Search Results

The LAGIS Suction Irrigation System has applications in laparoscopic procedures to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.

The LAGIS Suction Irrigation System consists of flexible tubing attached to a plastic housing/handle with a spring activated valve/stopper. Attached distally is a stainless steel probe and proximally is a plastic housing cap. When properly connected and operated, the device irrigates and evacuates fluids during laparoscopic procedures. The LAGIS Suction Irrigation System has multiple models, which can be categorized into two types based on the handle design, including direct type (e.g., SA-360C) and trumpet type (e.g., SA-320CT). Despite the different handle designs, all models provide the same function.

The provided document is a 510(k) summary for the LAGIS Suction Irrigation System, which is a medical device, not an AI/ML algorithm. Therefore, the information requested regarding acceptance criteria, study design, expert involvement, and ground truth for an AI/ML-based device is not applicable to this document.

This document details:

• Device Name: LAGIS Suction Irrigation System
• Intended Use: To provide suction and irrigation functions in laparoscopic procedures to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.
• Regulatory Class: Class II (Product Code GCJ - Laparoscope, General & Plastic Surgery)
• Predicate Device: Taiwan Surgical Disposable Suction Irrigation (K150253)
• Performance Tests: The summary lists performance bench tests conducted to verify design characteristics and ensure the device can be used as intended. These include:
  • Biocompatibility testing (following ISO 10993-1)
  • Sterilization validation (according to ISO 11135)
  • Functional and performance characteristics (airtightness, kinking resistance, flattening resistance, bending resistance, and pressing force performances).
• Conclusion: The tests met the predefined acceptance criteria, and no new questions of safety and effectiveness were identified. The device was deemed substantially equivalent to the predicate device.

Since the device is a physical medical instrument (suction irrigation system) and not a software/AI product, the detailed questions about AI model training, test sets, expert ground truth, adjudication methods, and MRMC studies are irrelevant to this submission.

Ask a specific question about this device