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510(k) Data Aggregation
(230 days)
Phyziofit Medical Surgical Masks are 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 a single use, disposable device(s), provided non-sterile.
The proposed device(s) are Blue color (colorant: Pigment blue 15:3/CAS No. 147-14-8), and Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose clips design for fitting the facemask around the nose. The proposed device(s) are manufactured with three layers, the outer layer is made of polypropylene non-woven fabric, the middle layer is made of melt blown non-woven fabric and the inner layer is made of absorbent nonwoven fabric.
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 facemask. The elastic ear loops are not made with natural rubber latex. The nose clips contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of PP plastic material.
The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided text describes the acceptance criteria and the study conducted for the Phyziofit Medical Surgical Mask (K201868).
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Test Method | Acceptance Criteria | Reported Device Performance (Average) | Result |
|---|---|---|---|---|
| Differential Pressure | EN 14683:2019+AC: 2019 (E), Annex C | < 5.0 mm H2O/cm² | 3.4 mm H2O/cm² (32/32) | Pass |
| Fluid Resistance | ASTM F1862/F1862M-17 | No Penetration at 80 mm Hg | No Penetration at 80 mm Hg (32/32) | Pass |
| Particulate Filtration Efficiency | ASTM F2299-03 (2017) | ≥95% | 98% (32/32) | Pass |
| Flammability | 16 CFR Part 1610 | Class I | Class I (32/32) | Pass |
| Bacterial Filtration Efficiency | ASTM F2101-19 | ≥95% | 99.9% (32/32) | Pass |
| Biocompatibility (Cytotoxicity) | ISO 10993-5:2009 | Non-Cytotoxic | Non-cytotoxic | Pass |
| Biocompatibility (Skin Irritation) | ISO 10993-10:2010 | Non-Irritating | Non-irritating | Pass |
| Biocompatibility (Skin Sensitization) | ISO 10993-10:2010 | Non-Sensitizing | Non-sensitizing | Pass |
2. Sample Size Used for the Test Set and Data Provenance
For the performance tests (Differential Pressure, Fluid Resistance, Particulate Filtration Efficiency, Flammability, Bacterial Filtration Efficiency), a sample size of 32 units was used for each test (indicated by "(32/32)").
The provenance of the data is non-clinical bench testing. The country of origin for the data is not explicitly stated, but the submission is from Wellpower Sporting Goods Co., Ltd. in China. The testing itself is explicitly described as "bench testing".
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the study did not involve human experts establishing ground truth. The acceptance criteria were based on established industry standards and test methods for medical surgical masks.
4. Adjudication Method for the Test Set
This information is not applicable. The study involved objective bench tests with predefined acceptance criteria. There was no need for adjudication as the results were quantitative measurements against a standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical data was not needed to demonstrate that the subject mask is substantially equivalent to the predicate. Therefore, determination of substantial equivalence is not based on an assessment of clinical performance data."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable to this device. The device is a physical medical surgical mask, not an AI algorithm or software. The "standalone" performance here refers to the mask's inherent physical and biological characteristics when tested against established standards.
7. The Type of Ground Truth Used
The ground truth used for this study was based on established scientific and regulatory standards and test methods for medical surgical masks (e.g., EN, ASTM, ISO, CFR standards). These standards define the acceptable performance limits for the various properties of a surgical mask.
8. The Sample Size for the Training Set
This information is not applicable. This device is a physical product and not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there was no training set for an algorithm.
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