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510(k) Data Aggregation
(162 days)
The Single-use medical face mask is intended to be worn to protect 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 nonsterile.
The Single-use medical face mask is flat pleated style mask, utilizing ear loops way for wearing, and they all has nose clip design for fitting the face mask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer facing layers are made of spunbonded non-woven, and the middle layer is made of melt-blown non-woven the model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex. The nose clip contained in the proposed device(s) is in the layers of face mask to allow the user to fit the mask around their nose, which is made of PE coated Tin-plate wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided document describes the FDA 510(k) clearance for a "Single-use medical face mask" (Model: HD0969). The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against the ASTM F2100 Level 3 standard for medical face masks.
| Test Methodology | Purpose | Acceptance Criteria for Level 3 | Reported Device Performance (Test Results) | Meets Criteria? |
|---|---|---|---|---|
| Fluid Resistance Performance (mmHg) | In order to verify whether the subject equipment meets the performance requirements of ASTM F2100 level 3. | Pass at 160mmHg | PASS (Average of 3 batch numbers: 160mmHg) | Yes |
| Particulate Filtration Efficiency (%) | In order to verify whether the subject equipment meets the performance requirements of ASTM F2100 level 3. | ≥ 98% | PASS (Average of 3 batch numbers: 98.79%) | Yes |
| Bacterial Filtration Efficiency (%) | In order to verify whether the subject equipment meets the performance requirements of ASTM F2100 level 3. | ≥ 98% | PASS (Average of 3 batch numbers: 99.87%) | Yes |
| Differential Pressure (mmH2O/cm²) | In order to verify whether the subject equipment meets the performance requirements of ASTM F2100 level 3. | <6.0 mmH2O/cm² | PASS (Average of 3 batch numbers: 4.7 mmH2O/cm²) | Yes |
| Flammability Class | In order to verify whether the subject equipment meets the performance requirements of ASTM F2100 level 3. | Class 1 | PASS (Class 1) | Yes |
Biocompatibility Testing:
| Test Item | Acceptance Criteria (Implied by PASS result) | Reported Device Performance (Result) | Meets Criteria? |
|---|---|---|---|
| Cytotoxicity | Non-cytotoxic | Under the conditions of the study, the subject device extract was determined to be non-cytotoxic. | Yes |
| Irritation | Non-irritating | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-irritating. | Yes |
| Sensitization | Non-sensitizing | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-sensitizing. | Yes |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Performance Tests: For the Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, and Differential Pressure tests, the reported results are "Average of 3 batch numbers." This implies testing was performed on samples from at least 3 distinct batches. The exact number of samples per batch or per test is not specified, but the methodology typically involves testing multiple samples to derive an average.
- Data Provenance: The document does not explicitly state the country of origin for the testing data. However, the applicant is "Zhuhai Herald Datanetics Limited." in China, and the correspondent is "Share Info (Guangzhou) Medical Consultant Ltd." also in China, suggesting the testing was likely conducted in China or by labs affiliated with the manufacturer. The tests are based on recognized international standards (ASTM, MIL, ISO), which ensures consistency in methodology. The data is retrospective for the purpose of this 510(k) submission, as it represents tests conducted prior to the submission.
3. Number of Experts and their Qualifications for Ground Truth
- Not Applicable: This submission is for a medical face mask, a physical device, and its performance is evaluated against established, quantitative engineering and biological standards (e.g., filtration efficiency, fluid resistance, biocompatibility). It does not involve interpretation of complex data (like medical images) by human experts to establish "ground truth." Therefore, there is no team of experts establishing ground truth in the way it would be for an AI/ML diagnostic device. The ground truth is the objective measurement against the specified standard.
4. Adjudication Method for the Test Set
- Not Applicable: As the test methods are objective, quantitative measurements against international standards for a physical device, there is no need for expert adjudication of results. The results are Pass/Fail based on the measured values compared to the defined thresholds.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. This type of study (comparing human reader performance with and without AI assistance) is typically performed for AI-driven diagnostic or assistive devices, not for physical medical devices like face masks. The performance evaluation here is based on the intrinsic physical and biological properties of the mask.
6. Standalone (Algorithm Only) Performance
- Not Applicable: This is not an AI/ML algorithm. The performance described is inherent to the physical characteristics of the manufactured face mask.
7. Type of Ground Truth Used
- The ground truth for the performance tests (Fluid Resistance, PFE, BFE, Differential Pressure, Flammability) is defined by objective, quantitative measurements against established international consensus standards (ASTM F1862, ASTM F2299, ASTM F2101, MIL-M-36954C, 16 CFR 1610 (Class 1)).
- For biocompatibility, the ground truth is established by biological test results (Cytotoxicity, Irritation, Sensitization) conforming to the principles outlined in ISO 10993-1:2018.
8. Sample Size for the Training Set
- Not Applicable: This device is a physical product, not an AI/ML model that requires training data.
9. How the Ground Truth for the Training Set was Established
- Not Applicable: As there is no training set for an AI/ML model, this question is not relevant.
In summary, the substantial equivalence of the "Single-use medical face mask" (Model: HD0969) was demonstrated through a series of non-clinical, objective performance tests designed to verify compliance with the ASTM F2100 Level 3 standard and biocompatibility requirements. The study does not involve human interpretation or AI algorithms, thus many of the questions related to those types of studies are not applicable.
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