(278 days)
The surgical face masks (Ear loops) 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 Surgical Face Mask are Non-sterile, single use, 3 layers, flat-pleated style with mask belt and nose clip. The outer layer and inner facing layer of face mask consist of spunbond polypropylene, and the middle layer consists of melt blown polypropylene filter. Each mask contains mask belt to secure the mask over the user's face and mouth with nose clip to firmly fit over the nose. This device is not made from any natural rubber latex.
The provided document (K210222) is a 510(k) premarket notification for a Disposable Medical Mask. This type of device is a Class II medical device, and the submission primarily focuses on demonstrating substantial equivalence to a predicate device (K160269) through performance testing against established standards for medical masks, rather than a clinical study involving human subjects or AI algorithm validation data.
Therefore, many of the requested points, such as "Sample sized used for the test set and the data provenance," "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," "training set establishment," etc., are not applicable to this specific submission. The "acceptance criteria" here refer to meeting the performance requirements for physical properties of the mask as per recognized standards (e.g., ASTM F2100-19), not diagnostic accuracy or clinical outcomes assessed by an algorithm.
Here's a breakdown based on the information available in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria and performance data are primarily derived from standard test methodologies for medical face masks.
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| Level ASTM F2100-19 | To define the performances of the medical face mask | Level 1 | Level 1 |
| Resistance to penetration by synthetic blood ASTM F1862 | To evaluate the resistance of medical face masks to penetration by the impact of a small volume of high-velocity stream of synthetic blood. Medical face mask pass/fail determinations are based on visual detection of synthetic blood penetration. | Minimum 80mmHg | Pass at 80mmHg |
| Particulate Filtration Efficiency ASTM F2299 | To measure the initial particle filtration efficiency of materials used in medical face mask using monodispersed polystyrene latex sphere aerosols. | ≥95% | Pass at 98.33% |
| BFE ASTM F2101 | To measure the bacterial filtration efficiency (BFE) of medical face mask materials, employing a ratio of the upstream bacterial challenge to downstream residual concentration to determine filtration efficiency of medical face mask materials. | ≥95% | Pass at 99.99% |
| Differential Pressure EN 14683:2019+AC:2019 AnnexC | To determine the breathability of medical face mask by measuring the differential air pressure with the airflow direction from the inside of the mask to the outside of the mask. |
§ 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.