Auris Health, Inc. · Class II · Cleared Jan 23, 2025
| K-number | K243219 |
| Device name | MONARCH Platform (MON-000008) |
| Applicant | Auris Health, Inc. |
| Product code | EOQ |
| Device class | Class II |
| Decision date | Jan 23, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 874.4680 |
The MONARCH Platform is a robotic-assisted bronchoscopy system that provides visualization of and access to patient airways for diagnostic and therapeutic procedures. It consists of a cart with robotic arms, a tower with display and control systems, a flexible bronchoscope with a working channel and distal camera, and a controller operated by a physician. The system enables precise navigation and manipulation of the bronchoscope under continuous direct physician control.
The subject device adds the capability to directly integrate 3D imaging data from Cone Beam CT (CBCT) systems via an ethernet connection to enable real-time navigation updates during procedures, addressing anatomical changes not reflected in pre-operative CT scans. It also includes software updates for navigation and anatomy presentation, firmware updates for a revised controller, and hardware and software revisions for cybersecurity purposes. The fundamental technology—electromechanical system with electromagnetic navigation, pull-wire distal tip movement, and direct physician control—remains identical to the predicate.
Not stated in this summary. The document references compliance with 'safety and EMC standards for medical devices' through an independent nationally recognized testing laboratory but does not cite specific ISO, IEC, or ASTM standard numbers.
The modified MONARCH Platform is substantially equivalent because it maintains identical intended use, indications for use, fundamental scientific technology, principles of operation, method of distal tip movement, and major system components as the predicate K211493. The design differences—CBCT integration, controller firmware updates, and cybersecurity enhancements—do not create new safety or effectiveness questions; non-clinical bench testing including location accuracy, software functionality, safety/EMC compliance, and simulated use accuracy testing all demonstrate the modified device meets performance specifications without raising new safety or effectiveness concerns.
View the full FDA submission: accessdata.fda.gov