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510(k) Data Aggregation
(124 days)
The Surgical Mask (model: KH8001& KH8002) is intended to be worn to protect both the patient and healtheare personnel from transfer of microorganisms, body fluids and particulate material. These face intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
The proposed devices (model: KH8001& KH8002) are White color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all has Nose clips design for fitting the face mask around the nose.
The proposed devices are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of polyester fiber and spandex. The nose piece in the proposed devices is made of Galvanized wire with polypropylene and is contained within the layers of face mask to allow the user to fit the face mask around their nose. The proposed devices are sold non-sterile and are intended to be single use, disposable devices.
This document is a 510(k) premarket notification for a Surgical Mask (models KH8001 & KH8002). The submission aims to demonstrate substantial equivalence to a legally marketed predicate device. The information provided focuses on the physical and performance characteristics of the surgical mask, not an AI/ML powered medical device. Therefore, many of the requested fields related to AI/ML device studies are not applicable.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Characteristic | Acceptance Criteria (ASTM F2100-19 for Level 2 & 3) | Reported Device Performance (KH8001 & KH8002) |
|---|---|---|
| Bacterial Filtration Efficiency | ≥ 98% | Level 3: 99.8% Level 2: 99.9% |
| Particulate Filtration Efficiency | ≥ 98% | Level 3: 99.5% Level 2: 99.6% |
| Fluid Resistance | Level 3: 29 out of 32 pass at 160 mmHgLevel 2: 29 out of 32 pass at 120 mmHg | Level 3: 32 out of 32 passed at 160 mmHgLevel 2: 32 out of 32 passed at 120 mmHg |
| Differential Pressure (Delta P) | < 6.0 mmH2O/cm² | Level 3: 3.1 mmH2O/cm²Level 2: 3.3 mmH2O/cm² |
| Flammability (16 CFR 1610) | Class 1 | Met Class 1 |
| Biocompatibility (Cytotoxicity) | Non-Cytotoxic | Passed, Non-Cytotoxic |
| Biocompatibility (Irritation) | Non-Irritating | Passed, Non-Irritating |
| Biocompatibility (Sensitization) | Non-Sensitizing | Passed, Non-Sensitizing |
2. Sample size used for the test set and the data provenance:
- Sample Size for performance tests: 3 non-consecutive lots with 32 samples for each lot were used for the performance testing (e.g., Fluid Resistance, BFE, PFE, Differential Pressure).
- Data Provenance: The document does not explicitly state the country of origin for the testing itself, but the manufacturer is TIANCHANG KANGHUI PROTECTIVE PRODUCTS CO., LTD. in China. The study is part of a premarket notification, implying prospective testing for the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a hardware/material performance evaluation, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" is established by standardized test methodologies and their acceptance criteria.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. See point 3.
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-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the mask performance tests, the "ground truth" is based on standardized test methodologies and their defined acceptance criteria (e.g., ASTM F2101-19, ASTM F1862-17, 16 CFR 1610, ISO 10993 series). These standards define what constitutes a "pass" or "fail" for each performance characteristic.
8. The sample size for the training set:
- Not Applicable. This is not an AI-powered device, so there is no training set in the AI/ML context.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
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