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)); Glean Urodynamics System Abdominal Sensor (GUS-1000-A)

The Glean Urodynamics System is a diagnostic device that measures pressure and flow characteristics of the lower urinary tract in adults to diagnose incontinence, urinary retention, and micturition disorders. It performs standard urodynamic tests including uroflow, cystometrogram, urethral pressure profile, and micturition studies using implantable sensors and associated software applications.

The subject device adds an Abdominal Sensor (GUS-1000-A) to the predicate's single Bladder Sensor, enabling multi-channel urodynamic measurements. Both use silicone sensors measuring 0–320 cm H₂O at 20 Hz sampling rate. The Abdominal Sensor measures up to 17.5 mm maximum diameter; the bladder sensor is less than 5.35 mm (16 Fr). Both are single-use with removal strings and wireless data transmission to mobile/web apps.

ISO 10993-1:2018 (biocompatibility), IEC 60601-1:2020 (electrical safety), IEC 60601-1-2:2020 (electromagnetic compatibility), ISO 11607-1:2019/Amd.1:2023 (packaging), USP <62> (bioburden), FDA guidance on software verification/validation, cybersecurity, and human factors engineering.

The subject device has identical intended use, indications, mode of operation, and performance specifications as the predicate device. Although it adds an abdominal pressure measurement capability, this difference does not raise new safety or effectiveness questions because multi-channel urodynamic testing is established clinical practice and the additional sensor uses the same technology, materials, and principles of operation as the predicate.