(211 days)
The Disposable Medical Surgical Mask is intended to be worn to protect and healthcare personnel from transfer of microorganisms, blood, body fluids and particulate material. This surgical mask is intended for use in infection control practices to reduce potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
The Disposable Medical Surgical Mask (rectangular) is single use, three-layer, flat-folded masks with ear loops and nose piece. The Surgical Mask is manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The mask is held in place by the elastic ear loops. The nose piece in the layers of surgical mask is to allow the user to fit the mask around their nose, which is made of malleable polyethylene wire. The mask is a single use, disposable device, provided non-sterile. This device is not made from Natural Rubber Latex.
The provided document is a 510(k) Premarket Notification for a Disposable Medical Surgical Mask, which is a Class II medical device. The document details the device's characteristics, intended use, and comparative analysis against a predicate device, focusing on non-clinical performance and biocompatibility testing. It is important to note that this document does not describe an AI/ML-driven medical device, and therefore, many of the requested criteria regarding AI model evaluation (e.g., training set, ground truth experts, MRMC studies) are not applicable.
However, I can extract the relevant information regarding the acceptance criteria and the study that proves the device meets those criteria, as detailed in the non-clinical performance testing section.
Here's the breakdown based on the provided text:
Device Type: Disposable Medical Surgical Mask (Not an AI/ML device)
1. A table of acceptance criteria and the reported device performance:
The device performance is evaluated against the ASTM F2100-19 standard for medical face masks, along with other relevant standards for specific tests.
| Performance testing Item | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|
| Fluid Resistance ASTM F1862 | ≥160 mmHg Pass: 29 out of 32 masks at 160 mmHg | 29 out of 32 pass at 160 mmHg | Pass |
| Particulate Filtration Efficiency ASTM F2299 | ≥ 98% | ≥ 98% | Pass |
| Bacterial Filtration Efficiency ASTM F2101 | ≥ 98% | ≥ 98% | Pass |
| Differential Pressure (Delta P) MIL-M-36954C |
§ 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.