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510(k) Data Aggregation
(109 days)
The non-sterile disposable medical face masks 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 intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
The sterile disposable medical face masks are intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
The proposed device. Disposable medical face masks, is provide in sterile and non-sterile two types.
Both the non-sterile disposable medical face masks and sterile disposable medical face masks are available in five sizes, which are 95mm×155mm, 95mm×140mm, 95mm×145mm and 95mm×160mm. And both the non-sterile disposable medical face masks and sterile disposable medical face masks are available in two ear strap types, Type A, which is ear-loop type, and Type B, which is tie-on type.
This document describes a 510(k) premarket notification for "Disposable Medical Face Masks" (K202719) by Jiangxi Sanxin Medtec Co., Ltd. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Disposable Medical Face Masks are based on Level 2 requirements of the ASTM F2100:2019 standard. The study demonstrates that the proposed device meets these requirements.
Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (ASTM F2100:2019 Level 2) | Proposed Device Performance (Non-sterile) | Proposed Device Performance (Sterile) |
|---|---|---|---|
| Fluid resistance | Pass at 120 mmHg | Pass at 120 mmHg | Pass at 120 mmHg |
| Particulate Filtration Efficiency (PFE) | ≥ 98% | Average 98.17% | Average 98.14% |
| Bacterial Filtration Efficiency (BFE) | ≥ 98% | Average 98.38% | Average 98.64% |
| Differential Pressure | < 5.0 mmH₂O/cm² | Average 1.78 mmH₂O/cm² | Average 1.78 mmH₂O/cm² |
| Flammability | Class 1 | Class 1 | Class 1 |
| Cytotoxicity | Non-cytotoxic | Non-cytotoxic | Non-cytotoxic |
| Sensitization | Non-sensitizing | Non-sensitizing | Non-sensitizing |
| Irritation | Non-irritating | Non-irritating | Non-irritating |
2. Sample Size and Data Provenance
The document does not explicitly state the specific sample sizes used for each non-clinical test (e.g., for BFE, PFE, fluid resistance). It only presents the "Average" values, implying that multiple samples were tested.
The data provenance is from non-clinical tests conducted by the manufacturer, Jiangxi Sanxin Medtec Co., Ltd., based in China. The studies are retrospective in the sense that they are conducted on the finished device to demonstrate compliance with standards.
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable as the evaluation relies on objective non-clinical performance standards and laboratory testing rather than expert-derived ground truth.
4. Adjudication Method for the Test Set
This is not applicable as the device performance is evaluated against predefined objective standards and laboratory test results, not through expert adjudication of ambiguous cases.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The device is a medical face mask, and its evaluation is based on material properties and barrier performance, not on interpretation by human readers.
6. Standalone Performance Study
Yes, a standalone (i.e., algorithm only without human-in-the-loop performance) study was done, though the "algorithm" here refers to the device itself, not a software algorithm. The non-clinical tests assess the inherent performance characteristics of the face mask (e.g., filtration efficiency, fluid resistance) independently of human interaction.
7. Type of Ground Truth Used
The ground truth used is based on objective performance standards and laboratory test results as defined by recognized standards such as ASTM F2100:2019. These standards specify quantitative thresholds for various performance metrics (e.g., filtration percentages, pressure differentials, fluid resistance levels).
8. Sample Size for the Training Set
This information is not applicable. The device is a physical product (medical face mask), not an AI/ML algorithm that requires a "training set." The materials and manufacturing processes are designed to meet the performance criteria, and the non-clinical tests verify this compliance.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no "training set" in the context of this device. The design and manufacturing are based on established engineering principles and material science to achieve the required performance for medical face masks as outlined in relevant standards.
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