(227 days)
The VarioGuide Drill Kit used in conjunction with BrainLab's VarioGuide is intended for creating an access point in the skull during intracranial procedures. The device is not intended for implant. This device is intended for "single patient use only."
The VarioGuide Drill Kit is a set of components that work in conjunction with the VarioGuide and each other to guide a drill bit along a desired trajectory to make an access hole in the skull. The components that comprise the VarioCuide Drill Kit are a Drill Guide, a 3.4mm Drill Bit, a Lancet, two Depth Stops and a Device Guide. The Drill Guide is made from Peek and has a 316L Stainless Steel tip which is pressed into the Drill Guide body. The Drill Guide Tip has two unique features. First, the tip has a double-chamfered edge which allows the unique into the bone and that also prevents the tip from bending over. The second feature is windows that allow drilled material to exit through the tip and thus prevents the drill bit from binding. The Drill Guide is used to constrain the prevents access bal access hole creation to a predetermined to assult the unit on unring. 316L Stainless Steel and is used to create an access hole through the skull. The Drill Bit tip is designed so that the amount of drill walk at the start of drilling is limited. This feature also helps Drill Bit to maintain its trajectory. The Lancet is made from 316L Stainless Steel and has a sharp point at the distal end to allow the Lancet to pierce the Dura and/or Pia. The Lancet has a reduced section (0.60)" long) which allows the Lancet to pass through the skull without any wall interference. The Depth Stops are made from 316L Stainless Steel and are used in conjunction with the Drill Bit and Lancet to set the desired depth. The Device Guide is made from Peek and is used to guide an instrument (such as a catherer) on a predetermined path. The Device Guide is available in two sizes, 0.075" for the small and 0.085" for the large.
This is a 510(k) summary for the MRII Varioguide Drill Kit, a medical device. It does not contain information about acceptance criteria or a study proving that the device meets those criteria, as an AI/ML device would. The document focuses on demonstrating substantial equivalence to a predicate device, which is typical for traditional (non-AI/ML) medical devices.
Therefore, I cannot provide the requested information. The provided text is for a mechanical drill kit, not an AI/ML device, and thus does not include the detailed performance study information typically found in submissions for AI/ML products.
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).