Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter))

The Glean Urodynamics System is a single-channel urodynamic analyzer for diagnosing lower urinary tract dysfunction in adult patients. It measures bladder pressure and flow characteristics through a minimally invasive electronic sensor inserted transurethrally, enabling standard urodynamic tests (uroflow, cystometrogram, urethral pressure profile, and micturition studies) to diagnose incontinence, urinary retention, and neurological micturition disorders.

The subject device uses an implantable electronic pressure sensor (silicone housing, <5.35mm diameter) housed in the bladder with integrated wireless data transmission and a removal string, compared to the predicate's external catheter (8 Fr, TPU-PVC material) connected to external sensors. Both measure 0-320 cm H2O at 20 Hz sampling rate, support ambulatory monitoring with single-use designs, and integrate uroflowmetry; the subject device omits integrated EMG capability present in the predicate.

ISO 10993-1:2018 (biocompatibility), IEC 60601-1:2020 (electrical safety), IEC 60601-1-2:2020 (electromagnetic compatibility), ISO 11135:2014 (ethylene oxide sterilization), FDA guidance on software verification/validation, cybersecurity risk management, and human factors engineering. A GLP chronic animal safety study on sheep was also conducted.

Although the subject device employs different technological characteristics (implantable sensor versus external catheter), both devices share identical intended use for standard urodynamic testing in adults with lower urinary tract dysfunction. The differences in design do not raise different safety or effectiveness questions because the subject device demonstrated comparable diagnostic accuracy, similar adverse event profiles, and successful pressure measurement in a 32-patient clinical study. The reference device (Dantec Duet) supported use of electronic pressure sensors, and extensive non-clinical testing (biocompatibility, electrical safety, sterilization) and clinical performance data demonstrated the subject device's safety and efficacy within the same clinical application.