GI Genius™ Intelligent endoscopy module Indications, Safety, and Warnings

Contraindications

GI Genius™ intelligent endoscopy module is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as polyps and adenomas) in real time during standard whitelight endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. The GI Genius computer-assisted detection device is limited for use with standard white-light endoscopy imaging only. This device is not intended to replace clinical decision making.

  • Warning; Do not use this system for any purpose other than its intended use.
  • Warning; The system does not perform any diagnosis.
  • Caution: The sale, distribution, and the use of the GI Genius are restricted to prescription use in accordance with 21 CFR 801.109.
  • Caution: The device is not intended to be used as a stand-alone diagnostic device.
  • Caution: The device is not intended to characterize lesions in a manner that would potentially replace biopsy sampling.
  • Caution: The device is not intended to replace clinical decision making.
  • Caution: The device is not intended to be used with equipment that was not tested against during validation activities.
  • Caution: The device has not been studied in patients with Inflammatory Bowel Disease (IBD), history of CRC, or previous colonic resection. The device performance may be negatively impacted by mucosal irregularities such as background inflammation from certain underlying disease.
  • Caution: Users should be aware, when using automated systems such as the GI Genius that provide assistance in identifying suspicious lesions, that a high level of reliance may be placed on the system output, potentially leading to user complacency and a bias towards accepting the system output results, rather than using the device as intended. The device is intended to provide adjunctive information to the endoscopist who performs endoscopic evaluations with an expected high level of clinical expertise. Placing too much reliance on the system in this way may lead to an unacceptably low level of procedural oversight ('situational awareness'), sub-par evaluation of the patient, and eventual endoscopist skill degradation, following which retraining may be necessary.
  • Danger: Using incompatible equipment can result in patient injury or equipment damage and makes it impossible to obtain the expected functionality.

Risks

Electrical risks

  • Strictly observe the following precautions. Failure to do so may place the patient and medical personnel in danger of electric shock.
  • Keep fluids away from the system. If fluids are spilled on or into the system, immediately stop any operation of the System. If fluids are spilled on or into the system, immediately stop any operation of the System and contact Support (see Section 14).
  • Do not use the System when not properly closed. Do not touch electrical contacts inside any component of the System.

Fire or Explosion Risks Danger

  • In order to prevent fire and explosion, do not expose the system where:
    • there is a high concentration of oxygen
    • air contains oxidizing agents (e.g. N2O)
    • air contains any flammable gases
    • there are flammable liquids nearby

Interferences

  • Warning: System may interfere with other equipment.
  • Caution: Electromagnetic interference may occur to this instrument when it is placed near equipment marked with the following symbol or other portable and mobile RF communications equipment such as cellular phones. If radio interference occurs, mitigation measures may be necessary, such as reorienting or relocating this instrument or shielding the location. Do not use GI Genius system and its cables closer than 30 cm (12 inches) to the equipment with the following symbol.

Electromagnetic fields

  • Warning; Do not use the System where there is a strong electromagnetic field (e.g. Magnetic Resonance, wireless devices, microwaves emitting devices, etc.).

Mechanical forces

  • Caution; While pressing buttons or touching the system, do not use hard or pointed objects or apply excessive force otherwise damage to the equipment will occur.

Connection and disconnections

  • Caution; Do not connect/disconnect any cable of the System while any component is powered on, otherwise damage to the equipment will occur.