(74 days)
The AIC Disposable Medical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The 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, provided nonsterile.
The AIC Disposable Medical Masks are Blue and white color, and Flat Pleated type mask, utilizing Tie-On or Ear Loops way for wearing, and they all has Nose Piece design for fitting the facemask around the nose.
The blue colorant is polypropylene (PP) master batch.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The model of proposed device, tie-on, is held in place over the users' mouth and nose by four ties welded to the facemask. The tie is made of spun-bond polypropylene.
The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex.
The nose piece contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire.
The proposed device(s) are sold non-sterile and are intended to be single use, disposable device
This document is a 510(k) Summary for a disposable medical mask, not an AI-powered medical device. Therefore, much of the requested information about acceptance criteria, ground truth, expert adjudication, MRMC studies, and training sets is not applicable to this type of submission.
However, I can extract the relevant non-clinical performance data and the acceptance criteria for those tests, as this is how the device's performance is proven to meet the required standards for a medical mask.
Here's the breakdown based on the provided document, addressing what is applicable:
Device: AIC Disposable Medical Mask
Device Type: Surgical Apparel (Class II Medical Device)
Purpose of the Study: To demonstrate substantial equivalence to a legally marketed predicate device (K153496) by showing that the AIC Disposable Medical Mask is as safe and effective as the predicate device. This is primarily done through non-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for medical masks are based on recognized standards (e.g., ASTM F2100). The document specifically details the performance against ASTM Level 3 requirements.
| Test Item | Test Standard/Method | Acceptance Criteria (Pass Criteria) | Reported Device Performance (Average) | Conclusion |
|---|---|---|---|---|
| Bacterial Filtration Efficiency | ASTM F2101-19 | ≥ 98% | 99.3% | Pass |
| Differential Pressure (Delta-P) | ASTM F2100-19 |
§ 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.