(242 days)
The Aurelia Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Aurelia Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, provided nonsterile.
The proposed device, Aurelia Surgical Masks are three-layer masks constructed of nonwoven polypropylene. The inner and outer layers are made of spun-bonded polypropylene. The middle layer consists of 25gsm melt-blown polypyrene. The mask contains an ear loop to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. Ear loops are made of polyurethane and nylon. The nose clip which is made of 3mm aluminum flat wire. The disposable surgical face mask is available in two different specifications: ASTM Level 1 and ASTM Level 2. The masks meet the following ASTM 1 and ASTM 2 Technical standards.
The provided document is an FDA 510(k) premarket notification for surgical masks (Aurelia Surgical Mask ASTM Level 1 and Level 2). It focuses on demonstrating substantial equivalence to predicate devices based on performance testing against established ASTM standards for surgical masks.
Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/Software as a Medical Device (SaMD) is not directly applicable to this document. The document describes a physical medical device (surgical masks) and its performance validation, not an AI or software product.
However, I can extract and present the performance criteria and the reported performance for the surgical masks as per the ASTM standards mentioned, which function as acceptance criteria for these physical devices.
1. A table of acceptance criteria and the reported device performance
The document provides the following "Acceptance Criteria per ASTM F2100-19" and "Results" for the Aurelia Surgical Masks:
Table: Acceptance Criteria and Reported Device Performance
| Test | Purpose | Acceptance Criteria per ASTM F2100-19 | Reported Device Performance (Results) |
|---|---|---|---|
| For Level 1 Mask | |||
| Fluid Resistance (ASTM F1862) | This test is performed to evaluate Personal Protective Equipment against fluid penetration. An arterial spray is simulated to test the PPE. | Level 1: 80mmHg | Aurelia Mask Level 1: 80mmHg |
| Differential Pressure (Delta-P) (ASTM F2100-19 EN 14683:2019) | The purpose of this test is to ensure the drop in pressure is not too great so the user may breathe through the subject device. | Level 1: |
§ 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.