(64 days)
Surgical Face Mask is Device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluids and particulate material.
Hong Ya Non-woven Products Co., Ltd. Surgical Face Mask (Yellow, White, Green, Pink) are flat pleated 3-ply (at least) masks with an inner and outer layer (spunbonded I mk) are nat produce o psy (a a meltblown polypropylene filter material, also with elastic loops and/or strip. The nosepiece for all Hong Ya Non-woven Products Co., Ltd. Surgical Face Mask (Yellow, White, Green, Pink) is malleable aluminum wire. All the materials used in the construction of the Hong Ya Non-woven Products Co., Ltd. Surgical Face Mask (Yellow, White, Green, Pink) are being used in currently marked devices.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to demonstrate the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance (Hong Ya Surgical Face Mask) | Predicate Device Performance (K022256) |
|---|---|---|---|
| Fluid Resistance | No Visual Penetration (implied by predicate) | Fluid Resistance (No Visual Penetration implied by comparison) | No Visual Penetration |
| Particulate Filtration Efficiency Performance (%) | Not explicitly stated, but predicate's 2.0 microns is the benchmark. | Average 96.8% at 0.1 micron | 2.0 microns (likely indicating filtration down to 2.0 microns, not a percentage at a specific size) |
| Bacterial Filtration Efficiency (BFE) (%) | Not explicitly stated, but predicate's 97.9% is the benchmark. | Higher than 99.9% | 97.9% |
| Differential Pressure (Delta-P) | Not explicitly stated, but predicate's 1.8 is the benchmark. | Average 2.34 | 1.8 |
| Flammability Class | Not explicitly stated, but predicate's Class 2 is the benchmark. | Class I (No Flame Spread) | Class 2 |
Note: The document sometimes lists the predicate's performance in the "Acceptance Criteria" column implicitly by comparing the new device's performance to it. For particulate filtration, it seems the predicate's "2.0 microns" is the filtration size it achieves, and the new device achieves a much higher percentage at a smaller particle size (0.1 micron), indicating superior performance.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set for any of the performance criteria (Fluid Resistance, Particulate Filtration, BFE, Delta-P, Flammability).
The data provenance is not explicitly stated. However, given that Hong Ya Non-Woven Products Co., Ltd. is located in P.R. China and the submission is to the FDA, it's highly probable the testing was conducted retrospectively on samples of the manufactured device. The location where the tests were performed is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is Not Applicable in this context. The study is a series of non-clinical, laboratory-based performance tests for a surgical mask. Ground truth is established by the standardized methods of the tests themselves, not by expert consensus on clinical data. For example, BFE is measured by a specific laboratory procedure, not by a panel of experts reviewing cases.
4. Adjudication Method for the Test Set
This information is Not Applicable. As with the ground truth, the tests are objective laboratory measurements, not subjective evaluations requiring adjudication among multiple observers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human interpretation is involved. The listed tests are non-clinical performance evaluations of a physical product.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, a standalone performance evaluation was done. All the tests (Fluid Resistance, Particulate Filtration Efficiency, BFE, Delta-P, Flammability) are standalone assessments of the device's physical properties and performance characteristics, without human intervention in the loop for interpreting results.
7. The Type of Ground Truth Used
The ground truth for the device's performance is established by standardized laboratory test methods. The specific standards mentioned include:
- Fluid Resistance: ASTM F1862-05 (Synthetic Blood Penetration Resistance Test)
- Bacterial Filtration Efficiency (BFE): ASTM F2101-01
- Particulate Filtration Efficiency: ASTM F1215 (Latex Particle Challenge)
- Differential Pressure (Delta-P): MIL M 36954 C
- Flammability: 16CFR 1610
- Biocompatibility: ISO 10993
8. The Sample Size for the Training Set
This information is Not Applicable. Surgical masks are not typically "trained" in the sense of machine learning algorithms. The device's performance is inherent to its design and materials.
9. How the Ground Truth for the Training Set Was Established
This information is Not Applicable for the reasons stated in point 8.
§ 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.