Zenflow Spring Scope

The Zenflow Spring Scope is a sterile, single-use flexible cystoscope that provides endoscopic visualization of the lower urinary tract. It connects to a separate Zenflow Camera Control Unit for image display on any compatible video monitor and is compatible with standard endoscopic accessories. The device is intended for use in hospital or medical office settings in adult patients.

The Spring Scope uses CMOS digital imaging with LED illumination, matching the predicate device. Key differences include a larger working channel (4.0 mm vs. 2.2 mm), wider maximum insertion portion (20 Fr vs. 18 Fr), shorter working length (345 mm vs. 390 mm), and greater upward deflection (180° vs. 210°). Both have identical field of view depth (3 to 100 mm) and direction of view (0°).

ISO 10993-1 (biocompatibility), ISO 11135 (sterilization validation), ISO 10993-7 (sterilization-related biocompatibility), IEC 60601-1-2 (electrical safety and EMC), IEC 60601-2-18 (medical electrical equipment safety), and IEC 62471 (photobiological safety).

The Spring Scope shares the same indications for use, single-use design, and electrical energy source as the Ambu aScope 4 Cysto predicate. Both employ identical CMOS and LED technologies for visualization. Although the Spring Scope has dimensional and performance differences (larger working channel, increased deflection, different working length), nonclinical bench testing including simulated use, image quality, accessory compatibility, and fatigue testing—combined with biocompatibility and sterilization validation—demonstrate these design variations raise no new safety or effectiveness questions compared to the predicate device.