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510(k) Data Aggregation
(248 days)
The Surgical 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 Surgical Face Masks are single use, three-layer, flat-folded masks with ear loops and nose piece. The Surgical Face Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of plastic wire. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
This document describes the premarket notification (510(k)) for the Surgical Face Mask (K201545) manufactured by Amphastar Nanjing Pharmaceuticals, Inc. The device's acceptance criteria and the study proving it meets these criteria are outlined in the non-clinical performance testing section.
1. Table of Acceptance Criteria and Reported Device Performance
The device performance was evaluated against specific ASTM and EN standards for surgical face masks.
| Item(s) | Acceptance Criteria | Reported Device Performance (K201545) | Result |
|---|---|---|---|
| Resistance to penetration by synthetic blood (ASTM F1862) | 29 out of 32 pass in 120 mm Hg | 32 out of 32 passed in 120 mm Hg | Pass |
| Sub-micron particulate filtration efficiency at 0.1 micron (ASTM F2299) | ≥98% | >98% | Pass |
| Bacterial filtration efficiency (ASTM F2101-19) | ≥98% | >98% | Pass |
| Differential pressure (EN 14683:2019) | < 6.0 mm H2O/cm2 | ≤ 3.0 mm H2O/cm2 | Pass |
| Flame spread (16 CFR 1610) | Class 1 | Class 1 (Non Flammable) | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- For Resistance to penetration by synthetic blood (ASTM F1862), the test required 32 samples, and the reported performance indicates "32 out of 32 passed."
- For other tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flame Spread), specific sample sizes are not explicitly stated within the provided extract beyond the reported percentage or value. However, the nature of these tests implies that sufficient samples were tested to achieve the reported values.
- Data Provenance: The document does not explicitly state the country of origin for the test data (e.g., where the testing labs are located) or whether the data was retrospective or prospective. Given the manufacturer is based in China, it's plausible the testing was conducted in China or by accredited labs elsewhere. The tests are "non-clinical tests performed on the proposed device," indicating they were specifically conducted for this submission (prospective in relation to the submission).
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This device is a surgical face mask, and its performance evaluation relies on standardized physical and material property tests, not on expert interpretation of medical images or clinical outcomes. Therefore, the concept of "experts" establishing ground truth in the traditional sense (e.g., radiologists for medical imaging) is not applicable here. The ground truth is established by the results of the specified laboratory tests adhering to recognized standards (ASTM, EN, CFR).
4. Adjudication Method for the Test Set
- Adjudication methods (e.g., 2+1, 3+1) are typically relevant for studies involving human reviewers, such as in clinical trials or medical imaging assessments, to resolve disagreements.
- Since the evaluation of this device is based on objective laboratory performance testing against established technical standards, there is no human-in-the-loop adjudication process described or required for the test results. The pass/fail criteria are based on quantitative measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was conducted or is relevant for this device. An MRMC study is used to assess the effectiveness of an AI system, often in diagnostic imaging, by comparing the performance of multiple human readers with and without AI assistance across multiple cases.
- This submission is for a physical medical device (surgical face mask), whose effectiveness is determined by its physical and material properties (filtration, breathability, fluid resistance, flame resistance), not by diagnostic interpretation or human-AI interaction.
6. Standalone (Algorithm Only) Performance
- Not applicable. This section typically relates to artificial intelligence or machine learning algorithms. The device in question is a physical surgical face mask; therefore, there is no "algorithm only" performance to be assessed. The performance is the inherent property of the physical device.
7. Type of Ground Truth Used
- The ground truth for the device's performance is established by objective, quantitative measurements obtained from standardized non-clinical laboratory tests. These tests assess physical properties like filtration efficiency, fluid resistance, breathability, and flammability. The acceptance criteria are derived directly from these technical standards (e.g., ASTM F1862, ASTM F2299, ASTM F2101-19, EN 14683:2019, 16 CFR 1610).
8. Sample Size for the Training Set
- Not applicable. This device is a physical product, not an AI or machine learning model that requires a training set. The manufacturing process and material selection are based on established engineering principles and quality control, not on a data-driven training process.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for a physical device like a surgical face mask.
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