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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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The STORZ Raney Scalp Clip is a device designed to stop bleeding during surgery on the scalp.

Not Found

This is a 510(k) premarket notification for a medical device called "Scalp Clips." The provided document is a letter from the FDA to the manufacturer, Rudolf Storz GmbH, stating that their device has been found substantially equivalent to a legally marketed predicate device.

The document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This type of information is typically found in the 510(k) summary or a more detailed technical submission, which is not included in the provided pages.

Therefore, I cannot answer the request with the provided input.

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Aesculap's Scalpfix clip system is indicated for use in temporary hemostasis of the scalp edge.

Aesculap's scalp clip gun (FF012R) is a hand held manual instrument. It is used in conjunction with Aesculap's scalp clip (FF013P) to insert sterile plastic scalp clips at the margin of scalp wounds during operations on the cranium. The gun consists of a handle, trigger, magazine lock, and a maqazine suspension pin.

The scalp clips are used for temporary hemostasis of the opened scalp. It has proven useful to use plastic clips to ligate the scalp during trepanation or large exposures of relatively long duration, thereby avoiding bleeding at the wound margin. Aescular scalp clips are intended for single use only. They may not be resterilized. The scalp clips are packaged as 10 scalp clips per magazine in a box of 20 magazines.

This K017219 premarket notification for the Scalpfix Clip System does not include specific acceptance criteria or a study that proves the device meets such criteria.

The document states:

• "No performance standards have been promulgated under Section 514 of the Food. Drug and Cosmetic Act for these devices."
• "The new Scalptix conforms to applicable ASTM and ISO standards." However, it does not specify which ASTM and ISO standards, nor does it provide data demonstrating compliance with them.

Therefore, the requested information elements cannot be extracted from the provided text for this specific device. The submission relies on substantial equivalence to predicate devices rather than independent performance studies with defined acceptance criteria.

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