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510(k) Data Aggregation
(203 days)
The Disposable Medical Mask is 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 potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
The Disposable Medical Mask is flat pleated style mask, utilizing ear Loops way for wearing, and they all have nose piece design for fitting the Disposable Medical Mask around the nose. The Disposable Medical Mask is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, only the outer layers' color is blue (colorant: 29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper, CAS number: 147-14-8), and the middle layer is made of Melt blown polypropylene filter. Ear loops, which is held to cover the users' mouth and nose by two Spandex and nylon bands ultrasonic welded to the Disposable Medical Mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the Disposable Medical Mask is in the middle layer of Disposable Medical Mask to allow the user to fit the Medical surgical mask around their noses, which is made of polypropylene coated iron wire. The Medical surgical mask is sold non-sterile and is intended to be single use, disposable device. The dimensions of each Disposable Medical Mask is length 17.5cm±1cm and width 9.5cm±1cm. The dimensions of nosepiece is length 85±1 mm and width 3.0±0.5 mm, and the ear loop is length 180±10 mm and width 3.0±0.5 mm.
The provided text describes the 510(k) summary for a Disposable Medical Mask (Model: Rlp001) seeking substantial equivalence to a predicate device (3M™ High Fluid-Resistant Procedure Mask, K191355). The acceptance criteria are based on recognized performance standards for medical face masks.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Item (Performance Level 3) | Test Method | Acceptance Criteria | Reported Device Performance / Verdict |
|---|---|---|---|
| Bacterial filtration efficiency (BFE) | ASTM F2101-14 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus according to ASTM F2100:2019 | ≥ 98% | 32/32 Passed at ≥98% / Pass |
| Differential pressure (Delta-P) | EN 14683: 2019, Annex C Medical face masks - Requirements and test methods according to ASTM F2100:2019 | < 6.0 mm H2O/cm² | 32/32 Passed at < 6 mmH2O/cm² / Pass |
| Sub-micron particulate filtration efficiency at 0.1 µm of Polystyrene Latex Spheres | ASTM F2299-03 Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres according to ASTM F2100:2019 | ≥ 98% | 32/32 Passed at ≥98% / Pass |
| Resistance to penetration by synthetic blood | ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) | Fluid resistant claimed at 160 mm Hg | 32/32 Passed at 160 mmHg / Pass |
| Flame spread | according to ASTM F2100:2019 16 CFR Part 1610 Standard for the Flammability of Clothing according to ASTM F2100:2019 | Class 1 | 32/32 Passed ≥3 Seconds burn Time-Class 1 / Pass |
| Biocompatibility (Cytotoxicity) | ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity | Non-cytotoxic | Determined to be non-cytotoxic |
| Biocompatibility (Irritation) | ISO 10993-10:2010 Biological evaluation of medical devices— Part 10: Tests for irritation and skin sensitization | Non-irritating | Determined to be non-irritating |
| Biocompatibility (Sensitization) | ISO 10993-10:2010 Biological evaluation of medical devices— Part 10: Tests for irritation and skin sensitization | Non-sensitizing | Determined to be non-sensitizing |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
For performance tests (BFE, Delta-P, Particulate Filtration, Fluid Resistance, Flammability): The sample size appears to be 32 for most tests, with flammability having a sub-sample of 5 (for the predicate device only, the subject device shows 32).
For biocompatibility tests (Cytotoxicity, Irritation, Sensitization): The sample size is not explicitly stated as a number, but the results refer to "the subject device extract." These tests are typically in vitro or in vivo (animal) studies, not typically involving human data directly.
- Data Provenance: The document does not specify the country of origin of the test data or whether the studies were retrospective or prospective, but it's reasonable to assume the non-clinical tests were conducted in a laboratory setting, likely in China given the manufacturer's location.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable. The tests performed are non-clinical, laboratory-based performance and biocompatibility tests for a medical mask. Ground truth is established by adherence to recognized international standards (ASTM, EN, ISO) and the physical measurements of the device properties, not through expert consensus on medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. As these are non-clinical laboratory tests, there is no expert adjudication process like those used in clinical reader studies. The "verdict" is a direct outcome of the test measurements against predefined criteria.
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
This section is not applicable. The device is a Disposable Medical Mask, and the submission is a 510(k) for substantial equivalence based on non-clinical performance and biocompatibility. It is not an AI-assisted diagnostic or therapeutic device, and therefore, no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. The device is a Disposable Medical Mask. There is no algorithm or AI component involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on established international consensus standards (ASTM, EN, ISO) for the performance characteristics of medical face masks (e.g., filtration efficiency, differential pressure, fluid resistance, flammability) and biocompatibility. The pass/fail criteria are defined by these standards.
8. The sample size for the training set
This section is not applicable. This is a physical medical device (mask), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
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