(205 days)
The Medical Surgical Mask is intended to be worn to protect 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 Medical Surgical Mask is a single use, three-layer, flat-pleated style surgical mask with ear loops and nose piece. The mask is 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 surgical masks is held over the user's mouth and nose via earloops made of nylon with spandex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The medical surgical mask includes blue colorant, Shining Blue R603. The medical surgical mask is sold non-sterile and is intended to be single use, and disposable.
This is a medical device submission for a "Medical Surgical Mask" (K210813). The document describes non-clinical performance testing against established standards and a predicate device.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (Predicate Device) | Reported Device Performance (Subject Device) | Result |
|---|---|---|---|
| Synthetic Blood Penetration Resistance | No penetration at 160 mmHg | No penetration at 160 mmHg | Pass |
| Particulate Filtration Efficiency (0.1 µm) | >98 % | >98 % | Pass |
| Bacterial Filtration Efficiency | >98 % | >98 % | Pass |
| Differential Pressure (Delta P) | ≤ 6.0 mmH2O/cm² | ≤ 6.0 mmH2O/cm² | Pass |
| Flammability | Class 1 | Class 1 | Pass |
| Cytotoxicity (ISO 10993-5) | Non-cytotoxic | Non-cytotoxic | Pass |
| Irritation (ISO 10993-10) | Non-irritating | Non-irritating | Pass |
| Sensitization (ISO 10993-10) | Non-sensitizing | Non-sensitizing | Pass |
The acceptance criteria for the subject device are explicitly stated as meeting or exceeding the performance of the predicate device (DemeMASK Surgical Mask, K201479) and conforming to relevant standards (ASTM F1862, ASTM F2299, ASTM F2101, EN 14683:2019+AC:2019, 16 CFR 1610, ISO 10993-5, ISO 10993-10).
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for each performance test. The data provenance is not specified, but the manufacturing company (Sichuan Pharmaceutical, Inc.) is based in China. The testing was conducted as part of a premarket notification for the FDA, making it a prospective study relative to the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This is a physical device (surgical mask), not an AI/software device. Therefore, the concept of "experts establishing ground truth" in the context of image interpretation or diagnosis is not applicable. The performance is measured objectively against established physical and biological standards using laboratory testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable for physical device performance testing. The results are obtained through standardized laboratory procedures, not expert adjudication of subjective assessments.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical medical device (surgical mask), not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this physical device, the "ground truth" is defined by the established performance standards (e.g., ASTM F1862 for synthetic blood penetration, ASTM F2299 for particulate filtration efficiency, ISO 10993 for biocompatibility). The device's performance is measured against these objective, quantitative criteria.
8. The sample size for the training set
Not applicable. This is a physical device, and there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned or implied for this physical device.
§ 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.