Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)

The Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM is a medical device designed for routine monitoring of temperature, heart sounds, and respiratory sounds in anesthetized patients. The device is inserted into the esophagus and is available in four sizes (9, 12, 18, and 24 Fr) for use in pediatric and adult populations.

The subject device uses DEHP-free PVC in the cuff, tube, and earpiece components, whereas the predicate device used standard PVC with DEHP and phthalates. Both devices are equivalent in intended purpose, indications for use, target population (except neonates), environment of use, invasiveness level, skin contact, duration of use, sterility, and contraindications. The material substitution does not adversely affect safety or effectiveness.

Performance testing followed ISO 80601-2-56:2017+A1:2018 and IEC 60601-1:2005/AMD2:2020 for temperature accuracy and time response, leakage current, dielectric strength, and excessive temperature testing. Biocompatibility testing followed ISO 10993-1, human factors evaluation followed EN 62366-1:2015+A1:2020 and IEC 62366-1:2015+A1:2020, and sterilization was validated to a sterility assurance level of 10⁻⁶ using ethylene oxide.

The Mon-a-Therm™ device is substantially equivalent to the predicate Hi-Lo Temp® Esophageal Stethoscope because both devices share identical intended use, indications, design, and functionality. The material change from standard PVC to DEHP-free PVC is a non-substantive modification supported by comprehensive verification, validation, and biocompatibility testing demonstrating that the new material maintains all required performance and safety characteristics.