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The Medtronic Neurosurgery Clip Gun Raney-type clips provide hemostasis during cranial surgery by preventing arterial bleeding from small vessels of the skin and deeper vessels under the scalp.

The Clip Gun Kit contains Raney-type clips intended to provide hemostasis during cranial surgery by preventing arterial bleeding from vessels under the scalp. The Clips are a non-implantable transient use device.

The provided text describes a 510(k) submission for the Medtronic Clip Gun Kit. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the input document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

Instead, the submission states:

• Technological comparison: "Medtronic Neurosurgery submits that the materials of fabrication, intended use, performance characteristics and design specifications of the Clip Gun Kit are the same as the previously reviewed and cleared Clip Gun with Raney Type Scalp Clips (K896723)."
• Substantial Equivalence: "Based upon the summary above, Medtronic Neurosurgery determines substantial equivalence, safety, and efficacy of the Clip Gun Kit products based upon the predicate and currently marketed devices."

The FDA's letter confirms: "We have reviewed your Section 510(k) premarket notification of intent to market the device... and have determined the device is substantially equivalent... to legally marketed predicate devices."

In summary, there is no clinical study data with specific acceptance criteria or performance metrics provided in this 510(k) submission. The device was cleared based on its substantial equivalence in design, materials, intended use, and performance characteristics to a previously cleared predicate device.

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