(15 days)
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.
§ 882.4150 Scalp clip.
(a)
Identification. A scalp clip is a plastic or metal clip used to stop bleeding during surgery on the scalp.(b)
Classification. Class II (performance standards).