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510(k) Data Aggregation
(232 days)
Wilson Tech Disposable Medical 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. Wilson Tech Disposable Medical Face Mask is single use, disposable device, provided non-sterile.
Wilson Tech Disposable Medical Face Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layer and inner layers (melt-blown polypropylene), and an inner layer (spun-bond polypropylene). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece made of galvanized iron wire coated with polyethylene to provide a firm fit over the nose.
The provided document is a 510(k) premarket notification for a medical device, specifically the Wilson Tech Disposable Medical Face Mask. It details the device's characteristics and its comparison to a predicate device to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
The document includes a detailed table comparing the subject device (Wilson Tech Disposable Medical Face Mask) with the primary predicate device (DemeMASK Surgical Mask - K201479). The key acceptance criteria are based on surgical mask performance standards, primarily ASTM F2100 Level 3.
| Test Methodology | Purpose of the test | Acceptance criteria | Test Results (Wilson Tech Disposable Medical Face Mask) |
|---|---|---|---|
| Bacterial Filtration Efficiency (BFE) | Performed in accordance with ASTM F2101 to determine the bacterial filtration efficiency using a biological aerosol of Staphylococcus aureus. | Level 3: ≥98% | 32/32 Passed at ≥99.3% |
| Particulate Filtration Efficiency (PFE) | Performed in accordance with ASTM F2299 to determine the particle filtration efficiency using latex spheres. | Level 3: ≥98% | 32/32 Passed at ≥99.28% |
| Differential Pressure (delta-P) | Performed in accordance with MIL-M-36954C. Measures the breathability of the mask. | <6.0 mmH2O/cm² | 32/32 Passed at <4.9 mmH2O/cm² |
| Resistance to penetration by synthetic blood | Performed in accordance with ASTM F1862/F1862M to evaluate the effectiveness of the sample from possible exposure to blood and other body fluids. | Level 3: No penetration at 160 mmHg | 32/32 Passed at 160mmHg |
| Flammability | Evaluates the flammability of the material. | Class 1 | 32/32 Passed Class 1 requirement |
| Biocompatibility Tests | |||
| In vitro Cytotoxicity test | Purpose is to demonstrate the biocompatibility of the subject device. | Non-Cytotoxic | Pass (device is non-cytotoxic) |
| Skin sensitization Test | Non-Sensitizing | Pass (device is non-sensitizing) | |
| Skin Irritation Test | Non-Irritating | Pass (device is non-irritating) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for performance tests: For the performance tests (BFE, PFE, Differential Pressure, Resistance to synthetic blood, Flammability), the test results state "32/32 Passed," indicating that 32 samples were tested for each of these criteria.
- Data Provenance: The document does not explicitly state the country of origin for the test data. However, the submitter is "Wilson Tech (International) Limited" based in Hong Kong, and the submission correspondent is in Shanghai, China. The testing was non-clinical. The information is presented as a retrospective summary of tests already conducted.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This section is not applicable as the document describes physical and chemical performance tests for a medical face mask, not a diagnostic or AI-driven device requiring expert-established ground truth. The "ground truth" for these tests are the established ASTM and MIL standards.
4. Adjudication Method for the Test Set:
This section is not applicable as the tests are objective, laboratory-based physical and chemical performance evaluations. There is no human adjudication involved in determining "ground truth" for these types of tests.
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 diagnostic devices (especially imaging) where human readers interpret results, sometimes with AI assistance. The Wilson Tech Disposable Medical Face Mask is a physical barrier device, and its safety and effectiveness are assessed through its material properties and performance against established standards, not human interpretation of cases.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
No, a standalone algorithm performance study was not done. This device is not an algorithm or AI. The performance tests are for the physical mask itself.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance is based on established industry standards and test methodologies (e.g., ASTM F2101, ASTM F2299, MIL-M-36954C, ASTM F1862, 16 CFR Part 1610, ISO10993 series for biocompatibility). These standards define the acceptable performance thresholds (acceptance criteria) for medical face masks.
8. The Sample Size for the Training Set:
This section is not applicable. The device is not an AI or machine learning model, so there is no "training set." The tests described are for the physical product.
9. How the Ground Truth for the Training Set was Established:
This section is not applicable as there is no training set for this type of device.
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