(63 days)
The High Fluid-Resistant Surgical and Procedure Mask is 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 potential exposure to blood and body fluids. The face mask is a single use, disposable device, provided non-sterile.
The High Fluid-Resistant Surgical and Procedure Mask is composed of four-layers and is flat-pleated. The mask materials consist of an outer cover web (polypropylene spunbond, white), insertion layer (polypropylene, spunbond, white), filter web (polypropylene melt-blown, white) and inner cover web (polypropylene thermal-bonded, white). Each mask contains ear loops to secure the mask to the user's face and mouth, as well as a fully enclosed, soft, bendable nose piece to fit over the nose. This device is not made from natural rubber latex.
The provided document is a 510(k) premarket notification for a High Fluid-Resistant Surgical and Procedure Mask, which is a Class II medical device. The study described focuses on benchtop performance testing and biocompatibility testing rather than a clinical study involving human readers or AI. Therefore, most of the requested information regarding AI, human readers, and ground truth establishment in a clinical context is not applicable.
Here's the summary of the acceptance criteria and the study performance for the device itself, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a Type 3 mask, as per ASTM F2100. The acceptance criteria and performance data are primarily drawn from Table 2 and Table 3.
| Test Item | Acceptance Criteria (ASTM Level 3 Mask Standard) | Reported Device Performance (High Fluid-Resistant Surgical and Procedure Mask ASTM Level 3) | Result |
|---|---|---|---|
| Benchtop Performance Testing | |||
| ASTM F1862/ISO 22609 Fluid Resistance | AQL 4%, single sampling plan, 29 out of 32 Pass at 160mmHg | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at 160mmHg: Lot 1: 32/32 pass, Lot 2: 32/32 pass, Lot 3: 32/32 pass | Pass |
| ASTM F2299 Particulate Filtration Efficiency | ≥ 98% | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at ≥98%: Lot 1: 32/32 pass, Lot 2: 32/32 pass, Lot 3: 32/32 pass | Pass |
| Bacterial Filtration Efficiency (BFE) ASTM F2101 | ≥ 98% | Three non-sequential lots of 32 (total of 96, AQL 4.0) passed at ≥98%: Lot 1: 32/32 pass, Lot 2: 32/32 pass, Lot 3: 32/32 pass | Pass |
| Differential Pressure ASTM F2100/EN 14683:2019 |
§ 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.