Bluebird Single-Use Respiratory Effort Belt

The Bluebird Single-Use Respiratory Effort Belt is a diagnostic device that measures chest and abdominal expansion during respiration using an inductive wire coil embedded in an elastic belt. It generates electrical signals proportional to breathing effort for connection to sleep study (polysomnography) systems in hospitals, clinics, and home settings. The device is intended for patients over 2 years old for diagnostic purposes only and is not an apnea monitor.

The device uses Respiratory Inductive Plethysmography (RIP) technology with a sinusoidal wire coil attached to an elastic belt, identical to the predicate. Both are single-use, pre-sized in the same four circumference ranges (pediatric 11-22 inches through large 40-75 inches), connect via touchproof DIN 42802 compliant connectors, and interface with standard physiological recording equipment. The primary difference is buckle material: polypropylene in the Bluebird versus ABS in the predicate, which the submitter argues does not affect safety or efficacy.

The document cites DIN 42802 for touchproof connection system compliance. No other specific ISO, IEC, or ASTM standards are explicitly referenced in the testing section.

Substantial equivalence is established through identical indications for use, identical intended environments and patient populations, and use of the same RIP technology with the same signal output characteristics. Comparative performance testing showed identical waveforms when both the Bluebird and XactTrace predicate belts were simultaneously connected to the same PSG recorder, demonstrating functional equivalence. The minor buckle material substitution is immaterial because both are standard plastic injection-molded materials that do not affect device performance, and the single-use nature eliminates concerns about durability or repeated cleaning requirements.