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510(k) Data Aggregation
(333 days)
West Tec Procedure and Surgical facemasks are intended to be worn by healthcare workers to protect the user and patient against transfer of microorganisms, blood and body fluids, and airborne particulates. The WestTec Procedure and Surgical facemasks are single use, disposable devices provided non-sterile.
The WestTec Procedure and Surgical facemasks are identical with the exception that the Surgical Mask has a Comfort Band to keep the inner layer away from the user's mouth to provide space between the users face and the mask making it more comfortable to wear. Both facemasks are manufactured with three layers of nonwoven polypropylene materials. The facemasks are held in place over the user's mouth and nose by two elastic ear loops welded to each facemask. The elastic ear loops are not made with natural rubber latex. The facemasks have a malleable Nose Band contained in the layers of the facemask to allow the user to fit the facemask around their nose. The facemasks are sold non-sterile and are intended to be a single use, disposable device.
The document describes the acceptance criteria and study results for WestTec Procedure and Surgical facemasks, which are intended to be substantially equivalent to the predicate device, Jingzhou Haixin Green Cross Medical Products Co., Ltd Surgical Mask (K123787). The devices are classified as Class II surgical apparel under 21 CFR 878.4040.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the WestTec facemasks are based on the ASTM F2100 Standard Specification for Performance of Materials Used in Medical Face Masks for Level 2 performance classification.
| Description | ASTM F2100 Requirement for Level 2 Classification | WestTec Masks Performance | Predicate Device (K123787) Performance |
|---|---|---|---|
| Fluid Resistance Performance ASTM F1862 | 29 out of 32 pass at 120mmHg | 32 out of 32 pass at 120mmHg | 29 out of 32 pass at 120mmHg |
| Particulate Filtration Efficiency ASTM F2299 | ≥98% | 98.0% | 99.1% |
| Bacterial Filtration Efficiency ASTM F2101 | ≥98% | 99.7% | 99.8% |
| Differential Pressure (Delta P) MIL-M-36954C | <5.0 mmH2O/cm² | 3.3 – 3.6 mmH2O/cm² | 2.6 – 2.9 mmH2O/cm² |
| Flammability 16 CFR 1610 | Class 1 | Class 1 (Non Flammable) | Class 1 (Non Flammable) |
| Biocompatibility ISO 10993-5, -10 | Not explicitly defined in table but met | Biocompatible | Biocompatible |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test in the test set. However, for the Fluid Resistance Performance (ASTM F1862), the pass/fail criterion refers to "29 out of 32 pass," implying a sample size of 32 for this particular test. The document does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The study involves non-clinical bench testing according to established ASTM and ISO standards, not expert assessments of a test set for ground truth.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this study relies on objective measurements from standardized tests, not human adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was performed as this is a non-clinical device performance study, not an AI or diagnostic imaging study.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. This is a study of a physical medical device (facemask), not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this study is established by the performance requirements and methodologies outlined in recognized international and national standards (e.g., ASTM F2100, ASTM F1862, ASTM F2299, ASTM F2101, MIL-M-36945C, 16 CFR Part 1610, ISO 10993-5 & -10). Compliance with these standards indicates the device performs as expected.
8. Sample Size for the Training Set
Not applicable. This study does not involve a training set as it concerns the physical properties and performance of a medical device, not a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device performance study.
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