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510(k) Data Aggregation
(75 days)
Resitu Slider 09 is intended to provide breast tissue for diagnostic analysis of imaged abnormalities.
Resitu Slider 09 (RESL09) is a minimally invasive, vacuum assisted device, intended to provide large intact breast tissue samples for histologic examination of imaged abnormalities. The device is provided sterile and is for single-use. Resitu Slider 09 is hand-held (vacuum is created in the handle) and is part of a monopolar high frequency electrosurgical system.
The intended sample site is reached via a skin incision followed by blunt penetration under ultrasound guidance. The sample capture relies on a combination of vacuum that fixates the sample and cutting with a circular knife. While cutting around the sample area, the vacuum allows the whole tissue sample to enter into the tube of the device. An electrosurgical electrode, designed to mimic a mechanical cutting blade, severs the top base of the breast tissue sample from surrounding area. The device is withdrawn with the intact breast tissue sample inside the tube.
The device functions as an active accessory by passing energy that is controlled by the electrosurgical generator to the tissue, similar to other electrosurgical tools.
The Resitu Slider 09 electrosurgical system consists of the following:
- Active Accessory (Monopolar)
- Electrosurgical Unit
- Active Accessory Cord
- Neutral Electrode
- Neutral Electrode Connection Cord
- Foot Switch (Pedal)
The device consists of a plastic handle, to which a transparent tube with a circular stainless steel knife at the end is attached. Inside the tube is a rod that creates a blunt end when in its outer position. The rod can be pulled back to expose the circular knife and create a vacuum, which will assist in excising the tissue, inside the tube.
In the center of the tube is an electrode, a diathermic knife, which can be pushed forward, backwards, and also turn 360 degrees, thereby enabling a radial cutting from the center.
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