(230 days)
Y ADU Surgical Masks (Model E (ear loops, sterile), Model T (tie on straps, sterile/non-sterile/) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. It is intended to be used in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided sterile and non sterile.
The YADU Surgical Masks are single use, three-layer, flat-pleated style with ear loops and nose piece. They have three layers structure: inner layer, and outer layer. The inner and outer layers are made of spun-bond polypropylene (SPP), and the middle layer is made of melt blown polypropylene filter. Y ADU Surgical Masks have two variants: The model with ear loop and the model with tie-on bands. The mask is held in place over the users' mouth and nose by two elastic ear loops or tie-on bands welded to the side of the mask. The ear loops are made from spandex and polyester elastic, while tie-on bands are made from SPP straps. Neither elastic ear loops nor tie-on bands are made with natural rubber latex. Y ADU Surgical Masks also have nose piece that allows the user to fit the mask around his/her nose. The nose piece is made of polyvinyl chloride coated iron wire. The Surgical Masks provide Level-1 protection per ASTM F2100 definition. They have blue color and are sold in both sterile and non-sterile versions and are intended to be single use, disposable devices.
This document is a 510(k) Pre-Market Notification for YADU Surgical Masks, demonstrating its substantial equivalence to a legally marketed predicate device. The information provided focuses on the technical performance of the surgical masks rather than an AI/ML powered device. Therefore, a direct mapping to the requested information about an AI/ML device is not fully applicable. However, I will extract relevant information from the provided text that corresponds to the structure of your request, interpreting "device" as the surgical mask in this context.
Here's an analysis of the provided text based on your request:
1. A table of acceptance criteria and the reported device performance
| Test Name | Acceptance Criteria | Reported Performance (YADU Surgical Masks) |
|---|---|---|
| ASTM F2101-19 Bacterial Filtration Efficiency (BFE) (Sterile) | ≥ 95% | Lot 1: 95.1-97.4%, Lot 2: 95.1-98.4%, Lot 3: 95.1-98.4% |
| ASTM F2299-03 Penetration by Particulates (Sterile) | ≥ 95% | Lot 1: 95.1-97.9%, Lot 2: 95.1-99.6%, Lot 3: 95.1-97.4% |
| EN 14683-2019 Differential Pressure (Sterile) |
§ 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.