(101 days)
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.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.