(675 days)
The CAREWE Surgical Face Masks Models N001-AW, N002-AW, and N003-AW are intended to be worn to protect both the adult patient and healthcare personnel from transfer of microorganisms, body fluids and material. These face masks are intended for use in infection control practices to reduce the posure to blood and body fluids. The masks are single-use and disposable.
The CAREWE Surgical Face Masks Models N001-AW, and N003-AW are flat-folded, single-use, disposable face masks which cover the user's nose and mouth. The mask is held in place by two elastic nylon ear loops ultrasonically bound to the mask, which attach to the user's ears. The mask is white. The CAREWE Surgical Face Mask consists of 4 ultrasonically bound layers: 1) an outer layer made of hydrophobic non-woven polypropylene; 2) a middle-layer made of polyester fiber; 3) a medium composed of melt-blown polypropylene; and 4) an inner-layer made of hydrophilic non-woven polypropylene. The mask also features a polyurethane (PU) nose pad which is attached to the mask's interior (on the hydrophilic layer). The mask meets ASTM F2100 Level 2 standards. The design, configuration, materials, and production process are all the same for all three proposed models N001-AW, N003-AW, N003-AW. They are all manufactured with the same technical specifications. The models are labeled differently strictly for marketing, sales and logistic reasons only.
The information provided pertains to the FDA 510(k) clearance for CAREWE Surgical Face Masks. This document describes non-clinical performance tests for the device, not a study evaluating an AI algorithm. Therefore, many of the requested categories regarding AI-specific studies, such as sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC studies, are not applicable.
Here's a breakdown of the available information regarding acceptance criteria and device performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Description | Purpose | Acceptance Criteria (Level 2) | Results |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | Demonstrate adequate resistance to fluid penetration | 29 out of 32 Pass at 120 mmHg | Pass |
| Particulate Filtration Efficiency (PFE) (ASTM F2100) | Demonstrate adequate particulate barrier properties | ≥ 98% | Pass |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | Demonstrate adequate bacterial barrier properties | ≥ 98% | Pass |
| Differential Pressure (Delta P) (ASTM F2100) | Demonstrate adequate air penetration properties |
§ 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.