Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12)
Opcom Medical Inc.The Flexible Ureteroscope (U-Scope) by Opcom Medical Inc. is a sterile, single-use, flexible digital video ureteroscope designed to visualize the urinary tract (including urethra, bladder, ureter, and kidney calyces) using a miniature CMOS camera and LED illumination. It connects to a reusable camera-controlled unit which processes and displays images and videos, enabling physicians to perform diagnostic and therapeutic procedures. This system aids clinicians by providing live, high-quality imaging to guide interventions in the urinary tract.
Intended Use
The Disposable Flexible Ureteroscope (U-Scope) is a sterile, single-use, flexible, digital video ureteroscope intended to be used to visualize organs, cavities, and canals in the urinary tract (urethra, bladder, ureter, calyces, and renal papillae) via trans-urethral or percutaneous access routes. It can also be used in conjunction with endoscopic instruments via its working channel to perform various diagnostic and therapeutic procedures in the urinary tract. The Images Systems (Camera-Controlled Unit) is intended to provide power to and receive, process, display, and output recordings of images from compatible visualization devices.
Technology
The flexible ureteroscope integrates a miniature CMOS camera and LED illumination module at the distal tip, a bending section allowing 270° bidirectional movement, and a working channel for instruments. The camera-controlled unit includes hardware, software, and firmware to drive the camera and LEDs, capture and store images and videos, and manage external connections such as USB, HDMI, and display touchscreen control.
Performance
Non-clinical testing verified that the device meets design specifications and is as safe and effective as the predicate device, including bending performance, working channel performance, optical characteristics like resolution and field of view, and comprehensive software verification. Electrical safety and electromagnetic compatibility were demonstrated per IEC standards. Biocompatibility testing was also conducted, and sterilization and shelf-life were validated.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/9/2024
8 months - 2
FDA Approval
5/28/2025
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