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510(k) Data Aggregation
(337 days)
The TOPWIDE surgical face mask is intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The TOPWIDE surgical intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This device is non-sterile and for single use only.
The Topwide surgical face mask is with white color outer laver and white inner layer. Subject device is a Flat Pleated type mask, utilizing ear-loop way for wearing, and it has a nose piece design for fitting the facemask around the nose. The mask materials consist of an outer layer (polypropylene spunbond), inner laver (polypropylene spunbond), filter (polypropylene melt-blown) and ear-loops. The mask contains a malleable nosepiece to provide a firm fit over the nose and then to secure the mask over the users' mouth and face. The mask has Level II fluid resistance under ASTM F2100. The mask is a single use, provided non sterile. This product contains no components made with natural rubber latex.
The provided document is a 510(k) summary for a Topwide Surgical Face Mask (K210102). It details the device's characteristics and its equivalence to a predicate device, based on non-clinical performance testing.
It is crucial to understand that this document describes a surgical face mask, not an AI-powered medical device or software. Therefore, the questions related to AI-specific elements like "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone (algorithm only) performance," "number of experts used to establish ground truth," "adjudication method," and "training set details" are not applicable to this type of device and the information provided.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the physical performance testing of the mask against established ASTM and ISO standards for medical face masks.
Here's the breakdown of the acceptance criteria and performance based on the provided document:
1. Table of acceptance criteria and the reported device performance
| Test Methodology, Standard | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| ASTM F1862 | Resistance to penetration by synthetic blood | 120 mm Hg | 120 mm Hg (32 out of 32 pass) |
| ASTM F2299 | Particulate filtration efficiency (PFE) | $\ge$ 98% | $\ge$ 99.78% (>99% for predicate) |
| ASTM F2101 | Bacterial filtration efficiency (BFE) | $\ge$ 98% | $\ge$ 98% (Same as predicate: >99%) |
| 16 CFR 1610 | Flammability | Class 1 | Class 1 |
| ASTM F2100 | Differential Pressure (Delta-P) (Breathability) |
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