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510(k) Data Aggregation
(134 days)
The surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The surgical mask is 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 surgical mask is a three-layer flat-pleated mask made of nonwoven polypropylene materials. The inner layer (white color) and the outer layer (blue color) are made of spunbonded polypropylene to provide comfort and breathability; the middle filtration layer is made of melt-blown polypropylene. The three layers are bonded together sonically along the four edges with the inner layer slightly folded over the outer layer along the long edges.
The mask is fitted to cover the wearer's nose and mouth with ear-loops. The ear-loops are made of knitted polyester/ elastane. They are welded to the mask. The materials do not contain natural rubber latex.
A malleable polyethylene laminated aluminum nosepiece is placed between the layers along the top edge of the mask for extra comfort and fit around the wearer's nose.
The surgical mask is intended to be a single-use disposable device, provided non-sterile.
The provided text is a 510(k) Summary for a Surgical Mask, specifically K210524 from Changzhou Holymed Products Co., Ltd. It details the device, its intended use, comparison to a predicate device, and performance testing to demonstrate substantial equivalence.
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 core of the performance testing is summarized in Table 2: Non-Clinical Performance Testing Table on page 6.
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | Determine the ability of the mask's material to resist penetration of blood and body fluids. | Pass/fail basis at any of three velocities corresponding to the range of human blood pressure:Level 1 – 80 mmHgLevel 2 – 120 mmHgLevel 3 - 160 mmHg | Level 3Passed at 160 mmHg.All 3 lots tested passed with no synthetic blood penetration observed at 160 mmHg, under the conditions of the test. |
| Particulate Filtration Efficiency (ASTM F2299) | Determine the ability of the mask's material to prevent passage of aerosolized submicron particulates. | Pass/fail basis:Level 1 – 95%Level 2 – 98%Level 3 – 98% | Level 3Passed at > 99.9%Average Filtration Efficiency:AMSB-LOT202010007: >99.979%AMSB-LOT202011002: >99.9814%AMSB-LOT202011005: >99.984% |
| Bacterial Filtration Efficiency (ASTM F2101-19) | Determine the ability of the mask's material to prevent passage of aerosolized bacteria. | Pass/fail basis:Level 1 - 95%Level 2 – 98%Level 3 – 98% | Level 3Passed at ≥ 99.9%All samples tested passed with a filtration efficiency percentage of at least 99.9%, under the conditions of the test. |
| Differential Pressure (ASTM F2101-19, same as BFE) | Determine the resistance of the surgical facemask to air flowing through the mask. | Pass/fail basis:Level 1 – <5 mm H2O/cm²Level 2 – <6 mm H2O/cm²Level 3 – <6 mm H2O/cm² | Level 1Passed, < 5 mm H2O/cm².AMSB-LOT202010007: ≤ 3.7 mm H2O/cm2.AMSB-LOT202011002: ≤ 3.7 mm H2O/cm2.AMSB-LOT202011005: ≤ 4.9 mm H2O/cm2. |
| Flammability (16 CFR Part 1610) | Determine the ability of the mask to resist ignition to an externally applied ignition source. | Pass/fail basis:Class 1, normal flammability specified in 16 CFR Part 1610. | Passed at Class 1All samples tested achieved a Class 1 flammability rating under the conditions of the test. |
Additionally, for safety (biocompatibility), Table 3: Summary of Biocompatibility Test Result and Comparison on page 8 details:
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Cytotoxicity (ISO 10993-5) | Determine the biological response of mammalian cells in-vitro | Non-cytotoxic | Under the conditions of the study, non-cytotoxicity effect |
| Skin-irritation (ISO 10993-10) | Assess the potential of a medical device and its constituent materials to produce skin irritation | Non-irritating | Under the conditions of the study, non-irritation |
| Sensitization (ISO 10993-10) | Assess the potential of a medical device and its constituent materials to produce host sensitization | Non-sensitizing | Under the conditions of the study, non-sensitization |
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/Differential Pressure, and Flammability tests, the report states "All 3 lots tested" for fluid resistance and "All samples tested" for the other filtration/flammability tests, with specific lot numbers provided for filtration efficiency and differential pressure (AMSB-LOT202010007, AMSB-LOT202011002, AMSB-LOT202011005). The exact number of masks or specimens per lot is not explicitly stated, but it's implied that multiple samples were taken from these lots. ASTM and ISO standards for these tests typically specify precise sample quantities.
- Sample Size for Biocompatibility Tests: "All samples met the test criteria" is stated, but the exact number of samples or specimens per biocompatibility test (Cytotoxicity, Skin-irritation, Sensitization) is not specified.
- Data Provenance: The device manufacturer is Changzhou Holymed Products Co., Ltd. in Jiangsu, China. The testing appears to be non-clinical (laboratory-based) and conducted to conform to international standards (ASTM, ISO, CFR). The document does not specify where the testing was physically performed (e.g., in China or a certified third-party lab elsewhere), but it would typically be done in a lab accredited for these specific tests. The data is retrospective in the sense that it was collected as part of the 510(k) submission prior to the FDA's review.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to this type of device and study. The "ground truth" for performance of a surgical mask (e.g., filtration efficiency, fluid resistance) is objectively determined by standardized laboratory tests using established scientific methods and equipment, not by human expert opinion or consensus. Similarly, biocompatibility is assessed by laboratory tests.
4. Adjudication Method for the Test Set
Not applicable. Since the performance metrics are objective physical measurements and chemical/biological assay results, there is no need for expert adjudication. The test results directly determine if the acceptance criteria are met.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. MRMC studies are typically performed for diagnostic medical devices where human readers (e.g., radiologists) interpret images or data, and the AI's impact on their performance is evaluated. This 510(k) submission is for a physical product (surgical mask) that does not involve human interpretation or AI assistance in a diagnostic context.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a surgical mask, not an algorithm or software. The "standalone" performance here refers to the physical properties of the mask itself, which are tested through the described non-clinical laboratory studies. There is no algorithm involved.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through objective, standardized laboratory measurements against established national and international standards (ASTM F1862, ASTM F2299, ASTM F2101-19, 16 CFR Part 1610, ISO 10993-5, ISO 10993-10). These standards define the test methodologies and the acceptance criteria based on scientific principles relevant to the function and safety of a surgical mask.
- Fluid Resistance: Measured penetration of synthetic blood.
- Particulate Filtration Efficiency: Measured percentage of submicron particulates filtered.
- Bacterial Filtration Efficiency: Measured percentage of aerosolized bacteria filtered.
- Differential Pressure (Breathability): Measured resistance to airflow.
- Flammability: Measured ignition and burn rate.
- Biocompatibility: Measured cellular response (cytotoxicity), skin irritation, and sensitization potential.
8. The Sample Size for the Training Set
Not applicable. This product is a physical device (surgical mask), not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data for model development. The manufacturing process involves quality control, but not a data-driven training process in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no training set. As explained above, for a physical product like a surgical mask, the performance validation relies on standardized physical, chemical, and biological testing rather than machine learning models that require training and ground truth from data sets.
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