(90 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 Products Co., Ltd. Surgical Face Mask (Blue) is flat pleated 3-ply masks with an inner and outer layer (spunbonded polypropylene) that sandwich a meltblown polypropylene filter material, also with elastic loops and/or strip. The nosepiece for all Hong Ya Products Co., Ltd. Surgical Face Mask (Blue) is malleable aluminum wire. All the material used in the construction of the Hong Ya Products Co., Ltd. Surgical Face Mask (Blue) are being used in currently marked devices.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Hong Ya Non-Woven Products Co., Ltd. Surgical Face Mask (Blue):
Summary: This document describes a 510(k) submission for a surgical face mask. The core of the submission is demonstrating substantial equivalence to a predicate device (Tucker & Associates Surgical Face Mask K022256) through a series of non-clinical, bench-top performance tests. No clinical studies or human-in-the-loop studies were performed.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state "acceptance criteria" but rather presents a comparison table showing the performance of the applicant's device against "K022256" (the predicate device). The implicit acceptance criterion is that the new device's performance should be comparable to or better than the predicate device.
| Test | Predicate Device (K022256) Performance | Hong Ya Surgical Face Mask (Blue) Performance | Implicit Acceptance Criterion (Comparison to Predicate) |
|---|---|---|---|
| Fluid Resistance | No visual Penetration | Fluid Resistant (Implicitly: No visual penetration) | Must demonstrate no visual penetration of fluid. |
| Particulate Filtration Efficiency Performance (%) | 2.0 microns (Note: This is a particle size, not a percentage efficiency) | Average 98.8% at 0.1 micron | Must demonstrate comparable or better particulate filtration efficiency. The predicate's stated '2.0 microns' is ambiguous here; it likely refers to the particle size at which a certain (unspecified) efficiency was achieved. The new device's 98.8% at 0.1 micron appears superior given the smaller particle size. |
| BFE (%) (Bacterial Filtration Efficiency) | 97.9% | 99.4% | Must demonstrate comparable or better BFE (≥97.9%). |
| Delta-P (Differential Pressure) | 1.8 | 1.6 | Must demonstrate comparable or better Delta-P (lower is generally better for breathability, but within an acceptable range). |
| Flammability Class | 2 | 1 | Must meet an acceptable flammability class (Class 1 is generally better than Class 2). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes used for each performance test (e.g., how many masks were tested for BFE). It just states "Performance testing met all relevant requirements."
- Data Provenance: The data is from non-clinical bench testing. The tests were performed to support substantial equivalence to a predicate device. The country of origin for the testing facilities is not explicitly stated, but the manufacturer is based in China. The data would be considered prospective in the sense that these tests were conducted specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. For this type of device (surgical mask) and submission (510(k) based on bench testing), "ground truth" established by human experts in the context of diagnostic interpretation is not relevant. The "ground truth" for these tests is defined by the objective results of the standardized test methods themselves (e.g., ASTM F1862 for fluid resistance, ASTM F2101 for BFE).
4. Adjudication Method for the Test Set
- Not Applicable. As there are no human interpretations or readings involved, no adjudication method (like 2+1 or 3+1 consensus) was used. The tests produce objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. A MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where different readers interpret cases with and without AI assistance to measure the impact of AI on their performance. This submission for a surgical mask focuses on material performance, not diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. There is no AI algorithm or software component in this device. The device is a physical surgical face mask.
7. The Type of Ground Truth Used
- The "ground truth" for the performance tests is derived from standardized physical and material property measurements as defined by the referenced ASTM (American Society for Testing and Materials) and other relevant standards (e.g., ASTM F1862-00a for fluid resistance, ASTM F2101-01 for BFE, ASTM F1215-89 for particulate filtration, MIL M 36954C for Delta P, 16 CFR 1610 for flammability, and ISO 10933 for biocompatibility). These standards define the test methods and the expected outcome or measurement for compliance.
8. The Sample Size for the Training Set
- Not Applicable. There is no AI model or algorithm, so there is no training set in the machine learning sense. The device is a physical product.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set, this question is irrelevant.
§ 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.