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510(k) Data Aggregation
(236 days)
The Surgical 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 Masks are single use, three-layer, flat-pleated masks with ear loops and nose clip.
Two layers of polypropylene non-woven fabric, with a layer of polypropylene melt-blown filter cloth in the middle; plastic nose clip, ear loop is spandex elastic belt.
The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the mask. The elastic ear loops are not made with natural rubber latex.
The nose clip in the layers of mask is to allow the user to fit the mask around their nose, which is made of malleable polyethylene wire.
The surgical masks will be provided in blue. The surgical masks are sold non-sterile and are intended to be single use, disposable devices.
This document describes the acceptance criteria and performance of the Wuhan Zonsen Medical Products Co., Ltd SURGICAL MASK (Model: ZSFM 21, barrier level 2, blue).
1. Table of Acceptance Criteria and Reported Device Performance:
| Item | Acceptance Criteria (Level 2) | Reported Device Performance (K202191) | Result |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg, 3 lots | Similar |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | Pass at 98.1% | Similar |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | Pass at 99.9% | Similar |
| Differential Pressure (Delta P) (EN 14683 Annex C) | < 6.0 mmH₂O/cm² | Pass at 4.7, 4.9, 4.7 mmH₂O/cm² | Similar |
| Flammability (CFR 1610) | Class 1 | Class 1 | Similar |
| Biocompatibility - Cytotoxicity | Non-cytotoxic | Non-cytotoxic | Same |
| Biocompatibility - Irritation | Non-irritating | Non-irritating | Same |
| Biocompatibility - Sensitization | Non-sensitizing | Non-sensitizing | Same |
2. Sample size used for the test set and the data provenance:
- Fluid Resistance (ASTM F1862): 3 lots of the proposed device were tested, with 32 samples per lot (total 96 samples).
- Particulate Filtration Efficiency (ASTM F2299), Bacterial Filtration Efficiency (ASTM F2101), Differential Pressure (Delta P), Flammability: The document states "Pass at" for these tests, implying testing was conducted on samples of the device. The exact sample sizes for these specific tests are not explicitly quantified beyond a general implication of adequate testing to assess compliance.
- Biocompatibility: The document states "Under the conditions of the study," indicating specific samples were used for these assays.
- Data Provenance: The document does not explicitly state the country of origin of the data for the testing. However, the manufacturer is Wuhan Zonsen Medical Products Co., Ltd in China, suggesting the testing was likely conducted in China or a laboratory commissioned by them. The studies appear to be non-clinical (laboratory-based) and conducted specifically for this premarket notification. Therefore, this testing can be considered prospective in relation to this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This document describes non-clinical performance testing of a surgical mask, not a diagnostic device that requires expert interpretation for ground truth. Therefore, the concept of "experts used to establish ground truth" with specific qualifications (like radiologists) is not applicable here. The ground truth is defined by the standardized testing methodologies (e.g., ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, CFR 1610, ISO 10993) and their respective acceptance criteria.
4. Adjudication method for the test set:
Not applicable. This is not a human-reader-based assessment requiring adjudication. The results are based on objective measurements and compliance with scientific standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This document is for a surgical mask, not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This document is for a physical medical device (surgical mask), not an algorithm or software.
7. The type of ground truth used:
The "ground truth" for the performance characteristics of the surgical mask is established by standardized laboratory testing protocols and their defined acceptance criteria. These standards are recognized industry-wide and often mandated by regulatory bodies like the FDA. Examples include:
- ASTM F1862 for Fluid Resistance
- ASTM F2299 for Particulate Filtration Efficiency
- ASTM F2101 for Bacterial Filtration Efficiency
- EN 14683 Annex C for Differential Pressure
- CFR 1610 for Flammability
- ISO 10993 for Biocompatibility (cytotoxicity, irritation, sensitization)
8. The sample size for the training set:
Not applicable. This document describes the performance of a physical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As this is not a machine learning model, there is no training set or ground truth in that context.
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