Fetal Doppler U8-25, U9-25

The Fetal Doppler U8-25 and U9-25 are handheld ultrasound devices that use the Doppler principle to detect fetal heart rate from a pregnant woman's abdomen. The devices are intended for use by healthcare professionals including nurses, midwives, and specialized technicians in hospitals, clinics, community settings, and homes, starting at or after 16 weeks gestation.

The subject device transmits ultrasound continuously at 2.5 MHz (compared to the predicate's 2.0, 2.5, and 3.0 MHz options). Both devices measure fetal heart rate in the range of 65–210 bpm (predicate: 50–210 bpm) with ±2 bpm accuracy. The subject device's acoustic output at 2.5 MHz is 2.99 mW/cm² ISATA, which is lower than the predicate's comparable frequency output but both meet FDA recommendations of <20 mW/cm² ISATA. Patient-contacting materials differ slightly: subject uses ABS only, while predicate includes ABS, silicone, and colorants.

IEC 60601-1 Edition 3.2 (general electrical safety), IEC 60601-1-2 Edition 4.0 (electromagnetic compatibility), IEC 60601-1-11 Edition 2.0 (home healthcare use), IEC 60601-2-37 Edition 2.1 (ultrasonic equipment safety), IEC TR 60601-4-2 Edition 1.0 (electromagnetic immunity guidance), NEMA UD-2 (ultrasound measurement), and ISO 10993-1 (biocompatibility evaluation). Software was validated per 2023 FDA guidance on device software.

The subject and predicate devices share identical intended use (fetal heart rate detection), same operating principles (continuous-wave Doppler ultrasound), equivalent FHR measurement specifications, and similar patient-contacting materials. Although acoustic outputs and ultrasound frequencies differ, both meet FDA safety recommendations and applicable standards. Differences in design and performance specifications do not raise new questions of safety or effectiveness, and comprehensive testing (biocompatibility, electrical safety, software validation, use-life) demonstrates the subject device is as safe and effective as the predicate.