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510(k) Data Aggregation
(116 days)
The Surgical Face Masks 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 to blood and body fluids. This is a single use, disposable device(s), provided sterile.
The Surgical Face Masks are single use, three-layer, flat –folded masks with ear loops and nose clamp. The Surgical Face Masks 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 ear loops are held in place over the users' mouth and nose by two ear loops welded to the facemask. The loops are made of Nylon and spandex. The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of Polypropylene. The Surgical Face Masks will be provided in blue. The Surgical Face Masks are sold sterilized and are intended to be single use, disposable devices.
The provided text describes the non-clinical performance testing for a surgical face mask (Trade Name: Surgical Face Mask, Model: Earloop17.5*9.5cm, K212264) to demonstrate its substantial equivalence to a predicate device (Kimberly-Clark KC100 Mask, K110455).
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against ASTM F2100-19 Level 2 acceptance criteria for medical face masks.
| Item | Acceptance Criteria (Level 2) | Result of LOT-WK20201006 | Result of LOT-WK20201204 | Result of LOT-WK20201208 |
|---|---|---|---|---|
| Synthetic Blood Penetration (ASTM F1862) | 29 out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg |
| Particulate Filtration Efficiency (ASTM F2299) | ≥98% | ≥99% | ≥99% | ≥99.9% |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥98% | ≥99% | ≥99% | ≥99.9% |
| Differential Pressure (Delta P) (EN 14683 Annex C, ASTM F2100-19) | <6.0 mmH2O/cm² | <6.0 mmH2O/cm² | <6.0 mmH2O/cm² | <6.0 mmH2O/cm² |
| Flammability (16 CFR 1610) | Class I | Class I | Class I | Class I |
Additionally, biocompatibility tests were conducted:
| Item | Acceptance Criteria | Result |
|---|---|---|
| Cytotoxicity | Non-Cytotoxic | No cytotoxic potential. |
| Irritation | Non-Irritating | The Primary Irritation Indexes for the test article extracts were both calculated to be 0.0 |
| Sensitization | Non-Sensitizing | Not considered a sensitizer |
2. Sample Size and Data Provenance
- Sample Sized used for the test set:
- For Bacterial Filtration Efficiency (BFE), Particulate Filtration Efficiency (PFE), and Differential Pressure (Delta P): AQL 4% (exact number not specified, but this refers to Acceptable Quality Level sampling plans).
- For Synthetic Blood: 32 masks (Pass = ≥ 29 passing, Fail = ≤ 2 passing).
- For Flammability: All samples (number not specified, but the criteria states 3.5 seconds or more burn time is acceptable).
- For Biocompatibility: Not specified, but standard tests were performed (Cytotoxicity, Irritation, Sensitization).
- Data Provenance: The device manufacturer, Nantong Taiweishi Medical Technology Co., Ltd., is located in Nantong City, Jiangsu Province, China. The tests are non-clinical lab tests, not human data. The nature of these tests suggests they were conducted prospectively as part of the device development and submission process.
3. Number of Experts and Qualifications for Ground Truth
This submission pertains to a surgical face mask, which relies on standardized physical and biological performance tests rather than expert interpretation of medical images or clinical outcomes. Therefore, there are no medical experts (e.g., radiologists) involved in establishing ground truth in the traditional sense of medical imaging AI. The "ground truth" is defined by the established ASTM and EN standards and their specific test methodologies.
4. Adjudication Method for the Test Set
Not applicable. The tests are laboratory-based, quantitative, and standardized. There is no human adjudication process involved in these performance tests.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a physical device (surgical face mask), not an AI-assisted diagnostic tool. Therefore, no MRMC study was performed or is relevant.
6. Standalone Performance (Algorithm Only)
Not applicable. This is a physical device, not an algorithm. The performance data presented is the "standalone" performance of the manufactured mask under the specified test conditions.
7. Type of Ground Truth Used
The ground truth is based on established industry standards and test methodologies for medical face masks, specifically:
- ASTM F2100 (Standard Specification for Performance of Materials Used in Medical Face Masks)
- ASTM F1862 (Resistance to Penetration by Synthetic Blood)
- EN 14683 (Medical Face Masks-Requirements and Test Methods)
- ASTM F2101 (Bacterial Filtration Efficiency)
- ASTM F2299 (Particulate Filtration Efficiency)
- 16 CFR 1610 (Flammability)
- ISO 10993 series for Biocompatibility (Cytotoxicity, Irritation, Sensitization)
8. Sample Size for the Training Set
Not applicable. This is a physical device requiring manufacturing and quality control, not an AI model requiring a "training set" in the machine learning sense. The tests are for product performance verification.
9. How the Ground Truth for the Training Set Was Established
Not applicable (as above). The "ground truth" for the performance of the manufactured masks is established through the adherence to and results from the specified standard tests.
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