(162 days)
The Banyan USA Surgical Mask Level 3 is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganism, body fluids, and particulate materials. This face mask are intended for use in infection control practices to reduce potential exposure to blood and body fluids. the face mask is single use, disposable device, provided non-sterile.
The Banyan USA Surgical Mask is composed of three-layers which are flat-pleated and ultrasonically welded together at the edges of the mask at embossment points. The mask materials consist of an outer layer (polypropylene spunbond, white), filter layer (polypropylene melt-blown, white) and inner layer web (polypropylene thermal-bonded, white (22 GSM Thermal Bond White Material)). Each mask has two ear loops ultrasonically welded onto the sides to secure the users' nose and mouth. The construction also includes a polyethylene wire nosepiece to provide a firm fit over the nose. The mask is a single use, disposable device, provided non-sterile.
The provided document is a 510(k) summary for the Banyan USA Surgical Mask Level 3. It details non-clinical laboratory testing performed to demonstrate substantial equivalence to a predicate device, rather than a study with human subjects (clinical study) for an AI/CADe device. Therefore, many of the requested criteria regarding AI device studies are not applicable.
Here's the information that can be extracted and a clear indication of which points are not applicable:
1. A table of acceptance criteria and the reported device performance
| Test | Purpose | Acceptance Criteria (ASTM F2100-11 Level 3) | Reported Device Performance (Banyan USA Surgical Mask Level 3) | Result |
|---|---|---|---|---|
| Fluid Resistance (ASTM F1862) | Determine synthetic blood penetration resistance | 160 mmHg | Pass at 160 mmHg | Pass |
| Particulate Filtration Efficiency (ASTM F2299) | Determine bacterial filtration efficiency | ≥ 98% | 98.69% | Pass |
| Bacterial Filtration Efficiency (ASTM F2101) | Determine submicron particulate filtration efficiency | ≥ 98% | 99.22% | Pass |
| Differential Pressure (Delta P) (EN 14683:2019) | Determine breathing resistance or differential pressure |
§ 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.