(169 days)
When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. This device is non sterile and for single use only.
The surgical face masks are single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consist of Spun-bond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the user's face and mouth with nose piece to firmly fit over the nose.
This document pertains to the 510(k) premarket notification for a Disposable Surgical Mask (K203756). The study described focuses on the device's functional performance and biocompatibility rather than human-in-the-loop performance with an AI. Therefore, the questions related to AI assistance, human reader improvement, multi-reader multi-case studies, and ground truth establishment from expert consensus for AI training are not applicable to the context of this traditional medical device submission.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The core of the device's performance evaluation is found in the "Summary of Non-clinical Testing" section, specifically in the table on page 8.
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | To evaluate the resistance of medical face masks to penetration by the impact of a small volume (~2 mL) of high-velocity stream of synthetic blood. Pass/fail determinations are based on visual detection of synthetic blood penetration. | 29 Out of 32 pass at 160 mmHg | Lot 1: 32 Out of 32 pass at 160 mmHg |
| Lot 2: 32 Out of 32 pass at 160 mmHg | |||
| Lot 3: 32 Out of 32 pass at 160 mmHg | |||
| Result: Pass | |||
| Particulate Filtration Efficiency (ASTM F2299) | To measure the initial particulate filtration efficiency of materials using monodispersed aerosols containing suspended latex spheres particulates of 0.1μm diameter. | ≥ 98% | Lot 1: 99.8% |
| Lot 2: 99.9% | |||
| Lot 3: 99.9% | |||
| Result: Pass | |||
| Bacterial Filtration Efficiency (ASTM F2101) | To determine the bacterial filtration efficiency of the mask. | ≥ 98% | Lot 1: > 99.9% |
| Lot 2: > 99.9% | |||
| Lot 3: > 99.9% | |||
| Result: Pass | |||
| Differential Pressure (EN 14683:2019) | To measure the differential pressure between the inside and 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.