(141 days)
The Single-use Surgical Masks (Model:FE2311) are intended to be worn to protect both the patient and healtheare personnel from transfer of microorganisms, body fluids and particulate material. These face 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 proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all has Nose Piece design for fitting the facemask around the nose.
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, 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 metal core plastic. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The document is a 510(k) summary for the BYD Single-use Surgical Mask, মডেল FE2311. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.
Here's the breakdown of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance:
The acceptance criteria are established by various standards and the FDA guidance for surgical masks. The reported performance of the subject device (BYD Single-use Surgical Mask) is compared to criteria from these standards and the predicate device.
| Test / Performance Characteristic | Acceptance Criteria / Predicate Performance (K153496) | Reported Subject Device Performance (BYD FE2311) | Meets Acceptance Criteria? |
|---|---|---|---|
| ASTM F2100 Level | Level 2 | Level 3 | Yes (exceeds) |
| Fluid Resistance | 32 out of 32 pass at 120 mmHg (ASTM F1862) | 32 out of 32 pass at 160 mmHg (ASTM F1862) | Yes (exceeds) |
| Particulate Filtration Efficiency | 98.46% (ASTM F2299) | Pass at 99.67% (ASTM F2299) | Yes (exceeds) |
| Bacterial Filtration Efficiency | 98.7% (ASTM F2101) | Pass at 99.95% (ASTM F2100) | Yes (exceeds) |
| Differential Pressure | 4.2 mmH20/cm² (MIL-M-36954C) | 5.62 mmH20/cm² (ASTM F2100) | Yes (within acceptable range for Level 3) |
| Flammability | Class 1 (16 CFR 1610) | Class 1 (16 CFR 1610) | Yes |
| Cytotoxicity | Comply with ISO 10993-5 (not cytotoxicity effect) | Not cytotoxicity effect | Yes |
| Irritation | Comply with ISO 10993-10 (not an irritant) | Not an irritant | Yes |
| Sensitization | (Predicate not specified, but implied compliance) | Not a sensitizer | Yes |
2. Sample size used for the test set and the data provenance:
- Fluid Resistance: 32 samples were tested.
- Other tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, Biocompatibility): The document does not explicitly state the sample sizes for each of these tests, but it indicates adherence to the respective ASTM and ISO standards, which would define appropriate sample sizes.
- Data Provenance: The tests were non-clinical, conducted in accordance with international standards (ASTM, ISO, CFR) and FDA guidance for surgical masks. No specific country of origin for the test data is mentioned, but the manufacturer is based in China. The data would be considered prospective, as it was generated specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is a non-clinical performance study of a device (surgical mask) based on standardized laboratory tests, not a diagnostic or AI-driven system requiring expert ground truth for interpretation of images or patient outcomes. The "ground truth" is established by the test methodologies and results themselves, as defined by the cited standards (e.g., ASTM F2100, ISO 10993). Therefore, the concept of "experts establishing ground truth" in the context of human interpretation is not applicable here. The experts involved would be the laboratory technicians and scientists performing the tests and ensuring compliance with the standards,
and this is not explicitly detailed in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is a non-clinical laboratory performance study, not a study involving human readers or expert adjudication of subjective findings. The test results are objective measurements against defined criteria.
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:
No. This is a 510(k) submission for a physical medical device (surgical mask), not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This is a non-AI medical device. The "standalone performance" refers to the device's intrinsic mechanical and filtration capabilities as measured by the laboratory tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" is based on standardized test methods and established performance criteria laid out in recognized industry standards (ASTM, ISO, CFR). For example:
- Fluid resistance is "ground-truthed" by passing or failing the 160 mmHg pressure spray.
- Filtration efficiencies are "ground-truthed" by the measured percentage retention of particles or bacteria.
- Biocompatibility is "ground-truthed" by standard cytotoxic, irritation, and sensitization assays.
8. The sample size for the training set:
Not applicable. This is a non-AI medical device; therefore, there is no "training set."
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of 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.