Search Results
Found 1 results
510(k) Data Aggregation
(269 days)
The HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) are single use, disposable device(s), provided non-sterile.
The subject devices are ASTM F2100 Level 1 (yellow in color) Procedure Masks. The ASTM F2100 Level 1 Procedure Mask family of products are a three-layer mask, constructed of well-known non-woven materials used in facial protection. The Procedure Masks are provided with earloops and a malleable nosepiece. The ASTM F2100 Level 1 Procedure Masks that are the subject of this submission are not provided with a fog-free foam or visor. These masks are single use, disposable devices, provided non-sterile.
The provided text describes a 510(k) premarket notification for two medical masks, HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867) and HALYARD* Level 1 Procedure Mask (48388). This document is a regulatory filing demonstrating "substantial equivalence" to a legally marketed predicate device, the Kimberly-Clark KC100 Face Masks (K110455).
The information provided does not pertain to an AI/ML-driven device or a comparative effectiveness study involving human readers with and without AI assistance. Instead, it details the performance characteristics and safety of physical medical masks based on standardized non-clinical tests. Therefore, many of the requested criteria regarding AI device studies cannot be answered from this document.
However, I can extract information related to the acceptance criteria and the non-clinical study performed for these masks.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
The document provides a "Technological Characteristics Comparison Table" and a "Summary of Non-Clinical Testing." These tables effectively outline the acceptance criteria (as defined by the predicate device's performance and relevant ASTM/ISO standards) and the results for the subject devices.
| Test / Characteristic | Acceptance Criteria (Predicate / Standard) | Reported Device Performance (Subject Device) |
|---|---|---|
| FDA Product Code | FXX | FXX |
| FDA Classification | Class II | Class II |
| Regulation Number | 21 CFR 878.4040 | 21 CFR 878.4040 |
| Common Name | Surgical Mask | Surgical Mask |
| Indications for Use | Protection from transfer of microorganisms, body fluids, and particulate material; infection control to reduce potential exposure to blood and body fluids. Single use, disposable, non-sterile. | Protection from transfer of microorganisms, body fluids, and particulate material; infection control to reduce potential exposure to blood and body fluids. Single use, disposable, non-sterile. |
| Over-the-Counter / Prescription | OTC | OTC |
| Number of Layers | 3 | 3 |
| Color | Yellow, blue, green, white, lavender | Yellow |
| Style | Pleated with earloops | Pleated with earloops |
| Outer Layer | Spunbond polypropylene | Spunbond polypropylene |
| Middle Layer | Meltblown polypropylene | Meltblown polypropylene |
| Inner Layer | Polyethylene/polyester | Subject 25867: Polyethylene/polyester; Subject 48388: Spunbond polypropylene |
| Bindings | Spunbond polypropylene or polyester spunlace | Subject 25867: Polyester spunlace; Subject 48388: Spunbond polypropylene |
| Earloop | Polyester/lycra | Polyester/lycra |
| Nose wire | Aluminum or polyethylene coated steel | Polyethylene coated steel |
| Mask Dimension Length | 6.875" ± 0.125" | 6.875" ± 0.125" |
| Mask Dimension Width (Flat) | 3.625" +/- 0.125" | 3.625" +/- 0.125" |
| ASTM F2100 Level | 1 | 1 |
| EN 14683 | Not explicitly stated for predicate in comparison table, but test result provided for subject. | Yes (Pass for breathability, < 5.0 mm H₂O/cm²) |
| Single Use | Yes | Yes |
| Sterility | Non-sterile | Non-sterile |
| Fluid Resistance (ASTM F1862) | 80 mmHg | 80 mmHg (Pass) |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 95% | ≥ 95% (Pass) |
| Differential pressure | < 5.0 mmH₂O/cm² | < 5.0 mmH₂O/cm² (Pass) |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 95% | ≥ 95% (Pass) |
| Flame Resistance (16 CFR 1610) | Class 1 | Class 1 (Pass) |
| ISO 10993-5 (Cytotoxicity) | Under conditions of testing, not cytotoxic | Under conditions of testing, not cytotoxic (Pass) |
| ISO 10993-10 (Sensitization) | Under conditions of testing, not a sensitizer | Under conditions of testing, not a sensitizer (Pass) |
| ISO 10993-10 (Irritation) | Under conditions of testing, not an irritant | Under conditions of testing, not an irritant (Pass) |
2. Sample size used for the test set and the data provenance:
The document refers to non-clinical tests (e.g., ASTM F2101, ASTM F1862). For these types of standardized tests, samples are drawn from production lots. The document does not specify the exact sample sizes used for each test. The data provenance is implied to be from the manufacturer's own testing as part of their regulatory submission, likely conducted in certified labs. There is no mention of country of origin of the data beyond the manufacturer's location (Mechanicsville, Virginia, USA). The studies are not retrospective or prospective in the sense of clinical imaging studies; they are laboratory-based performance and safety evaluations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable to this type of device and study. The "ground truth" for mask performance and safety is established by adherence to recognized international standards (e.g., ASTM, ISO, CFR), not by expert consensus on complex imaging data. The tests are objective measurements of physical and biological properties.
4. Adjudication method for the test set:
Not applicable. There is no subjective interpretation requiring adjudication. Results are based on objective pass/fail criteria defined by the standards.
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 is not an AI/ML-driven device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML-driven device.
7. The type of ground truth used:
The "ground truth" for the performance claims of these medical masks is established through adherence to recognized performance standards and regulations (e.g., ASTM F2101, ASTM F1862, 16 CFR 1610, ISO 10993 series). This involves objective measurements obtained in laboratory settings.
8. The sample size for the training set:
Not applicable. There is no AI/ML model for which a training set would be used.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set.
Ask a specific question about this device
Page 1 of 1