(137 days)
BAYLAB 3-Ply Surgical Masks (BEACON I) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided nonsterile.
BAYLAB 3-Ply Surgical Masks (BEACON I) are nonwoven, pleated, 3-ply, single use, disposable flat surgical masks, manufactured in Bay Blue color. The surgical masks are to be secured on users by means of elastic ear loops.
This is a 510(k) premarket notification for a surgical mask (BAYLAB 3-Ply Surgical Mask (BEACON I)). The document describes the acceptance criteria and performance of the device based on non-clinical testing.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Parameter | Acceptance Criteria (Level 3) | Reported Device Performance |
|---|---|---|
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | ≥98% | Pass at >98% |
| Differential Pressure (ΔP) (EN 14683) | 99% | |
| Resistance to penetration by Synthetic Blood (ASTM F1862) | 160mm Hg | Pass at 160mm Hg |
| Flammability (16 CFR Part 1610) | Class 1 | Class 1 |
| Cytotoxicity (ISO 10993-5) | Non-cytotoxic | Pass - non-cytotoxic |
| Irritation (ISO 10993-10) | Non-irritating | Pass - non-irritating |
| Sensitization (ISO 10993-10) | Non-sensitizing | Pass - non-sensitizing |
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 specify the exact sample sizes used for each test. For the performance tests (BFE, ΔP, PFE, Synthetic Blood Penetration, Flammability) and biocompatibility tests (Cytotoxicity, Irritation, Sensitization), it states that tests were conducted according to the respective ASTM, EN, and ISO standards. These standards typically define minimum sample sizes for testing, but the specific number tested for this device is not reported in this summary. The data provenance (country of origin, retrospective/prospective) is also not explicitly stated, but these are standard laboratory tests.
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 not applicable to the evaluation of a surgical mask. The acceptance criteria are based on objective, standardized physical and biological tests, not on expert interpretation or subjective ground truth from medical professionals.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable as the evaluation involves objective laboratory tests with clearly defined pass/fail criteria, so there is no subjective adjudication required.
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
This is not applicable. Surgical masks are not diagnostic devices that involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical product (surgical mask) and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device is established by objective, standardized laboratory test methods defined in the referenced national and international standards (ASTM F2101, EN 14683, ASTM F2299, ASTM F1862, 16 CFR Part 1610, ISO 10993-5, ISO 10993-10). These standards contain specific protocols and acceptance criteria for measuring filtration efficiency, breathability, fluid resistance, flammability, and biological safety.
8. The sample size for the training set
This is not applicable. The device is a manufactured item, not an AI/machine learning model, so there is no training set in this context.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set.
§ 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.