(108 days)
The Medical Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These surgical 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, provided non-sterile.
The Medical Surgical Masks are single use, flat-pleated masks that are provided in blue. The Medical Surgical Masks are available in two types, which are Level 3 based on ASTM F2100-19. The outer and inner layers of the mask are made of spunbond polypropylene. The middle filter layer of Level 2 mask is made of one layer of meltblown polypropylene filter, and the middle filter layer of Level 3 mask is made of two layers of meltblown polypropylene filter. The nose clip is made of polyethylene (PE) and iron. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off.
The Level 2 masks are ear-loop masks. The Level 3 masks are available in two types, ear-loop and Tie-on. The ear loops for Level 2 and Level 3 masks are made of spandex. The ties are made of spunbond polypropylene. The ear loops/ties are held in place over the users' mouth and nose by two ear loops/ties welded to the mask.
The provided document (K210030 510(k) Summary for the Medical Surgical Mask) describes the performance and testing of a medical surgical mask, not an AI/ML powered device. Therefore, many of the questions related to AI/ML specific studies (e.g., sample size for training set, MRMC study, ground truth establishment for training, number of experts for test set ground truth) are not applicable to this submission.
However, I can extract the acceptance criteria and performance data for the medical device described.
Summary of Device Performance and Testing (Medical Surgical Mask)
The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing against recognized standards. No clinical studies were included.
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against the requirements for ASTM F2100-19, which defines performance levels for medical face masks. The proposed device includes both Level 2 and Level 3 masks.
| Performance Metric | Acceptance Criteria (ASTM F2100-19) - Level 2 | Reported Device Performance - Level 2 Mask | Acceptance Criteria (ASTM F2100-19) - Level 3 | Reported Device Performance - Level 3 Mask |
|---|---|---|---|---|
| Bacterial Filtration Efficiency (BFE) | ≥98% | Average 99.7% | ≥98% | Average 99.9% |
| Particulate Filtration Efficiency (PFE) | ≥98% @ 0.1 micron | Average 99.71% | ≥98% @ 0.1 micron | Average 99.93% |
| Differential Pressure (Delta P) |
§ 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.