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The AEON™ Retrieval Bag is a sterile single use device that can be used for the encapture and removal of an organ, tissue, or fluid from the body cavity during laparoscopic surgery.

The AEON™ Retrieval Bag, is a sterile, disposable, single-use, individually-packaged polymeric sack with laparoscopic introducer system that is designed to facilitate the removal of tissues or organs in the process of laparoscopic surgery.

The system consists of a sack connected to a laparoscopic introducer system. The introducer system comprises an elongated rod for laparoscopic insertion, flexible arms to allow deployment of the sack in the surgical cavity, and a drawstring to facilitate sack closure and extraction.

The provided text describes the AEON Retrieval Bag, a medical device for laparoscopic surgery, and its 510(k) submission to the FDA. However, the document does not contain information about the acceptance criteria and the study that proves the device meets specific performance criteria.

Instead, it states:

• "Nonclinical tests were conducted with the AEON™ Retrieval Bag to verify that the proposed device is safe and effective, performs as intended, and meets all design specifications. Devices are tested for bag material/seal strength, bag material/seal leak integrity, and bag resistance to breakage in simulated removal testing. Real time shelf life testing was also performed."
• "This submission does not include data from Clinical Studies."

Therefore, I cannot provide the requested table, sample sizes, expert details, or other study-specific information because it is not present in the given text. The document focuses on regulatory approval based on substantial equivalence to a predicate device and non-clinical testing without detailing specific acceptance criteria or study results for those tests.

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