EdgeFlow Gel Pad

The EdgeFlow Gel Pad is a single-use, non-sterile silicone gel pad that provides acoustic coupling between an ultrasound transducer and a patient's intact abdominal skin during bladder ultrasound procedures. It enables transmission of ultrasound signals for bladder imaging and volume measurement and is intended for use in professional healthcare facilities by qualified healthcare professionals.

The device is a solid silicone elastomer gel pad supplied with two removable release films (blue and transparent) in a sealed pouch, designed for single-use application as a patch between probe and skin. The primary difference from the predicate is the base material composition (silicone versus aqueous gel), but both provide equivalent acoustic coupling and meet the same biocompatibility standards.

ISO 10993-5 and ISO 10993-10 for biocompatibility testing; ASTM F1929 for dye penetration testing; ASTM F88/F88M for seal strength testing. Bench testing evaluated axial and lateral distance measurement accuracy and bladder volume measurement accuracy using ultrasound phantoms.

The EdgeFlow Gel Pad is substantially equivalent to the SOLID GEL PAD (K131905) predicate because both devices have similar intended use, device form, single-use designation, non-sterile status, identical biocompatibility testing standards, and comparable acoustic coupling and imaging performance. Although the material composition differs (silicone versus gel), this difference does not raise new safety or effectiveness questions, as both materials provide equivalent acoustic coupling and meet the same regulatory standards.