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510(k) Data Aggregation
(553 days)
The Kangbeier Child Surgical Mask is intended to be worn by the patient (ages 5-10) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms and particulate materials. The Kangbeier Child Surgical Mask is a single use, disposable device, provided non-sterile. This Face Mask is recommended for use in a healthcare setting with appropriate adult supervision.
The Kangbeier Child Surgical Mask is composed of three layers of materials and pleated to form the mask. The inner layer is composed of spun-bond nonwoven polypropylene, the middle layer is meltblown polypropylene filter material, and the outer layer is spunbond nonwoven polypropylenen. The color on the outer layer is consists of Phthalocyanine Blue and PE wax and PP. Masks are held in place on wearer with elastic spun-bond polypropylene earloop and contain a malleable aluminum nosepiece strip.
The Kangbeier Child Surgical Mask is appropriately sized to the smaller faces of children across a diverse population.
The Kangbeier Child Surgical Mask is a single use, disposable device, provided nonsterile with no shelf-life. Storage conditions will not affect device safety of effectiveness. All of the materials used in this device are typical materials commonly used in the construction of Surgical Masks and are being used in current legally marketed devices.
The provided text is a 510(k) Summary for the Kangbeier Child Surgical Mask. It demonstrates the device's substantial equivalence to a predicate device, K160100, "Prestige Ameritech Pediatric/Child's Face Mask."
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Predicate Device Performance | Subject Device Performance | Comparison Summary |
|---|---|---|---|
| Particulate Filtration Efficiency at 0.1 microns | ≥98% | ≥98% | Same |
| Bacterial Filtration Efficiency (BFE) | 96.32% | ≥98% | Similar (Subject Device better) |
| Differential Pressure (Delta P, mm H2O/cm²) | <6.0 | <6.0 | Same |
| Flammability Class (16 CFR Part 1610) | Class I | Class I | Same |
| Resistance to penetration by synthetic blood (minimum pressure in mmHg for pass result) | ≥ 160 mmHg | ≥ 160 mmHg | Same |
| Biocompatibility (ISO 10993-1, ISO 10993-5, ISO 10993-10) | Conforming | Conforming | Same |
| Intended Use | Child (recommended ages 4-12) to provide protection for the respiratory tract. Single use, disposable, non-sterile. Healthcare setting with appropriate adult supervision. | Child (ages 5-10) to cover nose and mouth as a barrier for microorganisms and particulate materials. Single use, disposable, non-sterile. Healthcare setting with appropriate adult supervision. | Similar (Age range of Subject Device is smaller) |
| Suitable Population | Child (ages 4-12) | Child (ages 5-10) | Similar (Age range of Subject Device is smaller) |
| Intended Use Sites | Healthcare setting | Healthcare setting | Same |
| Product Code, Device Class, and Regulation | OXZ, Class II, 21 CFR 878.4040 | OXZ, Class II, 21 CFR 878.4040 | Same |
| Mask Construction and Technological Features | Ultrasonic bonding, three layers (nonwoven and meltblown polypropylene), decorative patterns, knitted polyester/spandex elastic earloop, malleable aluminum nosepiece. | Three layers (spun-bond nonwoven polypropylene, meltblown polypropylene, spun-bond nonwoven polypropylene), phthalocyanine blue, PE wax, PP color on outer layer, elastic spun-bond polypropylene earloop, malleable aluminum nosepiece. | Same (described materials are typical for surgical masks and similar in function) |
| Performance Standards Met | ASTM F2100, ASTM F1862, ASTM F2299, ASTM F2101, 16 CFR Part 1610, Mil M36954 C, CPSC-CH-E1002-08, CPSC-CH-E1001-09, EN71-3 | ASTM F2100, ASTM F1862, ASTM F2299, ASTM F2101, 16 CFR Part 1610, EN 14683:2019, CPSC-CH-E1002-08, CPSC-CH-E1001-09, EN71-3 | Same (with EN 14683:2019 being specific to the subject device and Mil M36954 C specific to the predicate, but overall performance standards are comparable) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each performance test. It only mentions that the device "has been tested under the following standards." The provenance of the data (country of origin, retrospective or prospective) is also not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The tests performed are primarily laboratory-based physical and biological performance tests, not human-reader-based assessments requiring expert ground truth establishment in the traditional sense.
4. Adjudication Method for the Test Set:
Not applicable. The tests are scientific measurements against established standards, not judgmental interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
Not applicable. This device is a physical surgical mask, not an AI-based diagnostic or assistive technology.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a physical surgical mask.
7. The Type of Ground Truth Used:
For the performance metrics, the "ground truth" is defined by the objective measurement criteria within the listed ASTM, EN, and CFR standards. For example:
- Particulate Filtration Efficiency: Measured electronically against documented particulate sizes.
- Bacterial Filtration Efficiency: Measured using a biological aerosol of Staphylococcus aureus.
- Differential Pressure: Measured as resistance to airflow.
- Flammability: Measured according to defined burn rate criteria.
- Resistance to Penetration by Synthetic Blood: Measured by resistance to a fluid challenge at specified pressure.
- Biocompatibility: In vitro cytotoxicity and irritation/sensitization tests as per ISO 10993 standards.
These are all objective, laboratory-derived measurements rather than expert consensus, pathology, or outcomes data in a clinical context.
8. The Sample Size for the Training Set:
Not applicable. This document describes a physical medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
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