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510(k) Data Aggregation
(94 days)
The medical surgical mask are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The medical surgical mask is pleated three-layer mask with ear loops and nose piece. The inner and outer layers are made of spun-bond non-woven fabric. The middle layer is made of melt blown non-woven fabric. only the outer layers' color is blue (colorant: Pigment Blue 15:3 /CAS number: 147-14-8), which is held to cover the users' mouth and nose by two spandex elastic bands ultrasonic welded to the medical surgical mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the medical surgical mask is in the middle layer of medical surgical mask to allow the user to fit the medical surgical mask around their noses, which is made of malleable aluminum wire coated with plastic materials. The dimensions of each medical surgical mask are length 175±5 mm and width 95±5 mm, The dimensions of nose piece is length 110±20 mm, and the ear loop is length 165±10 mm. The medical surgical mask are sold non-sterile and are intended to be single use, disposable devices.
The document provided pertains to a 510(k) premarket notification for a Medical Surgical Mask. It demonstrates substantial equivalence to a predicate device based on non-clinical performance testing. The device is a "Medical Surgical Mask" (K212867) from Nanchang Kanghua Health Materials Co., Ltd. and its predicate device is "Disposable Surgical Face Mask" (K153496) from Xiantao Rayxin Medical Products Co., Ltd.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Purpose | Acceptance Criteria (Level 2) | Reported Device Performance (Level 2) | Comparison |
|---|---|---|---|---|
| Bacterial Filtration Efficiency (BFE) ASTM F2101-19 | Evaluate BFE | BFE ≥ 98% | Lot A: 99.9%, Lot B: 99.875%, Lot C: 99.9% (3 non-consecutive lots, 32 samples/lot) | Meets/Exceeds Acceptance Criteria |
| Differential Pressure (Delta-P) EN 14683:2019, Annex C | Evaluate Differential pressure | Delta P < 6.0 H₂O/cm² | Lot A: 3.4 mm H₂O/cm², Lot B: 3.4 mm H₂O/cm², Lot C: 3.4 mm H₂O/cm² (3 non-consecutive lots, 32 samples/lot) | Meets/Exceeds Acceptance Criteria (Lower pressure is better for breathability) |
| Sub-micron particulate filtration efficiency at 0.1 micron ASTM F2299 | Evaluate sub-micron particulate filtration efficiency | PFE ≥ 98% | Lot A: 98.55%, Lot B: 98.63%, Lot C: 98.53% (3 non-consecutive lots, 32 samples/lot) | Meets/Exceeds Acceptance Criteria |
| Resistance to penetration by synthetic blood ASTM F1862 | Evaluate resistance to penetration by synthetic blood | 29 out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg (3 non-consecutive lots tested) | Meets/Exceeds Acceptance Criteria |
| Flammability (Flame spread) 16 CFR Part 1610 | Evaluate flammability | Class 1: Burn time ≥ 3.5 seconds | Class 1 (3 non-consecutive lots, 32 samples/lot) | Meets Acceptance Criteria |
| Biocompatibility (ISO 10993-5, ISO 10993-10) | Evaluate cytotoxicity, sensitization, and irritation | Non-cytotoxic, non-sensitizing, non-irritating | Device is non-cytotoxic, non-sensitizing, and non-irritating (Under the conditions of the studies employed) | Meets Acceptance Criteria; the predicate device also meets these criteria, indicating similar biocompatibility. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: For the performance tests (BFE, Delta-P, PFE, Flammability), the tests were conducted on 3 non-consecutive lots, using a sample size of 32 per lot. For the synthetic blood penetration test, it was 3 non-consecutive lots tested, with the outcome reported as 32 out of 32 passing at 120mmHg, implying 32 samples per lot were used or observed.
- Data Provenance: Not explicitly stated regarding the country of origin of the data, but the manufacturer is Nanchang Kanghua Health Materials Co., Ltd. in China, so it's highly probable the testing was conducted in China or by a contracted lab that sent the data to the manufacturer. The tests are prospective as they were conducted on the subject device to fulfill regulatory requirements for its 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This document describes non-clinical performance testing of a medical surgical mask. The "ground truth" for such tests is established by standardized laboratory test methods (e.g., ASTM, EN, CFR standards), not by human experts interpreting results. Therefore, no "experts establishing ground truth" in the diagnostic sense are involved. The results are quantitative measurements against predefined criteria.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, especially those involving human interpretation of medical images or symptoms, where discrepancies between initial readers might need to be resolved. This document details laboratory-based performance testing of a physical product.
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 a submission for a medical surgical mask, which is a physical product, not an AI-powered diagnostic device or software. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device (mask), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" here is determined by objective measurements obtained through standardized laboratory test methods (e.g., measuring filtration efficiency, differential pressure, resistance to synthetic blood, and flammability according to specified ASTM, EN, and CFR standards). For biocompatibility, it's based on the results of in vitro cytotoxicity, skin sensitization, and skin irritation tests following ISO standards.
8. The sample size for the training set
- Not applicable. This is not an AI or machine learning device; therefore, there is no "training set."
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of medical device.
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