(152 days)
The 039 Medical Surgical Face Mask is 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 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 039 Medical Surgical Face Mask is single use, four- layer folded masks with ear loops, or straps to tie behind the user's head, and a nose piece. The ear loops are 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 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 surgical face masks will be provided in blue. The 039 Surgical Face Mask is sold non-sterile and are intended to be single use, disposable devices.
This document describes the regulatory submission for the "039 Medical Surgical Face Mask," a Class II medical device, seeking clearance under a 510(k) premarket notification. The purpose of the submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device (Jiangsu Medplus Non-woven Manufacturer Co., Ltd. - K202605).
The core of the submission relies on non-clinical performance testing to meet established acceptance criteria, which are primarily based on ASTM F2100-2019 standards for medical face masks.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Methodology | Purpose | Acceptance Criteria for Level 2 Barrier | Reported Device Performance (039 Medical Surgical Face Mask) |
|---|---|---|---|
| Section 6.1 Bacterial Filtration Efficiency ASTM F2101 | Measure bacterial Filtration efficiency | >98% (87 of 96 pass) | 99.9% (96 of 96 passed) |
| Section 6.1 Differential Pressure (mm H$_{2}$O/cm$^{2}$) EN14683:2019+AC:2019 Annex C | Determine breathability of a mask | 99% (96 of 96 passed) | |
| Section 6.1 Resistance to Penetration by Synthetic Blood ASTM F1862/F1862M-2017 | Evaluate the resistance to penetration by impact of small volume of synthetic blood | 120 mmHg (Visual inspection, 87 of 96 pass) | None seen in 91 of 96 samples |
| Section 6.2 Flame spread 16CFR Part 1610-2008 | Response of materials to heat and flame | Class 1 (87 of 96 pass) | 96 of 96 passed (Class 1) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: For the non-clinical performance testing (BFE, Differential Pressure, PFE, Synthetic Blood Penetration, Flammability), three separate non-consecutive lots of 32 samples each were tested. This means a total of 96 samples were tested for each performance criterion.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given that this is a premarket notification for a new device, the testing would inherently be prospective and conducted specifically to support the submission. The manufacturer, AOK Tooling Limited, is located in Shen Zhen, China.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This submission pertains to the performance characteristics of a physical medical device (face mask). The "ground truth" for these tests is established by standardized laboratory testing methodologies (e.g., ASTM and EN standards) and the physical measurements and observations derived from these tests.
- Therefore, the concept of "experts" establishing ground truth in the sense of human interpretation of medical images or diagnoses (as would be relevant for an AI/CAD device) is not directly applicable here. The experts involved would be the laboratory technicians and engineers who conduct these standardized tests, ensuring adherence to the test protocols and accurate data collection. Their qualifications would typically include training in laboratory procedures, relevant instrumentation, and quality control. The document does not specify the number or specific qualifications of these laboratory personnel.
4. Adjudication Method for the Test Set:
- The testing involves objective measurements and observations based on standardized protocols, not subjective human interpretation requiring adjudication. For example, bacterial filtration efficiency is a measured percentage, and synthetic blood penetration is a visual inspection for the presence of fluid.
- Therefore, an "adjudication method" in the context of resolving discrepancies in expert opinions (like 2+1 or 3+1 for medical image interpretations) is not applicable to this type of device performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in tasks like image interpretation. This submission is for a physical medical device (face mask) that does not involve human readers interpreting data assisted by AI.
- The study focuses on the physical and performance characteristics of the mask itself, demonstrating its standalone efficacy in barrier protection, breathability, etc., against predefined objective criteria.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a form of standalone performance evaluation was done. The described non-clinical testing assesses the intrinsic performance of the medical face mask (the device itself) against objective physical and performance standards. It measures properties like filtration efficiency, breathability, fluid resistance, and flammability. These tests evaluate the device's technical specifications and capabilities without human intervention or interpretation of diagnostic output.
7. The Type of Ground Truth Used:
- The ground truth used for evaluating the device's performance is based on standardized, objective physical and material performance measurements as defined by:
- ASTM (American Society for Testing and Materials) standards: Specifically, ASTM F2100-2019 (Standard Specification for Performance of Materials Used in Medical Face Masks), ASTM F2101 (Bacterial Filtration Efficiency), ASTM F2299/F2299M-03 (Particulate Filtration Efficiency), and ASTM F1862/F1862M-2017 (Resistance to Penetration by Synthetic Blood).
- EN (European Norm) standard: EN14683:2019+AC:2019 Annex C (Differential Pressure).
- CFR (Code of Federal Regulations): 16CFR Part 1610-2008 (Flame spread).
- These standards specify the methodology and expected outcomes for each test, providing the objective "ground truth" for the device's performance.
8. The Sample Size for the Training Set:
- This is a submission for a physical medical device (face mask). The concept of a "training set" is typically associated with machine learning or AI models, where data is used to train an algorithm.
- Since this is not an AI/ML device, there is no training set in the conventional sense. The device's design and manufacturing processes are informed by engineering principles and material science, rather than data-driven training.
9. How the Ground Truth for the Training Set Was Established:
- As there is no training set for this type of device, this question is not applicable.
§ 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.