The Neocis Guidance System (NGS) (“Yomi”) is cleared for use by the FDA for use in the United States.
Indications for Use:
Yomi is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. Yomi is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.
Indications: Partially edentulous and fully edentulous adult patients who qualify for dental implants.
Contraindications: The Neocis Guidance System is not intended for use with patients that have insufficient bone or teeth to retain a Splint rigidly throughout a surgical procedure.
Caution: Carefully read all instructions prior to use, including other related documents such as the CT Scan Protocol and Application Software Manual. Observe all warnings and precautions noted throughout these instructions. Failure to do so may result in complications.
- Neocis Inc has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness of the Neocis Guidance System in applications other than the preparation of sites for placing dental implants.
- Sufficient bone or teeth are necessary for gripping the Splint rigidly in the patient mouth. Any slipping of the Splint or movement relative to the rest of the mouth may lead to inaccurate preparation of the implant site.
- The Neocis Guidance System is intended only to be used following installation qualification by a trained Neocis Inc. professional. The device is not to be used in an unqualified manner.
- All users must be properly trained, following approved Neocis Inc. training materials prior to use.
- All assembly, adjustment, modification or repairs associated with the Neocis guidance system shall only be performed by a trained Neocis Inc. representative.
- Do not touch the patient and non-medical electrical equipment simultaneously when operating the device.
The NGS is not intended for use in an MR environment, and has not been evaluated for use with RF emitting devices such as diathermy, RFID and electromagnetic security systems (metal detectors and EAS systems).
- The Neocis Guidance System should only be used by dentists trained in the placement of dental implants at facilities properly equipped for such procedures.
- Prior to using the Neocis Guidance System to guide drilling, check the integrity of the system by using anatomical landmarks for verification. Touch the drill tip to a distinct anatomical landmark and verify that the visualization on the screen matches.
- The device is intended to be used with a single phase 120VAC 60 Hz Mains power source. Do not attempt to use the device with any other power source.
- Device is not designed to protect against ingress of solid foreign objects, or liquids (IPN0N0).
- Device is only designed to be used on a hard, flat, stable surface.
- When transporting and stowing the system, take care to avoid putting excessive forces on the Guidance Arm and Patient Tracker subsystems.
- Ensure that the device is positioned in such a manner that the Device Power cord is accessible during normal operation.
The following adverse events are possible:
- Inaccurate implant site preparation, resulting in damage to patient anatomy.
- Delays in surgical procedure.
- Injury to user or patient due to unintended motion of the system.
- Electric shock to user or patient due to electric malfunction.
- Misuse or off label use of the system that leads to manual manipulation of the osteotomy, damage to patient anatomy, or hazard to the user.
Neocis Inc risk analysis documents reflect a complete description of potential adverse events. Although the system has been designed to mitigate all known or potential risks, there is the possibility that unknown risks exist.