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The intended use of the Surgical Dynamics Working Channel Scope for Automated Laparoscopic Discectomy is to decompress a herniated lumbar disc using direct visualization during a laparoscopic procedure.

The Surgical Dynamics 30K Working Channel Scope and Instrument Kit for Laparoscopic Discectomy are comprised of the following components:

30K Working Channel Scope Nucleotome 2.5 mm Laparoscopic Probe Nucleotome 3.5 mm Laparoscopic Probe Nucleotome 4.7 mm Laparoscopic Probe IA Cannula Grasping Forceps with Teeth for Laparoscopic Discectomy

The Nucleotome probes are used in conjunction with the Nucleotome console.

This FDA premarket notification (510(k)) K960046 describes a device that is substantially equivalent to a predicate device. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. Such studies are typically required for novel devices or significant modifications to existing devices where performance claims need to be substantiated.

For this 510(k), the submission focuses on establishing substantial equivalence based on design, materials, energy source, and intended use being identical or very similar to predicate devices. The only difference noted for the probes is an increase in length.

Therefore, I cannot provide the requested information from the provided text as it is not present in the document.

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