Atraverse Medical, Inc. · Class II · Cleared Aug 12, 2025
| K-number | K252083 |
| Device name | HOTWIRE System RF Generator and Footswitch (optional accessory) |
| Applicant | Atraverse Medical, Inc. |
| Product code | GEI |
| Device class | Class II |
| Decision date | Aug 12, 2025 |
| Decision | Substantially Equivalent |
| Regulation | — |
The HOTWIRE System RF Generator is an AC-powered radiofrequency device used with separately cleared RF puncture devices (specifically the HOTWIRE RF Guidewire) in cardiovascular transseptal access procedures to create an atrial septal defect by puncturing the fossa ovalis. It delivers monopolar RF energy at 470 kHz through a handpiece connection to facilitate septal puncture, with an optional footswitch for activation.
The subject device generates radiofrequency energy at 470 kHz (sinusoidal waveform) with maximum output of 50 watts and 0.6 amperes, powered by AC mains. It measures impedance with ±10% accuracy at 200-800 ohms and ±20% at 800-3500 ohms. The predicate device (Cross Vascular) operates at 462 kHz with 25 watts maximum output on a lithium-ion battery, while both devices employ monopolar delivery, optional footswitches, and conductive neutral electrodes.
IEC 60601-1:2005 (medical electrical equipment general requirements), IEC 60601-1-2:2020 (electromagnetic compatibility), IEC 60601-2-2:2017 (high-frequency surgical equipment), IEC 62304:2015 (software lifecycle), plus FDA cybersecurity guidance (FDA-2021-D-1158), standards for printed boards (IPC-A-600, IPC-A-610), shipping (ISTA 2A), flammability (UL 94), and RoHS compliance.
The subject device is substantially equivalent because it uses the same fundamental RF power generation, control, and monopolar delivery technology as the predicate device Cross Vascular RF Generator. Both connect to separately cleared RF puncture devices via handpiece, incorporate optional footswitches, and deliver single-mode RF energy to a commercial patient return electrode. Minor differences in frequency (470 vs 462 kHz), maximum power (50 vs 25 watts), power source (AC mains vs battery), and physical dimensions do not raise new safety or effectiveness questions, as confirmed by equivalent electrical safety/EMC testing per IEC 60601 standards and successful software validation, bench testing, and non-clinical animal studies.
View the full FDA submission: accessdata.fda.gov