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510(k) Data Aggregation
(110 days)
The Disposable Surgical 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. This a single use, disposable device(s), provided sterile and non-sterile.
The Disposable Surgical Face Masks are composed of mask body, nose clip and ear loop. The mask is composed of three layers: the inner and outer layers are made of spun-bond nonwoven fabric, and the middle layer is made of melt blown non-woven fabric. The nose clip is made of polyethylene and iron material, ear loop is made of nylon and spandex material. The size of the disposable surgical mask is 17.5*9.5cm with tolerance±5%cm, the length of the ear loop is ≥ 10.0cm. The outer layer of disposable surgical mask will be provided in blue, the inner layer of the disposable surgical mask will be provided in white, and it will be provided with sterile and is intended to be single use, disposable devices.
This is a 510(k) premarket notification for a Disposable Surgical Face Mask, which is a Class II medical device. The document summarizes the performance testing and substantial equivalence to a predicate device.
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:
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| Functional Tests | ASTM F2100 Level 3 Requirements | |||
| Fluid Resistance (ASTM F1862) | To demonstrate the functionality of the subject device. | 29 out of 32 pass at 160 mmHg for Level 3 | 32 out of 32 per lot pass at 160 mmHg (3 non-consecutive lots tested for sterile and non-sterile) | PASS |
| Particulate Filtration Efficiency (ASTM F2299) | To demonstrate the functionality of the subject device. | ≥ 98% | Lot1: 99.41% (before sterile), 99.50% (sterile), 99.44% (after aging)Lot2: 99.36% (before sterile), 99.26% (sterile), 99.18% (after aging)Lot3: 99.36% (before sterile), 99.29% (sterile), 99.27% (after aging) | PASS |
| Bacterial Filtration Efficiency (ASTM F2101) | To demonstrate the functionality of the subject device. | ≥ 98% | Lot1: 99.77% (before sterile), 99.79% (sterile), 99.74% (after aging)Lot2: 99.80% (before sterile), 99.83% (sterile), 99.77% (after aging)Lot3: 99.80% (before sterile), 99.78% (sterile), 99.76% (after aging) | PASS |
| Differential Pressure (EN 14683) | To demonstrate the functionality of the subject device. | < 6.0 mmH2O/cm² | Lot1: 4.52 (before sterile), 4.52 (sterile), 4.63 (after aging)Lot2: 4.51 (before sterile), 4.54 (sterile), 4.57 (after aging)Lot3: 4.50 (before sterile), 4.50 (sterile), 4.53 (after aging) | PASS |
| Flammability (16 CFR 1610) | To demonstrate the functionality of the subject device. | Class 1 | All lots (before sterile, sterile, after aging) for all three lots: Class 1 | PASS |
| Biocompatibility Tests | The purpose of the testing is to demonstrate the safety of the subject device. | |||
| Cytotoxicity (ISO 10993-5) | To demonstrate the safety of the subject device by evaluating its in vitro cytotoxicity. | Non-Cytotoxic | Under the conditions of the study, the device is non-cytotoxic. | PASS |
| Irritation (ISO 10993-10) | To demonstrate the safety of the subject device by evaluating its potential for irritation. | Non-Irritating | Under the conditions of the study, the device is non-irritating. | PASS |
| Sensitization (ISO 10993-10) | To demonstrate the safety of the subject device by evaluating its potential for skin sensitization. | Non-Sensitizing | Under the conditions of the study, the device is non-sensitizing. | PASS |
| EtO/ECH Residuals | To ensure residual levels of Ethylene Oxide (EtO) and Ethylene Chlorohydrin (ECH) meet safety standards after sterilization. | ECH residuals meet the requirement of less than 20ug/g at room temperature for 7 days.EO residuals meet the requirement of less than 10ug/g at room temperature for 7 days. | Max ECH residuals is 9 mg/day.Max EO residuals is 4.4 ug/g (Note: mg/day and ug/g are different units, but the reported values appear to be below the acceptance criteria if interpreted as concentrations) | PASS |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document explicitly mentions sample sizes for some tests.
- Fluid Resistance: 32 out of 32 mask samples were tested per lot, with 3 non-consecutive lots tested for both sterile and non-sterile versions.
- Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability: These tests were performed on 3 lots of masks, with samples tested "before sterile," "sterile," and "after aging" for each lot. The exact number of individual mask samples per lot for these tests isn't specified beyond "Lot1," "Lot2," and "Lot3" results being provided for each condition.
- Biocompatibility (Cytotoxicity, Irritation, Sensitization, EtO/ECH Residuals): The sample sizes for these tests are not explicitly stated in the summary, but the results indicate that the tests were performed "under the conditions of the study."
Data Provenance: The tests were conducted by Jiangxi Heying Pharmaceutical Co., Ltd, which is located in Shangrao City, Jiangxi Province, China. This indicates the country of origin of the data is China. The studies are prospective in nature, as they involve testing the manufactured device to ensure it meets performance and safety standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable to this type of device (Disposable Surgical Face Mask). The "ground truth" for a surgical mask is established by objective, standardized physical and chemical tests against recognized performance standards (like ASTM F2100 and ISO 10993), not by expert opinion or clinical assessment.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving subjective interpretations (e.g., medical image reading) where disagreement among experts needs resolution. For the objective performance tests of a surgical mask, the results are quantitative or qualitative (Pass/Fail) based on predefined criteria, not on expert consensus or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. These types of studies are relevant for diagnostic or interpretive devices where human performance with and without AI assistance is being evaluated. This is a Class II surgical mask, where performance is evaluated through standardized physical and chemical testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a physical product (a surgical face mask), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant. The performance reported is that of the physical device itself.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device is established by objective, standardized test methods and their defined acceptance criteria. These criteria are derived from international standards (e.g., ASTM F2100, ISO 10993, EN 14683, 16 CFR 1610) which specify the physical, chemical, and biological performance requirements for surgical masks.
8. The Sample Size for the Training Set:
Not applicable. This document describes the testing of a physical medical device (a surgical mask), not an AI/machine learning model. Therefore, there is no "training set" in the context of an algorithm. The "training" for mask production would relate to manufacturing processes and quality control, not data training.
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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