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510(k) Data Aggregation
(88 days)
The 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(s), provided non-sterile.
The Disposable Medical Face Mask is blue color, single use, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch.
The body of the mask is composed of three layers: the inner and outer layers are made of polypropylene spun-bond nonwoven fabric, and the middle layer is made of polypropylene melt blown non-woven fabric. The nose clip is made of Galvanized iron wire coated by PE, and the ear loop is made of polyester and spandex.
The disposable medical face masks are sold non-sterile and are intended to be single use, disposable devices.
This document is a 510(k) Premarket Notification for a Disposable Medical Face Mask. It focuses on demonstrating that the proposed device is substantially equivalent to a legally marketed predicate device (K210433) by providing non-clinical test data.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (ASTM F2100 Level 3) | Reported Device Performance |
|---|---|
| Fluid Resistance: 29 out of 32 pass at 160 mmHg | Pass: 32 out of 32 pass at 160 mmHg, 3 lots |
| Particulate Filtration Efficiency: $\ge$ 98% | Pass: Average 99.36% |
| Bacterial Filtration Efficiency: $\ge$ 98% | Pass: Average 99.40% |
| Differential Pressure (Delta P): < 6.0mmH2O/cm² | Pass: Average 2.8mmH2O/cm² |
| Flammability: Class 1 | Pass: Class 1 |
| Cytotoxicity: Non-cytotoxic | Pass: Under the conditions of the study, the device is non-cytotoxic. |
| Irritation: Non-irritating | Pass: Under the conditions of the study, the device is non-irritating. |
| Sensitization: Non-sensitizing | Pass: Under the conditions of the study, the device is non-sensitizing. |
2. Sample size used for the test set and the data provenance:
- Fluid Resistance: 32 samples per lot, across 3 lots.
- Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, Cytotoxicity, Irritation, Sensitization: The document does not specify the exact sample size for these tests, only that the results passed. The provenance of the data is not explicitly stated beyond originating from "Non-Clinical Test Conclusion," which implies laboratory testing. The manufacturer is Xiantao Topmed Nonwoven Protective Products Co., Ltd. in China, so the testing was likely conducted in China. The data is retrospective in the sense that it was collected as part of the submission process to demonstrate equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This submission does not involve expert-established ground truth in the context of diagnostic interpretation. It relies on standardized laboratory testing and established regulatory guidance (ASTM F2100, F1862, F2101, F2299, EN 14683, 16 CFR 1610, ISO 10993-5, ISO 10993-10) for evaluating the performance of the face mask. The "ground truth" for each performance metric is defined by the acceptance criteria of these standards. The experts would be the accredited laboratory personnel performing these standardized tests,
but their specific number and qualifications are not detailed in this document.
4. Adjudication method for the test set:
Not applicable. The tests are objective, standardized laboratory tests with defined passing criteria. There is no subjective interpretation or adjudication needed for the results.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a medical face mask, not an AI-powered diagnostic tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a medical face mask, not an AI-powered algorithm. It does not have a "standalone" or "human-in-the-loop" performance in the context of an algorithm.
7. The type of ground truth used:
The ground truth is based on pre-defined, internationally recognized technical standards and test methodologies for medical face mask performance, such as ASTM F2100, F1862, F2101, F2299, EN 14683, 16 CFR 1610, and ISO 10993 for biocompatibility.
8. The sample size for the training set:
Not applicable. This is a physical medical device (face mask), not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
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