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510(k) Data Aggregation
(62 days)
The Disposable 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 non-sterile.
The Disposable Surgical Face Mask is blue color, single use, that-folded masks with nose piece and ear loops or ties. The blue colorant is polypropylene (PP) master batch.
The body of the mask is composed of three layers: the inner and outer layers are made of polypropylene spun-bond nonwoven fabric, and the middle layer is made of polypropylene melt blown non-woven fabric. The nose clip is made of galvanized iron wire coated by polypropylene (PP), ear loop is made of Nylon and Spandex, and the ties are made of polypropylene spun-bond nonwoven fabric.
The size of surgical face masks is 17.5*9.5cm with tolerance±5%, the length of the ear loop is about 15.5cm to 16.5cm, and the length of the ties is 40 cm.
The disposable surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
The provided document is a 510(k) summary for a Disposable Surgical Face Mask. This type of medical device is generally subject to performance testing against established standards, rather than clinical studies requiring expert interpretation or AI/algorithm performance. Therefore, many of the requested elements (like MRMC studies, details on experts, ground truth for training sets, etc.) are not applicable to this specific device submission.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a non-powered, non-software-driven medical device (disposable surgical face mask). Its performance is evaluated against recognized industry standards for surgical masks.
| Test Methodology | Purpose | Acceptance Criteria (ASTM F2100 Level 3) | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | To assess resistance to penetration by synthetic blood. | 29 out of 32 pass at 160 mmHg for level 3 | Pass: 32 out of 32 pass at 160 mmHg, 3 lots |
| Particulate Filtration Efficiency (ASTM F2299) | To demonstrate functionality and efficiency of materials in filtering particulates. | ≥ 98% | Pass: Average 99.1% |
| Bacterial Filtration Efficiency (ASTM F2101) | To demonstrate functionality and efficiency in filtering bacteria. | ≥ 98% | Pass: Average 99.5% |
| Differential Pressure (EN 14683 Annex C) | To measure breathability. | < 6.0 mmH2O/cm² | Pass: Average 3.4 mmH2O/cm² |
| Flammability (16 CFR 1610) | To assess the flammability of the material. | Class 1 | Pass: Class 1 |
| Cytotoxicity (ISO 10993-5) | To demonstrate the safety of the subject device (biological evaluation). | Non-cytotoxic | Pass: Under the conditions of the study, the device is non-cytotoxic. |
| Irritation (ISO 10993-10) | To demonstrate the safety of the subject device (biological evaluation). | Non-irritating | Pass: Under the conditions of the study, the device is non-irritating. |
| Sensitization (ISO 10993-10) | To demonstrate the safety of the subject device (biological evaluation). | Non-sensitizing | Pass: Under the conditions of the study, the device is non-sensitizing. |
2. Sample Size Used for the Test Set and Data Provenance
- Fluid Resistance: 3 lots of devices were tested, with the acceptance criteria referencing "29 out of 32 passes", implying a sample size of at least 32 masks per test lot.
- Other Performance Tests (Particulate Filtration, Bacterial Filtration, Differential Pressure, Flammability): The specific sample sizes for these tests are not detailed beyond "Average 99.1%", "Average 99.5%", "Average 3.4mmH2O/cm²", and "Class 1", which usually indicates an average or singular result from a batch of samples tested according to the respective standards.
- Biocompatibility Tests (Cytotoxicity, Irritation, Sensitization): These tests are performed on extracts from the device material according to ISO 10993 standards. Specific sample sizes for the biological assays are not provided, but the conclusions ("non-cytotoxic," "non-irritating," "non-sensitizing") reflect the results from the required in-vitro or in-vivo tests.
Data Provenance: The tests were conducted as "Non-clinical tests" to verify that the proposed device met design specifications for the standards and test methods. The origin of the testing (e.g., country of actual lab) is not specified, but the applicant (FOMED INDUSTRIES INC.) is based in China. These are prospective tests performed specifically for device clearance.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. The device is a surgical mask, and its performance is evaluated through standardized laboratory tests, not by human experts establishing a diagnostic ground truth.
4. Adjudication Method for the Test Set
Not applicable. Performance is determined by objective physical and biological test results against defined numerical and qualitative criteria in recognized standards, not by expert consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. No MRMC study was done as the device is not an AI-assisted diagnostic or triaging tool.
6. Standalone (Algorithm Only) Performance
Not applicable. The device is a physical product (face mask), not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" for this device is based on established industry standards and test methodologies for medical face masks and biocompatibility, such as ASTM F2100, F1862, F2299, F2101, EN 14683, 16 CFR 1610, and ISO 10993. These standards define the acceptable performance limits for each characteristic.
8. Sample Size for the Training Set
Not applicable. This is a physical non-software medical device, so there is no "training set" in the context of machine learning or algorithms. The manufacturing process is subject to quality control, but this is distinct from training data for an algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an algorithm, this question is not relevant. The device manufacturer adheres to Good Manufacturing Practices (GMP) and ISO 13485 standards for quality management during production, ensuring consistency with the tested samples.
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