(50 days)
The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile.
The proposed devices are 3-ply, flat-pleated surgical masks. The devices are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. There surgical masks to be secured on users via earloops made of spandex and nylon. The devices are sold non-sterile and are intended to be single use and disposable.
This document is a 510(k) summary for the DemeMASK Surgical Mask. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the performance of an AI-powered device. Therefore, many of the requested categories related to AI device studies (like expert adjudication, MRMC studies, training set details) are not applicable to this document.
However, I can extract the acceptance criteria and reported device performance for the physical properties of the surgical mask, along with details about the studies conducted to demonstrate these properties.
1. Table of Acceptance Criteria and the Reported Device Performance (Bench Testing for DemeMASK Surgical Mask)
| Test | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|
| Resistance to penetration by synthetic blood (ASTM F1862) | 29 out of 32 passed in 160 mm Hg | 32 out of 32 passed in 160 mm Hg | Pass |
| Sub-micron particulate filtration efficiency at 0.1 micron (ASTM F2299) | ≥98% | ≥99% | Pass |
| Bacterial filtration efficiency (ASTM F2101-19) | ≥98% | ≥99% | Pass |
| Differential pressure (MIL-M-36954) |
§ 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.