(112 days)
The Expanded Chamber Surgical 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 the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber that are the subject of this submission are provided with a visor (39124). These masks are single use, disposable devices, provided non-sterile.
The subject devices, the HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123) and HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124), are the same devices as cleared under K143287.
The subject devices are ASTM F2100 Level 2 (blue and white in color) Surgical Masks. The HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123) and HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124) are a four- layer mask, constructed of well-known non-woven materials used in facial protection. A malleable nosepiece is placed within the bindings for comfort and individualized fit around the wearer's nose. When compared to a pleated/flat mask, the subject devices have a "duckbill" shape, which expands the volume of the chamber created when the mask is worn.
The provided text is a 510(k) Summary for a medical device (surgical masks). This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical performance testing. It does not typically contain information about AI/ML models, human reader studies, or detailed ground truth methodologies used in the context of advanced diagnostic or imaging AI.
Therefore, many of the requested points related to AI/ML device studies are not applicable to this document.
Here's the information that can be extracted and what is not applicable:
1. Table of acceptance criteria and the reported device performance:
| Purpose | Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Face Mask Performance | ASTM F2100 | ASTM Level 2 | Pass |
| Bacterial Filtration Efficiency | ASTM F2101 | ≥98% | Pass |
| Particulate Filtration Efficiency | ASTM F2299 | ≥98% | Pass |
| Differential Pressure | EN 14683 |
§ 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.