Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)

The Bard® Temporary Pacing Electrode Catheter is a bipolar pacing lead designed to transmit electrical signals between an external pulse generator and the heart for temporary cardiac pacing or monitoring. The Needle/Cannula (Introducer) is a vascular access device used to place the pacing catheter into the venous system. Both are single-use, prescription devices intended for professional healthcare settings.

The subject device shares identical intended use, indications for use, and design features with the predicate device (K241334). The only difference is removal of a labeling warning regarding unknown electromagnetic compatibility (EMC) with low-frequency emission sources such as mobile phones and wireless charging devices. The underlying device construction, materials, electrodes, and mechanical characteristics remain unchanged.

IEC 60601-1-2 (Edition 4.1): 2020, specifically Clause 8.11 for Immunity to Proximity Magnetic Fields using IEC 61000-4-39 (2017). Additional EMC testing included radiated emissions (CISPR11), electrostatic discharge immunity (IEC 61000-4-2), radiated RF immunity (IEC 61000-4-3), conducted RF immunity (IEC 61000-4-6), and power frequency magnetic field immunity (IEC 61000-4-8).

The device is substantially equivalent because it maintains identical intended use, indications, and technological design as the predicate K241334. The labeling change removing the low-frequency EMC warning is supported by new electromagnetic compatibility testing demonstrating compliance with IEC 60601-1-2 Clause 8.11 for proximity magnetic fields, eliminating the prior uncertainty. This improved compliance data does not raise different safety or effectiveness questions but rather provides substantiation for a more favorable label.