(181 days)
The PMW01 Procedure Mask is 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.
PMW01 Procedure Mask Level 1
The provided text is a U.S. FDA 510(k) clearance letter for the PMW01 Procedure Mask Level 1. This document confirms the device's substantial equivalence to previously marketed devices. However, this type of document does not contain information about acceptance criteria for device performance, the results of studies proving these criteria are met, sample sizes, expert qualifications, or ground truth establishment.
Instead, the FDA 510(k) clearance process primarily evaluates whether a new device is "substantially equivalent" to a legally marketed predicate device. This often involves demonstrating that the new device has the same intended use and technological characteristics as the predicate, or if there are differences, that those differences do not raise new questions of safety or effectiveness. For medical masks, this typically involves testing against recognized industry standards such as ASTM F2100 to show performance levels (e.g., Level 1, 2, or 3).
Therefore, based solely on the provided text, I cannot answer the questions regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth. These details would typically be found in a separate submission document or a summary of safety and effectiveness, which are not part of the clearance letter itself.
§ 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.