Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)

The Goldtrace Fetal Spiral Electrode (FSE) is a sterile, single-use device that transmits fetal ECG signals for continuous electronic monitoring of fetal heart rate during labor and delivery. It consists of a gold-plated stainless steel spiral needle electrode that attaches to the fetal presenting part, along with a reference plate, guide tube, and drive tube, and connects to a compatible fetal monitor via a standard adapter cable.

The subject device uses SS316 stainless steel electrodes with 10–25 µm gold plating (versus unspecified stainless steel in the predicate), has a spiral needle diameter of 4.7 mm with 0.55 mm outside diameter, a hub outside diameter of 0.219 inches, and 60 cm wire length. Both devices employ a single spiral needle with twisted two-wire concept and identical component structure (spiral needle, reference plate, connector, guide tube, drive tube, drive tube grip, wires). The subject device has a 5-year shelf life and is sterilized with ethylene oxide.

ISO 10993-1:2018 and 2024 FDA guidance for biocompatibility; ISO 10993-5, 10993-10, 10993-11; IEC 60601-1:2020 and IEC 60601-1-2:2014 for electrical safety and electromagnetic compatibility; ANSI/AAMI EC12:2000/(R)2015 and EC53:2013/(R)2020 for ECG electrodes and leadwires; ISO 11135:2014 for EO sterilization; ASTM D4169-22, F1980-21, F1929-15, F88/F88M-21, and F1886/F1886M-16 for transportation, shelf-life, and package integrity.

Both devices have identical intended use (fetal ECG monitoring during labor) and employ the same fundamental technology—a spiral needle electrode with twisted two-wire design and identical components. Although the subject device differs in materials (gold-plated SS316 versus unspecified stainless steel) and has specified dimensions where the predicate had none, comparative performance testing demonstrated electrical equivalence and equal ability to transmit fetal ECG signals with the Philips Avalon FM30 monitor. Comprehensive biocompatibility, electrical safety, sterility, mechanical, and shelf-life testing all support safety and effectiveness equivalent to the predicate, and the dimensional and material differences do not raise distinct safety or effectiveness questions.