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The EndoDrill® Model X is intended to be used with an ultrasound endoscope for ultrasonically guided fine needle sampling of submucosal- and extramural lesions within gastrointestinal tract (i.e. esophagus, mediastinal masses, stomach, pancreas, liver, small- and large intestines, lymph nodes and perirectal masses). This device is for diagnostic purposes only.

The EndoDrill® Model X biopsy instrument consists of a single-use handle with a flexible sheath and a cylinder tip that can be rotated to collect tissue samples. An outer sheath covers the tip to facilitate smooth insertion, positioning of the instrument and extraction. The hollow cylinder allows for multiple samples being taken continuously without removing the instrument for harvesting between biopsies. Rotation is facilitated by an isolated reusable electrical motor controlled by the user. No current, heat, smoke or sparks are introduced into the patient. The device is designed to be used in flexible endoscopic instruments with ultrasound (EUS) used for examinations of the gastrointestinal tract. The single-use biopsy instrument consists of a needle and handle that are supplied sterile and is for single patient use only. The needle contains all patient contact pathways and is fully disposable. Cleaning, reprocessing and/or re- sterilization of the instrument is prohibited. The needle is inserted through the working channel of a flexible endoscope and fixed at the endoscope handle. The single-use and handle consists of the following pre-assembled, sterile components: 1. A biopsy needle consisting of stainless-steel with a coring cylinder tip collecting samples in a fluid- and airtight tubing when rotated. 2. An outer sheath that surrounds the rotating needle and may be used to place the inner needle at the biopsy site. 3. A handle that is mounted to the working channel of an endoscope, used to control sampling and attaches to a reusable drive cable that mechanically transfers rotation. The reusable electrical motor and drive cable facilitating the rotation of the tip are supplied non-sterile and reusable. The motor unit contains an on/off safety switch and rotation is activated with a pedal attached to the motor. The drive cable that mechanically transmits rotation to the needle is mounted on the handle prior to sampling. The motor unit accommodates a DC motor which includes a power indicator light and attachments for power cable, drive cable and pedal. The motor is isolated and provides mechanical rotation to the single-use handle via the drive cable. No current, heat, smoke or sparks are introduced into the patient.