Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1)

The Saberscope™ Laparoscope (SAS-A-536L) with Xenocor® Video Processing Unit (VPUX-1) is a surgical endoscope system intended for diagnostic and therapeutic procedures within the thoracic and peritoneal cavities, including female reproductive organs. It consists of a single-use sterile laparoscope with a 0° camera on a 5 mm rigid shaft with ±90° articulating tip, 36 cm long shaft, and a video processing unit that converts the camera's digital signal to HDMI for display on an HD video screen.

The modified Saberscope™ system incorporates a new laser-cut hypotube bending section, new camera and imaging chain, and updated video processing functionality. The device maintains the same intended use and fundamental design principles as the predicate, with comparable performance and safety characteristics. Design improvements include enhanced image quality, durability of the articulating section, and refined video processing capabilities.

ISO 10993 (biocompatibility), ISO 13485 (quality management), IEC 60601-1, 60601-1-2, 60601-2-18 (electrical and electromagnetic safety), ISO 60601 standards for packaging and sterilization, and shelf life studies under accelerated aging and room temperature storage conditions.

The modified Saberscope™ system is substantially equivalent to the predicate SaberScope5 Laparoscope because it has the same indications for use, comparable design and operational principles, and equivalent functional performance. Testing demonstrates that design improvements raise no new safety or effectiveness questions beyond those identified for the predicate, and some risks have been reduced and captured through risk management.