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The INUMI™ Flex Needle is intended for use as part of the Aliya™ System for surgical ablation of soft tissue.

The INUMI™ Flex Needle (subject device) is an endoscopically compatible soft tissue ablation device that is used as part of the 510(k)-cleared Aliya™ System (K212871). The subject device has a 160 cm working length, and is compatible with endoscope working channels with a minimum of 2.0 mm diameter.

The Aliya System is indicated for the surgical ablation of soft tissue.

The Aliva System is designed to ablate soft tissue through the delivery of pulsed electric fields (PEF) energy to target tissue. The high frequency, short duration energy delivered to the target tissue to induce programmed cell death (apoptosis) while maintaining the cellular matrix. The Aliya System consists of an Aliya Generator, an Aliya Ablation Device and a cardiac monitor. Generator: The Aliya Generator is a transportable non-sterile electrical device compatible for use in the operating room environment. It consists of hardware, software, a display touch screen user interface, a power supply cord and a foot switch. It features controls to initiate and stop treatment as well as indicators to monitor the treatment and provide alerts to the user. The Aliya Generator creates high frequency short duration energy, which is delivered to the target tissue via the Aliya Ablation Device. The Generator interfaces with the commercially available Ivy Biomedical Model 7600 cardiac monitor (Cardiac Monitor), which is provided with the Aliya System and is used in accordance with its cleared indications. The Cardiac Monitor uses a 4-lead configuration, which detects the R-wave of the electrocardiogram (ECG) signal and sends a trigger signal to the Generator for precise synchronization of energy output to the patient. This ensures reliable energy delivery synchronization with the patient's cardiac cycle thereby reducing risk of cardiac rhythm disturbances. The Generator software includes an algorithm that interprets trigger signals from the Cardiac Monitor. The algorithm will only allow the initiation and delivery of energy output when the patient's heart rate is within acceptable limits. Aliya Ablation Device: The Aliya Ablation Device is a monopolar electrosurgical instrument comprising the Aliya Needle and the Aliya Electrode. Both the needle and electrode are designed for sterile, single use. The Aliya Needle consists of a 19 gauge, 20cm needle with a 1 cm exposed tip and a nested stylet (which is removed once the Aliya Electrode is in position). The Aliya Electrode consists of a 21 cm probe that connects with the needle, a 3-meter cable, and a plug that connects with the Aliya Generator. When connected to the Aliya Generator, the Aliya Ablation Device delivers PEF energy to the target zone at the distal 1 cm of the needle.