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The NiTi CAC (Compression Anastomosis Clip) is intended to be used to facilitate side-to-side anastomosis of the alimentary tract yielding an inverted serosa-to-serosa anastomosis. Once wound strength is sufficient to maintain the anastomosis, the NiTi CAC is passed from the body. The NiTi CAC is not applicable through Trocars in laparoscopic procedures.

The Compression Anastomosis Clip (CAC) device is a sterile single use device. The CAC provides a simple method for the creation of side-to-side compression anastomosis of the alimentary tract. The CAC device is comprised of two components:

• Clip double ring clip that is inserted into the two cut segments of the tissue to be anastomosed and performs the required compression on the tissue.
• Applier with which the Clip is introduced into the treated area.
  After a period of 7-10 days, a compression-induced necrosis of the tissue sides underneath the rings occurs and the whole device, together with the necrosed tissue that was compressed by the rings, detaches and is naturally expelled with the stool.

The provided text does not contain information about acceptance criteria for device performance, nor details of a study that proves the device meets such criteria. The document is a 510(k) summary for a Compression Anastomosis Clip (CAC), primarily focusing on:

• Applicant and Contact Information
• Trade Name and Classification
• Predicate Devices
• Intended Use
• Device Description
• Substantial Equivalence Claims
• FDA 510(k) Clearance Letter
• Indications for Use Statement

The "Substantial Equivalence" section mentions "validations and performance testing results, including animal studies," but it does not elaborate on what these results were, what acceptance criteria were used, or the specifics of the studies.

Therefore, I cannot provide the requested table and study details. The input document does not contain this information.

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