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510(k) Data Aggregation
(46 days)
When properly worn, the surgical face masks are intended to patient and healthcare workers from transfer of microorganisms, body fluids and particulate matter. This device is non-sterile and for single use only.
The Nordiwell Surgical Face Masks are composed of 3-layers and are flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, blue), inner layer (polypropylene spunbond white), filter (polypropylene melt-blown, white) and ties (polypropylene spunbond white). The mask contains a malleable nosepiece which is centrally positioned between the opposed side edges along the top edge of the mask. The nosepiece is a stable anchor in the vicinity of the nose and readily bent to conform to contours of a person's face. Thus the nosepiece can provide a firm fit over the nose and then to secure the mask over the users' mouth and face. The mask is a single use, provided non-sterile. This device is not made with natural rubber latex and Shelf-life of the device is 2 years. The subject of this submission is a design change to the ear-loop in the Nordiwell Medical Face Mask(K202615). The ear-loop of the Nordiwell Medical Face Mask(K202615) is changed to tie in the subject device.
This document describes the acceptance criteria and supporting study for the Nordiwell Surgical Face Mask (K210181), which is a surgical face mask.
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against the ASTM F2100 Level 3 standard for surgical face masks.
| Performance Characteristic | Acceptance Criteria (ASTM F2100 Level 3) | Reported Device Performance |
|---|---|---|
| Fluid Resistance | 160 mmHg | 32 of 32 pass at 160 mmHg |
| Particulate Filtration Efficiency (PFE) | ≥ 98% at 0.1 micron | > 99.9% |
| Bacterial Filtration Efficiency (BFE) | ≥ 98% | ≥ 98% |
| Differential Pressure (Delta P) | < 6.0 mmH2O/cm² | 5.6 mmH2O/cm² |
| Flammability | Class 1 | Class 1 |
| Biocompatibility: | ||
| - In Vitro Cytotoxicity | Non-cytotoxic | Non-Cytotoxic |
| - Skin Irritation | Non-irritating | Non-Irritating |
| - Skin Sensitization | Non-sensitizing | Non-Sensitizing |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each specific test, but it indicates "32 of 32 pass" for fluid resistance, implying a sample size of 32 for that particular test. The data provenance is implied to be from the manufacturer, Changzhou Combat Protective Equipment Co., Ltd., based in China, as per the contact information provided in the 510(k) summary. The studies are non-clinical (bench testing) and therefore not retrospective or prospective in the human study sense.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the studies are non-clinical bench tests comparing the device's physical properties against established industry standards (ASTM F2100). No human experts were used to establish ground truth in the context of clinical interpretation or diagnosis.
4. Adjudication Method for the Test Set
This information is not applicable as the studies are non-clinical bench tests for physical properties according to standardized methods. No human adjudication was involved.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was conducted. The device is a surgical face mask, and performance is evaluated through bench testing against established standards, not through reader studies.
6. Standalone Performance Study
Yes, a standalone study was done. The document explicitly states: "Bench testing was conducted to demonstrate the performance of the subject device." The results of these bench tests are presented against the ASTM F2100 Level 3 criteria, indicating the algorithm's (device's) standalone performance for various physical and filtration properties.
7. Type of Ground Truth Used
The ground truth used for evaluation is established industry standards (ASTM F2100 Level 3) for surgical face mask performance and international standards for biocompatibility (ISO 10993 series). These are objective, quantifiable criteria.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical product (surgical face mask), not an AI algorithm or a device requiring a training set in that context. The "training set" concept is irrelevant to a physical product's performance validation against standards.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the reasons stated in point 8.
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