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510(k) Data Aggregation
(119 days)
The medical face masks are intended to be worn to protect both the patient and healthcare persomel 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 Medical Face Masks are single use, flat-pleated, ear loop masks that are provided in blue. The medical face masks are available in three types, which are Level 1, Level 2 and Level 3 based on ASTM F2100-19, depending on marketing reasons. However, Level 2 and Level 3 masks are exactly the same. The outer and inner layers of the mask are made of spunbond polypropylene. The middle filter layer is made of meltblown polypropylene filter. The ear loops are made of nylon and spandex. The ear loops are held in place over the users' mouth and nose by two elastic ear straps. The nose of PE and galvanized iron wire. Users can adjust the nose clip according to the shape of the nose and fix the mask on the bridge of the nose to prevent the mask from falling off. The proposed devices are provided in non-sterile.
This document is a 510(k) summary for a Medical Face Mask (K212994) by Guangzhou Quantum Laser Intelligent Equipment Co., Ltd. It compares the proposed device to a predicate device (K160269) to demonstrate substantial equivalence.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The non-clinical performance characteristics evaluated, their acceptance criteria, and the reported results for the proposed device (Level 3 mask, as Level 1, 2, and 3 are physically the same) are presented in the following table:
| Performance Characteristics | Test Method | Reported Device Performance | Acceptance Criteria | Conclusion |
|---|---|---|---|---|
| Fluid Resistance Performance | ASTM F1862/F1862M: 2017 | Pass at 160 mmHg | No penetration at 160 mmHg | Meet the requirement |
| Particulate Filtration Efficiency | ASTM F2299/F2299M-03 (2017) | Pass at 99.2% | ≥98% | Meet the requirement |
| Bacterial Filtration Efficiency | ASTM F2101: 2019 | Pass at 99.2% | ≥98% | Meet the requirement |
| Differential Pressure (Delta-P) | EN 14683: 2019, Annex C | Pass at 3.8 mm H2O/cm² | <6.0 mmH2O/cm² | Meet the requirement |
| Flammability class | 16 CFR Part 1610 | Class 1 | Class 1 | Meet the requirement |
| Biocompatibility (Cytotoxicity) | ISO 10993-5:2009 | Non-cytotoxic | Non-cytotoxic | Meet the requirement |
| Biocompatibility (Sensitization) | ISO 10993-10:2010 | Non-sensitizing | Non-sensitizing | Meet the requirement |
| Biocompatibility (Irritation) | ISO 10993-10:2010 | Non-irritating | Non-irritating | Meet the requirement |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific non-clinical test. However, it indicates that the tests were conducted on the "proposed device" which is a "Medical Face Mask." The provenance of the data is not explicitly stated as country of origin, but the submission is from Guangzhou Quantum Laser Intelligent Equipment Co., Ltd., China. The tests are non-clinical (laboratory-based performance tests) and are inherently retrospective in the sense that they are conducted on finished products for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. These are non-clinical performance tests, not studies requiring expert interpretation of clinical data. The "ground truth" for these tests is defined by the standardized test methods (e.g., ASTM, EN, ISO standards) themselves, which specify objective measurements and criteria.
4. Adjudication Method for the Test Set
Not applicable. As described above, these are objective, standardized non-clinical tests, not subjective assessments requiring adjudication.
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 document is for the clearance of a medical device (face mask) based on non-clinical performance tests and substantial equivalence to a predicate device, not for evaluating the comparative effectiveness of human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, standalone non-clinical performance testing was done for the device. The results reported in the table (e.g., fluid resistance, filtration efficiency, differential pressure, flammability, biocompatibility) are all based on the performance of the device itself, without any human-in-the-loop component for evaluating its primary function.
7. The Type of Ground Truth Used
The ground truth used for these non-clinical tests is based on established industry standards and regulatory requirements. For example:
- Fluid Resistance: No penetration at 160 mmHg, as per ASTM F1862/F1862M.
- Particulate/Bacterial Filtration Efficiency: ≥98%, as per relevant ASTM standards (F2299/F2101) and ASTM F2100.
- Differential Pressure: <6.0 mmH2O/cm², as per EN 14683 Annex C and ASTM F2100.
- Flammability: Class 1, as per 16 CFR Part 1610.
- Biocompatibility: Non-cytotoxic, non-sensitizing, non-irritating, as per ISO 10993-5 and ISO 10993-10.
8. The Sample Size for the Training Set
Not applicable. This is a medical device (face mask) submission, not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/ML algorithm, there is no training set and therefore no ground truth establishment for a training set.
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