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The American Medical Manufacturing, Inc. Sharps Collection Container is to be used for collection and disposal of medical sharps in hospitals and doctors' offices.

The American Medical Manufacturing, Inc. Sharps Collection Container is an accessory to a single lumen hypodermic needle. The proposed device functions in the same manner as predicate devices in that they provide safe collection of sharps such as svringes, needles, and blades.

Device Design/Materials Used/Physical Properties: The proposed device is comprised of polypropylene plastic.

The provided text is a 510(k) summary for a Sharps Collection Container. It describes the device, its intended use, and a technological comparison to predicate devices. However, the document does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, or ground truth establishment.

Therefore, I cannot provide the requested table and detailed information as it is not present in the given text.

The document focuses on establishing substantial equivalence to legally marketed predicate devices based on design, materials, and intended function, rather than presenting a performance study with acceptance criteria.

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Magni-Guard functions in the same manner as predicate devices in that it provides protection to the surgical staff during surgical procedures.

Magni-Guard includes the same components as other marketed predicate devices. The concept of use is to hold it with one hand over a surgical site before releasing clamps from blood vessel grafts or during heavy irrigation to prevent blood splashing. The basic scientific concept that forms the Magni-Guard is that it consists of a clear, rigid, see through plastic. The Guard is made from styrene or PETG. The clear guard has raised side walls throughout its circumference (identical to a Petri-Dish) to prevent the splashing of blood across the surgical suite. It further has an extended handle attached to the circular guard for the surgical site as required intermittently during the surgical procedure.

The provided text describes a medical device, the AMMI MAGNI-GUARD™ Splash Prevention Device, and compares it to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device. This usually involves comparing design, materials, intended use, and performance characteristics (as shown in the provided table). It's a pre-market notification process, not a clinical trial report.

Therefore, I cannot fulfill your request for the specific details about acceptance criteria and the study proving the device meets them because this information is not present in the provided text.

Based on the information given, I can only extract these general points:

• Device Type: Splash Prevention Device
• Intended Use: To provide protection to surgical staff during surgical procedures by preventing the splashing of blood across the surgical suite.
• Mechanism: A clear, rigid, see-through plastic guard with raised side walls and an extended handle.

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