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510(k) Data Aggregation
(116 days)
The Innonix Anti-Influenza Child's Face Mask (Models BF-200-3015A is a single use, disposable device that is intended to be worn by children (recommended ages 5-10) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms, body fluid and particulate materials. The mask is specifically for child or pediatic patients to provide protection for the respiratory tract. This face mask is recommended for use in a healthcare setting with appropriate adult supervision. The Influenza Child's Face Mask has hydrophilic plastic coating (active ingredient: citric acid 2%, a pH lowering agent) that rapidly absorbs away from the outer surface of the mask and a second inner layer treated with metal ions (active ingredients: copper 1.6%) that inactivate influenza viruses.
The Innonix Anti-Influenza Child's Face Masks, (both Model BF-200-3015A and BF-200-2005A) comprise four layers of material: an outer layer of spun bond polypropylene, a second layer of cellulose/polyester, a third layer of melt-blown polypropylene filter material and an inner (fourth) layer of spun-bond polypropylene. All of the construction materials used in this device are typical construction materials commonly used in surgical facemasks and being used in current legally marketed devices, and are not made with natural rubber latex. The outer active layer of the face mask is coated with a hydrophilic plastic containing citric acid. The second inner layer is treated with copper and zinc ions. Both of these layers inactivate influenza viruses using different mechanisms of action (pH lowering and ionic disruption).
Model: BF-200-3015A is flat-folded and expands into a convex-shaped mask with polyamide/spandex elastic ear-loops to secure the mask to the user's face, and has a malleable aluminum strip covered with polyurethane foam positioned above the nose for a tighter seal around the nose and face.
Model: BF-200-2005A is a flat pleated mask with polyamide/spandex elastic ear-loops to secure the mask to the user's face, and has a malleable aluminum strip covered with polyurethane foam positioned above the nose for a tighter seal around the nose and face.
This document is a 510(k) premarket notification for the Innonix Anti-Influenza Child's Face Mask, detailing its acceptance criteria and non-clinical studies.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ISO 10993-10 | Tests for irritation and skin sensitization | Not an irritant or sensitizer | Not an irritant or sensitizer |
| ISO 10993-18 | Chemical characterization of materials | All extracted chemicals had margin of safety > 1 | All extracted chemicals had margin of safety > 1 |
| ASTM F2101 | Bacterial Filtration Efficiency | >99% | 99.5% |
| ASTM F2299 | Sub-micron Particulate Filtration Efficiency | >99% | >99.5% |
| ASTM F1862 | Fluid Penetration Resistance | Fluid Resistant (>80 mm Hg) | Fluid Resistant (160 mm Hg) |
| MIL-M-3654C | Breathing Resistance | <2.6 mm H2O/cm² | 2.5 mm H2O/cm² |
| 16 CFR 1610 | Flammability Testing | Pass - Class 1 | Pass - Class 1 |
| EN71-1 | Safety of Toys. Mechanical and Physical Properties | Pass | Pass |
| EN71-3 | Chemical Testing (Migration of Certain Elements) | Pass | Pass |
| CPSC-CH-E1002-08 | Total Lead Content Analysis | Pass | Pass |
| CPSC-CH-E1001-09.3 | Phthalate Analysis | Pass (DEHP, DBP, BBP, DINP, DnOP, and DnHP) | Pass (for all listed phthalates) |
| Viral Inactivation | (Influenza A & B, Measles, Coronavirus 229E) | ≥4 log reduction (99.99%) in specified timeframes | ≥4 log reduction (99.99%) |
| Viricidal Activity Maintenance | During simulated use (8 hours) | Maintain viricidal activity (≥4-logs vs untreated) | Maintained viricidal activity |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each non-clinical test conducted on the final device. The studies were non-clinical (laboratory-based) tests of the device's material properties and viral inactivation capabilities. The data provenance is laboratory (in vitro) testing, without specifying the country of origin. The data is prospective in the sense that controlled experiments were performed to evaluate the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for the non-clinical tests is established by standardized laboratory test methods and their defined acceptance criteria, not by expert consensus in clinical interpretation.
4. Adjudication Method for the Test Set
Not applicable. This device is evaluated through objective, quantitative non-clinical laboratory tests, not through human interpretation requiring adjudication.
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 device is a child's face mask, not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was conducted or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance tests were standalone in the sense that they evaluated the device's intrinsic properties and capabilities (e.g., filtration efficiency, fluid resistance, viral inactivation) without human intervention in its mechanism of action.
7. The Type of Ground Truth Used
The ground truth for the non-clinical tests is based on:
- Standardized Test Methods and Criteria: Established by recognized organizations such as ISO, ASTM, MIL, 16 CFR, EN, and CPSC. These standards define the expected performance metrics for safety and effectiveness.
- Quantitative Measurement: Laboratory measurements (e.g., percent filtration, pressure differentials, viral log reduction) provide objective ground truth.
- Comparative Efficacy: For viral inactivation, the "ground truth" for efficacy is expressed as a ≥4 log difference (99.99% inactivation) compared to identical untreated control mask textiles.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device requiring a training set. The mask is a physical medical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/ML device, there is no training set or corresponding ground truth establishment for such a set.
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