teleoperation platform that allows medical professionals to remotely operate, assist, review, monitor, and standardize medical imaging and diagnostic devices. It supports video and USB interfaces for human interface devices, enabling read-only or full access control to these devices. The system facilitates remote collaboration and training across healthcare sites, helping clinicians efficiently share expertise and improve workflow, even when not physically present with the imaging equipment.
Intended Use
roclub TeleOperationPlatform (rTOP) is intended for remote operation, assistance, review, monitoring and standardization of medical imaging or diagnostic devices with video and optional USB interface for HID. It allows read-only or full access control to connected devices and supports training of medical personnel on imaging devices.
Technology
rTOP is a client-server architecture system with cloud infrastructure, featuring a local operator and remote operator roles. It provides remote access to modality consoles via a connector device with video splitting and emulation of mouse and keyboard. Remote connections can be full-control or read-only, with local user control over access. Communication includes video, audio calls, and text chat. Hardware includes KVM switch functionality; software is browser-based for remote clients.
Performance
Software verification and validation testing confirmed that rTOP meets design requirements and intended use. Non-clinical performance testing showed that rTOP performs equivalently to the predicate device. No clinical performance data were necessary. The latency and operating system independence were comparable or improved versus predicate. Overall, performance testing demonstrated safety and effectiveness comparable to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/24/2024
3 months - 2
FDA Approval
2/4/2025
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